Montelukast Ranbaxy 5 Mg Chewable Tablets
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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.
- 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 5 mg chewable tablets are and what they are used for
2. What you need to know before you take Montelukast 5 mg chewable tablets
3. How to take Montelukast 5 mg chewable tablets
4. Possible side effects
5. How to store Montelukast 5 mg chewable tablets
6. Contents of the pack and other information
1. What Montelukast 5 mg chewable tablets are and what they are used for
Montelukast 5 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.
Yourdoctor 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 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 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.
• This medicine also helps prevent the narrowing of airways triggered by exercise.
Your doctor will determine how these tablets should be used depending on the symptoms and severity of yourchild'sasthma.
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 5 mg chewable tablets
Tell your doctor about any medical problems or allergiesyou oryourchild has noworhashad.
Do not take Montelukast 5 mg chewable tablets ifyou oryourchild
• 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 5 mg chewable tablets
• Ifyou or your child's asthma or breathing gets worse, tell yourdoctor immediately.
• This oral medicine is not meant to treat acute asthma attacks. If an attack occurs, follow the instructions yourdoctor 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 medications prescribed by your doctor.
• This medicine 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 ifyou 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, you should consult yourdoctor.
• You or your child should not take aspirin (acetylsalicylic acid) or anti-inflammatory medicines (also known as non-steroidal antiinflammatory drugs or NSAIDs) if they make yourasthma worse.
Children and adolescents
For children 2to5 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 5 mg chewable tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines may affect how Montelukast 5 mg chewable tablets work, or Montelukast 5 mg chewable tablets may affect how other medicines work.
Tell your doctor if you or your child is taking the following medicines before starting Montelukast 5mg chewable tablets:
• phenobarbital (used fortreatmentof epilepsy)
• phenytoin (used fortreatmentof epilepsy)
• rifampicin (used to treat tuberculosis and some other infections)
• gemfibrozil (used for treatment of high lipid levels in plasma)
Montelukast 5 mg chewable tablets with food and drink
These tablets should not be taken immediately with food; it should be taken at least 1 hour before or2 hours after food.
Pregnancy, breast-feeding and fertility
Ifyou are pregnantor breast-feeding, think you maybe pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
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 tablet during this time.
Use in breast-feeding
It is not known if this medicine appears in breast milk. You should consult your doctor before taking this tablet if you are breast-feeding or intend to breastfeed.
Driving and using machines
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 Montelukast 5 mg chewable tablets may affect some patients' ability to drive or operate machinery.
Montelukast 5 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 this tablet contains phenylalanine (equivalent to 0.842 mg phenylalanine per 5 mg chewable tablet).
3. How to take Montelukast 5 mg chewable tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your
doctororpharmacistifyou are not sure.
• You oryourchild should take only one tablet of Montelukast 5 mg chewable tablets once a day as prescribed by yourdoctor.
• Itshould be taken even when you oryourchild has no symptoms or has an acute asthma attack.
• To be taken by mouth
For children 6to 14years of age:
One Montelukast 5 mg chewable tablet daily to be taken in the evening. This tablet should not be taken immediately with food; itshould be taken at least 1 hourbeforeor2 hours afterfood.
If you or your child is taking this medicine, be sure that you or your child does not take any other products that contain the same active ingredient, montelukast.
Ifyou oryourchild takes more Montelukast 5 mg chewable tablets than you should
Contact yourdoctor 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 5 mg chewable tablets or give Montelukast 5 mg chewable tablets to your child
Try to take this medicine as prescribed. However, ifyou oryourchild 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.
Ifyou oryourchild stops taking Montelukast 5 mg chewable tablets
This medicine can treat you or your child's asthma only ifyou or your child continues to take it.
It is important to continue taking these tablets for as long as your doctor prescribes. It will help control you oryourchild's asthma.
If you have any further questions on the use of this medicine, askyourdoctoror pharmacist.
4. Possible side effects
• 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
• jointormuscle 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 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 5 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 lastday of that month.
Store in the original package in order to protect from lightand 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 you experience any of the following, stop taking the medicine and tell your doctor immediately or go to the casualty department of your nearest 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 orswallowing.
• 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 5 mg chewable tablets, the commonly reported side effects (occurring in at least 1 of 100 patients and less than 1of 10 paediatric patients treated) thought to be related to these medicines were:
• headache
Additionally, the following side effect was reported in clinical studies with Montelukast 10 mg film coated 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).
Very common: may affect more than 1 in 10 people
• upper respiratory infection
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
What Montelukast 5 mg chewable tablets contain
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, red iron oxide (E172), croscarmellose sodium, cherry flavour (Flavourings, Maize Maltodextrin, Moisture), aspartame (E951), magnesium stearate
What Montelukast 5 mg chewable tablets look like and contents ofthe pack
Montelukast 5 mg chewable tablets are Pink to red coloured, mottled, round, biconvex tablet with "MT5"debossed on one side and plain on theotherside.
Blisters in packages of 28,30 or 50 tablets.
Not all pack sizes may be marketed.
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
Terapia SA 124 Fabricii Street 400632 ClujNapoca Romania
This leaflet was last revised in December2013.
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