Package leaflet: Information for the user

<Montelukast Gedeon Richter> 10 mg film coated tablets

montelukast

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

-    Keep this leaflet. You may need to read it again. <Montelukast Gedeon Richter> 10 mg film coated tablets will be referred to as <Montelukast Gedeon Richter> throughout this leaflet.

-    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 possible side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What <Montelukast Gedeon Richter> is and what it is used for

2.    What you need to know before you take <Montelukast Gedeon Richter>

3.    How to take <Montelukast Gedeon Richter>

4.    Possible side effects

5.    How to store <Montelukast Gedeon Richter>

6.    Contents of the pack and other information

1. What <Invented name> is and what it is used for

The active ingredient of this medicine is called montelukast. It blocks naturally occurring compounds in the lungs called leukotrienes. These compounds cause narrowing and swelling of the airways and inflammation in the lungs which can lead to asthma symptoms such as cough and wheeze. By blocking leukotrienes, <Montelukast Gedeon Richter> 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 Gedeon Richter> to treat asthma, preventing your asthma symptoms during the day and night.

-    <Montelukast Gedeon Richter> is used for the treatment of patients who are not adequately controlled on their medication and need additional therapy.

-    <Montelukast Gedeon Richter> also helps prevent the narrowing of airways triggered by exercise.

-    In those asthmatic patients in whom <Montelukast Gedeon Richter> is indicated in asthma, <Montelukast Gedeon Richter> can also provide symptomatic relief of seasonal allergic rhinitis.

Your doctor will determine how <Montelukast Gedeon Richter> should be used depending on the symptoms and severity of your asthma.

2. What you need to know before you use <Montelukast Gedeon Richter>

Do not take <Montelukast Gedeon Richter>

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

Warnings and precautions

Talk to your doctor before taking <Montelukast Gedeon Richter>.

-    If you have now or have ever had any medical problems or allergies.

-    If your asthma or breathing get 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. Always have your inhaled rescue medicine for asthma attacks with you.

-    It is important that you or your child 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 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 aspirin or anti-inflammatory medicines (also known as non-steroidal antiinflammatory drugs or NSAIDs) if they make your asthma worse.

-    Montelukast should not be substituted for inhaled or oral corticosteroids.

Children and adolescents

<Montelukast Gedeon Richter> 10 mg film-coated tablets are not recommended for use in children and adolescents under the age of 15. 5 mg chewable tablets are available for paediatric patients 6 to 14 years of age. 4 mg chewable tablets are available for children 2 to 5 years of age.

Other medicines and <Montelukast Gedeon Richter>

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

Some medicines may affect how <Montelukast Gedeon Richter> works, or <Montelukast Gedeon Richter> may affect how other medicines work.

Tell your doctor if you are taking the following medicines before starting <Montelukast Gedeon Richter>:

-    phenobarbital (used for treatment of epilepsy)

-    phenytoin (used for treatment of epilepsy)

-    rifampicin (used to treat tuberculosis and some other infections)

-    gemfibrozil (used for the treatment of high lipid levels in plasma)

-    any other products that contain the same active ingredient, montelukast.

<Montelukast Gedeon Richter> with food and drink

Montelukast 10 mg may be taken with or without food.

Pregnancy and breast-feeding

If you 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 this medicine.

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

It is not known if <Montelukast Gedeon Richter> appears in breast milk. You should consult your doctor before taking <Montelukast Gedeon Richter> if you are breast-feeding or intend to breast-feed.

Driving and using machines

<Montelukast Gedeon Richter> 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 Gedeon Richter> may affect some patients’ ability to drive or operate machinery.

<Montelukast Gedeon Richter> contains lactose

<Montelukast Gedeon Richter> 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 take <Montelukast Gedeon Richter>

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

You should take only one tablet of <Montelukast Gedeon Richter> once a day as prescribed by your doctor.

It should be taken even when you have no symptoms or have an acute asthma attack.

For adults and adolescents aged 15 years and older:

One 10 mg tablet to be taken by mouthdaily in the evening. <Montelukast Gedeon Richter> 10 mg may be taken with or without food.

Use in children and adolescents

10 mg film-coated are available for adults and adolescents 15 years of age and older.

5 mg chewable tablets are available for paediatric patients 6 to 14 years of age.

4 mg chewable tablets are available for children 2 to 5 years of age.

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

If you take more <Montelukast Gedeon Richter> than you should

Contact your doctor immediately for advice.

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

If you forget to take <Montelukast Gedeon Richter>

Try to take <Montelukast Gedeon Richter> as prescribed. However, if you miss a dose, just resume the usual schedule of one tablet once daily.

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

If you stop taking <Montelukast Gedeon Richter>

<Montelukast Gedeon Richter> can treat your asthma only if you continue to take it.

It is important to continue taking <Montelukast Gedeon Richter> for as long as your doctor prescribes. It will help control your asthma.

If you have any further questions on the use of this 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 10 mg film-coated tablets, the most commonly (occurring in 1 or more of 100 patients and less than 1 of 10 patients treated) reported side effects 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 of possible side effects listed below is defined using the following convention:

Very common (may affect more than 1 in 10 people)

Common (may affect up to 1 in 10 people)

Uncommon (may affect more than 1 in 100 people)

Rare (may affect more than 1 in 1000 people)

Very rare (may affect more than 1 in 10,000 people)

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

Very common:

-    upper respiratory infection Common:

-    nausea, vomiting, diarrhoea

-    rash

-    fever

Uncommon:

-    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 [dream abnormalities, including nightmares, trouble sleeping, sleep walking], irritability, feeling anxious, restlessness, agitation including aggressive behaviour or hostility, depression

-    dizziness, drowsiness, pins and needles/numbness, seizure

-    joint or muscle pain, muscle cramps

-    dry mouth, indigestion

-    nosebleed

-    bruising, itching, hives

-    weakness/tiredness, feeling unwell, swelling

Rare:

-    tremor, disturbance in attention, memory impairment

-    palpitations

-    increased bleeding tendency

Very rare:

-    hallucinations, disorientation, suicidal thoughts and actions

-    hepatitis (inflammation of the liver)

-    tender red lumps under the skin most commonly on the shins (erythema nodosum), severe skin reactions (erythema multiforme) that may occur without warning

-    In asthmatic patients treated with montelukast, very rare cases of a 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) have been reported. You must tell your doctor right away if you get one or more of these symptoms.

Reporting of side effects

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 national reporting system Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

Ask your doctor or pharmacist for more information about side effects. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store <Montelukast Gedeon Richter>

Keep out of the reach and sight of children.

Do not use “Montelukast Gedeon Richter” after the expiry date which is stated on the carton and the blister after EXP:.

The expiry date refers to the last day of that month.

Store below 25°C. Store in the original package in order to protect from moisture and light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What <Montelukast Gedeon Richter> contains

The active substance is montelukast.

Each film-coated tablet contains 10 mg of montelukast equivalent to 10.4 mg montelukast sodium. The other ingredients are:

Lactose monohydrate, cellulose microcrystalline , hydroxypropylcellulose, croscarmellose sodium, magnesium stearate (E572).

Coat (Opadry Yellow 20B32427): hypromellose, hydroxypropylcellulose, titanium dioxide (E171), macrogol 400, iron oxide yellow (E172)

What <Montelukast Gedeon Richter> looks like and contents of the pack

Yellow, round, biconvex, with “R15” engraving on one side.

Blister: OPA-Al-PVC/Al blister

Pack sizes: 20x, 28x, 30x, 50x, 98x, 100x tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Gedeon Richter Plc.

1103 Budapest, Gyomroi ut 19-21 Hungary

Manufacturer

GEDEON RICHTER POLSKA Sp. z o.o. ul. ks. J. Poniatowskiego 5 05-825 Grodzisk Mazowiecki Poland

This medicinal product is authorised in the Member States of the EEA under the following names:

Belgium: Montelukast Apotex France: Montelukast Gedeon Richter Germany: Montelukast Gedeon Richter Hungary: Montelukast Gedeon Richter Italy: Montelukast Gedeon Richter United Kingdom: Montelukast Gedeon Richter

This leaflet was last revised in {12/2013}.

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