Montelukast Romastru 4 mg kauwtabletten

1. What is and what it is used for

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

Your doctor has prescribed <Product name> to treat your child’s asthma, preventing asthma symptoms during the day and night.

• <Product name> is used for the treatment of 2 to 5 year old patients who are not adequately controlled on their medication and need additional therapy.
• <Product name> may also be used as an alternative treatment to inhaled corticosteroids for 2 to 5 year old patients who have not recently taken oral corticosteroids for their asthma and have shown that they are unable to use inhaled corticosteroids.
• <Product name> also helps prevent the narrowing of airways triggered by exercise for patients 2 years of age and older.

Your doctor will determine how <Product name> should be used depending on the symptoms and severity of your child's 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.

PIL-Montelukast 4 mg chewable tablets - Day 160-v.3

2. What you need to know before your child takes

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

Do not give <Product name> to your child if he/she

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

Warnings and precautions

Talk to your doctor or pharmacist before giving to your child <Product name>.

• If your child’s asthma or breathing gets worse, tell your doctor immediately.
• Oral <Product name> 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 take all asthma medications prescribed by your doctor. <Product name> 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.

Other medicines and <Product name>

Some medicines may affect how <Product name> works, or <Product name> 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 <Product name>:

• phenobarbital (used for treatment of epilepsy)
• phenytoin (used for treatment of epilepsy)
• rifampicin (used to treat tuberculosis and some other infections)

<Product name> with food and drink

<Product name> should not be taken immediately with food; it should be taken at least 1 hour before or two hours after food.

Pregnancy and breast-feeding

This subsection is not applicable for the <Product name> 4 mg chewable tablets since they are intended for use in children 2 to 5 years of age, however the following information is relevant to the active ingredient, montelukast.

Use in pregnancy

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. Your doctor will assess whether you can take <Product name> during this time.

Use in breast-feeding

PIL-Montelukast 4 mg chewable tablets - Day 160-v.3

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

Driving and using machines

This subsection is not applicable for the <Product name> 4 mg chewable tablets since they are intended for use in children 2 to 5 years of age, however the following information is relevant to the active ingredient, montelukast.

<Product name> 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.

<Product name> 4 mg chewable tablets contain aspartame

Contains a source of phenylalanine. May be harmful for people with phenylketonuria.

3. How to give to your child

• This medicine is to be given to a child under adult supervision.
• Your child should take only one tablet of <Product name> 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.
• Always have your child take <Product name> as your doctor or pharmacist has told you. Check with your child’s doctor or pharmacist if you are not sure.
• To be taken by mouth

For children 2 to 5 years of age:

One <Product name> 4 mg chewable tablet daily to be taken in the evening. <Product name> 4 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 <Product name>, be sure that he/she does not take any other medicines that contain the same active ingredient, montelukast.

For children 2 to 5 years old, <Product name> 4 mg chewable tablets are available.

For children 6 to 14 years old, <Product name> 5 mg chewable tablets are available. The <Product name> 4 mg chewable tablet is not recommended below 2 years of age.

If your child takes more <Product name> 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 <Product name> to your child

Try to give <Product name> 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 <Product name>

<Product name> can treat your child’s asthma only if your child continues taking it.

PIL-Montelukast 4 mg chewable tablets - Day 160-v.3

It is important for your child to continue taking <Product name> 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.

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

In clinical studies with montelukast 4 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 montelukast were:

• abdominal pain
• thirst

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

• 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 up to 1 in 100 people Rare: may affect up to 1 in 1,000 people Very rare: may affect up to 1 in 10,000 people

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 of the 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 (Rare); hallucinations, disorientation, suicidal thoughts and actions (Very rare)]
• dizziness, drowsiness, pins and needles/numbness, seizure (Uncommon)
• palpitations (Rare)
• nosebleed (Uncommon)
• diarrhoea, nausea, vomiting (Common); dry mouth, indigestion (Uncommon)
• hepatitis (inflammation of the 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 (erythema multiforme) that may occur without warning (Very rare)
• joint or muscle pain, muscle cramps (Uncommon)
• fever (Common); tiredness, feeling unwell, swelling (Uncommon).

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 your child gets one or more of these symptoms.

PIL-Montelukast 4 mg chewable tablets - Day 160-v.3

Ask your doctor or pharmacist for more information about side effects. If your child gets any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

5. How to store

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

Do not give to your child this medicine after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from light.

Do not throw away 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.

What <Product name> contains

• The active substance is montelukast. Each tablet contains montelukast sodium which corresponds to 4 mg of montelukast.
• The other ingredients are: mannitol (E421), cellulose microcrystalline (E460), low- substituted hydroxypropyl cellulose (E463), iron oxide red (E172), croscarmellose sodium (E468), cherry flavour [containing flavouring substances, arabic gum (E414), maltodextrin, propylene glycol (E1520)], aspartame and magnesium stearate (E572).

What <Product name> looks like and contents of the pack

<Product name> 4 mg chewable tablets are pink, flat, round tablets with beveled edges and a diameter of 7 mm, marked with ‘4’ on one side and plain on the other.

Blisters in packages of: 14, 28 chewable tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

SC Romastru Trading SRL

67-77 Biharia Street, 2end Floor, Building 124A-147B, 013981 Bucharest

Roemenië

Manufacturer:

Genepharm S.A.

18km Marathonos Avenue,

15351 Pallini Attiki

Griekenland

In het Register ingeschreven onder: RVG 111820

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

PIL-Montelukast 4 mg chewable tablets - Day 160-v.3

Roemenië ISPYRRA 4 mg comprimate masticabile

This leaflet was last revised in: juli 2013