Montelukast 5 Mg Chewable Tablets
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Montelukast 5 mg chewable tablets
For children from 6 to 14 years Montelukast
Read all of this leaflet carefully before you or your child start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, please ask your doctor or pharmacist.
- This medicine has been prescribed for you or your child. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours or 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 you take Montelukast
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 control asthma.
Your doctor has prescribed Montelukast to treat asthma, preventing asthma symptoms during the day and night.
- Montelukast is used for the treatment of patients 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 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.
- Montelukast also helps prevent the narrowing of airways triggered by exercise.
Your doctor will determine how Montelukast should be used depending on the symptoms and severity of your or 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. BEFORE YOU TAKE MONTELUKAST
Tell your doctor about any medical problems or allergies you or your child has now or has had.
Do not take Montelukast if you are or your child is
- allergic (hypersensitive) to montelukast or any of the other ingredients of Montelukast (see section 6. Further information).
Take special care with Montelukast
- If your or your child’s asthma or breathing gets worse, tell your doctor immediately.
- Montelukast is not meant to treat acute asthma attacks. If an attack occurs, follow the instructions your doctor has given for you or your child. Always have your or your child’s inhaled rescue medicine for asthma attacks with you.
- It is important that you or your child take all asthma medications prescribed by your doctor. Montelukast should not be used instead of other asthma medications your doctor has prescribed for you or your child.
- If you or your child is on anti-asthma medicines, be aware that if you or 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.
- You or your child should not take acetyl-salicylic acid (aspirin) or antiinflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they make your or his/her asthma worse.
Taking other medicines
Some medicines may affect how Montelukast works, or Montelukast 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 Montelukast:
- phenobarbital (used for treatment of epilepsy)
- phenytoin (used for treatment of epilepsy)
- rifampicin (used to treat tuberculosis and some other infections)
Taking Montelukast with food and drink
Montelukast 5 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
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 breast-feeding or intend to breast-feed.
Driving and using machines
This subsection is not applicable for the Montelukast 5 mg chewable tablets since they are intended for use in children 6 to 14 years of age, however the following information is relevant to the active ingredient, montelukast.
Montelukast 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.
Important information about some of the ingredients of Montelukast
Montelukast chewable tablets contain aspartame, a source of phenylalanine. May be harmful for patients with phenylketonuria. If you or your child has phenylketonuria (a rare, hereditary disorder of the metabolism), you should take into account that each 5mg chewable tablet contains phenylalanine (equivalent to 0.221 mg phenylalanine per 5 mg chewable tablet).
3. HOW TO TAKE
- You or your child should take only one tablet of Montelukast once a day as prescribed by your doctor.
- It should be taken even when you or your child has no symptoms or if you or your child has an acute asthma attack.
- Always take Montelukast as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
- To be taken by mouth. The tablet can be chewed or swallowed. If swallowed it should be taken with a sufficient amount of fluid (e. g. with a glass of water).
For children 6 to 14 years of age:
One Montelukast 5 mg chewable tablet daily to be taken in the evening.
Montelukast 5 mg chewable tablets should not be taken immediately with food; it should be taken at least 1 hour before or two hours after food.
If you or your child is taking Montelukast, be sure that you or your child does not take any other products that contain the same active ingredient, montelukast.
For children 2 to 5 years old, Montelukast 4 mg chewable tablets are available.
For children 6 to 14 years old, Montelukast 5 mg chewable tablets are available.
If you or your child takes more Montelukast than you/he/she 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 Montelukast or give Montelukast to your child
Try to take Montelukast as prescribed. However, if you or your child misses 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 or your child stops taking Montelukast
Montelukast can treat your or your child’s asthma only if you or your child continues taking it.
It is important to continue taking Montelukast for as long as your doctor prescribes. It will help control your or your child’s asthma.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Montelukast can cause side effects, although not everybody gets them.
The frequency of possible side effects listed below is defined using the following convention:
Very common (affects more than 1 user in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)
Rare (affects 1 to 10 users 10,000)
Very rare (affects less than 1 user in 10,000)
Not known (frequency cannot be estimated from the available data).
Common side effects: In clinical studies the following side effects were reported:
- abdominal pain
- thirst
- 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 montelukast 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, sleepwalking, irritability, feeling anxious, restlessness, agitation including aggressive behaviour or hostility, tremor, depression, trouble sleeping, suicidal thoughts and actions (in very rare cases)]
• dizziness, drowsiness, pins and needles/numbness, seizure
• palpitations
• nosebleed
• diarrhoea, 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 you or 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 in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE MONTELUKAST
Keep out of the reach and sight of children.
Do not use Montelukast after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special temperature storage conditions. 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 to protect the environment.
6. FURTHER INFORMATION
What Montelukast contains
The active substance is montelukast. Each tablet contains 5.2 mg montelukast sodium which corresponds to 5 mg of montelukast.
The other ingredients are: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, aspartame (E951), iron oxide red (E172), mannitol (E421), cherry flavour (Firmenich CHERRY 501027 AP0551).
What Montelukast looks like and contents of the pack
Montelukast 5 mg chewable tablets are pink coloured, round, uncoated tablets, with breakline on both sides
Tablets are packed into Alu/Alu blisters. The blisters are packed into cartons.
Pack sizes:
UK/H/2393/002/DC 10, 14, 20, 28, 50, 56, 98, 100 tablets UK/H/3719/002/DC 28, 56, 98 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Orion Corporation Orionintie 1 FI-02200 Espoo Finland
<This medicinal product is authorised in the Member States of the EEA under the following names:>
UK - Montelukast 5mg chewable tablets.