APOTEX

PRINTED PACKAGING MATERIAL MASTER

ADVANCING GEN ERICS

NOTE: Pharmacode is vendor-specific information and may vary.

Page 1 of 2

210 mm -►

105 mm    105 mm -►

E

E

E

E

E

E

PACKAGE LEAFLET: INFORMATION FOR THE USER

Montelukast Apotex 5 mg chewable tablets

montelukast

Read all of this leaflet carefully before your child starts taking this medicine because it contains important information.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, please 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 your child gets any side effects, talk to his/hers 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 is and what it is used for

2.    What you need to know before Montelukast is taken

3.    How to take Montelukast

4.    Possible side effects

5.    How to store Montelukast

6.    Contents of the pack and other information

1. What Montelukast is and what it is used for

280; mm

E

E

E

E

E

E

E

E

Montelukast is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of airways in the lungs. By blocking leukotrienes, Montelukast improves asthma symptoms and helps control asthma.

Your doctor has prescribed Montelukast to prevent your child’s asthma symptoms during the day and night.

•    Montelukast is used for the treatment of asthma of patients who are not adequately controlled on their medication and need additional therapy.

•    Montelukast may also be used as an alternative prevention of asthma to inhaled corticosteroids for 6 to 14 year old patients who have not recently taken oral corticosteroids for their asthma and have shown that they are unable to use inhaled corticosteroids.

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

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

What is asthma?

Asthma is a long-term disease.

Asthma includes:

•    difficulty breathing because of 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.

2. What you need to know before Montelukast is taken

E

E

Tell your doctor about any medical problems or allergies your child has now or has had.

Do not give Montelukast to your child if he/she

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

•    is currently having an asthma attack.

Warning and precautions

Talk to your child’s doctor or pharmacist before giving this medicine to him/her.

•    Oral Montelukast is not meant to treat acute asthma attacks. If an attack occurs, follow the instructions your doctor has given you for your child. Always have your child’s inhaled rescue medicine for asthma attacks with you.

•    It is important that your child takes all asthma medications prescribed by your doctor. Montelukast 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 take acetyl-salicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they make his/her asthma worse.

Use in children

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.

Other medicines and Montelukast

Some medicines may affect how Montelukast works, or Montelukast may affect how your child’s other medicines work.

Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.

Tell your doctor if your child is taking the following medicines before starting Montelukast:

•    gemfibrozil (used for lower lipid levels)

•    phenobarbital (used for treatment of epilepsy)

•    phenytoin (used for treatment of epilepsy)

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

Montelukast with food and drink

Montelukast chewable tablets should not be taken immediately with food; they should be taken at least 1 hour before or 2 hours after food.

Pregnancy and breast-feeding

Use in 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 during this time.

Use in breast-feeding

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.

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 chewable tablets contain aspartame, a source of phenylalanine.

If your child has phenylketonuria (a rare, hereditary disorder of the metabolism) you should take into account that each Montelukast 5 mg chewable tablet contains phenylalanine (equivalent to 0.842 mg phenylalanine per 5 mg chewable tablet).

E

E

E

E

E

E

E

E

Non Text Area

E

E

E

E

E

E

E

E

105 mm

105 mm

Inside Margins 4 mm Top & Bottom 10 mm Left & Right

PRINTED PACKAGING MATERIAL MASTER

APOTEX

ADVANCING GENERICS

NOTE: Pharmacode is vendor-specific information and may vary.

Page 2 of 2

- 210 mm -

105 mm    105 mm

3. How to take Montelukast

E

E

E

E

E

E

E

E

280; mm

E

E

Always have your child take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. You should check with your child’s doctor or pharmacist if you are not sure.

•    This medicine is to be given to a child under adult supervision.

•    Your child should take only one tablet of Montelukast once a day as prescribed by your doctor.

•    It should be taken even when your child has no symptoms or if he/she has an acute asthma attack.

•    To be taken by mouth.

Use in children 6 to 14 years of age:

One Montelukast 5 mg chewable tablet daily to be taken in the evening. Montelukast 5 mg chewable tablets should not be taken immediately with food; it should be taken at least 1 hour before or 2 hours after food.

If your child is taking Montelukast chewable tablets, be sure that he/she does not take any other medicines that contain the same active ingredient, montelukast.

If your child takes more Montelukast than he/she should

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.

If you forget to give Montelukast to your child

Try to give Montelukast as prescribed. However, if your child misses a dose, just resume the usual schedule of one tablet once daily.

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

If your child stops taking Montelukast

Montelukast can treat your child’s asthma only if your child continues taking it.

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

If you have any further questions on the use of this medicine, ask your child’s doctor or pharmacist.

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

•    upper respiratory infection (very common; may affect at least 1 user in 10)

•    fever; rash; diarrhoea, nausea, vomiting (common; may affect 1 to 10 users in 100)

•    allergic reactions including rash, swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing; dizziness, drowsiness, pins and needles/numbness, seizure; nosebleed; joint or muscle pain, muscle cramps; weakness/tiredness, feeling unwell, swelling; dry mouth, indigestion; behaviour and mood related changes (dream abnormalities, including nightmares, trouble sleeping, sleep walking, irritability, feeling anxious, restlessness, agitation including aggressive behaviour or hostility), depression; bruising, itching, hives (uncommon, may affect 1 to 10 users in 1000)

•    increased bleeding tendency; palpitations; tremor (rare, may affect 1 to 10 users in 10 000)

•    hallucinations, disorientation, suicidal thoughts and actions; hepatitis; tender red lumps under the skin most commonly on your shins (erythema nodosum), severe skin reactions (erythema multiforme) that may occur without warning (very rare, may affect less than 1 user in 10 000).

Reporting of side effects

If your child gets any side effects, talk to his/hers 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 (website: www. mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Montelukast

•    Keep this medicine out of the sight and reach of children.

•    Do not use this medicine after the expiry date which is stated on 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.

•    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

E

E

E

E

E

E

E

E

E

E

4. Possible side effects

E

E

E

E

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

Tell your doctor right away if your child gets one or more of these symptoms:

•    flu-like illness

•    pins and needles

•    numbness of arms and legs

•    worsening of pulmonary symptoms and/or rash (Churg-Strauss syndrome)

In clinical studies with Montelukast 5 mg chewable tablets, the most commonly reported side effects (occurring in at least 1 of 100 patients and less than 1 in 10 paediatric patients treated) thought to be related to Montelu-kast were:

•    headache

What Montelukast contains

•    The active substance is montelukast.

Each Montelukast 5 mg tablet contains montelukast sodium equivalent to 5 mg of montelukast.

•    The other ingredients are:

Mannitol (E421), microcrystalline cellulose, croscarmellose sodium, aspartame (E951), FLV ART cherry, red iron oxide, magnesium stearate.

What Montelukast looks like and contents of the pack

Pink coloured, round shaped, biconvex tablets, engraved with “APO” on one side and “M 5”on the other side. The tablets may be mottled.

Blisters in packages of: 10, 28, 30, 98 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Apotex Europe BV, Darwinweg 20, 2333 CR Leiden, The Netherlands

E

E

E

E

E

E

Additionally, the following side effect was reported in clinical studies with Montelukast 10 mg film-coated tablets and 5 mg chewable tablets:

• abdominal pain

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

Manufacturer:

Apotex Nederland BV, Archimedesweg 2, 2333 CN Leiden, The Netherlands

This leaflet was last revised in 10/2014.

APOTEX

E

E

105 mm

A

105 mm--

Inside Margins 4 mm Top & Bottom 10 mm Left & Right