<§) ABDIFARMA MONTELUKASHOmg

nm*w*m\ #11 livi/i montelukasho mg film-coated tablets

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

Montelukast.

FOR ADOLESCENTS AND ADULTS FROM 15 YEARS

If you take more Montelukast than you should

PACKAGE LEAFLET: INFORMATION FOR THE USER

Contact your doctor immediately for advice.

Montelukast 10 mg film-coated tablets

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.

For adolescents and adults from 15 years

Montelukast

If you forget to take Montelukast

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

Read all of this leaflet carefully before you start taking this medicine.

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

- Keep this leaflet. You may need to read it again later.

- If you have any further questions, ask your doctor or pharmacist.

If you stop taking Montelukast

- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the

Montelukast can treat your asthma only if you continue to take it.

same as yours.

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

- 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

If you have any further questions on the use of this product, ask your doctor or pharmacist.

pharmacist.

4. POSSIBLE SIDE EFFECTS

In this leaflet:

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

1. What Montelukast is and what it is used for

2. Before you take Montelukast

Some side effects can be serious and need immediate medical attention:

3. How to take Montelukast

4. Possible side effects

You must tell your doctor right away if you or your child gets one or more of these symptoms:

5. How to store Montelukast

- allergic reactions including rash, swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or

6. Further information

swallowing

- suicidal thoughts and actions (in very rare cases)

1. WHAT Montelukast IS AND WHAT IT IS USED FOR

- combination of symptoms such as flu-like illness, pins and needles or numbness of arms and legs, cough, shortness of breath,

Montelukast is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and

chest pain, coughing up blood and/or rash (Churg-Strauss syndrome)

swelling of airways in the lungs and also cause allergy symptoms. By blocking leukotrienes, Montelukast improves asthma

symptoms, helps to control asthma and improves seasonal allergy symptoms (also known as hay fever or seasonal allergic

In clinical studies with Montelukast 10 mg film-coated tablets, the most commonly reported side effects (occurring in at least

rhinitis).

1 of 100 patients and less than 1 of 10 patients treated) thought to be related to Montelukast were:

- abdominal pain

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

- headache

- Montelukast is used for the treatment of adolescents and adults from 15 years of age who are not adequately controlled on

These were usually mild and occurred at a greater frequency in patients treated with Montelukast than placebo (a pill containing

their medication and need additional therapy.

no medication).

- Montelukast also helps prevent the narrowing of airways triggered by exercise.

- In those asthmatic patients in whom Montelukast is indicated in asthma, Montelukast can also provide symptomatic relief

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

of seasonal allergic rhinitis.

- upper respiratory infection

- increased bleeding tendency

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

- behaviour and mood related changes (dream abnormalities, including nightmares, hallucinations, irritability, feeling anxious,

restlessness, agitation including aggressive behaviour or hostility, tremor, depression, trouble sleeping, sleepwalking,

What is asthma?

- dizziness, drowsiness, pins and needles/numbness, fit (seizure)

Asthma is a long-term disease.

- sensation of rapid or irregular heartbeat (palpitations)

- palpitations

_m Asthma includes:

- nosebleed

5 - Difficulty breathing because narrowed airways. This narrowing of airways worsens and improves in response to various

- diarrhea, dry mouth, indigestion, nausea, vomiting

■ conditions.

- hepatitis (inflammation of the liver)

- Sensitive airways that react to many things, such as cigarette smoke, pollen, cold air, or exercise.

- bruising, itching, hives, tender red lumps under the skin most commonly on your shins (erythema nodosum)

- Swelling (inflammation) in the lining of the airways.

- joint or muscle pain, muscle cramps

- tiredness, feeling unwell, swelling, fever

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

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, please tell your doctor or pharmacist.

What are seasonal allergies?

Seasonal allergies (also known as hay fever or seasonal rhinitis) are an allergic response often caused by airborne pollens from

5. HOW TO STORE Montelukast

trees, grasses and weeds. The symptoms of seasonal allergies typically may include: stuffy, runny, itchy nose; sneezing; watery,

- Keep out of reach and sight of children.

swollen, red, itchy eyes.

- Do not use this medicine after the date shown by the six numbers following <EXP> on the blister. The first two numbers

2. BEFORE YOU TAKE Montelukast

indicate the months; the last four numbers indicate the year. This medicine expires at the end of the months shown.

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

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

- Do not store above 30°C.

product

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

Do not take Montelukast if you

- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines

- are allergic (hypersensitive) to Montelukast or any of the other ingredients in Montelukast

no longer required. These measures will help protect the environment.

(see 6. FURTHER INFORMATION).

6. FURTHER INFORMATION

Take special care with Montelukast

What Montelukast contains

- If your asthma or breathing gets worse, tell your doctor immediately.

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

- Oral Montelukast is not meant to treat acute asthma attacks. If an asthma attack occurs, follow the instructions your doctor

has given you. Always have your inhaled rescue medicine for asthma attacks with you.

- The other ingredients are:

- It is important that you take all asthma medicines prescribed by your doctor.

Microciystalline cellulose, lactose monohydrate, croscarmellose sodium, hyprolose (E 463) and magnesium stearate

Montelukast should not be substituted for other asthma medications your doctor has prescribed for you.

Film coating: Black Iron oxide (E172), Hypromellose, Red Iron Oxide (E172), Polyethylene Glycol, Titanium Dioxide (E171),

- Any patient on anti-asthma medicines should be aware that if you develop a combination of symptoms such as flu-like illness,

Yellow Iron Oxide (E172), Macrogol (6000).

pins and needles or numbness of arms or legs, cough, shortness of breath, chest pain, coughing up blood, and/or rash occur,

you should consult your doctor.

What Montelukast looks like and contents of the pack

- You should not take aspirin (acetylsalicylic acid) or other anti-inflammatory medicines (also known as non-steroidal anti-

Montelukast 10 mg film-coated tablets are beige, square and biconvex with MOK 10 engraved on one side and PHD471 on

inflammatory drugs or NSAIDs) if they make your asthma worse.

the other.

Blister in packages of: 14,20,28, 30, 50, 98,100 film-coated tablets

Use in children

Not all pack sizes may be marketed.

For children 2 to 5 years old, Montelukast 4 mg chewable tablets are available.

For children 6 to 14 years old, Montelukast 5 mg chewable tablets are available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Taking other medicines

ABDIFARMA, Unipessoal Lda

Some medicines may affect how Montelukastworks, or Montelukastmay affect how other medicines work.

Quinta da Fonte, Rua dos Malhoes,

Edificio D. Pedro I

Please tell your doctor or pharmacist if you are taking or have recently taken other medicines, including those obtained without

2770 - 071 PaQO de Arcos, Portugal

a prescription.

abdifarma@abdiibrahim.com.tr

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

Manufacturer:

- phenobarbital (used for treatment of epilepsy)

Bluepharma Industria Farmaceutica, S.A.

- phenytoin (used for treatment epilepsy)

Sao Martinho do Bispo

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

3045-016 Coimbra

Portugal

Taking Montelukast with food and drink

or

Montelukast 10 mg may be taken with or without food.

Cemelog-BRS Kft.

H-2040 Budaors, Vasut u. 13

Pregnancy and breast-feeding

Hungary

Use in pregnancy

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

Women who are pregnant or intend to become pregnant should consult their doctor before taking Montelukast. Your doctor

Belgium: Montelukast ABDI

will assess whether you can take Montelukast during this time.

Luxembourg: Montelukast ABDI

Netherlands: Montelukast ABDI

Use in breast-feeding

United Kingdom Montelukast 10 mg film-coated tablets

It is not known if Montelukast appears in breast milk. You should consult your doctor before taking Montelukast if you are

breast-feeding or intend to breast-feed.

This leaflet was last approved in 03/2012

Driving and using machines

Montelukast is not expected to affect your ability to drive 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.

Important information about some of the ingredients of Montelukast

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 TAKE Montelukast

- You should take only one table of Montelukast once a day as prescribed by your doctor.

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

- Always take Montelukast as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

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- To be taken by mouth.

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For adults 15 years of age and older:

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One 10 mg tablet to be taken daily in the evening, Montelukast 10 mg may be taken with or without food.