• 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 10 mg Film-coated Tablets is and what it is used for
2. What you need to know before you take Montelukast 10 mg Film-coated Tablets
3. How to take Montelukast 10 mg Film-coated Tablets
4. Possible side effects
5. How to store Montelukast 10 mg Film-coated 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. 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.

Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are an allergic response often caused by airborne pollen from trees, grass and weeds. The symptoms of seasonal allergies typically may include stuffy, runny, itchy nose; sneezing; watery, swollen, red and itchy eyes.

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

Talk to your doctor or pharmacist before taking this medicine.

• If your asthma or breathing gets worse, tell your doctor immediately.
• Oral Montelukast 10 mg Film-coated Tablets is not meant to treat acute asthma attacks. If an attack occurs, follow the instructions your doctor has given you. Always have with you, your inhaled rescue medicine for asthma attack.
• Any patient on anti-asthma medicines should be aware that if you develop a combination of symptoms such as a flu-like illness, pins and needles or numbness of arms or legs, worsening of pulmonary symptoms, and/or rash, you should consult your doctor.
• You should not take acetyl-salicyclic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti--inflammatory drugs or NSAIDS) if they make your asthma worse.
• It is important that you or your child takes all asthma medicines as prescribed by your doctor.

Montelukast should not be used in place of other asthma medications your doctor has prescribed for you.

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 15 years of age.

For children from the age of 2 to 5 years old, Montelukast 4 mg Chewable Tablets are available.

For children from the age of 6 to 14 years old, Montelukast 5 mg Chewable Tablets are available.

For children 6 months to 5 years 4mg granules are also available.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those medicines obtained without a prescription. This includes medicines, herbal remedies, health products or supplements that you have obtained without a prescription.

Treatment with Montelukast 10 mg Film-coated Tablets can be affected by other medicines. Some medicines may affect how montelukast works, or montelukast may affect how other medicines work. Tell your doctor if you are taking any of the following medicines before starting Montelukast 10 mg Film-coated Tablets:

Phenobarbital (used for treatment of epilepsy)

Phenytoin (used for treatment of epilepsy)

Rifampicin (used to treat tuberculosis and some other infections)

Gemfibrozil (used for treatment of high lipid levels in plasma).

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

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 intend to breast-feed.

This medicine 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 with this medicine may affect some patients ability to drive or operate machinery, therefore caution is advised.

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars (rare hereditary problems, galactose intolerance, the lapp lactose deficiency of glucose-galactose malabsorption), you should contact your doctor before taking this medicine.

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

The recommended dose is one 10 mg tablet to be taken daily in the evening. This medicine may be taken with or without food.

If you are taking this medicine, be sure that you do not take any other products that contain the same active ingredient, montelukast.

If you take more tablets than you should contact your 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 adolescents included abdominal pain, sleepiness, thirst, headache, vomiting and hyperactivity (unusually active).

Try to take this medicine as recommended to you by your doctor. However, if you miss a dose, just take your tablet as soon as you remember. Take your next dose of one tablet once daily at the usual time. Do not take a double dose to make up for a forgotten tablet.

This medicine can treat your asthma only if you continue to take it. It is important to continue taking this medicine as prescribed to you by your doctor. It will help control your asthma.

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 10 mg of montelukast.
• The other ingredients are:

Core:

Cellulose microcrystalline

Lactose monohydrate

Croscarmellose sodium

Hydroxypropylcellulose (E463)

Magnesium stearate

Film-coating:

Hypromellose (E464)

Hydroxypropylcellulose (E463)

Titanium dioxide (E171)

Iron Oxide yellow (E172)

Carnauba wax (E903)

Iron Oxide red (E172)

10 mg tablets are beige, round, 8 mm biconvex, film-coated tablets, engraved with ‘G’ on one side and ‘392’on the other side.

Montelukast 10 mg Film-coated Tablets are available in Aluminium/Aluminium blister pack or HDPE containers in cardboard carton with polypropylene child resistant closure and silica gel desiccant canister.

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

Not all pack sizes may be marketed.

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