• 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 your child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as your child’s.
• 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 4 mg Chewable Tablets is and what it is used for
2. What you need to know before your child is given Montelukast 4 mg Chewable Tablets
3. How Montelukast 4 mg Chewable Tablets is given
4. Possible side effects
5. How to store Montelukast 4 mg Chewable Tablets
6. Contents of the pack and other information

Asthma is a long-term disease.

Asthma includes:

• Difficulty in breathing because of the narrowed airways. The narrowing of airways can worsen and improve 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 tightness in the chest.

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

Talk to your doctor or pharmacist before giving Montelukast 4 mg Chewable Tablets to your child

• If your child’s asthma or breathing gets worse, tell your doctor immediately.
• Montelukast 4 mg chewable tablets is not meant to treat acute asthma attacks. If an attack, follow the instructions your doctor has given you for your children. Always have your child’s inhaled rescue medicine for asthma attacks with you.
• It is important that your child taken all asthma medicines prescribed by your doctor; Montelukast 4 mg Chewable Tablets 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 be given acetylsalicylic 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). If you develop such symptoms while taking montelukast, you should contact your doctor.

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

For children 6 months to 2 years montelukast 4mg granules are available.

Tell your doctor or pharmacist if your child is taking, have recently taken or might take any other medicines, including those medicines obtained without a prescription. This is because some medicines may affect how montelukast works, or montelukast can affect how other medicines work.

Please tell your doctor if your child is given any of the following medicines before using Montelukast 4 mg Chewable Tablets:

• Phenobarbital (used for treatment of epilepsy)
• Phenytoin (used for treatment of epilepsy)
• Rifampicin (used to treat tuberculosis and some other infections)

This medicine should not be taken immediately with food; it should be taken at least 1 hour before or two hours after food.

This subsection is not applicable for this medicine, since it is intended for use in children aged 2 to 5 years old, however the following information is relevant to the active ingredient, montelukast.

Pregnancy

Women who are pregnant or intend to become pregnant should consult their doctor before taking this medicine. Your doctor will assess whether you can take this medicine during this time.

Breast-feeding

It is not known if this medicine appears in breast milk. You should consult your doctor before taking this medicine if you are breast-feeding or if you intend to breast feed.

Ask your doctor or pharmacist for advice before taking any medicine.

This subsection is not applicable for this medicine since it is intended for use in children aged 2 to 5 years old, however the following information is relevant to the active ingredient, montelukast.

Montelukast is not expected to affect your ability to drive or operate machinery. However, individual response to the 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.

Aspartame is a source of phenylalanine. If your child has phenylketonuria (a rare, hereditary disorder of the metabolism) you should take into account that each tablet contains phenylalanine (equivalent to 0.674 mg/tablet).

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

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 (unusually active).

Always give this medicine as prescribed by your doctor. However, if you forget to give a dose to your child , just resume the usual schedule of one tablet once daily. Do not give a double dose to make up for a forgotten tablet.

This medicine can treat your child’s asthma only if your child continues to take it. It is important for your child to continue taking this medicine for as long as recommended by your doctor. It will help control your child’s asthma symptoms.

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 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 sodium. Each tablet contains montelukast sodium which corresponds to 4 mg of montelukast
• The other ingredients are:Mannitol [E421], Cellulose microcrystalline. Hydroxypropylcellulose [E463], Croscarmellose sodium, Cherry flavour, Aspartame [E951], Magnesium stearate.

The 4 mg chewable tablets are white to off-white, 11 x 7.8mm oval, biconvex uncoated tablets, with ‘G’ engraved on one side, and ‘390’ on the other side.

The tablets are packed in HDPE containers which includes a desiccant protecting the tablets from moisture. The desiccant should not be swallowed.

Pack sizes: 20, 28, 30, 50 and 100.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer