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MONTAS Paediatric is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of airways in the lungs. By blocking leukotrienes, MONTAS Paediatric improves asthma symptoms and helps control asthma. Your doctor has prescribed MONTAS Paediatric to treat asthma, preventing your asthma symptoms during the day and night. MONTAS Paediatric is used for the treatment of patients who are not adequately controlled on their medication and need additional therapy. MONTAS Paediatric may also be used as an alternative treatment 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. MONTAS Paediatric also helps prevent the narrowing of airways triggered by exercise. Your doctor will determine how MONTAS Paediatric should be used depending on the symptoms and severity of you or your child's asthma. How to use How to take MONTAS Paediatric You or your child should take only one tablet of MONTAS Paediatric once a day as prescribed by your doctor. It should be taken even when you or your child has no symptoms or has an acute asthma attack. Always take MONTAS Paediatric as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. To be taken by mouth For children 6 to 14 years of age: One MONTAS Paediatric 5 mg chewable tablet daily to be taken in the evening. MONTAS Paediatric 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 you or your child is taking MONTAS Paediatric, be sure that you or your child does not take any other products that contain the same active ingredient, montelukast. Warnings and precautions Do not take MONTAS Paediatric if you or your child Is allergic (hypersensitive) to montelukast or any of the other ingredients of MONTAS Paediatric (see 6. Further information). Take special care with MONTAS Paediatric If you or your child’s asthma or breathing gets worse, tell your doctor immediately. Oral MONTAS Paediatric is not meant to treat acute asthma attacks. If an attack occurs, follow the instructions your doctor has given you or your child. 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. MONTAS Paediatric should not be used instead of other asthma medications your doctor has prescribed for you or your child. 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 or 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 your asthma worse. Side Effects In clinical studies with MONTAS Paediatric 5 mg chewable tablets, the most commonly reported side effects (occurring in at least 1 of 100 patients and less than 1 of 10 paediatric patients treated) thought to be related to MONTAS Paediatric were: Hadache Additionally, the following side effect was reported in clinical studies with MONTAS 10 mg film-coated tablets: Abdominal pain 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 reaction (erythema multiforme) that may occur without warning (Very rare) joint or muscle pain, muscle cramps (Uncommon) fever (Common); tiredness, feeling unwell, swelling (Uncommon) Storage Information Store below 30°C Drug Interactions Some medicines may affect how MONTAS Paediatric works, or MONTAS Paediatric may affect how other medicines work. Please tell your doctor or pharmacist if you or your child is taking or has recently taken other medicines, including those obtained without a prescription. Tell your doctor if you or your child is taking the following medicines before starting MONTAS Paediatric: Phenobarbital (used for treatment of epilepsy) Phenytoin (used for treatment of epilepsy) Rifampicin (used to treat tuberculosis and some other infections) Ingredients The active substance is montelukast.
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