Montelukast 4 mg chewable tablets

• 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 Montelukast is and what it is used for
2. What you need to know before you take Montelukast
3. How to take Montelukast
4. Possible side effects
5. How to store Montelukast
6. Contents of the pack and other information

Montelukast is a leukotriene receptor antagonist that blocks substances called leukotrienes.

Leukotrienes cause narrowing and swelling of airways in the lungs. By blocking leukotrienes, Montelukast improves asthma symptoms and helps control asthma.

Your doctor has prescribed Montelukast to treat your child’s asthma, preventing asthma symptoms during the day and night.

• Montelukast is used for the treatment of 2 to 5 year old patients who are not adequately controlled on their medication and need additional therapy.
• Montelukast may also be used as an alternative treatment to inhaled corticosteroids for 2 to 5 year old patients who have not recently taken oral corticosteroids for their asthma and have shown that they are unable to use inhaled corticosteroids.
• Montelukast also helps prevent the narrowing of airways triggered by exercise for patients 2 years of age and older.

Your doctor will determine how Montelukast should be used depending on the symptoms and severity of your child’s asthma.

Asthma is a long-term disease.

Asthma includes:

• difficulty breathing because of narrowed airways. This narrowing of airways worsens and improves in response to various conditions.
• sensitive airways that react to many things, such as cigarette smoke, pollen, cold air, or exercise.
• swelling (inflammation) in the lining of the airways.

Symptoms of asthma include: Coughing, wheezing, and chest tightness.

• is allergic to montelukast or any of the other ingredients of this medicine (listed in section 6)

Talk to your doctor or pharmacist before you give Montelukast to your child.

• If your child’s asthma or breathing gets worse, tell your doctor immediately.
• Oral Montelukast is not meant to treat acute asthma attacks. If an attack occurs, follow the instructions your doctor has given you for your child. Always have your child’s inhaled rescue medicine for asthma attacks with you.
• It is important that your child take all asthma medications prescribed by your doctor. Montelukast should not be used instead of other asthma medications your doctor has prescribed for your child.
• If your child is on anti-asthma medicines, be aware that if he/she develops a combination of symptoms such as flu-like illness, pins and needles or numbness of arms or legs, worsening of pulmonary symptoms, and/or rash, you should consult your doctor.
• Your child should not take acetyl-salicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they make his/her asthma worse.

Various neuropsychiatric events (for example behaviour and mood-related changes, depression and suicidality) have been reported in patients of all ages treated with montelukast (see section 4). There have also been reports of these symptoms continuing after treatment is stopped. If you develop such symptoms while taking montelukast or if these symptoms do not resolve after montelukast is stopped, you should contact your prescriber.

Do not give this medicine to children less than 2 years of age.

There are different form(s) of this medicine available for paediatric patients under 18 years of age based on age range.

Tell your doctor or pharmacist if your child is taking or has recently been given or might be given any other medicines including those obtained without a prescription.

Some medicines may affect how Montelukast works, or Montelukast may affect how your child’s other medicines work.

Tell your doctor if your child is taking the following medicines before starting Montelukast:

• phenobarbital (used for treatment of epilepsy)
• phenytoin (used for treatment of epilepsy)
• rifampicin (used to treat tuberculosis and some other infections)

Montelukast 4 mg chewable tablets should not be taken immediately with food; they should be taken at least 1 hour before or two hours after food.

This subsection is not applicable for the Montelukast chewable tablets since they are intended for use in children 2 to 5 years of age.

This subsection is not applicable for the Montelukast 4 mg chewable tablets since they are intended for use in children 2 to 5 years of age, however the following information is relevant to the active ingredient, montelukast.

Montelukast is not expected to affect your ability to drive a car or operate machinery. However, individual responses to medication may vary.

Certain side effects (such as dizziness and drowsiness) that have been reported very rarely with Montelukast may affect some patients’ ability to drive or operate machinery.

Montelukast contain aspartame, a source of phenylalanine. If your child has phenylketonuria (a rare, hereditary disorder of the metabolism) you should take into account that each Montelukast 4 mg chewable tablet contains phenylalanine (equivalent to 0.674 mg phenylalanine per 4 mg chewable tablet).

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

The recommended dose is one 4 mg chewable tablet daily to be taken in the evening.

If your child is taking Montelukast, be sure that he/she does not take any other medicines that contain the same active ingredient, montelukast.

This medicine is for oral use.

The tablets are to be chewed before swallowing.

Montelukast 4 mg chewable tablets should not be taken immediately with food; it should be taken at least 1 hour before or 2 hours after food.

Contact your child’s doctor immediately for advice.

There were no side effects reported in the majority of overdose reports. The most frequently occurring symptoms reported with overdose in adults and children included abdominal pain, sleepiness, thirst, headache, vomiting, and hyperactivity.

Try to give Montelukast as prescribed. However, if your child misses a dose, just resume the usual schedule of one tablet once daily.

Do not give a double dose to make up for a forgotten dose.

Montelukast can treat your child’s asthma only if your child continues taking it.

It is important for your child to continue taking Montelukast for as long as your doctor prescribes.

It will help control your child’s asthma.

Talk with your doctor immediately if you notice any of the following side effects, which may be serious, and for which you may need urgent medical treatment.

Uncommon: the following may affect up to 1 in 100 people

• allergic reactions including swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing
• behaviour and mood related changes: agitation including aggressive behaviour or hostility, depression
• seizure

Rare: the following may affect up to 1 in 1,000 people

• increased bleeding tendency
• tremor
• palpitations

Very rare: the following may affect up to 1 in 10,000 people

• combination of symptoms such as flu-like illness, pins and needles or numbness of arms and legs, worsening of pulmonary symptoms and/or rash (Churg-Strauss syndrome) (see Section 2)
• low blood platelet count
• behaviour and mood related changes: hallucinations, disorientation, suicidal thoughts and actions
• swelling (inflammation) of the lungs
• severe skin reactions (erythema multiforme) that may occur without warning
• inflammation of the liver (hepatitis)

Very common: the following may affect more than 1 in 10 people

• upper respiratory infection

Common: the following may affect up to 1 in 10 people

• diarrhoea, nausea, vomiting
• rash
• fever
• elevated liver enzymes

Uncommon: the following may affect up to 1 in 100 people

• behaviour and mood related changes: dream abnormalities, including nightmares, trouble sleeping, sleepwalking, irritability, feeling anxious, restlessness
• dizziness, drowsiness, pins and needles/ numbness
• nosebleed
• dry mouth, indigestion
• bruising, itching, hives
• joint or muscle pain, muscle cramps
• bedwetting in children
• weakness/tiredness, feeling unwell, swelling

Rare: the following may affect up to 1 in 1,000 people

• behaviour and mood related changes: disturbance in attention, memory impairment, uncontrolled muscle movements

Very rare: the following may affect up to 1 in 10,000 people

• tender red lumps under the skin, most commonly on your shins (erythema nodosum)
• behaviour and mood related changes: obsessive-compulsive symptoms
• stuttering

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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is montelukast. Each chewable tablet contains montelukast sodium, which is equivalent to 4 mg montelukast.
• The other ingredients are mannitol (E421), cellulose, microcrystalline, hydroxypropyl cellulose 2% (6 to 10 mpaS), croscarmellose sodium, iron oxide red (E172), aspartame (E951), artificial cherry flavour (contains flavouring ingredients and modified food starch) and magnesium stearate.

Chewable tablets

Pink coloured, mottled, oval, biconvex, uncoated tablets debossed with ‘X’ on one side and ‘52’ on other side.

Montelukast chewable tablets are available in PVC/ Polyamide/ Aluminium foil/ PVC blister pack and HDPE bottle with polypropylene closure containing silica gel desiccant.

Presentations

Blister pack: 7, 10, 14, 20, 28, 30, 49, 50, 56, 60, 84, 90, 98, 100, 140 and 200 chewable tablets.

HDPE bottle pack: 30, 90 and 500 chewable tablets

Not all pack sizes may be marketed.

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