Montelukast Romastru 10 mg filmomhulde tabletten

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 and also cause allergy symptoms. By blocking leukotrienes, <Product name> improves asthma symptoms, helps control asthma and improves seasonal allergy symptoms (also known as hay fever or seasonal allergic rhinitis).

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

• <Product name> is used for the treatment of patients who are not adequately controlled on their medication and need additional therapy.
• <Product name> also helps prevent the narrowing of airways triggered by exercise.
• In those asthmatic patients in whom <Product name> is indicated in asthma, <Product name> can also provide symptomatic relief of seasonal allergic rhinitis.

Your doctor will determine how <Product name> should be used depending on the symptoms and severity of your 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 10 mg film-coated tablets - Day 160-v.2

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 of seasonal allergies typically may include: stuffy, runny, itchy nose; sneezing; watery, swollen, red, itchy eyes.

2. What you need to know before you take

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

Do not take <Product name> 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 or pharmacist before taking <Product name>.

• If your 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. Always have your inhaled rescue medicine for asthma attacks with you.
• It is important that you take all asthma medications prescribed by your doctor. <Product name> 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 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 acetyl-salicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they make your asthma worse.

Use in children

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.

Other medicines and <Product name>

Some medicines may affect how <Product name> works, or <Product name> may affect how other medicines work.

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

Tell your doctor if you are 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)
• gemfibrozil (used for treatment of high lipid levels in plasma)

<Product name> with food and drink

<Product name> 10 mg film-coated tablets may be taken with or without food.

Pregnancy and breast-feeding

PIL- Montelukast 10 mg film-coated tablets - Day 160-v.2

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

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

<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> 10 mg film-coated tablets contain aspartame

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

3. How to take

• You should take only one tablet of <Product name> 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 <Product name> as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
• To be taken by mouth

For adults 15 years of age and older:

One <Product name> 10 mg film-coated tablet to be taken daily in the evening. <Product name> 10 mg film-coated tablets may be taken with or without food.

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

If you take more <Product name> than you should

Contact your 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 take <Product name>

Try to take <Product name> 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 <Product name>

<Product name> can treat your asthma only if you continue to take it.

It is important to continue taking <Product name> for as long as your doctor prescribes. It will help control your asthma.

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

PIL- Montelukast 10 mg film-coated tablets - Day 160-v.2

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 reported side effects (occurring in at least 1 of 100 patients and less than 1 in 10 patients treated) thought to be related to montelukast were:

• headache
• abdominal pain

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 you get one or more of these symptoms.

Ask your doctor or pharmacist for more information about side effects. If you get 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 use 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.

PIL- Montelukast 10 mg film-coated tablets - Day 160-v.2

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 10 mg of montelukast.
• The other ingredients are: mannitol (E421), cellulose microcrystalline (E460), low- substituted hydroxypropyl cellulose (E463), croscarmellose sodium (E468), banana flavour [containing flavouring substances, maltodextrin, modified starch (E1450), propylene glycol (E1520)], aspartame, magnesium stearate (E572). In addition the coating of the tablets contains Opadry yellow 20A33251 (which consists of: hypromellose 3cP (E464), hydroxypropyl cellulose (E463), talc (E553b), titanium dioxide (E171), iron oxide yellow (E172) and iron oxide red (E172)

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

<Product name> 10 mg film-coated tablets are beige, round and biconvex with a diameter of 8 mm.

Blisters in packages of: 14, 28 film-coated 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 111822

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

Roemenië ISPYRRA 10 mg comprimate masticabile

This leaflet was last revised in: juli 2013.