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

Warnings:

This medication may rarely cause serious mental/mood changes. These effects may occur even after the medication has been stopped. Tell your doctor right away if you or a caregiver/family member notice symptoms such as agitation, anxiety, abnormal dreams, depression, memory/attention problems, hallucinations, trouble sleeping, or changes in behavior (such as aggression, hostility, restlessness, sleepwalking, suicidal thoughts/attempts). Talk to your doctor about the risks and benefits of this medication.

Warnings:

This medication may rarely cause serious mental/mood changes. These effects may occur even after the medication has been stopped. Tell your doctor right away if you or a caregiver/family member notice symptoms such as agitation, anxiety, abnormal dreams, depression, memory/attention problems, hallucinations, trouble sleeping, or changes in behavior (such as aggression, hostility, restlessness, sleepwalking, suicidal thoughts/attempts). Talk to your doctor about the risks and benefits of this medication.

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Uses

Montelukast is used to control and prevent symptoms caused by asthma (such as wheezing and shortness of breath). It is also used before exercise to prevent breathing problems during exercise (bronchospasm). This medication can help decrease the number of times you need to use your quick relief inhaler.Montelukast is also used to relieve symptoms of hay fever and allergic rhinitis (such as sneezing, stuffy/runny/itchy nose). Since there are other allergy medications that may be safer (see also Warning section), this medication should be used for this condition only when you cannot take other allergy medications or they do not work well.This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden asthma attacks or breathing problems. If an asthma attack or sudden shortness of breath occurs, use your quick-relief inhaler as prescribed. This drug works by blocking certain natural substances (leukotrienes) that may cause or worsen asthma and allergies. It helps make breathing easier by reducing swelling (inflammation) in the airways.

How to use Singulair oral

Read the Medication Guide provided by your pharmacist before you start taking montelukast and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor. The dosage is based on your age and medical condition.

If you are using the chewable tablets, chew them thoroughly before swallowing. If your child cannot safely chew and swallow them, consult the doctor or pharmacist for advice.

Take this medication at the same time each day. If you are taking this medication for asthma or for both asthma and allergies, take your dose in the evening. If you are taking montelukast to prevent only allergies, take your dose either in the morning or the evening.

If you are taking this medication to prevent breathing problems during exercise, take your dose at least 2 hours before exercise. Do not take more than one dose in 24 hours. Do not take a dose before exercise if you are already taking this medication daily for asthma or allergies. Doing so may increase the risk of side effects.

Do not increase or decrease your dose or stop using this medication without consulting your doctor. Continue to use this medication regularly to keep your asthma under control, even during sudden asthma attacks or periods when you have no asthma symptoms. Continue to also take other medications for asthma as directed by your doctor. This medication works over time and is not meant to relieve sudden attacks of asthma. If an asthma attack or other breathing problem occurs, use your quick-relief inhaler as prescribed. You should always have a quick-relief inhaler with you. Consult your doctor or pharmacist for more details.

Get medical help right away if your asthma symptoms worsen and your quick-relief inhaler is not helping. Tell your doctor promptly if asthma symptoms, breathing problems, allergy symptoms, number of times you use your rescue inhaler last or get worse.

Side Effects

See also Warning section.

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: numbness/tingling/shooting pain in the arms or legs, sinus pain/swelling, muscle weakness, uncontrolled muscle movements, stuttering.

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.

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.

Precautions

Before taking montelukast, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this drug, tell your doctor or pharmacist your medical history, especially of: liver disease, mental/mood problems (such as anxiety, depression, thoughts of suicide).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

The chewable tablets may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to limit/avoid aspartame (or phenylalanine) in your diet, ask your doctor or pharmacist about using this medication safely.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Consult your doctor before breast-feeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Does Singulair oral interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: thirst, drowsiness, inability to keep still, vomiting, or severe stomach pain.

Do not share this medication with others.

Lab and/or medical tests (such as lung function) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up. Do not take more than 1 dose in 24 hours.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Images

Singulair 5 mg chewable tablet

Color: pinkShape: roundImprint: MSD 275 SINGULAIR

This medicine is a pink, round, cherry, chewable tablet imprinted with “MSD 275” and “SINGULAIR”.

Singulair 10 mg tablet

Color: beigeShape: square (rounded corners)Imprint: MSD 117 SINGULAIR

This medicine is a pink, round, cherry, chewable tablet imprinted with “MSD 275” and “SINGULAIR”.

Singulair 5 mg chewable tablet

Color: pinkShape: roundImprint: SINGULAIR MRK 275

This medicine is a pink, round, cherry, chewable tablet imprinted with “MSD 275” and “SINGULAIR”.

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

Singulair (Montelukast sodium) Drug / Medicine Information

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

Montelukast sodium

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about SINGULAIR. It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking SINGULAIR 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 SINGULAIR is used for

SINGULAIR is used to prevent asthma symptoms, including those that occur during the day and at night-time. It also prevents the narrowing of airways triggered by exercise.

If you have seasonal allergic rhinitis (hay fever), SINGULAIR also treats your allergic rhinitis symptoms.

It can be used in children 2 years of age and older, teenagers and adults.

SINGULAIR tablets are not used to treat an acute attack of asthma. If an acute attack occurs, follow your doctor’s instructions for your reliever medicine, and keep taking your SINGULAIR each night or as prescribed.

As a preventive medicine for asthma, SINGULAIR can be used alone or in combination with other preventive medicines, such as inhaled corticosteroids. Your doctor may reduce your dose of inhaled corticosteroid while you are taking SINGULAIR.

Asthma is a lung disease and has the following characteristics:

narrowed airways causing breathing to become difficult

inflamed airways, which means the lining of airways become swollen

sensitive airways that react to many things, such as cigarette smoke, pollen, or cold air.

Symptoms of asthma include coughing, wheezing and chest tightness. Not all people with asthma wheeze. For some, coughing may be the only symptom of asthma. Symptoms often occur during the night or after exercise.

For further information about asthma, contact the Asthma Foundation in your state on 1800 645 130, or www.asthmaaustralia.org.au

Seasonal allergic rhinitis (also known as hay fever) is an allergic response often caused by airborne pollens from trees, grasses, and weeds. The daytime and night-time symptoms of seasonal allergic rhinitis typically may include: stuffy, runny, itchy nose; sneezing; watery, swollen, red, itchy eyes.

How SINGULAIR works

SINGULAIR belongs to a group of medicines called leukotriene receptor antagonists. It works by blocking substances in your lungs called leukotrienes that cause narrowing and swelling of airways. Blocking leukotrienes improves asthma symptoms and helps prevent asthma attacks. Leukotrienes also cause allergic rhinitis symptoms. By blocking leukotrienes, SINGULAIR improves seasonal allergic rhinitis symptoms.

Your doctor may have prescribed SINGULAIR for another reason. Ask your doctor if you have any questions about why SINGULAIR has been prescribed for you.

SINGULAIR is not addictive.

Before you take SINGULAIR

When you must not take it

Do not take SINGULAIR if:

you have an allergy to SINGULAIR or any of the ingredients listed at the end of this leaflet

the packaging is torn or shows signs of tampering

the expiry date on the pack has passed.

If you take this medicine after the expiry date has passed, it may not work.

If you are not sure whether you should start taking SINGULAIR, talk to your doctor.

Do not give SINGULAIR to children under 2 years of age.

Safety and effectiveness in children younger than 2 years of age have not been studied.

In studies investigating the effect of SINGULAIR on the growth rate of children, it was shown that SINGULAIR did not affect the growth rate of children when given for up to 56 weeks in one study.

Before you start to take it

Tell your doctor if:

1. you are pregnant or intend to become pregnant

SINGULAIR has not been studied in pregnant women.

2. you are breast-feeding or plan to breast-feed

It is not known if SINGULAIR passes into breast milk.

3. you have or have had any medical conditions

4. your child has a condition called phenylketonuria

The 5 mg and 4 mg chewable tablets contain aspartame, corresponding to 0.842 mg phenylalanine in each 5 mg tablet and 0.674 mg in each 4 mg tablet.

5. you have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes.

If you have not told your doctor about any of the above, tell them before you take any SINGULAIR.

Taking other medicines

Some medicines may affect how SINGULAIR works, or SINGULAIR may affect how your other medicines work.

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

How to take SINGULAIR

How much to take

For patients with asthma and/or seasonal allergic rhinitis, take SINGULAIR only when prescribed by your doctor.

For adults and teenagers 15 years and older, the dose is one 10 mg film-coated tablet taken each day.

For children 6 to 14 years old, the dose is one 5 mg chewable tablet taken each day.

For children 2 to 5 years old, the dose is one 4 mg chewable tablet taken each day.

For patients with asthma, take SINGULAIR once a day in the evening.

For patients with seasonal allergic rhinitis, take SINGULAIR once a day as prescribed by your doctor.

Follow all directions given to you by your doctor carefully.

They may differ from the information contained in this leaflet.

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

How to take it

SINGULAIR comes as three types of tablets:

10 mg film-coated tablets for adults and teenagers 15 years and older

5 mg chewable tablets for children 6-14 years old

4 mg chewable tablets for children 2-5 years old.

Swallow the 10 mg film-coated tablet with a glass of water.

Chew the 5 mg or 4 mg chewable tablets thoroughly and swallow. Do not swallow whole

When to take it

Asthma:

Take your SINGULAIR at bedtime each day.

Taking your tablet at bedtime each day is expected to have the best effect. It will also help you remember when to take the tablets.

Seasonal allergic rhinitis:

Take your SINGULAIR once a day as prescribed by your doctor.

Your doctor will advise you on the best time of the day to take your tablet.

Asthma and seasonal allergic rhinitis:

Take your SINGULAIR at bedtime each day if you have both asthma and seasonal allergic rhinitis.

It does not matter if you take SINGULAIR before or after food.

How long to take it

SINGULAIR helps control your asthma. Therefore SINGULAIR must be taken every day. Continue taking SINGULAIR for as long as your doctor prescribes.

If you forget to take it

Skip the dose you missed and take your next dose as usual.

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

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

If you take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, if you think that you or anyone else may have taken too much SINGULAIR. Do this even if there are no signs of discomfort or poisoning.

The most common symptoms reported with overdose in adults and children include thirst, sleepiness, dilated pupils, hyperactivity, and stomach pain.

While you are using SINGULAIR

Things you must do

Continue taking SINGULAIR every day as directed by your doctor, even if you have no asthma symptoms or if you have an asthma attack.

If your asthma gets worse while taking SINGULAIR, tell your doctor immediately.

SINGULAIR is not for the treatment of acute asthma attacks. If an acute attack of asthma occurs, follow your doctor’s instructions on what reliever medicine to use to relieve the attack.

All thoughts of suicide must be taken seriously. If you experience behaviour and mood-related changes including suicidal thoughts while taking SINGULAIR (see “Behavioural and mood related changes under Side Effects”), tell your doctor immediately.

In asthmatic patients treated with montelukast, very rare cases of a combination of allergic symptoms including a flu-like illness, pins and needles or numbness of arms or legs, and/or rash have been reported. Although it is unknown if montelukast can cause this condition, you must tell your doctor right away if you get one or more of these symptoms.

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

If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking SINGULAIR.

Things you must not do

If you have been prescribed the 10 mg film-coated tablets, do not take two 5 mg chewable tablets in its place. If you have been prescribed the 5 mg tablets, do not take half a 10 mg tablet in its place.

The different strength tablets may not have the same effect, as they are absorbed slightly differently in the body.

Do not take SINGULAIR to relieve an acute asthma attack. In case of an acute asthma attack, follow your doctor’s instructions on what reliever medicine to use.

Do not give SINGULAIR to anyone else, even if they have the same condition as you.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking SINGULAIR.

SINGULAIR helps most people with asthma and/or seasonal allergic rhinitis, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

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

Tell your doctor if you notice any of the following and they worry you:

fluid retention

nose bleed

headache, dizziness, drowsiness

feeling unusually weak or tired

upper respiratory tract infection

bedwetting in children

Muscle or nerve problems:

muscle aches or cramps, joint pain

decreased feeling or sensitivity, especially in the skin

pins and needles/numbness

Stomach or bowel problems:

stomach pain

nausea, vomiting

diarrhoea

Behaviour and mood-related changes, including suicidal thoughts and actions, have been reported in patients taking montelukast. If you or your child experience these changes while taking montelukast, tell your doctor.

Tell your doctor if you notice any of the following behaviour and mood-related changes:

agitation, including aggressive behaviour or hostility

anxiousness, depression (sad mood)

disorientation, dream abnormalities, hallucinations (seeing or hearing things that are not there)

insomnia, irritability, restlessness, sleep walking

stuttering

tremors

disturbance in attention, memory impairment

uncontrolled muscle movements

obsessive-compulsive symptoms

These are usually mild side effects of SINGULAIR.

Tell your doctor immediately if you notice any of the following:

suicidal thoughts and actions

skin rash or itchiness

increased tendency to bleed, bruising

fast or irregular heart beats, also called palpitations

swelling (inflammation) of the lungs

symptoms of liver disease such as nausea, vomiting, loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes, and dark coloured urine

These may be serious side effects. You may need urgent medical attention. Serious side effects are rare.

If any of the following happen, stop taking SINGULAIR and tell your doctor immediately or go to accident and emergency at your nearest hospital:

swelling of the face, lips, mouth, throat or tongue which may cause difficulty in breathing or swallowing

pinkish, itchy swellings on the skin, also called hives or nettle rash, severe skin reactions that may occur without warning

seizure

These may be serious side effects. If you have them, you may be having a serious allergic reaction to SINGULAIR. You may need urgent medical attention. These side effects are rare.

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

Other side effects not listed above may also occur in some patients. Some of these side effects (for example, increased bleeding tendency, low blood platelet count) can only be detected when your doctor does tests from time to time to check your progress.

Tell your doctor if you notice any other effects.

After using SINGULAIR

Storage

Keep your tablets in the blister pack until it is time to take them.

If you take the tablets out the blister pack they may not keep well.

Keep SINGULAIR in a cool dry place, away from light, where the temperature stays below 30°C.

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

Do not leave it in the car or on window sills.

Heat and dampness can destroy some medicines.

Keep it where children cannot reach it.

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 the tablets, or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.

Product description

What it looks like

SINGULAIR comes as three types of tablets:

10 mg film-coated tablet – beige, rounded square tablet with SINGULAIR marked on one side and MSD 117 on the other.

5 mg chewable tablet – pink, round tablet with SINGULAIR marked on one side and MSD 275 on the other.

4 mg chewable tablet – pink, oval tablet with SINGULAIR marked on one side and MSD 711 on the other.

A box of SINGULAIR contains 14 or 28 tablets. To start treatment, SINGULAIR may also be supplied in packs of 4 tablets.

Ingredients

Active ingredient:

10 mg film-coated tablet contains 10 mg montelukast

5 mg chewable tablet contains 5 mg montelukast

4 mg chewable tablet contains 4 mg montelukast

Inactive ingredients:

1. 10 mg film-coated tablets

microcrystalline cellulose

lactose monohydrate

croscarmellose sodium

hyprolose

magnesium stearate

hypromellose

titanium dioxide

iron oxide red

iron oxide yellow

carnauba wax

2. 5 mg and 4 mg chewable tablets

mannitol

microcrystalline cellulose

hyprolose

croscarmellose sodium

artificial cherry flavour aromolok 181612 (proprietary ingredient: 2916)

magnesium stearate

aspartame

iron oxide red

SINGULAIR 10 mg film-coated tablets, and 5 mg and 4 mg chewable tablets do not contain gluten, sucrose, tartrazine or any other azo dyes. The 10 mg film-coated tablets contain lactose monohydrate; the 5 mg and 4 mg chewable tablets do not.

Supplier

SINGULAIR is supplied in Australia by:

Organon Pharma Pty Ltd

Building A 26 Talavera Road

MACQUARIE PARK NSW 2113

This leaflet was prepared in November 2022.

Australian Register Numbers:

10 mg – AUST R 61846

5 mg – AUST R 61847

4 mg – AUST R 74890

S-WPPI-MK-0476-MF–052019

RCN100002584

This CMI leaflet was current at the time of printing.