Montelukast 5 Mg Chewable Tablets
Out of date information, search anotherPACKAGE LEAFLET: INFORMATION FOR THE USER
MONTELUKAST 5 mg CHEWABLE TABLETS
For children from 6 to 14 years of age Montelukast
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- 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 only. 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. See section 4.
E
E
E
o
CO
Font Size 9.5pt
What is in this leaflet:
1. What Montelukast is and what it is used for
2. What you need to know before your child takes Montelukast
3. How to take Montelukast
4. Possible side effects
5. How to store Montelukast
6. Content of the pack and other 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 this medicine to treat asthma, preventing your asthma symptoms during the day and night.
- This medicine is used for the treatment of patients who are not adequately controlled on their medication and need additional therapy.
- This medicine may also be used as an alternative treatment to inhaled corticosteroids for children from 6 to 14 years of age who have not recently taken oral corticosteroids for their asthma and have shown that they are unable to use inhaled corticosteroids
- This medicine also helps prevent the narrowing of airways triggered by exercise.
Your doctor will determine how this medicine should be used depending on the symptoms and severity of you and 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 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 or your child
- is allergic (hypersensitive) to montelukast or any of the other ingredients in this medicine (see 6. FURTHER INFORMATION).
Warnings and precautions
Take special care with Montelukast
- If you or your child’s asthma or breathing gets worse, tell your doctor immediately.
- These oral tablets are 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 medicines prescribed by your doctor.
These tablets 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 occur, you should consult your doctor.
- You or your child should not take aspirin (acetyl-salicylic acid) or other anti-inflammatory medicines (also known as non-steroidal antiinflammatory drugs or NSAIDs) if they make your asthma worse.
Use in children
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.
Other medicines and Montelukast
Some medicines may affect how your tablets work, or these tablets 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 or has recently taken one of the following medicines before starting this medicine:
- phenobarbital (used for treatment of epilepsy)
- phenytoin (used for treatment of epilepsy)
- rifampicin (used to treat tuberculosis and some other infections)
Montelukast with food and drink
These tablets should not be taken immediately with food; it 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 this medicine. Your doctor will assess whether you can take this medicine during this time.
Use in breast-feeding
It is not known if montelukast appears in breast milk. You should consult your doctor before taking this medicine if you are breast-feeding or intend to breast-feed.
Driving and using machines
This medicine 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 these tablets may affect some patients' ability to drive or operate machinery.
Important information about some of the ingredients of Montelukast
These 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 5 mg chewable tablet contains phenylalanine (equivalent to 1.123 mg phenylalanine per 5mg chewable tablet)
3. HOW TO TAKE MONTELUKAST
- You or your child should take only one tablet of this medicine 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 the tablets as your doctor has told you. You should check with your doctor or pharmacist if
E
E
E
o
CO
Font Size 9.5pt
you are not sure.
- To be taken by mouth.
For children 6 to 14 years of age:
One Montelukast 5 mg chewable tablet daily to be taken in the evening. The tablet 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 this medicine, be sure that you or your child does not take any other medicines that contain the same active ingredient, montelukast. If you or your child takes more Montelukast than you 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 this medicine 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
This medicine can treat you or your child’s asthma only if you or your child continues to take it.
It is important to continue taking the tablets for as long as your doctor prescribes. It will help control you 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 this medicine can cause side effects, although not everybody gets them.
Seek immediate medical advice if you or your child experiences allergic reactions including swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing (Uncommon).
Tell your doctor right away if you or your child experience any behaviour and mood related changes such as:
Uncommon (may affect up to 1 in 100 people) dream abnormalities, including nightmares, trouble sleeping, sleepwalking, irritability, feeling anxious, restlessness, agitation including aggressive behaviour or hostility, depression
Rare (may affect up to 1 in 1,000 people) tremor, disturbance in attention, memory impairment
Very rare (may affect up to 1 in 10,000 people) hallucinations, disorientation, suicidal thoughts and actions
In asthmatic patients treated with montelukast, very rare cases of a combination of symptoms such as flulike 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.
In clinical studies with these 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 the medicine were:
- headache
Additionally, the following side effect was reported commonly in clinical studies with the 10 mg film-coated tablets and the 5 mg chewable tablets:
- abdominal pain
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:
Very common (may affect more than 1 in 10 people):
- upper respiratory infection
Common (may affect up to 1 in 10 people):
- diarrhoea, nausea, vomiting; rash; fever
Uncommon (may affect up to 1 in 100 people):
- dizziness, drowsiness, pins and needles/numbness, seizure
- nosebleed
- dry mouth, indigestion
- bruising, itching, hives
- joint or muscle pain, muscle cramps
- tiredness, feeling unwell, swelling
Rare (may affect up to 1 in 1,000 people)
- increased bleeding tendency
- palpitations
Very rare (may affect up to 1 in 10,000 people)
- hepatitis (inflammation of the liver)
- tender red lumps under the skin most commonly on your shins (erythema nodosum), severe skin reaction (erythema multiforme) that may occur without warning
Reporting of side effects
If your child gets any side effects, talk to your child's doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effect directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting the side effects you can help provide more information on the safety of the medicine.
5. HOW TO STORE MONTELUKAST
- Keep out of sight and reach 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 month; the last four numbers indicate the year. This medicine expires at the end of the month shown.
- Store in the original package in order to protect from light and moisture.
- Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. CONTENT OF THE PACK AND OTHER INFORMATION
What Montelukast contains
- The active substance is montelukast. Each tablet contains montelukast sodium which corresponds to 5 mg of montelukast.
- The other ingredients are:
Mannitol, microcrystalline cellulose, low-substituted hydroxypropyl-cellulose (E463), red ferric oxide (E172), croscarmellose sodium, cherry flavour (E1518-glyceryltriacetate, E1450-sodium octenylsuccinate), aspartame (E951), and magnesium stearate.
What Montelukast looks like and content of the pack
Montelukast 5 mg chewable tablets are pink, round and biconvex with MOK 5 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
Dexcel®-Pharma Ltd., 7 Sopwith Way, Drayton Fields, Daventry, Northamptonshire, NN11 8pB UK.
Manufacturer:
MC Pharma AD
35, Zemliane Str., 1618 Sofia, Bulgaria.
This medicinal product is authorised in the Member States of the EEA under the following names:
United Kingdom: Montelukast 5 mg chewable tablets This leaflet was last revised in December 2013