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Exforge side effects. Exforge HCT: Comprehensive Guide to Side Effects, Uses, and Warnings

What are the key components of Exforge HCT. How does Exforge HCT work to control high blood pressure. What are the potential side effects and warnings associated with Exforge HCT. When should you not take Exforge HCT. How should Exforge HCT be used effectively for hypertension management.

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Understanding Exforge HCT: A Powerful Combination for Hypertension Treatment

Exforge HCT is a prescription medication designed to control high blood pressure, also known as hypertension. This powerful drug combines three active ingredients: amlodipine besilate, valsartan, and hydrochlorothiazide. Each component plays a unique role in reducing blood pressure through different mechanisms, making Exforge HCT an effective option for patients whose hypertension is not adequately controlled by single-drug therapies.

What is hypertension and why is it concerning?

Hypertension occurs when blood pressure remains consistently higher than normal, even during periods of rest and relaxation. If left untreated, high blood pressure can lead to serious health complications, including:

  • Stroke
  • Heart failure
  • Kidney failure
  • Increased risk of heart attacks

By effectively lowering blood pressure, Exforge HCT helps reduce the risk of these potentially life-threatening conditions.

The Triple-Action Mechanism of Exforge HCT

Exforge HCT’s effectiveness lies in its unique combination of three active ingredients, each targeting a different aspect of blood pressure regulation:

1. Amlodipine Besilate: Calcium Channel Blocker

Amlodipine besilate belongs to a class of drugs known as calcium channel blockers. It works by:

  • Blocking the movement of calcium into heart and blood vessel cells
  • Relaxing blood vessels
  • Increasing blood and oxygen supply to the heart
  • Reducing the heart’s workload

2. Valsartan: Angiotensin II Receptor Blocker

Valsartan is an angiotensin II receptor blocker (ARB). Its mechanism of action includes:

  • Blocking the effects of angiotensin II, a substance that tightens blood vessels
  • Promoting blood vessel relaxation
  • Lowering blood pressure

3. Hydrochlorothiazide: Diuretic

Hydrochlorothiazide is a diuretic, often referred to as a “water pill.” It functions by:

  • Increasing urine production
  • Reducing excess fluid in the body
  • Contributing to lower blood pressure

Dosage Forms and Strengths of Exforge HCT

Exforge HCT is available in various dosage combinations to suit individual patient needs. The available strengths include:

  • 5/160/12.5 mg
  • 5/160/25 mg
  • 10/160/12.5 mg
  • 10/160/25 mg
  • 10/320/25 mg

The dosage prescribed will depend on factors such as the severity of hypertension, patient response, and any other medical conditions present.

Important Warnings and Precautions for Exforge HCT Use

While Exforge HCT can be highly effective in managing hypertension, it’s crucial to be aware of potential risks and contraindications:

Who should not take Exforge HCT?

Exforge HCT is contraindicated in patients with:

  • Known allergies to amlodipine besilate, valsartan, or hydrochlorothiazide
  • History of allergic reactions to dihydropyridines (used to treat blood pressure and heart problems)
  • Sensitivity to sulfonamide-derived medicines
  • Allergies to any of the inactive ingredients in Exforge HCT

Symptoms of an allergic reaction may include difficulty breathing, swelling of the face or other body parts, and skin rashes. If you experience these symptoms, seek immediate medical attention.

What precautions should be taken when using Exforge HCT?

Before starting Exforge HCT, inform your doctor if you have:

  • Severe kidney or liver problems
  • Heart conditions, including recent heart attack or heart failure
  • A history of angioedema (swelling of face, lips, tongue, or throat)
  • Diabetes or high blood sugar levels
  • High cholesterol or triglyceride levels
  • Gout or high uric acid levels
  • Lupus or other autoimmune disorders
  • Allergies or asthma

These conditions may affect how Exforge HCT works in your body or increase the risk of side effects.

Potential Side Effects of Exforge HCT

Like all medications, Exforge HCT can cause side effects, although not everyone experiences them. Common side effects may include:

  • Dizziness or lightheadedness
  • Headache
  • Swelling of hands, ankles, or feet
  • Fatigue
  • Nausea or stomach discomfort
  • Increased urination

Most side effects are mild and tend to improve as your body adjusts to the medication. However, if side effects persist or worsen, consult your healthcare provider.

Are there any serious side effects to be aware of?

While rare, some patients may experience more severe side effects that require immediate medical attention:

  • Severe allergic reactions (anaphylaxis)
  • Chest pain or irregular heartbeat
  • Severe dizziness or fainting
  • Vision changes or eye pain
  • Severe muscle pain or weakness
  • Signs of liver problems (e.g., yellowing of skin or eyes, dark urine)
  • Symptoms of low blood pressure (e.g., severe dizziness, fainting)

If you experience any of these serious side effects, seek immediate medical help.

Drug Interactions and Exforge HCT

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

What are some common drug interactions with Exforge HCT?

Some medications that may interact with Exforge HCT include:

  • Other blood pressure medications
  • Nonsteroidal anti-inflammatory drugs (NSAIDs)
  • Potassium supplements or salt substitutes containing potassium
  • Lithium (used to treat certain mental health conditions)
  • Certain diabetes medications
  • Cholesterol-lowering drugs (e.g., simvastatin)
  • Digoxin (a heart medication)

This list is not exhaustive, and other drug interactions may occur. Always consult your healthcare provider or pharmacist before starting any new medication while taking Exforge HCT.

Proper Usage and Administration of Exforge HCT

To ensure the best results and minimize potential side effects, it’s essential to take Exforge HCT exactly as prescribed by your healthcare provider. Here are some key points to remember:

How should Exforge HCT be taken?

  • Take Exforge HCT once daily, preferably at the same time each day
  • Swallow the tablet whole with a glass of water
  • Exforge HCT can be taken with or without food
  • Do not crush, chew, or break the tablet
  • If you miss a dose, take it as soon as you remember. If it’s close to your next scheduled dose, skip the missed dose and continue with your regular dosing schedule
  • Never take a double dose to make up for a missed one

What should be monitored while taking Exforge HCT?

Your healthcare provider may recommend regular check-ups to monitor:

  • Blood pressure levels
  • Kidney function
  • Electrolyte levels (particularly potassium)
  • Blood sugar levels, especially if you have diabetes

These check-ups help ensure that Exforge HCT is working effectively and safely for you.

Lifestyle Modifications to Enhance Exforge HCT’s Effectiveness

While Exforge HCT is a powerful medication for managing hypertension, combining it with healthy lifestyle choices can significantly improve its effectiveness and your overall cardiovascular health.

What lifestyle changes can complement Exforge HCT treatment?

Consider incorporating the following habits into your daily routine:

  • Maintain a healthy diet low in sodium and rich in fruits, vegetables, and whole grains
  • Engage in regular physical activity (consult your doctor before starting any new exercise regimen)
  • Achieve and maintain a healthy weight
  • Limit alcohol consumption
  • Quit smoking
  • Manage stress through relaxation techniques or mindfulness practices
  • Monitor your blood pressure at home, if recommended by your healthcare provider

These lifestyle modifications, when combined with Exforge HCT, can lead to better blood pressure control and reduce the risk of cardiovascular complications.

Long-term Considerations for Exforge HCT Users

Managing hypertension with Exforge HCT is typically a long-term commitment. Understanding what to expect over time can help you maintain consistent treatment and achieve optimal results.

What should patients know about long-term Exforge HCT use?

  • Regular follow-ups: Attend all scheduled appointments with your healthcare provider to monitor your progress and adjust treatment if necessary.
  • Consistent use: Do not stop taking Exforge HCT without consulting your doctor, even if you feel better or your blood pressure readings improve.
  • Pregnancy considerations: Inform your doctor if you become pregnant or plan to become pregnant, as Exforge HCT may not be suitable during pregnancy.
  • Travel preparations: When traveling, ensure you have enough medication to last the duration of your trip, plus extra in case of unexpected delays.
  • Ongoing education: Stay informed about hypertension and your treatment by discussing any questions or concerns with your healthcare provider.

By understanding these long-term considerations, you can work effectively with your healthcare team to manage your hypertension and maintain your overall health.

Exforge HCT (amlodipine besilate/valsartan/hydrochlorothiazide) Drug / Medicine Information

5/160/12.5, 5/160/25, 10/160/12.5, 10/160/25, 10/320/25

amlodipine besilate/valsartan/hydrochlorothiazide

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Exforge HCT.

It does not contain all the available information. It does not take the place of talking
to your doctor or pharmacist.

The information in this leaflet was last updated on the date listed on the final page.
More recent information on the medicine may be available.

You should ensure that you speak to your pharmacist or doctor to obtain the most up
to date information on the medicine. You can also download the most up to date leaflet
from www.novartis.com.au.

Those updates may contain important information about the medicine and its use of
which you should be aware.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking
this medicine against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Exforge HCT is used for

Exforge HCT is used to control high blood pressure, also called hypertension.

Everybody has blood pressure. This pressure helps get your blood all around your body.
Your blood pressure may be different at different times of the day, depending on how
busy or worried you are. You have hypertension (high blood pressure) when your blood
pressure stays higher than is needed, even when you are calm and relaxed.

High blood pressure increases the workload of the heart and blood vessels. If it continues
for a long time, it can damage the blood vessels in the brain, heart and kidneys.
This can lead to stroke, heart failure or kidney failure. High blood pressure increases
the risk of heart attacks. Lowering your blood pressure reduces the chance of these
disorders happening.

Exforge HCT contains amlodipine besilate, valsartan and hydrochlorothiazide. These
medicines reduce blood pressure in three different ways.

1. Amlodipine besilate blocks the movement of calcium into the cells of the heart and
blood vessels. As a result, they relax blood vessels and increase the supply of blood
and oxygen to the heart while reducing its workload.

2. Valsartan blocks the effect of angiotensin II, which is a substance in the body that
tightens blood vessels and makes your blood pressure rise. When the effect of angiotensin
II is blocked, your blood vessels relax and your blood pressure goes down.

3. Hydrochlorothiazide helps reduce the amount of excess fluid in the body by increasing
the amount of urine produced. This helps lower your blood pressure.

Ask your doctor if you have any questions about why this medicine has been prescribed
for you.

Your doctor may have prescribed it for another purpose.

There is not enough information to recommend the use of Exforge HCT in children.

This medicine is only available with a doctor’s prescription. It is not addictive.

Before you take Exforge HCT

When you must not take it

Do not take Exforge HCT if you have ever had an allergic reaction after taking:

amlodipine besilate, valsartan or hydrochlorothiazide (the active ingredients in Exforge
HCT)

medicines belonging to a group of chemicals called dihydropyridines, used to treat
blood pressure and other heart problems

medicines belonging to a group of chemicals called sulfonamide-derived (such as some
antibiotics e.g. Bactrim trimethoprim and sulfamethoxazole)

any of the other ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty
breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching
or hives on the skin.

Do not take Exforge HCT if you are pregnant or intend to become pregnant.

Exforge HCT is not recommended for use in pregnancy. Like other similar medicines,
it could affect your unborn baby.

Do not take Exforge HCT if you have any of the following medical conditions:

severe kidney disease or are having dialysis

severe liver disease including biliary cirrhosis

cholestasis, which is reduced or stopped bile flow

anuria, which is a condition where you are unable to urinate

high uric acid levels in the blood, which may cause gout

low level of potassium or sodium, or high level of calcium in your blood.

Check with your doctor if you are unsure if you have any of the above conditions.

Do not take Exforge HCT if you are also taking other blood pressure medicines containing
aliskiren and have type 2 diabetes.

Do not take Exforge HCT after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering.

In that case, return it to your pharmacist.

Before you start to take it

Tell your doctor if you have/have had any of the following health problems/medical
conditions:

kidney problems or received a kidney transplant

liver problems

systemic lupus erythematosus, a disease affecting the skin, joints and kidneys

heart problems, including obstructed blood flow from narrowing of valves (stenosis)
or enlarged septum (HOCM)

swelling, mainly of the face and throat, while taking other medicines (including an
ACE inhibitor or aliskiren)

a hormone disorder causing fluid retention known as primary hyperaldosteronism (Conn’s
syndrome)

passing less urine than is normal for you or difficulty passing urine

salt restricted diet

suffering from several episodes of vomiting or diarrhoea.

skin cancer

Your doctor may want to take special precautions if you have any of the above conditions.

Tell your doctor if you are breast-feeding a baby. Ask your doctor about the risks
and benefits of taking Exforge HCT in this case.

Hydrochlorothiazide and amlodipine are known to pass into the breast milk, however
it is not known if valsartan, the other active ingredient of Exforge HCT, passes into
the breast milk and could affect your baby. Therefore, Exforge HCT is not recommended
if you are breast-feeding.

Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.

Your doctor will want to know if you are prone to allergies.

If you have not told your doctor about any of these things, tell him/her before you
take Exforge HCT.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including medicines
that you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines and Exforge HCT may interfere with each other. These include:

medicines used to treat high blood pressure and some other heart conditions including
fluid tablets or diuretic medicines, ACE-inhibitors, aliskiren and beta blockers

simvastatin (a medicine used to help lower cholesterol levels), since the dose may
have to be reduced when taken with Exforge HCT

intravenous dantrolene used to treat malignant hyperthermia

some antibiotics (rifampicin), anti-rejection drugs (cyclosporin), antiretrovirals
(ritonavir) which may increase the effect of valsartan

tablets, preparations or supplements which increase the potassium levels in your blood
(such as certain types of diuretics, potassium supplements, salt substitutes etc.)

non-steroidal anti-inflammatory drugs (NSAIDs) and selective Cyclooxygenase-2 Inhibitors
(Cox-2 inhibitors), medicines used to relieve swelling and other symptoms of inflammation,
including arthritis (Your doctor may also check your kidney function)

medicines or supplements containing calcium

vitamin D

medicines used to relax muscles before or during surgery

steroid medicines such as cortisone, prednisone and ACTH

lithium, antidepressants, antipsychotics, medicines used to treat mood swings and
some types of depression

cyclophosphamide or methotrexate

penicillin

amphotericin, a medicine used to treat fungal infections

insulin and tablets used to treat diabetes

medicines used to treat gout

cyclosporine

carbamazepine, an anticonvulsant and mood stabilising drug used primarily in the treatment
of epilepsy and bipolar disorder

digoxin or other digitalis glycosides (medicines used to treat heart problems)

antiarrhythmics (medicines used to treat heart problems)

medicines used for oesophageal ulceration and inflammation

amantadine, and anti-Parkinson therapy also used to treat or prevent certain illnesses
caused by viruses

cytotoxic drugs used in cancer therapy

medicine used to treat gastrointestinal cramps, urinary bladder spasm, asthma, motion
sickness, muscular spasms, Parkinson’s disease and as aid to anaesthesia from a class
called anticholinergic agents

cholestyramine, colestipol, and other resins (medicines used mainly to treat high
levels of lipids in the blood)

pressor amines, such as noradrenaline (substances that raise blood pressure)

barbiturates, narcotics (medicines with sleep-inducing properties) and alcohol.

radioactive iodine, used as a medical tracer or diagnosis.

Your doctor and pharmacist have a more complete list of medicines to be careful of
while taking Exforge HCT.

How to take Exforge HCT

Follow carefully all directions given to you by your doctor and pharmacist.

These instructions may differ from the information contained in this leaflet.

If you do not understand the instructions on the label, ask your doctor or pharmacist
for help.

How much to take

Your doctor will tell you how many tablets to take each day. The usual dose is one
tablet a day.

When to take it

Take your Exforge HCT dose at the same time each day.

This also helps you remember to take it, especially if you take it as part of your
usual routine (e.g. at breakfast time). This medicine will keep working for the whole
24 hours until the next dose is due.

How to take it

Swallow the tablet with a full glass of water.

Always take Exforge HCT in the same way, with or without food.

You can take it with or without food but it will work best if you always take it in
the same way every day.

How long to take it

Take this medicine until your doctor tells you to stop even if you feel quite well.

People who have high blood pressure often feel well and do not notice any signs of
this problem.

If you forget to take it

If it is almost time for your next dose, skip the missed dose and take the next one
when you are meant to.

Otherwise, take the dose as soon as you remember and then go back to taking it as
you would normally.

Do not take a double dose to make up for the one that you missed.

This may increase the chance of side effects.

If you have trouble remembering when to take your medicine, ask your pharmacist for
some hints.

If you take too much (Overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone number:
13 11 26) for advice, or go to Accident and Emergency at your nearest hospital if
you think that you or anyone else may have taken too much Exforge HCT. Do this even
if there are no signs of discomfort or poisoning.

Keep the telephone numbers for these places handy.

Too much Exforge HCT may make you feel dizzy, light headed or faint. You may experience
rapid, shallow breathing or cold, clammy skin. Your heartbeat may be faster than usual.
This is because your blood pressure is too low.

While you are taking Exforge HCT

Things you must do

If you become pregnant while taking Exforge HCT, tell your doctor immediately.

You should not take this medicine while you are pregnant.

Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.

Otherwise your doctor may think that it was not effective and change your treatment
unnecessarily.

Be sure to keep all of your doctor’s appointments so that your progress can be checked.
Do this even if you feel well.

People with high blood pressure often do not notice any signs of this problem. But
it is important to keep track of your progress. Your doctor will want to check your
blood pressure and your kidney and liver function from time to time.

If you are going to have surgery, tell your doctor and anaesthetist that you are taking
Exforge HCT.

Exforge HCT may affect some medicines you receive during surgery.

If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking Exforge HCT.

Tell any other doctor, dentist or pharmacist who treats you that you are taking Exforge
HCT.

Things you must not do

Do not take Exforge HCT to treat any other complaints unless your doctor says you
can.

Do not give this medicine to anyone else, even if their condition seems to be similar
to yours.

Things to be careful of

Avoid eating grapefruit or drinking grapefruit juice.

Grapefruit juice can affect the metabolism of some medicines, including amlodipine.

Be careful driving, operating machinery or doing jobs that require you to be alert
while you are taking Exforge HCT until you know how it affects you.

This medicine can cause tiredness, sleepiness or dizziness in some people. If you
have these symptoms, do not drive or do anything else that could be dangerous.

If this medicine makes you feel dizzy or light-headed, be careful when getting up
from a sitting or lying position.

Dizziness can usually be prevented by getting up slowly and flexing leg muscles and
toes to get the blood flowing. When getting out of bed, dangle your legs over the
side for a minute or two before standing up.

When you are outdoors, wear protective clothing and use a factor 30 (or higher), water
resistant sunscreen.

Do not use a sunlamp.

This medicine may cause your skin to be much more sensitive to sunlight than it normally
is.

Exposure to sunlight may cause a skin rash, itching, redness or severe sunburn. If
your skin does appear to be burning, tell your doctor.

Treatment with Exforge HCT, particularly long-term use with high doses, may increase
the risk of some types of skin and lip cancer (non-melanoma skin cancer).

Protect your skin from sun exposure and UV rays while taking Exforge HCT. Regularly
check your skin for any new lesions and promptly report any suspicious skin lesions
to your doctor.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking Exforge HCT, even if you do not think it is connected with the medicine.

All medicines can have side effects. Sometimes they are serious, but most of the time
they are not. You may need medical treatment if you get some of the side effects.

Do not be alarmed by this list of possible side effects. You may not experience any
of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of these side effects and they worry you:

headache

buzzing, whistling, ringing or other persistent noise in the ears

dizziness, spinning sensation, changes in vision, uncoordinated movements

dizziness on standing up, especially when getting up from a sitting or lying position

sleepiness, tiredness, weakness or difficulty sleeping

pain in the back or joints

muscle pain, muscle tenderness or weakness, cramps

runny nose or congested sinuses

dry cough, sore throat or hoarse voice

dry mouth

bleeding, tender or enlarged gums

indigestion, loss of appetite, stomach upset, pain, diarrhoea, constipation or wind

nausea (feeling sick) or vomiting

tingling or numbness in hands or feet

rash, redness, blistering or peeling of skin, itching

appearance of a lump or discoloured patch on the skin

lip cancer; the signs and symptoms include:

a sore that doesn’t heal or comes back after healing

pale white or yellow flat areas that look like scars

raised and scaly red patches

small, smooth and shiny lumps that are pearly white, pink or red

a pink growth with raised edges and indents in the centre

a growth that has small blood vessels on the surface.

excessive sweating

feeling anxious or sad

problems with sexual function

breast enlargement in men

unusual hair loss or thinning

pain when passing urine, passing more urine than normal or frequent urge to urinate

redness and warm feeling of the face and/or neck

swelling of the ankles, feet, face or hands

flushing

palpitations

unusual tiredness or weakness

weight gain

feeling nervous, depressed or moody

distorted sense of taste

sensitivity to light

symptoms of sunburn which happens more quickly than normal

facial pain.

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital
if you notice any of the following:

signs of allergy such as rash, itching or hives on the skin; swelling of the face,
lips, tongue or other parts of the body; shortness of breath, wheezing or troubled
breathing

feeling of fast or irregular heart beat (pounding, racing, skipping beats)

chest pain

tiredness or lack of energy, being short of breath when exercising

bleeding or bruising more easily than normal

constant “flu-like” symptoms such as chills, fever, sore throat, aching joints, sores
in mouth, swollen glands

severe dizziness or fainting

stomach pain with nausea, vomiting, loss of appetite, feeling generally unwell, fever,
itching, yellowing of the skin and eyes, and dark coloured urine

signs of a serious skin reaction such as painful red areas, large blisters, peeling
of layers of skin, bleeding in the lips, eyes, mouth, nose or genitals. These signs
may be accompanied by fever and chills, aching muscles and feeling generally unwell

unusual bleeding or bruising under the skin

passing less urine than normal

decrease in vision or pain in your eyes due to high pressure.

Tell your doctor immediately if you notice any new skin or lip lesions during or after
treatment or if an existing lesion changes its appearance.

The above list includes serious side effects which may require medical attention.
These side effects do not occur frequently.

Tell your doctor if you notice anything else that is making you feel unwell.

Other side effects not listed above may also occur in some people.

After taking Exforge HCT

Storage

Keep your tablets in the original container until it is time to take them.

Store them in a cool dry place below 30°C (room temperature).

Do not store Exforge HCT or any other medicine in the bathroom or near a sink.

Do not leave Exforge HCT in the car or on window sills.

Heat and dampness can destroy some medicines. Exforge HCT will keep well if it is
cool and dry.

Keep medicines where children cannot reach them.

A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.

Disposal

If your doctor tells you to stop taking Exforge HCT, or it has passed its expiry date,
ask your pharmacist what to do with any tablets that are left over.

Product description

What it looks like

Exforge HCT 5/160/12.5 (5 mg amlodipine, 160 mg valsartan and 12.5 mg hydrochlorothiazide)
tablets are white, ovaloid, biconvex with bevelled edge and imprinted with NVR on
one side and VCL on the other. Packs of 7’s and 28’s.

Exforge HCT 10/160/12.5 (10 mg amlodipine, 160 mg valsartan and 12.5 mg hydrochlorothiazide)
tablets are pale yellow, ovaloid, biconvex with bevelled edge and imprinted with NVR
on one side and VDL on the other. Packs of 7’s and 28’s.

Exforge HCT 5/160/25 (5 mg amlodipine, 160 mg valsartan and 25 mg hydrochlorothiazide)
tablets are yellow, ovaloid, biconvex with bevelled edge and imprinted with NVR on
one side and VEL on the other. Packs of 7’s and 28’s.

Exforge HCT 10/160/25 (10 mg amlodipine, 160 mg valsartan and 25 mg hydrochlorothiazide)
tablets are brown yellow, ovaloid, biconvex with bevelled edge and imprinted with
NVR on one side and VHL on the other. Packs of 7’s and 28’s.

Exforge HCT 10/320/25 (10 mg amlodipine, 320 mg valsartan and 25 mg hydrochlorothiazide)
tablets are brown yellow, ovaloid, biconvex with bevelled edge and imprinted with
NVR on one side and VFL on the other. Packs of 7’s and 28’s.

Exforge HCT tablets are non-divisible and cannot be divided into equal doses.

Ingredients

Exforge HCT tablets contain amlodipine besilate (5 mg or 10 mg), valsartan (160 mg
or 320 mg) and hydrochlorothiazide (12.5 mg or 25 mg) as the active ingredients.

The tablets contain the following inactive ingredients:

cellulose – microcrystalline

crospovidone

silica – colloidal anhydrous

magnesium stearate

hypromellose

macrogol 4000

talc – purified

Exforge HCT 5/160/12.5 tablets also contain:

titanium dioxide.

Exforge HCT 5/160/25 and also contain:

titanium dioxide

iron oxide yellow.

Exforge HCT 10/160/12.5 tablets also contain:

titanium dioxide

iron oxide yellow

iron oxide red.

Exforge HCT 10/160/25 and 10/320/25 tablets also contain:

iron oxide yellow.

Sponsor

Exforge HCT is supplied in Australia by:

ABN 18 004 244 160

54 Waterloo Road

Macquarie Park NSW 2113

Telephone: 1 800 671 203.

Australian Registration Numbers:

Exforge HCT 5/160/12.5: AUST R 157954

Exforge HCT 5/160/25: AUST R 158162

Exforge HCT 10/160/12.5: AUST R 158164

Exforge HCT 10/160/25: AUST R 158166

Exforge HCT 10/320/25: AUST R 158168.

This leaflet was prepared in August 2019.

© Copyright 2019.

® = Registered Trademark.

Internal document code: exh050821c based on PI exh050821i

Valsartan: medicine to treat high blood pressure

It’s usual to take valsartan once or twice a day.

If you take valsartan once a day, your doctor may suggest that you take your first dose before bedtime, because it can make you dizzy. After the very first dose, you can take valsartan at any time of day. Try to take it at the same time every day.

You can take valsartan tablets with or without food. Swallow the tablets whole with a drink of water.

How much will I take?

The dose of valsartan you take depends on why you need the medicine. Take it as instructed by your doctor.

The usual dose for adults is:

  • 80mg to 320mg once a day for high blood pressure
  • 40mg to 160mg twice a day for heart failure
  • 20mg to 160mg twice a day after a recent heart attack

The dose may be lower if you’ve recently lost body fluids (for example because you’ve been sick or have diarrhoea).

The dose for children depends on their weight. The usual dose for children is:

  • 40mg to 80mg once a day (for children weighing 18kg to 35kg)
  • 80mg to 160mg once a day (for children weighing 35kg to 80kg)
  • 80mg to 320mg once a day (for children weighing 80kg and more)

Will my dose go up or down?

After a few weeks your doctor will check your blood pressure and ask you if you’re getting any side effects. You may also have blood tests to check how well your kidneys are working and the amount of potassium in your blood. Your doctor will then decide whether to change your dose of valsartan.

If valsartan doesn’t bring your blood pressure down, your doctor may want to increase the dose. If your blood pressure gets too low or you get side effects, your doctor may want to lower your dose of valsartan.

How to take it

You can take valsartan tablets with or without food. Swallow the tablets with a drink of water.

If you’re taking valsartan as a liquid, it will come with a plastic syringe or spoon to help you measure out the right dose. If you don’t have one, ask your pharmacist for one. Do not use a kitchen teaspoon as it will not give the right amount of medicine.

Some people take valsartan in combination with other medicines:

  • with amlodipine (brand name Exforge) to treat high blood pressure
  • with hydrochlorothiazide (brand name Co-Diovan) to treat high blood pressure
  • with sacubitril (brand name Entresto) to treat a type of long-term heart failure

What if I get sick while I’m taking it?

If you get severe diarrhoea or vomiting for any reason, contact your doctor or a pharmacist. They’ll be able to advise you about what to do.

They may recommend that you stop taking valsartan until you’re better, and you’re able to eat and drink normally again.

What if I forget to take it?

If you miss a dose of valsartan, take it as soon as you remember, unless it’s almost time for your next dose. Do not take a double dose to make up for a forgotten one.

If you forget doses often, it may help to set an alarm to remind you. You could also ask your pharmacist for advice on other ways to help you remember to take your medicine.

What if I take too much?

If you take too many valsartan tablets by accident, contact your doctor or go to your nearest hospital A&E department straight away. An overdose of valsartan can cause dizziness, sleepiness and a pounding heartbeat.

The amount of valsartan that can lead to an overdose varies from person to person.

Valsartan Side Effects | Liver Damage, Tumors & Other Effects

Valsartan is a high blood pressure drug that is considered generally safe and tolerated better by patients than alternative treatments. Like any drug, however, it comes with side effects.

Some side effects of the blood pressure medication are more serious than others and require medical attention. Possible serious side effects include allergic reactions and rare instances of liver damage.

Less serious, but more common, side effects include headache and dizziness. The medication may also cause weight gain, and it poses a serious risk to the unborn if taken during pregnancy.

Cancer is not a known side effect of valsartan, but in July 2018 manufacturers issued a valsartan recall for some batches of medication contaminated with N-nitrosodimethylamine (NDMA) — a toxic chemical known to cause cancer and death in animals. NDMA may also cause liver damage in humans.

Suffering from liver damage, tumors or cancer after taking Valsartan?

Common Side Effects

Common side effects of valsartan are generally mild and brief. They don’t necessarily require patients to stop taking valsartan, which is sold under the Diovan brand name. In addition to side effects listed on the label, people also reported weight gain and hair loss after taking the drug.


The most common side effects of valsartan include:

  • Nausea

  • Cough

  • Dizziness

  • Tiredness

  • Diarrhea

  • Headache

  • Pain in the abdomen

  • Lower blood pressure

  • High blood potassium

  • Flu-like symptoms

  • Joint pain

  • Back pain

Weight Gain Reports

Weight gain is not listed on the valsartan label as a side effect. But a study of FDA reports found incidents of weight gain among patients who took the drug. Weight gain was more pronounced for women 60 and older who took the drug for less than one month or between two and five years and also took the drug Lyrica and had high cholesterol or asthma. eHealthMe published the study online.

No Proven Link to Hair Loss

Hair loss is not among the side effects listed on valsartan’s label. A review of FDA reports found that out of more than 29,000 people reporting side effects while taking the drug, 297 people reported hair loss. It’s not clear whether those people might have experienced hair loss without taking the medication.

Serious Side Effects

The drug carries warnings about the potential for low blood pressure. If you also take water pills and are on a low-salt diet while taking the drug, you are most likely to develop low blood pressure.

The drug’s label warns health care providers to monitor kidney function and potassium in vulnerable patients. The medication has also been linked to rare instances of acute liver injury.


EXPAND

Valsartan is considered extremely dangerous to the unborn. Patients should not take the medication when they may be pregnant. The drug carries a black box warning against use during pregnancy.


Potentially serious side effects include:

  • Allergic reactions

  • Impotence

  • Acute liver injury

  • Low blood pressure

  • Fetal toxicity

  • Reduced renal (kidney) function

  • Hyperkalemia (higher than normal potassium in the blood)

Kidney Problems

Patients taking the drug have reported renal (kidney) impairment to the FDA. For patients with kidney disease, this medication can make it worse. Symptoms of kidney impairment include unexplained weight gain and swelling in hands, feet or ankles.

The drug may increase the level of potassium in your blood. This risk is increased in people with heart failure and kidney problems.

Allergic Reactions

The drug may cause serious allergic reactions. If you have trouble breathing, develop hives or if your tongue or throat swells, seek immediate medical help. In rare cases, some people suffered angioedema, or severe swelling beneath the skin’s surface.

Some patients who took valsartan and experienced angioedema had previously suffered the problem with other drugs, including ACE inhibitors. The drug’s label advises patients not to take it again if they had angioedema.

Pregnancy Side Effects

Women should not take valsartan if they are pregnant. It can cause injury or even death to a developing fetus when taken during the second and third trimesters of pregnancy, according to a black box warning on the drug’s label. You should stop taking the drug as soon as possible after you know you are pregnant.

Fact

Women who may be pregnant should not take valsartan.

It’s not known if valsartan passes through breast milk and harms infants. Because of this, you should talk to your doctor before breastfeeding.

Liver Damage

The FDA has received reports of elevated liver enzymes and very rare reports of hepatitis in patients taking the drug. In clinical trials, patients treated with Diovan experienced occasional elevations of liver chemistries, according to the drug label. Three patients treated with valsartan stopped taking the drug because of elevated liver chemistries.

Sexual Function of ED Patients Improved

The FDA has received reports of impotence among patients taking valsartan. The drug label does not specify whether that impotence refers to erectile dysfunction. However, some studies have suggested that drugs in the same category may actually have a beneficial effect on the sexual function of patients with high blood pressure.

Erectile Dysfunction Study

Valsartan did not increase the risk of ED, and it improved sexual function in men with ED and hypertension.

Two studies found that the drug improved all aspects of sexual function, particularly erectile function. The Journal of Clinical Hypertension included the research in a January 2007 study.

The findings are significant because many patients won’t stay on their blood pressure drugs, fearing erectile dysfunction, researchers said.

One study of 2,202 patients with high blood pressure reported an increase of sexual activity for those taking valsartan compared to people using other drugs or no medications. Each patient filled out a questionnaire about their health and sex life during three visits to their doctor over a four-month period.

“Valsartan increases the rate of sexual intercourse per week, whereas conventional therapy affects sexual activity adversely,” researchers said in the 2003 study.

Another study of more than 3,500 patients found “valsartan therapy markedly reduced” erectile dysfunction. That study, originally published in Blood Pressure Supplement journal in 2003, found that the drug reduced ED by as much as 53 percent. Additionally, it improved “orgasmic function, intercourse and overall satisfaction.”


Please seek the advice of a medical professional before making health care decisions.

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Get Exforge Online Prescription. Request Exforge HCT Medication Online And Get Exforge Generic At A Nearby Pharmacy.

  • Request Exforge online prescription
  • Same day prescriptions available
  • Convenient care from home

Exforge – Overview

Exforge is a combination medication that is sometimes prescribed to people for the treatment of hypertension. People who might need an Exforge medication prescription, including Exforge HCT and Exforge generic tablets, can use Push Health to connect with a local medical provider who can prescribe Exforge when appropriate to do so.

What Is Exforge?

Exforge is a combination medication that consists of amlodipine (Norvasc) and valsartan (Diovan). In doing so, Exforge provides a dihydropyridine calcium channel blocker and an angiotensin II receptor blocker (ARB) which can be used in treating high blood pressure in some patients – particularly ones who are not well controlled on one medication only. Exforge exerts its antihypertensive effects through a mechanism of action involving reduction in peripheral vascular resistance through smooth muscle relaxation and through blocking angiotensin II. The combined effect of these two actions caused by Exforge medication use often reduces blood pressure to a greater degree when compared to using either drug alone.

Exforge – Dosage and Coupon

Exforge is typically available as Exforge 5/160 tablets, Exforge 10/160 tablets, Exforge 5/320 tablets and Exforge 10/320 tablets. Many patients are started at Exforge 5/160 although the determination of the best dosage to use depends on the prescribing medical provider and the health characteristics of the patient. Following oral administration of Exforge, both component drugs will have passed their elimination half-life within five days. The drug components of Exforge are eliminated via both the liver and the kidney. Exforge is a slightly expensive medication, costing approximately 70 cents per Exforge 5mg / 160 mg tablet at many pharmacies in the United States. For people paying for their Exforge medication, Exforge coupons can sometimes be found online or through other sources. Additionally, some insurance plans may cover costs associated with an Exforge medication prescription.

Can I Buy Exforge Online?

Exforge OTC is not available in the United States because Exforge is a prescription medication and requires a consultation with a licensed medical provider before it can be dispensed by a pharmacy. Prior to a consultation, one cannot just buy Exforge online, either. People who might need an Exforge prescription, however, can use Push Health to connect with a local medical provider who can prescribe Exforge medication, including Exforge HCT and Exforge generic tablets, when appropriate to do so.

Exforge – Side Effects

Exforge, like similar medications, can cause side effects when used. Side effects that can result from Exforge use include vertigo, edema, low blood pressure, dizziness and nasopharyngitis. Exforge should be titrated slowly in people with kidney or liver dysfunction. Drug-drug interactions can occur in selected cases while using Exforge. Exforge and alcohol should not be used together. People with a known hypersensitivity to Exforge or ingredients in the formulation should not take Exforge medication. Before using Exforge tablets, it is important to discuss concerns and possible side effects with a pharmacist and qualified medical practitioner.

More Exforge Information

Last updated May 28, 2021. Given the evolving nature of medicine and science, this information might not be accurate and should not be construed as medical advice or diagnosis / treatment recommendations. Please consult a licensed medical provider if you have additional questions.

Exforge HCT 10/320/25 | healthdirect

What it is used for

Exforge HCT is indicated ONLY as substitution therapy for the treatment of hypertension in patients whose blood pressure is already adequately controlled on the triple combination of amlodipine, valsartan and hydrochlorothiazide taken either as three single component formulations or as dual-component formulation with a single component formulation, all components at the same dose level. Treatment should not be initiated with these fixed-dose combinations (see DOSAGE AND ADMINISTRATION).

How to take it

The way to take this medicine is: Oral.
This medicine is taken by mouth.

  • Store below 30 degrees Celsius
  • Protect from Moisture
  • Shelf lifetime is 2 Years.

You should seek medical advice in relation to medicines and use only as directed by a healthcare professional.

Always read the label. If symptoms persist see your healthcare professional.

Visual appearance

Brown yellow film coated tablet, ovaloid, biconvex with bevelled edge with “NVR” on one side and “VFL” on the other side.

Images are the copyright of the Pharmacy Guild of Australia

Do I need a prescription?

What is the medicines and poisons schedule?

All medicines and poisons in Australia are categorised by how they are made available to the public. Medicines with a low safety risk are usually less tightly controlled than medicines with a higher safety risk. This system is called ‘scheduling’.

You can read more about the scheduling of medicines as well as the different scheduling categories on our Scheduling of medicines and poisons information page.

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This medicine is available from a pharmacist and requires a prescription. It is
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                              TELEPHONE TO CALL THE VETERINARY DOCTOR FOR STERILIZATION OF THE CAT – +7 (812) -903-97-27

                              Type of sterilization

                              Price

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                              Sterilization of a cat “Classic” (arrival, import anesthesia, removal of the ovaries and uterus, consultation on feeding and maintenance)

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