Montelukast 4 Mg Chewable Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Montelukast 4 mg chewable tablets For children from 2 to 5 years of age
Montelukast
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again later.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for your child. Do not pass it on to others. It may harm them, even if their symptoms are the same as your child's.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Montelukast is and what it is used for
2. Before Montelukast is taken
3. How to take Montelukast
4. Possible side effects
5. How to store Montelukast
6. Further information
1. WHAT MONTELUKAST IS AND WHAT IT IS USED FOR
Montelukast is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of airways in the lungs. By blocking leukotrienes, Montelukast improves asthma symptoms and helps to control asthma.
Your doctor has prescribed Montelukast to treat your child’s asthma, preventing asthma symptoms during the day and night.
- Montelukast is used for the treatment of children from 2 to 5 year who are not adequately controlled on their medication and need additional therapy.
- Montelukast may also be used as an alternative treatment to inhaled corticosteroids for children from 2 to 5 year who have not recently taken oral corticosteroids for their asthma and have shown that they are unable to use inhaled corticosteroids.
- Montelukast also helps prevent the narrowing of airways triggered by exercise for children from 2 years of age and older. Your doctor will determine how Montelukast 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 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. BEFORE MONTELUKAST IS TAKEN
Tell your doctor about any medical problems or allergies your child has now or has had.
Do not give Montelukast to your child if he/she
- is allergic (hypersensitive) to montelukast or any of the other ingredients in Montelukast (see 6. FURHTER INFORMATION). Take special care with Montelukast
- If your child’s asthma or breathing gets worse, tell your doctor immediately.
- Oral Montelukast is not meant to treat acute asthma attacks. If an asthma 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 medicines prescribed by your doctor.
Montelukast 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 different symptoms such as flu-like illness, pins and needles or numbness of arms or legs, worsening of pulmonary symptoms, and/or rash occur, you should consult your doctor.
- Your child should not take acetyl-salicylic acid (aspirin) or other anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they make his/her asthma worse.
Taking other medicines
Some medicines may affect how Montelukast works, or Montelukast may affect how your child’s other medicines work. Please tell your doctor or pharmacist if your child is taking or has recently taken other medicines, including those obtained without a prescription.
Tell your doctor if your child is taking one of the following medicines before starting Montelukast:
- phenobarbital (used for treatment of epilepsy)
- phenytoin (used for treatment epilepsy)
- rifampicin (used to treat tuberculosis and some other infections)
Taking Montelukast with food and drink
Montelukast 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 Montelukast 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
Women who are pregnant or intend to become pregnant should consult their doctor before taking Montelukast. Your doctor will assess whether you can take Montelukast during this time.
Use in breast-feeding
It is not known if Montelukast appears in breast milk. You should consult your doctor before taking Montelukast if you are breastfeeding or intend to breast-feed.
Driving and using machines
This subsection is not applicable for the Montelukast 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. Montelukast is not expected to affect your ability to drive 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.
Important information about some of the ingredients of Montelukast
Montelukast chewable tablets contain aspartame, a source of phenylalanine. May be harmful for children with phenylketonuria.
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 0.898 mg phenylalanine per 4mg chewable tablet)
3. HOW TO TAKE MONTELUKAST
- This medicine is to be given to a child under adult supervision.
- Your child should take only one table of Montelukast 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 Montelukast as your doctor has told you. You should check with your child’s doctor or pharmacist you are not sure.
- To be taken by mouth.
For children 2 to 5 years of age:
One 4 mg chewable tablet daily to be taken in the evening. Montelukast 4 mg chewable tablets should not be taken immediately with food; it should be taken at least 1 hour before and 2 hours after food. If your child is taking Montelukast, 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, Montelu-kast 4 mg chewable tablets are available. For children 6 to 14 years old, Montelukast 5 mg chewable tablets are available. The Montelukast 4 mg chewable tablet is not recommended below 2 years of age.
If your child takes more Montelukast 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 Montelukast to your child
Try to give Montelukast 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 Montelukast
Montelukast can treat your child’s asthma only if he/she continues taking it. It is important for your child to continue taking Montelukast 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 product, ask your child’s doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines Montelukast 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 of 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 chew-able tablets:
- headache
These were usually mild and occurred at a greater frequency in patients treated with Montelukast than placebo (a pill containing no medication).
Additionally, while the medicine has been on the market, the following have been reported:
- upper respiratory infection
- increased bleeding tendency
- allergic reactions including rash, swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing
- behaviour and mood related changes [dream abnormalities, including nightmares, hallucinations, irritability, feeling anxious, restlessness, agitation including aggressive behaviour or hostility, tremor, depression, trouble sleeping, sleepwalking, suicidal thoughts and actions (in very rare cases)]
- dizziness, drowsiness, pins and needles/numbness, seizure
- palpitations
- nosebleed
- diarrhea, dry mouth, indigestion, nausea, vomiting
- hepatitis (inflammation of the liver)
- bruising, itching, hives, tender red lumps under the skin most commonly on your shins (erythema nodosum),
- joint or muscle pain, muscle cramps
- tiredness, feeling unwell, swelling, fever
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. Ask your doctor or pharmacist for more information about side effects. If any of the side effects gets serious, or if you notice any side effects not listed, please tell your child’s doctor or pharmacist.
5. HOW TO STORE MONTELUKAST
- Keep out of reach and sight of children.
- Do not use this medicine after the date shown by the six numbers following <EXP> on the blister. The first two numbers indicate the months; the last four numbers indicate the year. This medicine expires at the end of the months shown.
- Store in the original package in order to protect from light and moisture.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. FURTHER INFORMATION What Montelukast contains
- The active substance is montelukast. Each tablet contains montelukast sodium which corresponds to 4 mg of montelukast.
- The other ingredients are:
Mannitol, microcrystalline cellulose, low-substituted hydroxypropyl-cellulose (E463), red ferric oxide (E172), croscarmellose sodium, cherry flavour (E1518 - glyceryl triacetate; E1450 -sodium octenylsuccinate), aspartame (E951), and magnesium stearate.
What Montelukast looks like and contents of the pack
Montelukast 4 mg chewable tablets are pink, oval and biconvex with MOK 4 engraved on one side and PHD471 on the other. Packaged in oPA/Al/PVC/aluminium blisters packed in cardboard boxes.
Pack sizes of 14, 20, 28, 30, 50, 98 and 100 chewable tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
Noridem Enterprises Ltd.
Evagorou & Makariou Mitsi Building 3 Suit. 115, 1065 Nicosia Cyprus
Manufacturer:
1. Bluepharma Industria Farmaceutica, S.A.
Sao Martinho do Bispo
3045-016 Coimbra Portugal
2. DEMO S.A.
Pharmaceutical Industry
21st km. National road Athens-Lamia
145 68 Krioneri, Athens
Tel. 2108161802, Fax. 2108161587
This medicinal product is authorised in the Member States of the EEA under the following names:
Cyprus: Singodem 4mg chewable tablets
Greece: Singodem 4mg chewable tablets
United Kingdom: Montelukast 4mg chewable tablets
This leaflet was last approved in
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