Montelukast 4 Mg Chewable Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Montelukast 4 mg Chewable Tablets
montelukast
For children from 2 to 5 years
Read all of this leaflet carefully before your child starts taking this medicine because it contains important information for you.
- 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as your child's.
- If you get 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 Montelukast 4 mg Chewable Tablets is and what it is used for
2. What you need to know before Montelukast 4 mg Chewable Tablets is taken
3. How to take Montelukast 4 mg Chewable Tablets
4. Possible side effects
5. How to store Montelukast 4 mg Chewable Tablets
6. Contents of the pack and other information
1. What Montelukast 4 mg Chewable Tablets is and what it is used for
Montelukast 4 mg Chewable Tablets is a Leukotriene receptor antagonist that blocks the substances called leukotrienes. Leukotrienes cause narrowing and swelling of airways in the lungs. By blocking leukotrienes, Montelukast 4 mg Chewable Tablets improves asthma symptoms and helps control asthma.
Your doctor has prescribed Montelukast 4 mg Chewable Tablets to treat your child's asthma, preventing asthma symptoms during the day and night.
• Montelukast 4 mg Chewable Tablets is used for the treatment of 2 to 5 year old patients who are not adequately controlled on their medication and need additional therapy.
• Montelukast 4 mg Chewable Tablets 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.
• Montelukast 4 mg Chewable Tablets also helps prevent the narrowing of airways triggered by exercise for patients 2 years of age and older.
Your doctor will determine how Montelukast 4 mg Chewable Tablets should be used depending on the symptoms and severity of you 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. What you need to know before Montelukast 4 mg Chewable Tablets is taken
Tell your doctor about any medical problems or allergies your child has now or has had.
Do not give Montelukast 4 mg Chewable Tablets 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 taking Montelukast 4 mg Chewable Tablets
- If your child’s asthma or breathing gets worse, tell your doctor immediately.
- Oral Montelukast 4 mg Chewable Tablets 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, Montelukast 4 mg Chewable Tablets should not used instead of other asthma medications your doctor has presribed for your child.
- If your child is on anti-asthma medicines be aware that if he/she develops a combination of symptoms such as a 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 her/his asthma worse.
Other medicines and Montelukast 4 mg Chewable Tablets
Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines, including medicines obtained without a prescription. Some medicines may affect how montelukast works, or montelukast may affect how other medicines work.
Tell your doctor if your child is taking the following medicines before starting Montelukast 4 mg Chewable Tablets:
- Phenobarbital ( used for treatment of epilepsy)
- Phenytoin (used for treatment of epilepsy)
- Rifampicin (used to treat tuberculosis and some other infections)
Montelukast 4 mg Chewable Tablets with food and drink
Montelukast 4 mg Chewable Tablets 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 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.
Pregnancy
Women who are pregnant or intend to become pregnant should consult their doctor before taking Montelukast 4 mg Chewable Tablets. Your doctor will assess whether you can take Montelukast 4 mg Chewable Tablets during this time.
Breast-feeding
It is not known if Montelukast 4 mg Chewable Tablets appears in breast milk. You should consult your doctor before taking Montelukast 4 mg Chewable Tablets if you are breast-feeding or intend to breast-feed.
Driving and using machines
This subsection is not applicable for 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 a car or operate machinery. However, individual responses in 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.
Montelukast 4 mg Chewable Tablets contains aspartame
Aspartame is a source of phenylalanine. If your child has phenylketonuria ( a rare, hereditary disorder of the metabolism) you should take into account that each tablet contains phenylalanine (equivalent to 1.20 mg /tablet).
3. How to take Montelukast 4 mg Chewable Tablets
Always have your child take Montelukast 4 mg Chewable Tablets as your doctor 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.
• Your child should take only one tablet of Montelukast 4 mg Chewable Tablets once a day as prescribed by your doctor.
• It should be taken even when your child has no symptoms or has an acute asthma attack.
• Always have your child take Montelukast 4 mg Chewable Tablets as your doctor has told you. You should check with your child’s doctor or pharmacist if you are not sure.
• To be taken by mouth
For Children 2 to 5 years of age:
One Montelukast 4 mg Chewable Tablets 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 or 2 hours after food. The tablets are to be chewed before swallowing.
If your child is taking Montelukast 4 mg Chewable Tablets, 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, Montelukast 4 mg Chewable Tablets chewable tablets are available.
For children 6 to 14 years old, Montelukast 5 mg chewable tablets are available.
Montelukast 4 mg chewable tablet is not recommended below 2 years of age.
If your child takes more Montelukast 4 mg Chewable Tablets than he/she should Contact your child's doctorimmediately 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 4 mg Chewable Tablets to your child
Try to giveMontelukast 4 mg Chewable Tablets 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 4 mg Chewable Tablets
Montelukast 4 mg Chewable Tablets can treat your childs asthma only if he/she continues taking it. It is important for your child to continue taking Montelukast 4 mg Chewable Tablets for as long as your doctor prescribes. It will help control your childs 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 4 mg Chewable Tablets 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 4 mg chewable tablets were:
• abdominal pain
• thirst
Additionally, the following side effect was reported in clinical studies with montelukast 10 mg film-coated tablets and 5 mg chewable tablets:
• headache
These were usually mild and occurred at a greated frequency in patients treated with montelukast than placebo (a pill containing no medication).
The frequency of possible side effects listed below is defined using the following convention:
Very common (affects at least 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 in 10,000)
Very rare (affects less than 1 user in 10,000)
Additionally, while the medicine has been on the market, the following have been reported:
• upper respiratory infection (Very common)
• increased bleeding tendency (Rare)
• allergic reactions including swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing (Uncommon)
• behaviour and mood related changes [dream abnormalities, including nightmares, trouble sleeping, sleep walking, irritability, feeling anxious, restlessness, agitation including aggressive behaviour or hostility, depression (Uncommon); tremor, disturbance in attention, memory impairment (Rare); hallucinations, disorientation, suicidal thoughts and actions (Very rare)
• dizziness, drowsiness, pins and needles/numbness, seizure (Uncommon)
• palpitations (Rare)
• nosebleed (Uncommon), swelling (inflammation) of the lungs (very rare)
• diarrhoea, nausea, vomiting (Common); dry mouth, indigestion (Uncommon)
• hepatitis (inflammation of the liver) (Very rare)
• rash (Common), bruising, itching, hives (Uncommon); tender red lumps under the skin most commonly on your shins (erythema nodosum), severe skin reactions (erythema multiforme) that may occur without warning (Very rare)
• joint or muscle pain, muscle cramps (Uncommon)
• fever (Common); weakness/tiredness, feeling unwell, swelling (Uncommon).
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 your child gets one or more of these symptoms.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Montelukast 4 mg Chewable Tablets
Keep this medicine out of thesight and reach of children.
Do not use after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month. Use within 30 days of opening. Once the pack has been opened write the date of opening on the space provided on the package label and also write the date by when the product should be used.
Store in the original package to protect from moisture. This medicinal product does not require any special temperature storage conditions.
Do not throw away this medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Montelukast 4 mg Chewable Tablets contains
- The active substance is Montelukast Sodium
- The other ingredients are:
Mannitol [E421]
Cellulose microcrystalline Hydroxypropylcellulose [E463]
Croscarmellose sodium Cherry flavour Aspartame [E951]
Magnesium stearate.
What Montelukast 4 mg Chewable Tablets looks like and contents of the pack
4 mg chewable tablets are white to off-white, 11 x 7.8mm oval, biconvex uncoated tablets, with ‘G’ engraved on one side, and ‘390’ on the other side.
The tablets are packed in HDPE containers which includes a desiccant protecting the tablets from moisture. The desiccant should not be swallowed.
Pack sizes: 20, 28, 30
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Glenmark Pharmaceuticals s.r.o.
City Tower, Hvezdova 1716/2b, 140 78 Prague 4,
Czech Republic
Manufacturer
Glenmark Pharmaceuticals s.r.o.
City Tower, Hvezdova 1716/2b, 140 78 Prague 4,
Czech Republic
Accord Healthcare Limited Sage House, 319 Pinner Road,
Harrow, Middlesex, HA1 4HF,
United Kingdom
This leaflet was last approved in 06/2015.
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