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.