Montelukast Ranbaxy 4 Mg Chewable Tablets
Out of date information, search anotheraccount that each tablet contains phenylalanine (equivalent to 0.674 mg phenylalanine per 4 mg chewable tablet).
3. How to take Montelukast 4 mg chewable tablets
Read all of this leaflet carefully before you start taking this medicine because it contains important information foryou.
- 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 you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- 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 are and what they are used for
2. What you need to know before you take Montelukast4 mg chewable tablets
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 are and what they are used for
Montelukast 4 mg chewable tablets are a leukotriene receptor antagonist that blocks substances called leukotrienes.
Leukotrienes cause narrowing and swelling of airways in your lungs. By blocking leukotrienes, this medicine improves asthma symptoms and helps control asthma.
Your doctor has prescribed this medicine to treat your child's asthma, preventing asthma symptoms during the day and night.
• This medicine is used for the treatment of 2 to 5 year old patients who are not adequately
are medication
and need
controlled on their additional therapy.
• This medicine 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.
• This medicine also helps prevent the narrowing of airways triggered by exercise for patients 2 years of age and older.
Your doctor will determine how these tablets 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 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 you take Montelukast 4 mg chewable tablets
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 giving Montelukast 4 mg chewable tablets
• If your child's asthma or breathing gets worse, tell your doctor immediately.
• This oral medicine 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 yourdoctor.
• This medicine should not be used instead of other asthma medications your doctor has prescribed foryourchild.
• 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 consultyourdoctor.
• Your child should not take aspirin (acetylsalicylic acid) or anti-inflammatory medicines (also known as non-steroidal antiinflammatory drugs or NSAIDs) if they make his/her asthma worse.
Children and adolescents
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.
The 4 mg chewable tablets are not recommended in children below 2 years of age.
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.
Some medicines may affect how Montelukast 4 mg chewable tablets work, or Montelukast 4 mg chewable tablets may affect how your child's other medicines work.
Tell your doctor if your child is taking the following medicines before starting Montelukast 4 mg chewable tablets:
• phenobarbital (usedfortreatmentof epilepsy)
• phenytoin (usedfortreatmentof epilepsy)
• rifampicin (used to treat tuberculosis and some other infections)
• gemfibrozil (used for treatment of high lipid levels in plasma)
Montelukast 4 mg chewable tablets with food and drink
These tablets should not be taken immediately with food; they should be taken atleast 1 hour before or two 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 this medicine. Yourdoctorwill assess whetheryou can take this tablet during this time.
Use in breast-feeding
It is not known if this medicine appears in breast milk. You should consult yourdoctor before taking this tablet, if you are breast-feeding or intend to breastfeed.
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.
This medicine 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 with this medicine 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
Always give this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
• This medicine is to be given to a child under adult supervision. For children who have problems consuming a chewable tablet, an oral granule formulation is available.
• Your child should take only one tablet of Montelukast 4 mg chewable tablets once a day as prescribed byyourdoctor.
• It should be taken even when your child has no symptoms or if he/she has an acute asthma attack.
• To be taken by mouth
For children 2 to 5 years of age:
One Montelukast 4 mg chewable tablet daily to be taken in the evening. This tablet should not be taken immediately with food; it should be taken at least 1 hour before or 2 hours after food.
If your child is taking this medicine, be sure that he/she does not take any other medicines that contain the same active ingredient, montelukast.
If your child takes more Montelukast 4 mg chewable tablets than he/she should
Contact your child's doctor immediately for advice. There were no side effects reported in the majority of over dose reports. The most frequently occurring symptoms reported with over dose 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 give this medicine 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
This medicine can treat your child's asthma only if your child continues taking it.
It is important for your child to continue taking these tablets for as long as your doctor prescribes. It will help control yourchild's asthma.
If you have any further questions on the use of this medicine, askyourchild's doctor or pharmacist.
4. Possible side effects
Common: may affect up to 1 in 10 people
• diarrhea, nausea, vomiting
• changes in liverfunction test
• rash
• fever
Uncommon: may affect up to 1 in 100 people
• dream abnormalities, including nightmares, trouble sleeping, sleep walking, irritability, feeling anxious, restlessness, agitation including aggressive behaviour or hostility, depression
• 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
• tremor
• palpitations
Very rare: may affect up to 1 in 10,000 people
• hallucinations, disorientation
• 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 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 the sight and reach of children.
Do not use this medicine after the date which is stated on the carton after EXP.The expiry date refers to the last day of that month.
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 throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
If your child experiences any of the following, stop giving the medicine and tell your doctor immediately or go to the casualty department of yournearest hospital.
• Allergic reactions: If your child have allergic reactions, stop having this medicine and see a doctor straight away. You may need urgent medical treatment. The signs may include rashes, swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing.
• Behaviour and mood related changes:
Suicidal thoughts and actions.
• Churg-Strauss syndrome: Symptoms include flu-like illness, pins and needles or numbness of arms and legs, worsening of pulmonary symptoms and/or rash.
Other side effects
In clinical studies with Montelukast 4 mg chewable tablets, the commonly reported side effects (occurring in at least 1 of 100 patients and less than 1in 10 paediatric patients treated) thought to be related to this medicine 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 greater frequency in patients treated with Montelukast than placebo (a pill containing no medication).
Very common: may affect more than 1 in 10 people
• upper respiratory infection
What Montelukast 4 mg chewable tablets contain
• The active substance is montelukast. Each tablet contains montelukast sodium which corresponds to4 mg of montelukast.
• The other ingredients are: Mannitol, microcrystalline cellulose, low substituted hydroxypropyl cellulose, red iron oxide (E172), croscarmellose sodium, cherry flavour (Flavourings, Maize Maltodextrin, Moisture), aspartame (E951), magnesium stearate.
What Montelukast 4 mg chewable tablets look like and contents of the pack
Montelukast 4 mg chewable tablets are Pink to red coloured, mottled, oval shaped, biconvex tablet with“MT4” debossed on one side and plain ontheotherside.
Blisters in package of 28 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
RanbaxyUKLtd Building 4 Chiswick Park,
566 Chiswick High Road London, W45YE United Kingdom
Manufacturers:
Ranbaxy Ireland Ltd
Spafield, Cork Road
Cashel
Co. Tipperary
Ireland
TerapiaSA 124 Fabricii Street 400 632 ClujNapoca Romania
This leafletwas last revised in December2013.