SINGULAIR 4MG CHEWABLE TAB 28

SINGULAIR 4MG CHEWABLE TAB 28
Product Description
 
Singulair Paediatric 4 mg tablets
Package leaflet: Information for the user
Singulair® Paediatric 4 mg chewable tablets
montelukast
Read all of this leaflet carefully before you give this medicine to your child because it contains important information.
Keep this leaflet. You may need to read it again.
If you have any further questions, 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 your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Singulair Paediatric is and what it is used for
2. What you need to know before your child takes Singulair Paediatric
3. How to take Singulair Paediatric
4. Possible side effects
5. How to store Singulair Paediatric
6. Contents of the pack and other information
1. What Singulair Paediatric is and what it is used for
What Singulair Paediatric is
Singulair Paediatric is a leukotriene receptor antagonist that blocks substances called leukotrienes.
How Singulair Paediatric works
Leukotrienes cause narrowing and swelling of airways in the lungs. By blocking leukotrienes, Singulair Paediatric improves asthma symptoms and helps control asthma.
When Singulair Paediatric should be used
Your doctor has prescribed Singulair Paediatric to treat your child’s asthma, preventing asthma symptoms during the day and night.
Singulair Paediatric is used for the treatment of 2 to 5 year old patients who are not adequately controlled on their medication and need additional therapy.
Singulair Paediatric 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.
Singulair Paediatric also helps prevent the narrowing of airways triggered by exercise for patients 2 years of age and older.
Your doctor will determine how Singulair Paediatric 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 your child takes Singulair Paediatric
Tell your doctor about any medical problems or allergies your child has now or has had.
Do not give Singulair Paediatric 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 you give Singulair Paediatric to your child.
If your child’s asthma or breathing gets worse, tell your doctor immediately.
Oral Singulair Paediatric 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. Singulair Paediatric 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.
Patients should be aware that various neuropsychiatric events (for example behaviour and mood-related changes) have been reported in adults, adolescents and children with Singulair (see section 4). If your child develops such symptoms while taking Singulair, you should consult your child’s doctor.
Children and adolescents
Do not give this medicine to children less than 2 years of age.
There are different form(s) of this medicine available for paediatric patients under 18 years of age based on age range.
Other medicines and Singulair Paediatric
Tell your doctor or pharmacist if your child is taking or has recently been given or might be given any other medicines including those obtained without a prescription.
Some medicines may affect how Singulair Paediatric works, or Singulair Paediatric may affect how your child’s other medicines work.
Tell your doctor if your child is taking the following medicines before starting Singulair Paediatric:
phenobarbital (used for treatment of epilepsy)
phenytoin (used for treatment of epilepsy)
rifampicin (used to treat tuberculosis and some other infections)
Singulair Paediatric with food and drink
Singulair Paediatric 4 mg 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
This subsection is not applicable for the Singulair Paediatric 4 mg chewable tablets since they are intended for use in children 2 to 5 years of age.
Driving and using machines
This subsection is not applicable for the Singulair Paediatric 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.
Singulair Paediatric 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 with Singulair Paediatric may affect some patients’ ability to drive or operate machinery.
Singulair Paediatric 4 mg chewable tablets contain aspartame, a source of phenylalanine and sodium
If your child has phenylketonuria (a rare, hereditary disorder of the metabolism) you should take into account that each 4 mg chewable tablet contains phenylalanine (equivalent to 0.674 mg phenylalanine per 4 mg chewable tablet).
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. How to take Singulair Paediatric
Always have your child take this medicine exactly as your doctor or pharmacist has told you. 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. For children who have problems consuming a chewable tablet, an oral granule formulation is available.
Your child should take only one chewable tablet of Singulair Paediatric 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.