How does esomeprazole work to reduce stomach acid. What are the proper dosages and administration methods for esomeprazole. When should you take esomeprazole and for how long. What are the potential side effects and precautions associated with esomeprazole use.

Understanding Esomeprazole: A Powerful Acid Reducer

Esomeprazole is a medication widely used to lower stomach acid levels. It belongs to a class of drugs known as proton pump inhibitors (PPIs) and is effective in treating various gastrointestinal conditions. This article will provide a comprehensive overview of esomeprazole, its uses, dosage instructions, and important considerations for patients.

The Mechanism of Action: How Esomeprazole Reduces Stomach Acid

Esomeprazole works by inhibiting the proton pump in the stomach’s parietal cells. This pump is responsible for producing hydrochloric acid. By blocking this mechanism, esomeprazole significantly reduces the amount of acid produced in the stomach. This action helps alleviate symptoms associated with excess stomach acid and allows the esophagus and stomach lining to heal from acid-related damage.

Key Benefits of Esomeprazole

• Relieves heartburn and acid reflux symptoms
• Treats gastroesophageal reflux disease (GERD)
• Helps heal stomach ulcers
• Manages Zollinger-Ellison syndrome
• Prevents and treats NSAID-induced ulcers

Proper Dosage and Administration of Esomeprazole

Esomeprazole is available in various forms, including delayed-release capsules, tablets, and granules for suspension. The dosage and administration method depend on the specific condition being treated and whether the medication is prescription or over-the-counter.

Prescription Esomeprazole Dosage

For prescription esomeprazole, the typical dosage ranges from 20mg to 40mg per day. In some cases, such as for Zollinger-Ellison syndrome, doses may be as high as 80mg to 160mg daily. It’s crucial to follow your doctor’s instructions precisely.

Over-the-Counter Esomeprazole Dosage

Non-prescription esomeprazole is usually taken as a 14-day course, with one dose (typically 20mg) taken daily in the morning. This course can be repeated every 4 months if needed.

Administration Methods

1. Swallow capsules or tablets whole with water
2. For difficulty swallowing, dissolve tablets in water before drinking
3. Open capsules and mix contents with water if necessary
4. Use granules mixed with water for children under 12

Timing and Duration: When to Take Esomeprazole and for How Long

The timing of esomeprazole intake is crucial for its effectiveness. It’s generally recommended to take the medication at least one hour before a meal, preferably in the morning. For twice-daily dosing, take one dose in the morning and one in the evening.

The duration of treatment varies depending on the condition:

• Short-term use (2-4 weeks) for mild symptoms or as needed
• Longer-term use for chronic conditions like GERD
• Continuous use for Zollinger-Ellison syndrome

Always consult your healthcare provider about the appropriate duration for your specific situation.

Potential Side Effects and Precautions of Esomeprazole Use

While esomeprazole is generally well-tolerated, it’s important to be aware of potential side effects and take necessary precautions.

Common Side Effects

• Headache
• Nausea
• Diarrhea
• Abdominal pain
• Flatulence

Rare but Serious Side Effects

In rare cases, long-term use of esomeprazole may lead to more serious side effects, including:

• Increased risk of bone fractures
• Vitamin B12 deficiency
• Increased risk of certain infections
• Hypomagnesemia (low magnesium levels)

If you experience any unusual or severe symptoms while taking esomeprazole, contact your healthcare provider immediately.

Drug Interactions and Contraindications

Esomeprazole can interact with various medications, potentially altering their effectiveness or increasing the risk of side effects. It’s crucial to inform your doctor about all medications, supplements, and herbal products you’re taking.

Notable Drug Interactions

• Clopidogrel (reduced effectiveness)
• Diazepam (increased blood levels)
• Cilostazol (increased blood levels)
• Digoxin (increased blood levels)
• Certain HIV medications

Esomeprazole is contraindicated in patients with known hypersensitivity to proton pump inhibitors. Caution is advised in patients with liver disease, as dosage adjustments may be necessary.

Special Considerations for Specific Patient Groups

Certain patient groups may require special attention when using esomeprazole:

Pregnant and Breastfeeding Women

Limited data suggests esomeprazole is safe during pregnancy, but it should be used only if clearly needed. It’s excreted in breast milk, so caution is advised for breastfeeding mothers.

Elderly Patients

Older adults may be more sensitive to the effects of esomeprazole. Regular monitoring for potential side effects is recommended.

Children

Esomeprazole is approved for use in children aged 1 year and older for certain conditions. Dosage is typically based on weight.

Long-Term Use of Esomeprazole: Benefits and Risks

While esomeprazole can be highly effective in managing chronic acid-related conditions, long-term use requires careful consideration.

Benefits of Long-Term Use

• Effective management of chronic GERD
• Prevention of complications like Barrett’s esophagus
• Improved quality of life for patients with persistent symptoms

Potential Risks of Long-Term Use

• Increased risk of certain infections
• Potential for nutrient deficiencies
• Possible increased risk of kidney problems
• Rare risk of fundic gland polyps

Regular follow-ups with your healthcare provider are essential to monitor for any potential long-term effects and to assess the ongoing need for treatment.

Alternatives to Esomeprazole: Other Treatment Options

While esomeprazole is highly effective, there are alternative treatments for acid-related conditions:

Other Medications

• H2 blockers (e.g., ranitidine, famotidine)
• Antacids for quick symptom relief
• Prokinetics to improve stomach emptying

Lifestyle Modifications

Many patients find relief through lifestyle changes, including:

• Dietary modifications (avoiding trigger foods)
• Weight loss
• Elevating the head of the bed
• Avoiding late-night meals
• Stress management techniques

Discussing these options with your healthcare provider can help determine the most appropriate treatment approach for your individual needs.

Esomeprazole remains a cornerstone in the treatment of acid-related gastrointestinal disorders. Its effectiveness in reducing stomach acid production makes it a valuable tool for managing conditions like GERD, peptic ulcers, and Zollinger-Ellison syndrome. However, as with any medication, it’s crucial to use esomeprazole under proper medical guidance, considering both its benefits and potential risks. Regular follow-ups with your healthcare provider, adherence to prescribed dosages, and awareness of potential side effects are key to maximizing the benefits of esomeprazole while minimizing risks. Remember, while esomeprazole can provide significant relief, it’s often most effective when combined with appropriate lifestyle modifications and a comprehensive approach to gastrointestinal health.

Esomeprazole: medicine to lower stomach acid

It’s usual to take esomeprazole once a day, first thing in the morning. You can take it with or without food.

If you take esomeprazole twice a day, take one dose in the morning and one dose in the evening.

Swallow tablets whole with a drink of water. If you have problems swallowing tablets, you can put them in a glass of water. Stir until the tablets start to break up, then drink straight away.

If you have problems swallowing capsules, you can open up esomeprazole capsules and empty the contents into a glass. Mix with some water and drink straight away. Fill the glass with water again, and drink that as well to make sure there’s no medicine left at the bottom of the glass.

If your child is under 12 years old, their doctor may prescribe esomeprazole granules which come in sachets. Empty the granules into a glass and mix with some water, then encourage them to drink it straight away.

How much to take

Each tablet or capsule contains 20mg or 40mg. Each sachet contains 10mg.

The usual dose to treat:

• heartburn and acid reflux is 20mg a day
• gastro-oesophageal reflux disease is 20mg to 40mg a day
• stomach ulcers is 20mg a day
• Zollinger-Ellison syndrome is 80mg a day – this can increase to 160mg a day depending on how well it works for you

Doses are usually lower for children and people with liver problems.

Will my dose go up or down?

Sometimes your doctor will increase your dose if it isn’t working well enough.

Depending on the reason you take esomeprazole, you may take a higher dose to begin with, usually for a month or two. After this, your doctor may recommend that you take a lower dose.

How long will I take it for?

If you have bought the medicine yourself from a pharmacy or supermarket, tell your doctor if you feel no better after taking esomeprazole for 2 weeks. They may want to do tests to find out what’s causing your symptoms or change you to a different medicine.

If you take it on prescription, you may only take it for a few weeks or months, depending on your illness. Sometimes your doctor may advise you to take it for longer, even many years.

Your doctor may suggest taking esomeprazole only when you have symptoms. This means you won’t have to take it every day. Once you feel better, you can stop taking it – often after a few days or weeks. Taking esomeprazole this way isn’t suitable for everyone. Speak to your doctor about what’s best for you.

What if I forget to take it?

If you usually take it:

• once a day, take the missed dose as soon as you remember, unless it’s less than 12 hours until your next dose – in which case skip the missed dose.
• twice a day, take the missed dose as soon as you remember, unless it’s less than 4 hours until your next dose – in which case skip the missed dose.

Do not take a double dose to make up for a forgotten dose. If you often forget doses, it may help to set an alarm to remind you. You could also ask your pharmacist for advice on other ways to remember your medicine.

What if I take too much?

It is very unlikely that taking one or two extra doses by accident will cause any problems. However, check with your doctor if you have taken too much and have any of these symptoms:

• feeling sweaty
• a fast heartbeat
• feeling sleepy
• blurred vision
• feeling confused or agitated

Esomeprazole: MedlinePlus Drug Information

Prescription esomeprazole comes as a delayed-release (releases the medication in the intestine to prevent break-down of the medication by stomach acids) capsule to take by mouth or to open, mix with water, and give through a feeding tube, and as packets of delayed-release (releases the medication in the intestine to prevent break-down of the medication by stomach acids) granules for suspension (to be mixed with water) to take by mouth or give through a feeding tube. Nonprescription (over-the-counter) esomeprazole comes as a delayed-release capsule and tablet to take by mouth. Prescription esomeprazole is usually taken once a day at least 1 hour before a meal. When prescription esomeprazole is used to treat certain conditions in which the stomach makes too much acid, it is taken twice a day. The nonprescription delayed-release capsules and tablets are usually taken once a day in the morning at least 1 hour before eating for 14 days in a row. If needed, additional 14-day treatments may be repeated, not more often than once every 4 months.

Take esomeprazole at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take esomeprazole exactly as directed. Do not take more or less of it or take it more often than or for a longer period of time than prescribed by your doctor or stated on the package.

Swallow the capsules whole; do not split, chew, or crush them. If you cannot swallow the capsule, put 1 tablespoon of cool, soft applesauce in an empty bowl. Open one esomeprazole capsule and carefully sprinkle the pellets onto the applesauce. Mix the pellets with the applesauce and swallow the entire tablespoonful of the applesauce and pellet mixture immediately. Do not crush or chew the pellets in the applesauce. Do not save the pellets and applesauce for later use.

If you are taking the granules for oral suspension, you will need to mix it with water before use. If you are using the 2.5- or 5-mg packet, place 1 teaspoonful (5 mL) of water in a container. If you are using the 10-, 20-, or 40-mg packet, place 1 tablespoonful (15 mL) of water in a container. Add the contents of the powder packet and stir. Wait 2 to 3 minutes to allow the mixture to thicken, and stir the mixture again. Drink the entire mixture within 30 minutes. If any of the mixture is stuck to the container, pour more water into the container, stir and drink all the mixture immediately.

The granules and the contents of the prescription delayed-release capsules can both be given through a feeding tube. If you have a feeding tube, ask your doctor or pharmacist how you should take the medication. Follow those directions carefully.

Do not take nonprescription esomeprazole for immediate relief of heartburn symptoms. It may take 1 to 4 days for you to feel the full benefit of the medication. Call your doctor if your symptoms get worse or do not improve after 14 days or if your symptoms return sooner than 4 months after you finish your treatment. Do not take nonprescription esomeprazole for longer than 14 days or treat yourself with esomeprazole more often than once every 4 months without talking to your doctor.

Continue to take prescription esomeprazole, even if you feel well. Call your doctor if your symptoms worsen or do not improve during this time. Do not stop taking esomeprazole without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.

Nexium Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

See also Precautions section.

Headache or abdominal pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: symptoms of a low magnesium blood level (such as unusually fast/slow/irregular heartbeat, persistent muscle spasms, seizures), signs of lupus (such as rash on nose and cheeks, new or worsening joint pain).

This medication may rarely cause a severe intestinal condition due to a bacteria called C. difficile. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop: diarrhea that doesn’t stop, abdominal or stomach pain/cramping, fever, blood/mucus in your stool.

If you have these symptoms, do not use anti-diarrhea or opioid products because they may make symptoms worse.

Rarely, proton pump inhibitors (such as esomeprazole) have caused vitamin B-12 deficiency. The risk is increased if they are taken every day for a long time (3 years or longer). Tell your doctor right away if you develop symptoms of vitamin B-12 deficiency (such as unusual weakness, sore tongue, or numbness/tingling of the hands/feet).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, signs of kidney problems (such as change in the amount of urine).

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US –

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Common and Rare Side Effects for Nexium oral

COMMON side effects

If experienced, these tend to have a Severe expression i

Sorry, we have no data available. Please contact your doctor or pharmacist.

If experienced, these tend to have a Less Severe expression i

• constipation
• itching
• sensation of spinning or whirling
• dizziness
• headache
• nausea
• gas
• diarrhea
• reactions at the site of the injection
• intense abdominal pain

INFREQUENT side effects

If experienced, these tend to have a Severe expression i

• inflammation of the tissue lining the sinuses

If experienced, these tend to have a Less Severe expression i

• throat irritation
• dry mouth
• indigestion
• urinary tract infection
• difficulty sleeping
• vomiting
• anxious feelings

RARE side effects

If experienced, these tend to have a Severe expression i

• diarrhea from an infection with Clostridium difficile bacteria
• a herpes simplex infection
• stomach and intestinal infection caused by the fungus Candida
• a goiter
• a type of blood disorder with a decrease in all types of blood cells called pancytopenia
• anemia
• decreased blood platelets
• very low levels of granulocytes, a type of white blood cell
• agitation
• depression
• aggressive behavior
• blurred vision
• high blood pressure
• atrial fibrillation
• bronchospasm
• stomatitis, a condition with painful swelling and sores inside the mouth
• a type of stomach irritation called gastritis
• inflammation of the lining of the stomach and intestines
• liver failure
• inflammation of the liver called hepatitis
• gallstones
• a type of kidney inflammation called interstitial nephritis
• skin inflammation
• increased sensitivity of the skin to the sun
• erythema multiforme, a type of allergic skin reaction
• a skin disorder with blistering and peeling skin called toxic epidermal necrolysis
• a skin disorder with blistering and peeling skin called Stevens-Johnson syndrome
• subacute cutaneous lupus erythematosus
• hives
• systemic lupus erythematosus, an autoimmune disease
• joint pain
• muscle weakness
• muscle pain
• hallucinations
• abnormal liver function tests
• a broken bone
• a significant type of allergic reaction called anaphylaxis
• a type of allergic reaction called angioedema
• a yellowing of the eyes or skin from buildup of bilirubin called jaundice
• pancreatitis
• non-cancerous growths in the stomach called benign fundic gland polyposis
• a high alanine transaminase level
• a high aspartate transaminase level

If experienced, these tend to have a Less Severe expression i

• inadequate vitamin B12
• a common cold
• inflammation of the large intestine
• enlarged breasts
• hair loss
• backache
• drowsiness
• fever
• low energy
• flu-like symptoms
• excessive sweating
• pain
• chills
• taste impairment
• visible water retention
• fluid retention in the legs, feet, arms or hands
• puffy face from water retention
• temporary redness of face and neck
• decreased appetite
• weight gain
• weight loss
• increased hunger
• heart throbbing or pounding
• chest pain
• difficulty swallowing
• ineffective painful straining of stool or urine
• increased number of bowel movements
• an increased need to urinate often
• abdominal bloating
• generalized weakness
• a feeling of general discomfort called malaise

Esomeprazole (Oral Route) Description and Brand Names

Description and Brand Names

Drug information provided by: IBM Micromedex

US Brand Name

1. NexIUM

Descriptions

Esomeprazole is used to treat conditions where there is too much acid in the stomach. It is used to treat duodenal and gastric ulcers, erosive esophagitis, gastroesophageal reflux disease (GERD), and Zollinger-Ellison syndrome, a condition wherein the stomach produces too much acid. Esomeprazole is also used with antibiotics (eg, amoxicillin, clarithromycin) to treat ulcers that are caused by the H. pylori bacteria. This medicine is also used to prevent stomach ulcers and stomach irritation in patients taking NSAIDs (eg, aspirin, ibuprofen) for long periods of time.

Esomeprazole is a proton pump inhibitor (PPI). It works by decreasing the amount of acid that is produced by the stomach.

This medicine is available both over-the-counter (OTC) and with your doctor’s prescription.

This product is available in the following dosage forms:

• Capsule, Delayed Release
• Packet
• Tablet, Delayed Release

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Esomeprazole to reduce stomach acid – Emozul, Nexium

About esomeprazole

Acid is produced naturally in your stomach to help you digest food and to kill germs (bacteria). This acid is irritant so your body produces a natural mucous barrier which protects the lining of your stomach. In people who take painkillers called non-steroidal anti-inflammatory drugs (NSAIDs), this barrier can break down, allowing the acid to damage the stomach, causing inflammation, ulcers and other conditions. Other people can have a problem with the muscular band at the top of the stomach that keeps the stomach tightly closed. This may allow the acid to escape and irritate the oesophagus, causing heartburn. This is often referred to as ‘acid reflux’.

Proton pump inhibitors such as esomeprazole stop cells in the lining of the stomach from producing too much acid. This helps to prevent ulcers from forming, or assists the healing process where damage has already occurred. By decreasing the amount of acid, they can also help to reduce the symptoms of acid reflux disease, such as heartburn.

Esomeprazole is available on prescription and can be bought from pharmacies and other retail outlets for the relief of reflux symptoms.

Esomeprazole is also used as one part of a treatment to get rid of Helicobacter pylori, a bacterium found in the stomach, which can cause ulcers.

Before taking esomeprazole

Some medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken. For these reasons, before you start taking esomeprazole it is important that your doctor or pharmacist knows:

• If you are pregnant, trying for a baby or breastfeeding.
• If you have any problems with the way your liver works, or with the way your kidneys work.
• If you have any of the following symptoms: difficulty swallowing, loss of blood, weight loss, or if you are being sick (vomiting).
• If you have ever had an allergic reaction to a medicine.
• If you are taking any other medicines. This includes any medicines you are taking which are available to buy without a prescription, as well as herbal and complementary medicines.

How to take esomeprazole

• Before you start this treatment, read the manufacturer’s printed information leaflet from inside the pack. It will give you more information about esomeprazole and will provide you with a full list of the side-effects which you may experience from taking it.
• Take esomeprazole exactly as your doctor tells you to. There are different strengths of tablets and capsules available so your doctor will tell you which is right for you. It is common to take just one dose a day, although if you are taking it for either Helicobacter pylori eradication or for Zollinger-Ellison syndrome, you will be asked to take two doses a day. Your doctor will tell you which dose is right for you and the directions will also be on the label of the pack to remind you.
• It is important that you don’t chew esomeprazole before you swallow. The tablets, capsules and granules (in the sachets) are all manufactured with a special coating which must not be crushed. If you have difficulties swallowing, you can stir the tablets into a glass of water to make swallowing easier. The capsules likewise can be opened up and the contents mixed into water to make swallowing easier. If you make up your doses in this way, make sure that you drink the mixture within 30 minutes of making it. If you have been given sachets, pour the contents of each sachet into 15 ml of water. Stir the liquid and then leave it to thicken for a minute or so before stirring it again. Then swallow the liquid, rinse out the glass with a little more water, and then swallow this water too.
• You can take esomeprazole before or after food.
• If you forget to take a dose at your usual time, you can take it when you remember (unless it is nearly time for your next dose, in which case leave out the missed dose). Do not take two doses together to make up for a forgotten dose.

Getting the most from your treatment

• Try to keep your regular appointments with your doctor. This is so your progress can be checked. If you are taking esomeprazole on a long-term basis your doctor will want to review your treatment at least once a year to make sure it is still right for you.
• Some foods may make your symptoms worse. Foods and drinks that have been suspected of this include peppermint, tomatoes, chocolate, spicy foods, hot drinks, coffee, and alcoholic drinks. If it seems that a food is aggravating your symptoms, try avoiding it for a while to see if your symptoms improve. Also, try avoiding eating large meals, as these can make your symptoms worse too.
• If you are overweight, it puts extra pressure on your stomach and encourages the symptoms of acid reflux. Losing some weight and eating a healthy balanced diet may help you.
• Smoking increases the amount of acid produced by the stomach and may make your symptoms worse. If you are a smoker, speak with your doctor or pharmacist about how to quit.
• Recent studies suggest that there may be a slight increase in the risk of bone fractures when proton pump inhibitors like esomeprazole are taken for longer than a year. If this affects you, your doctor will check that you are taking enough vitamin D and calcium to reduce this risk.
• If you buy any medicines ‘over the counter’, always check with a pharmacist that they are safe to take alongside your other medicines.

Can esomeprazole cause problems?

Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains some of the most common ones associated with esomeprazole. You will find a full list in the manufacturer’s information leaflet supplied with your medicine. The unwanted effects often improve as your body adjusts to the new medicine, but speak with your doctor or pharmacist if any of the following continue or become troublesome.

Common esomeprazole side-effects (these affect fewer than 1 in 10 people)	What can I do if I experience this?
Headache	Drink plenty of water and ask a pharmacist to recommend a suitable painkiller. If the headaches continue, let your doctor know
Constipation	Try to eat a well-balanced diet and drink several glasses of water each day
Diarrhoea	Drink plenty of water to replace lost fluids
Feeling sick (nausea) or being sick (vomiting), stomach ache, wind	Stick to simple meals – avoid rich or spicy foods

Important: long-term use of esomeprazole (for at least three months) may lead to low levels of magnesium in your blood. Initial signs this might be happening include feeling tired, dizzy or confused and an irregular heartbeat (palpitations). Let your doctor know if you think this applies to you

If you experience any other symptoms which you think may be due to the medicine, speak with your doctor or pharmacist for further advice.

How to store esomeprazole

• Keep all medicines out of the reach and sight of children.
• Store in a cool, dry place, away from direct heat and light. 

Important information about all medicines

Esomeprazole 40 mg Gastro-resistant Tablets – XML Patient Information Leaflet (XPIL) – print friendly

Esomeprazole 20 mg gastro-resistant tablets

Esomeprazole 40 mg gastro-resistant tablets

esomeprazole

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Esomeprazole is and what it is used for

2. What you need to know before you take Esomeprazole

3. How to take Esomeprazole

4. Possible side effects

5. How to store Esomeprazole

6. Contents of the pack and other information

Esomeprazole contains a medicine called esomeprazole. This belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid that your stomach produces.

Esomeprazole is used to treat the following conditions:

Adults

• ‘Gastroesophageal reflux disease’ (GERD). This is where acid from the stomach escapes into the gullet (the tube which connects your throat to your stomach) causing pain, inflammation and heartburn.
• Ulcers in the stomach or upper part of the gut (intestine) that are infected with bacteria called ‘Helicobacter pylori’. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Esomeprazole can also be used to stop stomach ulcers or ulcers in the upper part of the gut (intestine) from forming if you are taking NSAIDs.
• Too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome).
• Prolonged treatment after prevention of rebleeding of ulcers with intravenous esomeprazole.

Adolescents aged 12 years and above

• ‘Gastroesophageal reflux disease’ (GERD). This is where acid from the stomach escapes into the gullet (the tube which connects your throat to your stomach) causing pain, inflammation and heartburn.
• Ulcers in the stomach or upper part of the gut (intestine) that are infected with bacteria called ‘Helicobacter pylori’. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

• If you are allergic to esomeprazole or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other proton pump inhibitor medicines (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).
• If you are taking a medicine containing nelfinavir (used to treat HIV infection).

Do not take Esomeprazole if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Esomeprazole.

Talk to your doctor or pharmacist before taking Esomeprazole:

• If you have severe liver problems.
• If you have severe kidney problems.
• If you have ever had a skin reaction after treatment with a medicine similar to Esomeprazole that reduces stomach acid.
• If you are due to have a specific blood test (Chromogranin A).

Esomeprazole may hide the symptoms of other diseases. Therefore, if any of the following happen to you before you start taking Esomeprazole or while you are taking it, talk to your doctor straight away:

• You lose a lot of weight for no reason and have problems swallowing.
• You get stomach pain or indigestion.
• You begin to vomit food or blood.
• You pass black stools (blood-stained faeces).

If you have been prescribed Esomeprazole “on demand” you should contact your doctor if your symptoms continue or change in character.

Taking a proton pump inhibitor like Esomeprazole, especially over a period of more than one year, may slightly increase your risk of fracture in the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

If you get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment with Esomeprazole. Remember to also mention any other ill-effects like pain in your joints.

Information on dosing for children aged 1 to 11 years is provided in the product information of other dosage forms e.g. sachet (ask your doctor or pharmacist if you require further information).

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Esomeprazole can affect the way some medicines work and some medicines can have an effect on Esomeprazole.

Do not take Esomeprazole if you are taking a medicine containing nelfinavir (used to treat HIV infection).

Tell your doctor or pharmacist if you are taking any of the following medicines:

• Atazanavir (used to treat HIV infection).
• Clopidogrel (used to prevent blood clots).
• Ketoconazole, itraconazole or voriconazole (used to treat infections caused by a fungus).
• Erlotinib (used to treat cancer).
• Citalopram, imipramine or clomipramine (used to treat depression).
• Diazepam (used to treat anxiety, relax muscles or in epilepsy).
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking Esomeprazole.
• Medicines that are used to thin your blood, such as warfarin. Your doctor may need to monitor you when you start or stop taking Esomeprazole.
• Cilostazol (used to treat intermittent claudication – a pain in your legs when you walk which is caused by an insufficient blood supply).
• Cisapride (used for indigestion and heartburn).
• Digoxin (used for heart problems).
• Methotrexate (a chemotherapy medicine used in high doses to treat cancer) – if you are taking a high dose of methotrexate, your doctor may temporarily stop your Esomeprazole treatment.
• Tacrolimus (organ transplantation).
• Rifampicin (used for treatment of tuberculosis).
• St. John’s wort (Hypericum perforatum) (used to treat depression).

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin as well as Esomeprazole to treat ulcers caused by Helicobacter pylori infection, it is very important that you tell your doctor about any other medicines you are taking.

You can take the tablets with food or on an empty stomach.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Your doctor will decide whether you can take Esomeprazole during this time.

It is not known if Esomeprazole passes into breast milk. Therefore, you should not take Esomeprazole if you are breast-feeding.

Esomeprazole is not likely to affect you being able to drive or use any tools or machines. However, side effects such as dizziness and blurred vision may uncommonly or rarely occur (see section 4). If affected, you should not drive or use machines.

If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicinal product.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• If you are taking this medicine for a long time, your doctor will want to monitor you (particularly if you are taking it for more than a year).
• If your doctor has told you to take this medicine as and when you need it, tell your doctor if your symptoms change.

• Your doctor will tell you how many tablets to take and how long to take them for. This will depend on your condition, how old you are and how well your liver works.
• The usual doses are given below.

To treat heartburn caused by gastroesophageal reflux disease (GERD):

• If your doctor has found that your food pipe (gullet) has been slightly damaged, the recommended dose is one Esomeprazole 40 mg tablet once a day for 4 weeks. Your doctor may tell you to take the same dose for a further 4 weeks if your gullet has not yet healed.
• The recommended dose once the gullet has healed is one Esomeprazole 20 mg tablet once a day.
• If your gullet has not been damaged, the recommended dose is one Esomeprazole 20 mg tablet each day. Once the condition has been controlled, your doctor may tell you to take your medicine as and when you need it, up to a maximum of one Esomeprazole 20 mg tablet each day.
• If you have severe liver problems, your doctor may give you a lower dose.

To treat ulcers caused by Helicobacter pylori infection and to stop them coming back

• The recommended dose is one Esomeprazole 20 mg tablet twice a day for one week.
• Your doctor will also tell you to take antibiotics for example amoxicillin and clarithromycin.

To treat stomach ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs)

• The recommended dose is one Esomeprazole 20 mg tablet once a day for 4 to 8 weeks.

To prevent stomach ulcers if you are taking NSAIDs (Non-Steroidal Anti-Inflammatory Drugs)

• The recommended dose is one Esomeprazole 20 mg tablet once a day.

To treat too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome)

• The recommended dose is Esomeprazole 40 mg twice a day.
• Your doctor will adjust the dose depending on your needs and will also decide how long you need to take the medicine for. The maximum dose is 80 mg twice a day.

Prolonged treatment after prevention of rebleeding of ulcers with intravenous esomeprazole

• The recommended dose is one Esomeprazole 40 mg tablet once a day for 4 weeks.

To treat heartburn caused by gastroesophageal reflux disease (GERD)

• If your doctor has found that your food pipe (gullet) has been slightly damaged, the recommended dose is one Esomeprazole 40 mg gastro-resistant tablet once a day for 4 weeks. Your doctor may tell you to take the same dose for a further 4 weeks if your gullet has not yet healed.
• The recommended dose once the gullet has healed is one Esomeprazole 20 mg gastro-resistant tablet once a day.
• If your gullet has not been damaged, the recommended dose is one Esomeprazole 20 mg gastro-resistant tablet each day.
• If you have severe liver problems, your doctor may give you a lower dose.

To treat ulcers caused by Helicobacter pylori infection and to stop them coming back

• The recommended dose is one Esomeprazole 20 mg gastro-resistant tablet twice a day for one week.
• Your doctor will also tell you to take antibiotics for example amoxicillin and clarithromycin.

• You can take the tablets at any time of the day.
• You can take the tablets with food or on an empty stomach.
• Swallow the tablets whole with a drink of water. Do not chew or crush the tablets. This is because the tablets contain coated pellets which stop the medicine from being broken down by the acid in your stomach. It is important not to damage the pellets.

• If you have trouble swallowing the tablets:
  
  • Put them into a glass of still (non-fizzy) water. Do not use any other liquids.
  • Stir until the tablets break up (the mixture will not be clear). Then drink the mixture straight away or within 30 minutes. Always stir the mixture just before drinking it.
  • To make sure that you have drunk all of the medicine, rinse the glass very well with half a glass of water and drink it. The solid pieces contain the medicine – do not chew or crush them.
• If you cannot swallow at all, the tablet can be mixed with some water and put into a syringe. It can then be given to you through a tube directly into your stomach (‘gastric tube’).

Esomeprazole gastro-resistant tablets are not recommended for children less than 12 years old.

Dose adjustment is not required in the elderly.

If you take more Esomeprazole than prescribed by your doctor, talk to your doctor or pharmacist straight away.

• If you forget to take a dose, take it as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

• Sudden wheezing, swelling of your lips, tongue and throat or body, rash, fainting or difficulties in swallowing (severe allergic reaction).
• Reddening of the skin with blisters or peeling. There may also be severe blisters and bleeding in the lips, eyes, mouth, nose and genitals. This could be ‘Stevens-Johnson syndrome’ or ‘toxic epidermal necrolysis’.
• Yellow skin, dark urine and tiredness which can be symptoms of liver problems.

These effects are rare and may affect up to 1 in 1,000 people.

Other side effects include:

Common (may affect up to 1 in 10 people)

• Headache.
• Effects on your stomach or gut: diarrhoea, stomach pain, constipation, wind (flatulence).
• Feeling sick (nausea) or being sick (vomiting).
• Benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people)

• Swelling of the feet and ankles.
• Disturbed sleep (insomnia).
• Dizziness, tingling feelings such as “pins and needles”, feeling sleepy.
• Spinning feeling (vertigo).
• Dry mouth.
• Changes in blood tests that check how the liver is working.
• Skin rash, lumpy rash (hives) and itchy skin.
• Fracture of the hip, wrist or spine (if Esomeprazole is used in high doses and over long duration).

Rare (may affect up to 1 in 1,000 people)

• Blood problems such as a reduced number of white cells or platelets. This can cause weakness, bruising or make infections more likely.
• Low levels of sodium in the blood. This may cause weakness, being sick (vomiting) and cramps.
• Feeling agitated, confused or depressed.
• Taste changes.
• Eyesight problems such as blurred vision.
• Suddenly feeling wheezy or short of breath (bronchospasm).
• An inflammation of the inside of the mouth.
• An infection called “thrush” which can affect the gut and is caused by a fungus.
• Liver problems, including jaundice which can cause yellow skin, dark urine, and tiredness.
• Hair loss (alopecia).
• Skin rash on exposure to sunshine.
• Joint pains (arthralgia) or muscle pains (myalgia).
• Generally feeling unwell and lacking energy.
• Increased sweating.

Very rare (may affect up to 1 in 10,000 people)

• Changes in blood count including agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, feeling or hearing things that are not there (hallucinations).
• Severe liver problems leading to liver failure and inflammation of the brain.
• Sudden onset of a severe rash or blistering or peeling skin. This may be associated with a high fever and joint pains (Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Severe kidney problems.
• Enlarged breasts in men.

Not known (frequency cannot be estimated from the available data)

• If you are on esomeprazole for more than three months it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness or increased heart rate. If you get any of these symptoms, please tell your doctor promptly. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.
• Inflammation in the gut (leading to diarrhoea).
• Rash, possibly with pain in the joints.

Esomeprazole may in very rare cases affect the white blood cells leading to immune deficiency. If you have an infection with symptoms such as fever with a severely reduced general condition or fever with symptoms of a local infection such as pain in the neck, throat or mouth or difficulties in urinating, you must consult your doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can be ruled out by a blood test. It is important for you to give information about your medication at this time.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is esomeprazole.

20mg: Each tablet contains 20 mg esomeprazole (as esomeprazole magnesium amorphous).

40mg: Each tablet contains 40 mg esomeprazole (as esomeprazole magnesium amorphous).

The other ingredients are:

Tablet core: Hydroxypropyl cellulose (E463), Crospovidone (Type A),

Tablet coating: Povidone (K30), Macrogol-400, Macrogol-4000, Macrogol 6000, Hypromellose phthalate (HP-55S), Hypromellose phthalate (HP-50), Diethylphthalate, Hydroxypropyl cellulose, Microcrystaline cellulose (PH 101), Microcrystaline cellulose (PH 112), Crosspovidone (TypeB), Sodium stearyl fumarate, Opadry 03B86651 Brown (HMPC 2910/Hypromellose 6cP, Titanium Dioxide(E171), Macrogol/PEG 400, Iron Oxide red (E172)), Sugar spheres (sucrose and maize starch), Talc (E553b)

Esomeprazole 20 mg gastro-resistant tablets are light brick red to brown coloured, oval, biconvex, film-coated tablets with ‘E5’ debossed on one side and plain on other side

Esomeprazole 40 mg gastro-resistant tablets are light brick red to brown coloured, oval, biconvex, film-coated tablets with ‘E6’ debossed on one side and plain on other side

Product is available in following pack sizes

20mg and 40mg:

• OPA-AI-PE-dessicant-HDPE/AI blister with 7, 14, 15, 28, 30, 56, 60, 90 and 100 tablets
• Polyamide-Al-PVC/Al cold form laminate blister 7, 14, 15, 28, 30, 56, 60, 90 and 100 tablets

Not all pack sizes may be marketed

Marketing Authorisation Holder

Ranbaxy (UK) Limited
5th floor, Hyde Park
Hayes 3
11 Millington Road
Hayes
UB3 4AZ
United Kingdom

Manufacturer

Sun Pharmaceutical Industries Europe B. V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

Terapia SA
124 Fabricii Street
400 632 Cluj Napoca
Romania

This medicinal product is authorised in the Member states of the EEA under the following names:

Belgium: Esomeprazole AB 20 mg / 40 mg, Maagsapresistente Tabletten

France: ESOMEPRAZOLE SUN 20mg/ 40mg, Comprimé Gastro-Résistant

Germany: ESOMEPRAZOL BASICS 20mg/ 40mg, Magensaftresistente Tabletten

Italy: Esomeprazolo Sun Pharmaceutical Industries (Europe) BV 20mg/ 40mg, Compresse Gastro-resistenti

Netherlands: Esomeprazol 20mg/ 40mg SUN, Maagsapresistente Tabletten

Sweden: Esomeprazole SUN 20mg/ 40mg, Enterotabletter

United Kingdom: Esomeprazole 20mg/ 40mg, Gastro-resistant Tablets

This leaflet was last revised in March 2021.

Memorial Sloan Kettering Cancer Center

This document, provided by Lexicomp ^® , contains all the information you need to know about the drug, including the indications, route of administration, side effects and when you should contact your healthcare provider.

Trade names: USA

Esomep-EZS [DSC]; GoodSense Esomeprazole [OTC]; NexIUM; NexIUM 24HR Clear Minis [OTC]; NexIUM 24HR [OTC]; NexIUM I.V.

Trade names: Canada

APO-Esomeprazole; MYL-Esomeprazole; MYLAN-Esomeprazole [DSC]; NexIUM; PMS-Esomeprazole DR; RAN-Esomeprazole; SANDOZ Esomeprazole; TEVA-Esomeprazole

What is this drug used for?

• Used to treat gastroesophageal reflux disease (GERD; acid reflux).
• It is used for the treatment and prevention of gastrointestinal ulcers caused by infection.
• It is used for the treatment and prevention of esophageal ulcers.
• Used to treat symptoms caused by excessive amounts of stomach acid in the body.
• It is used for the treatment and prevention of gastrointestinal ulcers while taking non-steroidal anti-inflammatory drugs (NSAIDs) in patients with a history of ulcers. Examples of NSAIDs include ibuprofen and naproxen.
• Used to treat heartburn.
• Used to reduce the risk of bleeding ulcers after a specific procedure (endoscopy).
• This medicinal product can be used for other indications. Consult your doctor.

What should I tell my doctor BEFORE taking this drug?

• If you are allergic to this drug, any of its ingredients, other drugs, foods or substances.Tell your doctor about your allergy and how it manifested itself.
• If you are taking any of these medicines: atazanavir, clopidogrel, nelfinavir, rifampin, rilpivirine, or St. John’s wort.
• If you have any of the following health problems: black or bloody stools; heartburn with dizziness, sweating, or dizziness; chest pain; shoulder pain with shortness of breath; pain that spreads to the arm, neck, or shoulders; dizziness; excessive sweating; vomiting of blood; difficulty or pain in swallowing food.

This list of drugs and diseases that may be adversely associated with this drug is not exhaustive.

Tell your doctor and pharmacist about all the medicines you take (both prescription and over-the-counter, natural products and vitamins) and your health problems. You need to make sure that this drug is safe for your medical condition and in combination with other drugs you are already taking.Do not start or stop taking any medication or change the dosage without your doctor’s approval.

What do I need to know or do while taking this drug?

• Tell all healthcare providers that you are taking this drug. These are doctors, nurses, pharmacists and dentists.
• Do not take this drug for longer than your doctor prescribed.
• This drug may interfere with some laboratory tests.Tell all healthcare providers and laboratory staff that you are taking this drug.
• In people with fragile bones (osteoporosis), this drug increases the chance of fractures of the hip, spine, and wrist. This likelihood may increase if you take the drug at high doses or for more than one year, or if you are over 50 years old.
• Be careful if you are at risk of developing a condition in which bones become fragile and soft (osteoporosis).These risks may include drinking alcoholic beverages, smoking, taking steroids, anticonvulsants, or having osteoporosis in a family member. Talk to your doctor about the risks of developing osteoporosis.
• In rare cases, people who have taken drugs like this have decreased magnesium levels for 3 months or more. In most cases, this effect developed after 1 year of treatment. If you take this drug for a long time or in combination with certain other drugs, you will need to have a blood test.
• Long-term treatment (for example, longer than 3 years) with drugs such as this, in rare cases, caused a decrease in the content of vitamin B-12. Please consult your doctor.
• Lupus and lupus that has worsened have been reported with this drug. If you have lupus, tell your doctor. Call your doctor right away if you have symptoms of lupus, such as a rash on your cheeks or other parts of your body, rapid sunburn, muscle or joint pain, chest pain or shortness of breath, or swelling in your arms or legs.
• Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding. The benefits and risks for you and your child will need to be discussed.

What side effects should I report to my doctor immediately?

WARNING. In rare cases, some people with this drug can have serious and sometimes deadly side effects. Call your doctor or get medical help right away if you have any of the following signs or symptoms, which may be associated with serious side effects:

All forms of issue:

• Signs of an allergic reaction such as rash, hives, itching, reddened and swollen skin with blistering or scaling, possibly associated with fever, wheezing or wheezing, tightness in the chest or throat, difficulty breathing, swallowing or speaking, unusual hoarseness, swelling in the mouth, face, lips, tongue, or throat.
• Signs of low magnesium, such as sudden changes in mood, muscle pain or weakness, muscle cramps or spasms, seizures, unsteadiness, lack of appetite, severe stomach upset or vomiting, or a feeling of disturbed heartbeat.
• Signs of kidney problems, including lack of urination, change in urine volume, blood in the urine, or rapid weight gain.
• Severe dizziness or fainting.
• Bone pain.
• Fever, chills, or sore throat.
• Shortness of breath.
• Significant weight loss.
• This drug may increase the risk of a severe form of diarrhea, diarrhea caused by the bacteria Clostridium difficile (C. diff.) [CDAD]. If you have abdominal pain or cramps or very thin, watery, or bloody stool, see your doctor right away. Do not try to treat diarrhea on your own without first consulting your doctor.
• Possible severe skin reaction (Stevens-Johnson syndrome / toxic epidermal necrolysis).This can lead to serious and permanent health problems and sometimes death. Get immediate medical attention if you experience symptoms such as redness, skin swelling with blistering or scaling (with or without a high fever), eye redness or irritation, or ulceration in the mouth, throat, nose, or eyes.

Injection:

• Injection site irritation.

What are some other side effects of this drug?

Any medicine can have side effects.However, many people have little or no side effects. Call your doctor or get medical help if these or any other side effects bother you or do not go away:

• Headache.
• Sleepiness.
• Abdominal pain or diarrhea.
• Constipation.
• Gas.
• Dry mouth.
• Nausea.

This list of potential side effects is not exhaustive.If you have any questions about side effects, please contact your doctor. Talk to your doctor about side effects.

You can report side effects to the National Health Office.

You can report side effects to the FDA at 1-800-332-1088. You can also report side effects at https://www.fda.gov/medwatch.

What is the best way to take this drug?

Use this drug as directed by your healthcare practitioner.Read all the information provided to you. Follow all instructions strictly.

Pills:

• The drug should be taken no later than 1 hour before meals with a full glass of water.
• Swallow whole. Do not chew, break, or crush.
• Continue taking this drug as directed by your doctor or other healthcare professional, even if you feel well.

Capsules:

• The drug should be taken no later than 1 hour before meals with a full glass of water.
• Swallow whole. Do not chew or crush.
• Continue taking this drug as directed by your doctor or other healthcare professional, even if you feel well.
• If you cannot swallow this drug whole, add the contents of the capsule to the applesauce. Then swallow the mixture straight away without chewing.
• When mixed with applesauce, the puree should not be warm. Do not sprinkle into other liquids or food.
• Patients with feeding tubes can take the drug in liquid form. Place the contents of the capsule in a 60 ml syringe and add 50 ml of water. Insert the plunger into the syringe and shake it for 15 seconds. Flush the feeding tube before and after taking this medicine.

Suspension powder:

• Take this medication 1 hour before meals.
• Dilute 2.5 mg or 5 mg granules in 1 teaspoon (5 ml) water and 10 mg, 20 mg or 40 kg granules in 1 tablespoon (15 ml) water; leave for a few minutes.Stir and drink.
• Add more water and drink the rest.
• Take your dose within 30 minutes of mixing the drug. Throw away any portions not used within 30 minutes of mixing.
• Continue taking this drug as directed by your doctor or other healthcare professional, even if you feel well.
• Patients with feeding tubes can prepare fluid. Empty the contents of the bag into a syringe with 1 teaspoon or 1 tablespoon (5 ml or 15 ml) of water.Insert plunger and shake. Wait a few minutes for the medicine to settle. After taking this drug, refill the syringe with water, shake it, and flush the feeding tube.

Injection:

• This drug is injected intravenously or intravenously continuously over a period of time.

What should I do if a dose of a drug is missed?

All oral preparations:

• Take the missed dose as soon as you can.
• If it is time for your next dose, do not take the missed dose and then return to your normal dose.
• Do not take 2 doses at the same time or an additional dose.

Injection:

• Call your doctor for further instructions.

How do I store and / or discard this drug?

All oral preparations:

• Store at room temperature in a dry place.Do not store in the bathroom.

Tablets and capsules:

• The lid must be tightly closed.

Injection:

• If you need to store this drug at home, ask your doctor, nurse, or pharmacist for information about how it is stored.

All forms of issue:

• Store all medicines in a safe place. Keep all medicines out of the reach of children and pets.
• Dispose of unused or expired drugs. Do not empty into toilet or drain unless directed to do so. If you have any questions about the disposal of your medicinal products, consult your pharmacist. Your area may have drug recycling programs.

General information on medicinal products

• If your health does not improve or even worsens, see your doctor.
• You should not give your medicine to anyone and take other people’s medicines.
• Some medicines may have different patient information sheets. If you have questions about this drug, talk with your doctor, nurse, pharmacist, or other healthcare professional.
• Some medicines may have different patient information sheets. Check with your pharmacist. If you have questions about this drug, talk with your doctor, nurse, pharmacist, or other healthcare professional.
• If you think there has been an overdose of a drug, call a Poison Control Center immediately or seek medical attention. Be prepared to tell or show which drug you took, how much and when it happened.

Use of information by consumer and limitation of liability

This information should not be used to make decisions about taking this or any other drug. Only the attending physician has the necessary knowledge and experience to make decisions about which drugs are suitable for a particular patient.This information does not guarantee that the drug is safe, effective, or approved for the treatment of any disease or specific patient. Here are only brief general information about this drug. It does NOT contain all available information on the possible use of the drug with instructions for use, warnings, precautions, information about interactions, side effects and risks that may be associated with this drug. This information should not be construed as a guide to treatment and does not replace the information provided to you by your healthcare professional.For complete information on the possible risks and benefits of taking this drug, consult your doctor. Use of this information is governed by the Lexicomp End User License Agreement available at https://www.wolterskluwer.com/en/solutions/lexicomp/about/eula.

Copyright

© UpToDate, Inc. and its affiliates and / or licensors, 2021. All rights reserved.

Act Esomeprazole – instructions for use, dosage, composition, analogs, side effects / Pillintrip

Usual Adult Dose for Gastroesophageal Reflux Disease:

Effect of Esomeprazole Magnesium:

-20 mg orally once a day for 4 weeks

Effect of Esomeprazole Strontium:

-24.65 mg orally once a day within 4-8 weeks.

Comment:

-If symptoms persist after 4 weeks, an additional 4 weeks may be considered.

GERD with erosive esophagitis:

Effect of Esomeprazole sodium:

intravenous injection -20 mg or 40 mg once a day, for at least 3 minutes, or intravenous infusion once a day, for at least 10-30 minutes

Comment: The safety and efficacy of intravenous esomeprazole sodium for injection over 10 days have not been demonstrated.

Application: Short-term treatment of heartburn and symptomatic gastroesophageal reflux disease, short-term treatment of GERD with erosive esophagitis, including as an alternative to oral therapy, if the oral route cannot be used

Usual adult dose for Erosive esophagus50002 9000

– Action of Esomeprazole magnesium: 20 to 40 mg orally once a day for 4-8 weeks

– Action of Esomeprazole Strontium: 24.65 to 49.3 mg orally once a day for 4-8 weeks

– An additional 4-8 week course of therapy may be considered in patients not cured after initial treatment.

Maintenance of healing:

-Effects of Esomeprazole Magnesium: 20 mg orally once a day

-Effects of Esomeprazole Strontium: 24.65 mg orally once a day

Comments:

-Effects of Esomeprazole sodium injections can be used in as an alternative to oral therapy if the oral route cannot be used.

-Maintain Healing: Controlled studies did not last more than six months.

Application: Short-term treatment for healing and symptomatic resolution of diagnosed erosive esophagitis, to maintain resolution of symptoms and healing of erosive esophagitis

Usual Adult Dose for Helicobacter pylori Infection:

Effect of Esomeprazole

Magnesium2 Therapy:

Magnesium2 Therapy:

-40 mg orally once a day for 10 days, along with amoxicillin 1000 mg and clarithromycin 500 mg orally twice a day for 10 days

Effect of Esomeprazole Strontium:

Triple therapy:

-49.3 mg orally once a day for 10 days, along with amoxicillin 1000 mg and clarithromycin 500 mg orally twice a day for 10 days

Comments:

– Susceptibility testing should be performed in patients who are not on therapy.

– If clarithromycin resistance has been demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted.

-Eradication of H. pylori has been shown to reduce the risk of recurrence of duodenal ulcer.

Uses: Triple therapy (Action of Esomeprazole plus amoxicillin and clarithromycin): Treatment of H. pylori infection and duodenal ulcer (active or past 5 years history) to eradicate H.pylori

Usual adult dose for gastric ulcer caused by NSAIDs:

Effect of Esomeprazole Magnesium:

20 mg to 40 mg orally once a day for 6 months

Effect of Esomeprazole Strontium:

-24 65 mg to 49.3 mg orally once a day for 6 months

Comment:

-Patients over 60 years of age and / or with a history of gastric ulcer are considered at risk of developing stomach ulcers.

-Controlled studies do not extend for more than 6 months

Application: Reducing the incidence of gastric ulcers associated with continuous NSAID therapy in patients at risk of developing gastric ulcers.

Usual Adult Dose for Zollinger-Ellison Syndrome:

Effect of Esomeprazole Magnesium:

-40 mg orally twice a day

Effect of Esomeprazole Strontium:

-49.3 mg orally

Comment: Doses up to 240 mg per day have been used.

Application: Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

Usual Adult Dose for Pathological Hypersecretory Conditions:

Effect of Esomeprazole Magnesium:

-40 mg orally twice a day

Effect of Esomeprazole Strontium:

-49.3 mg Oral

: Doses up to 240 mg per day have been used.

Application: Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

Usual Adult Dose for Prophylaxis of Duodenal Ulcer:

Effect of Esomeprazole Sodium:

– Initial dose: 80 mg intravenous infusion over 30 minutes

– Maintenance dose: 8 mg / h intravenous total 72 hours (includes an initial 30-minute dose plus 71.5 hours of continuous infusion)

Comments:

– Intravenous therapy is aimed exclusively at the acute initial treatment of bleeding gastric or duodenal ulcers and is not a complete treatment.

-Intravenous therapy should be accompanied by oral acid suppression therapy.

Application: Reducing the risk of rebleeding from gastric or duodenal ulcers after therapeutic endoscopy.

Usual Adult Dose for the Prevention of Peptic Ulcer:

Effect of Esomeprazole Sodium:

– Initial dose: 80 mg intravenous infusion over 30 minutes

– Maintenance dose: 8 mg / h intravenous continuous infusion for a total of 72 hours (includes an initial 30-minute dose plus 71.5 hours of continuous infusion)

Comments:

-Intravenous therapy is aimed exclusively at the acute initial treatment of bleeding gastric or duodenal ulcers and is not a complete treatment.

-Intravenous therapy should be accompanied by oral acid suppression therapy.

Application: Reducing the risk of rebleeding from gastric or duodenal ulcers after therapeutic endoscopy.

Usual Pediatric Dose for Gastroesophageal Reflux Disease:

Effects of Esomeprazole Magnesium:

Less than 1 year:

-No data

1-11 years:

-10 mg 8 weeks once daily

-Comment: Doses over 1 mg / kg / day have not been studied.

from 12 to 17 years:

-20 mg once a day for 4 weeks

Effect of Esomeprazole sodium:

GERD with erosive esophagitis:

Less than 1 month:

-Not recommended.

1 month to less than 1 year:

-0.5 mg / kg IV over 10-30 minutes

1 to 17 years:

-Less 55 kg: 10 mg IV over 10-30 minutes

-55 kg or more: 20 mg intravenously over 10-30 minutes

Effect of Esomeprazole Strontium: Not recommended.

Application: Short-term treatment of symptomatic GERD, short-term treatment of GERD with erosive esophagitis, including as an alternative to oral therapy if the oral route cannot be used

Usual Pediatric Dose for Erosive Esophagitis:

Effect of Magnetizome

:

Less than 1 year:

-No data

from 1 to 11 years:

-Less than 20 kg: 10 mg once a day for 8 weeks

-20 kg or more: 10 mg or 20 mg once a day for 8 weeks

from 12 to 17 years:

-20 or 40 mg once a day for 4-8 weeks

Comment: Doses over 1 mg / kg / day have not been studied.

Erosive esophagitis due to acid-mediated GERD:

Less than 1 month:

-No data

1 month to less than 1 year:

– 3 kg to 5 kg: 2.5 mg once a day

-From 5 kg to 7.5 kg: 5 mg once a day

-From 7.5 kg to 12 kg: 10 mg once a day

Duration of therapy: Up to 6 weeks

Comment: Doses over 1.33 mg / kg / day has not been studied.

1 year or older:

-No data

Application: Short-term treatment for healing and symptomatic resolution of diagnosed erosive esophagitis, short-term treatment for erosive esophagitis due to acid-mediated GERD in infants

Analgesic therapy on balancing cardiovascular and gastrointestinal risks

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Esomeprazole Magnesium Capsule in English – Item

instructions, application, analogues of the drug, composition, indications, contraindications, side effects in the reference book of medicines from UNIAN

Application of Ezolong

Ezolong – composition and release form of the drug

Ezolong: how to take the drug

Ezolong – contraindications, side effects

Ezolong’s analogs

Ezolong is a drug that is used to treat peptic ulcers and gastroesophageal reflux disease.

Application of Ezolong

Indications.

• Gastroesophageal reflux disease (GERD):
• – treatment of erosive reflux esophagitis;
• – long-term treatment to prevent relapse;
• – Symptomatic treatment of gastroesophageal reflux disease.
• In combination with antibacterial agents for the eradication of Helicobacter pylori:
• – treatment of duodenal ulcer associated with Helicobacter pylori;
• – Prevention of recurrence of peptic ulcers in patients with ulcers caused by Helicobacter pylori.
• Treatment and prevention of ulcers caused by long-term use of non-steroidal anti-inflammatory drugs (NSAIDs):
• – treatment of ulcers caused by NSAID therapy;
• – Prevention of gastric and duodenal ulcers in patients at risk of taking NSAIDs.
• Prevention of recurrent bleeding from gastric or duodenal ulcers after intravenous treatment with esomeprazole.
• Treatment of Zollinger-Ellison syndrome.

Application during pregnancy or lactation.

The drug should be prescribed with caution during pregnancy. Esomeprazole should not be used during breastfeeding.

Ezolong – composition and release form of the drug

Composition:

active substance: esomeprazole;

1 film-coated tablet contains esomeprazole magnesium trihydrate equivalent to esomeprazole 20 mg or 40 mg;

excipients: microcrystalline cellulose, sodium bicarbonate, anhydrous colloidal silicon dioxide, crospovidone, povidone (K-30), magnesium stearate, talc, mint flavor, shell (opadry white 58901 (Opadry White), yellow talc (E 172) – available in film-coated tablets, 20 mg each, iron oxide red (E 172) – available in film-coated tablets, 40 mg each.

Dosage form. Film-coated tablets.

Ezolong: how to take the drug

Method of administration and dosage.

The drug is administered orally to adults and children over 12 years of age. Take the tablets whole 1 hour before meals and drink plenty of water. Tablets should not be chewed or crushed. Usually, the duration of the course of treatment is determined by the doctor.

Children. The drug should be used in children aged 12 years and older.

Ezolong – contraindications, side effects

Contraindications.

Known hypersensitivity to esomeprazole, substituted benzimidazoles or other components of the drug. Simultaneous use with atazanavir, nelfinavir.

Adverse reactions.

• Blood and lymphatic system disorders: leukopenia, thrombocytopenia; agrunolocytosis, pancytopenia.
• From the immune system: hypersensitivity reactions, including fever, angioedema, anaphylactic reactions / shock.
• From the side of metabolism and nutrition: peripheral edema; hyponatremia; hypomagnesemia; severe hypomagnesemia can lead to hypocalcemia.
• Mental disorders: insomnia; agitation, depression, confusion; aggression, hallucinations.
• From the nervous system: often: headache; dizziness, weakness, paresthesia, drowsiness, taste disturbance.
• From the side of the organs of vision: blurred vision.
• From the side of hearing organs and labyrinth disorders: vertigo.
• From the respiratory system, chest and mediastinal organs: bronchospasm.
• From the digestive tract: abdominal pain, constipation, diarrhea, bloating, nausea, vomiting; dry mouth; stomatitis, candidiasis of the gastrointestinal tract; microscopic colitis.
• On the part of the hepatobiliary system: increase in rivnivpechin enzymes; hepatitis with or without jaundice; liver failure, encephalopathy in patients with liver disease.
• Skin and subcutaneous tissue disorders: dermatitis, pruritus, urticaria, rash; alopecia, photosensitivity; erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.
• Musculoskeletal and connective tissue disorders: fracture of the hip, wrist or spine, arthralgia, myalgia; muscle weakness.
• From the kidneys and urinary system: interstitial nephritis (in some patients – simultaneously with renal failure).
• From the reproductive system and mammary glands: gynecomastia.
• General disorders and disorders at the injection site: weakness, increased sweating.

Ezolong’s analogs

Source: State Register of Medicines of Ukraine. The instructions are published with abbreviations for information only. Before use, consult your doctor and read the instructions carefully. Self-medication can be harmful to your health.

Arpimed

How to take Diazepam

Always take this medication exactly as directed by your doctor. You should not take Diazepam for more than 4 weeks. If you have any doubts about taking the drug, then you should consult with your doctor or pharmacist.

Tablets are swallowed whole with a glass of water.

Dosage

Adults

• For anxiety or mental illness: 5mg-30mg every day in divided doses
• For insomnia: 5 mg-15 mg at night.
• For cerebral palsy or other spastic conditions: 5mg-60mg every day in divided doses
• For muscle spasm: 5mg-15mg every day in divided doses
• For epilepsy: 2 mg to 60 mg every day in divided doses.
• For relief of alcohol withdrawal symptoms: 5mg-20mg should be repeated after 2 to 4 hours if necessary.
• Before dental procedure: 5 mg at night before the procedure, 5 mg in the morning and 5 mg 2 hours before the procedure
• For premedication: 5 mg – 20 mg

Children

For cerebral spasticity to eliminate tension and irritability:

5 mg – 40 mg every day in divided doses.

If a doctor has prescribed Diazepam for your child before surgery, the usual dose is 2 mg-10 mg.

Elderly or sickly patients

If you are an elderly patient or a sick patient, then you are more sensitive to the effects of Diazepam, such as confusion, and your doctor should reduce the dose. The dose should not be more than half the adult dose.

If you have liver or kidney problems, you should also lower your dose.

If you took more Diazepam than you recommended

If you (or someone else) have taken many pills at the same time, or you suspect a child may have swallowed the pills, go to the nearest emergency room or tell your doctor immediately.

In case of overdose, you may feel awkward and uncoordinated, feeling drowsy or deep sleep, difficulty speaking, irregular or slow heartbeats, uncontrolled eye movements, muscle weakness or agitation.

Severe overdose can lead to the development of coma (lack of consciousness), impaired reflexes and difficulty breathing.

If you forget to take Diazepam

Do not take a double dose to make up for a missed appointment.

If you forget to take the next dose of the drug, take it as soon as you remember and continue taking the next dose as usual.

If you stop taking Diazepam

Do not stop taking the drug without consulting your doctor, because before you stop taking the drug, the dose should be gradually reduced until the drug is completely discontinued.

If you suddenly stop taking Diazepam, you may experience unpleasant side effects, including depression, nervousness, irritability, sweating or diarrhea. If you have taken a large dose, you may sometimes experience confusion, seizures, or unusual behavior.

• Treatment should be withdrawn gradually, as otherwise the symptoms for which you were treated may recur more intensely than before (recurrent insomnia and anxiety).The risk of all this increases with sudden discontinuation of the drug. You may also experience changes in mood, anxiety, restlessness, or changes in sleep patterns.

If you have any further questions on the use of this medicine, you should contact your doctor or pharmacist.

Possible side effects

Like all medicines, Diazepam can cause side effects, although not everybody gets them.

Call your doctor immediately if you notice any of these side effects or if you experience any side effects not listed in this leaflet:

Some side effects can be serious and require immediate medical attention:

Uncommon: may affect 1 to 10 out of 1,000 people

• Respiratory depression (very slow and / or shallow breathing)

Rare: may affect 1 to 10 in 10,000 people

• Respiratory arrest
• Loss of consciousness
• Jaundice (yellowing of the skin or the whites of the eyes)

Very rare: may affect 1 in 10,000 people

• anaphylactic reaction (acute allergic reaction) with symptoms such as sudden shortness of breath, swelling of the lips, tongue and throat or body, rash, fainting or difficulty swallowing .

Other side effects:

Very common: may affect 1 in 10 people

Frequent: may affect 1 to 10 out of 100 people

• Fatigue
• Withdrawal syndrome (see “If you stop taking Diazepam” for possible symptoms)
• Entanglement
• Lack of coordination of muscle movements (ataxia) and other movement disorders, tremor

Uncommon: may affect 1 to 10 out of 1,000 people

• Muscle weakness
• Memory Loss
• Concentration disorder
• Vestibular disorders
• Dizziness
• Headache
• Slurred speech
• Gastrointestinal disorders such as nausea, vomiting, constipation, diarrhea
• Increased salivation
• Allergic skin reactions in the form of itching, skin redness and edema and skin rash.

Rare: may affect 1 to 10 in 10,000 people

Psychic side effects such as agitation, agitation, anxiety, irritation, aggressiveness, memory loss, delusion, rage, psychosis, nightmares or hallucinations. A severe course can also acquire. These side effects are most likely in children or the elderly.

Please inform your doctor about this.

• Decreased alertness
• Depression
• Emotional Care
• Insomnia
• Heart problems such as slow heartbeats (bradycardia), heart failure, and heart rhythm interruption (cardiac arrest).
• Decreased blood pressure, fainting
• Increased secretion of mucus in the lungs
• Dry mouth
• Increased appetite
• Changes in the level of some liver enzymes, as detected by the results of liver tests
• Lack of urination, loss of control of the bladder sphincter (urinary incontinence)
• Breast enlargement in men
• Impotence, changes in sexual desire (libido)
• Disorders of the hematopoietic system (may appear sore throat, nosebleeds or infections)

Very rare: may affect 1 in 10,000 people

• Decreased leukocyte count (leukopenia)
• Increase in the level of certain enzymes in the blood (transaminase)

Unknown: frequency cannot be estimated from available data

• Blurred vision, double vision and involuntary eye movements (these side effects disappear after you stop taking diazepam).

Withdrawal Syndrome: See “If you stop taking Diazepam”.

Reporting side effects:

If you notice any side effects, tell your doctor, pharmacist or pharmacist about it, including any side effects not listed in this leaflet. You can also report the side effects of Arpimed LLC by going to the website www.arpimed.com and fill out the appropriate form “Report side effects or ineffectiveness of the drug” and to the Scientific Center for the Expertise of Drugs and Medical Technologies. Academician E. Gabrielyan by going to the website www.pharm.am in the section “Report side effects of the drug” and fill out the form “Card of messages about side effects of the drug”. Scientific center hotline: +37410237665; +37498773368.

How to store Diazepam

• The drug should be stored out of the reach of children, protected from moisture and light at a temperature of 15-25 ° C.
• Shelf life – 3 years. Do not use after the expiration date printed on the drug packaging. The expiry date refers to the last day of the specified month.

Do not empty the medicine into waste water or sewers. Ask your pharmacist how to dispose of a drug you no longer need. These measures are aimed at protecting the environment.

Contents of the box and additional information

One 5 mg diazepam tablet contains:
Active ingredient: diazepam 5 mg

Other components: microcrystalline cellulose, monohydrate lactose, ethyl cellulose, sodium starch glycolate, magnesium stearate

What Diazepam looks like and contents of the pack:

White, round, flat tablets with a score on one side and a bevel on both sides.

Packaging description

Cardboard package containing 24 tablets (1 blister of 24 tablets) together with an enclosed leaflet.