MONTELUKAST 10 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

1. whatmontelukast 10 mg film-coated tablets is and what itis used for

Montelukast is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling ofairways in the lungs andalso cause allergy symptoms.

By blocking leukotrienes, montelukast improves asthma symptoms, helps control asthma and improves seasonal allergy symptoms (also known as hay fever or seasonal allergic rhinitis).

Your doctor has prescribed Montelukast 10 mg film-coated tablets to treat asthma, preventing your asthma symptoms during the day and night.

• Montelukast 10 mg film-coated tablets is used for the treatment ofpatients aged 15 years and older who are not adequately controlled on their medication and need additional therapy.
• Montelukast 10 mg film-coated tablets also helps prevent the narrowing of airways triggered by exercise.
• In those asthmatic patients in whom Montelukast 10 mg film-coated tablets is indicated in asthma, Montelukast 10 mg film-coated tablets can also provide symptomatic reliefofseasonal allergic rhinitis.

Your doctor will determine how Montelukast 10 mg film-coated tablets should be used depending on the symptoms and severity ofyour asthma.

What is asthma?

Asthma is a long-term disease.

Asthma includes:

• difficulty breathing because ofnarrowed airways. This narrowing ofairways 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 ofthe airways.

Symptoms ofasthma include coughing, wheezing, and chest tightness.

What are seasonal allergies?

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

2. what you need to know before you takemontelukastl0 mg film-coated tablets

Tell your doctor about any medical problems or allergies you have now or have had.

Do not takeMontelukast 10 mg film-coated tablets

• Ifyou are allergic (hypersensitive) to montelukast or any ofthe other ingredients ofthis medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Montelukast 10 mg film-coated tablets:

• Ifyour 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 your inhaled rescue medicine for asthma attacks with you.
• It is important that you take all asthma medications prescribed by your doctor. Montelukast should not be substituted for other asthma medications your doctor has prescribed for you.
• Any patient on anti-asthma medicines should be aware that ifyou develop a combination ofsymptoms such as a flu-like illness, pins and needles or numbness ofarms or legs, worsening ofpulmonary symptoms, and/or rash, you should consult your doctor.
• You should not take acetyl-salicylic acid (aspirin) or anti-inflammatory medicines (also known as nonsteroidal anti-inflammatory drugs or NSAIDs) ifthey make your asthma worse.

Children and adolescents

Montelukast 10 mg film-coated tablets is not suitable for children and adolescents under 15 years ofage for whom alternative products available in lower strengths are recommended.

Other medicines andMontelukast

Tell your doctor or pharmacist ifyou are taking, have recently taken or might take any other medicines.

Some medicines may affect how Montelukast IOmg film-coated tablets works or Montelukast 10 mg film-coated tablets may affect how other medicines work.

Tell your doctor ifyou are taking the following medicines before starting Montelukast:

• phenobarbital (used for treatment ofepilepsy)
• phenytoin (used for treatment ofepil sy)
• rifampicin (used to treat tuberculosis and some other infections)
• gemfibrozil (used for treatment ofhigh lipid levels in plasma)

Montelukast 10 mg film-coated tablets with food and drink

Montelukast may be taken with or without food.

Pregnancy and breast-feeding

Ifyou are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking thismedicine.

Pregnancy

Women who are pregnant or intend to become pregnant should consult their doctor before taking Montelukast. Your doctor will assess whether you can take Montelukast 10 mg film-coated tablets during this time.

Breast-feeding

It is not known ifmontelukast appears in breast milk. You should consult your doctor before taking Montelukast 10 mg film-coated tablets ifyou are breast-feeding or intend to breast-feed.

Driving and using machines

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 10 mg film-coated tablets contain lactose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. how to takemontelukast

Always take this medicine exactly as your doctor has told you. Check with your doctor ifyou are not sure.

• The recommended dose is only one tablet ofMontelukast 10 mg film-coated tablets once a day as prescribed by your doctor.
• It should be taken even when you have no symptoms or have an acute asthma attack.
• To be taken by mouth.

Use in adults and adolescent 15 years of age and older

The recommended dose is one 10 mg tablet to be taken daily in the evening. Montelukast 10 mg film-coated tablets may be taken with or without food.

Use in children and adolescentsyounger than 15 years

This product is not suitable for children and adolescents under 15 years of age for whom alternative products available in lower strengths are recommended.

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

If you take moreMontelukast 10 mg film-coated tablets than you should

Contact your doctor immediately for advice.

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

If you forget to takeMontelukast 10 mg film-coated tablets

Try to take Montelukast 10 mg film-coated tablets as prescribed. However, if you miss a dose, just resume the usual schedule ofone tablet once daily.

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

If you stop takingMontelukast 10 mg film-coated tablets

Montelukast 10 mg film-coated tablets can treat your asthma only ifyou continue to take it.

It is important to continue taking Montelukast 10 mg film-coated tablets for as long as your doctor prescribes. It will help control your asthma.

Ifyou have any further questions on the use ofthis product, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In clinical studies with montelukast, the most commonly reported side effects (occurring in at least 1 of 100 patients and less than I of10 patients treated) thought to be related to montelukast were:

• abdominal pain
• headache

These were usually mild and occurred at a greater frequency in patients treated with montelukast than placebo (a pill containing no medication).

The frequency ofpossible side effects listed below is defined using the following convention:

• Very common (affects at least 1 user in 10)
• Common (affects 1 to IOusers in 100)
• Uncommon (affects I to I0users in 1,000)
• Rare (affects 1 to lOusers in 10,000)
• Very rare (affects less than 1 user in 10,000)

Additionally, while the medicine has been on the market, the following have been reported:

• upper respiratory infection ( Very common)
• increased bleeding tendency (Rare)
• allergic reactions including swelling ofthe face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing (Uncommon)
• behaviour and mood related changes [dream abnormalities, including nightmares, trouble sleeping, sleep walking, irritability, feeling anxious, restlessness, agitation including aggressive behaviour or hostility, depression (Uncommon); tremor, disturbance in attention, memory impairment (Rare); hallucinations, disorientation, suicidal thoughts and actions (Very rare)]
• dizziness, drowsiness, pins and needles/numbness, seizure (Uncommon)
• palpitations (Rare)
• nose bleed (Uncommon)
• diarrhoea, nausea, vomiting (Common); dry mouth, indigestion (Uncommon)
• hepatitis (inflammation ofthe liver) (Very rare)
• rash (Common); bruising, itching, hives (Uncommon); tender red lumps under the skin most commonly on your shins (erythema nodosum), severe skin reactions (erytherna multiforme) that may occur without warning (Very rare)
• joint or muscle pain, muscle cramps (Uncommon)
• fever (Common); weakness/tiredness, feeling unwell, swelling (Uncommon)

5. how to storemontelukast 10 mg film-coated tablets

Keep this medicine out ofthe sight and reach ofchildren.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day ofthat month.

Do not store above 30 °C.

Store in the original package in order to protect from moisture and light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

WhatMontelukast 10 mg film-coated tablets contains

The active substance is montelukast. Each film-coated tablet contains montelukast sodium which corresponds to 10 mg ofmontelukast.

The other ingredients are: cellulose, microcrystalline (E460), lactose monohydrate, hydroxypropyl­cellulose, low substituted (E463), croscarmellose sodium (E468), magnesium stearate (E572).

Film coating: hypromellose, type 2910 (E464), hydroxypropyl­cellulose (E463), titanium dioxide(E171), carnauba wax (E903), iron oxide yellow (El 72), iron oxide red (El 72).

WhatMontelukast 10 mg film-coated tablets looks like and contents of the pack

Montelukast 10 mg film-coated tablets are beige coloured, rounded square, film coated, biconvex tablets, 8.1 mm x 8.1 mm, plain on both sides.

Packaged in OPA-AI-PVC/Al blister in following pack sizes 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 100, 140 and 200 tablets.

Not all pack sizes may be marketed.

MarketingAutho­risation Holder andManufacturer

Marketing Authorisation Holder

Rivopharm UK Ltd.

30th Floor, 40 Bank Street

Canary Wharf,

London, E14 5NR, UK

Manufacturer

IMUNAPHARM, a.s.

Jarkova269/17

082 22 Sarisske Michal'any

Slovak Republic

This leaflet was last revised inDecember201 9

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