Montelukast 10 Mg Film-Coated Tablets
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Montelukast 10 mg Film-Coated Tablets
Montelukast
For adolescents from 15 years and older and adults
Read all of this leaflet carefully before you 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• 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 Montelukast is taken
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 your lungs and also cause allergy symptoms. By blocking leukotrienes, Montelukast improves asthma symptoms, helps control asthma and improves seasonal allergy symptoms (also known as hay fever or seasonal allergic rhinitis).
Your doctor has prescribed Montelukast to treat asthma, preventing your asthma symptoms during the day and night.
• Montelukast is used for the treatment of patients from 15 years of age and older who are not adequately controlled on their medication and need additional therapy.
• Montelukast also helps prevent the narrowing of airways triggered by exercise in patients from 15 years of age and older.
• In those asthmatic patients in whom Montelukast is indicated in asthma, Montelukast can also provide symptomatic relief of seasonal allergic rhinitis.
Your doctor will determine how Montelukast should be used depending on the symptoms and severity of your 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.
What are seasonal allergies?
Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are an allergic response often caused by airborne pollens from trees, grasses and weeds. The symptoms of seasonal allergies typically may include: stuffy, runny, itchy nose; sneezing; watery, swollen, red, itchy eyes.
2. Before Montelukast is taken
Tell your doctor about any medical problems or allergies you have now or have had.
Do not take Montelukast if
• you are allergic (hypersensitive) to montelukast or any of the other ingredients of Montelukast film-coated tablets (see section 6. Further information).
Take special care with Montelukast
• If your 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 you. Always have your inhaled rescue medicine for asthma attacks with you.
• It is important that you take all asthma medications prescribed by your doctor. Montelukast should not be used instead of other asthma medications your doctor has prescribed for you.
• If you are on anti-asthma medicines, 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, you should consult your doctor.
• You should not take acetyl-salicylic acid (aspirin) or antiinflammatory medicines (also known as non-steroidal antiinflammatory drugs or NSAIDs) if they make your asthma worse.
Use in children
Montelukast film-coated tablets are for adolescents from 15 years old and older, and for adults.
For children 2 to 5 years old, 4 mg chewable tablets and 4 mg granules are available. For children 6 to 14 years old, 5 mg chewable tablets are available.
Taking other medicines
Some medicines may affect how Montelukast works, or Montelukast may affect how your other medicines work.
Please tell your doctor or pharmacist if you are taking or have recently taken other medicines, including those obtained without a prescription.
Tell your doctor if you are 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 may be taken with or without 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 these tablets 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
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 film-coated tablets contain the milk sugar lactose. If you have been told by your doctor that you have an intolerance to some sugars, such as lactose, contact your doctor before taking this medicine.
3. How to take Montelukast
• You should take only one tablet of Montelukast once a day as prescribed by your doctor.
• It should be taken even when you have no symptoms or if you have 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.
One 10 mg tablet to be taken daily in the evening. Montelukast may be taken with or without food.
If you are taking Montelukast film-coated tablets, be sure that you do not take any other products that contain the same active ingredient, montelukast.
If you take 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
Try to take Montelukast as prescribed. However, if you miss 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 stop taking Montelukast
Montelukast can treat your asthma only if you continue taking it.
It is important for you to continue taking Montelukast for as long as your doctor prescribes. It will help control your 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.
If you notice any of the following serious side effects, stop taking Montelukast and contact a doctor immediately:
• swelling of the face, lips, tongue and/or throat which may cause difficulties in breathing or swallowing, itching, rash, hives (allergic reaction)
• 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)
The following side effects have also been reported with Montelukast:
Common side effects (may affect up to 1 in 10 people)
• headache
• abdominal pain
• thirst
Very rare side effects (may affect up to 1 in 10,000 people)
• suicidal thoughts and actions
Frequency not known (frequency cannot be estimated from the available data)
• upper respiratory infection
• tiredness, restlessness, agitation including aggressive behaviour or hostility, irritability, tremor, depression, dizziness, drowsiness, hallucinations, dream abnormalities, including nightmares and trouble sleeping, sleepwalking, pins and needles/numbness, seizure
• feeling unwell, joint or muscle pain, muscle cramps, dry mouth, nausea, vomiting, indigestion, diarrhoea, hepatitis (inflammation of the liver)
• increased bleeding tendency, bruising, tender red lumps under the skin most commonly on your shins (erythema nodosum), palpitations
• swelling
• feeling anxious
• nosebleed
• fever
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 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.
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 film-coated tablets contain
The active substance is montelukast. Each tablet contains montelukast sodium which corresponds to 10 mg of montelukast.
The other ingredients are:
Tablet Core: lactose monohydrate, cellulose, microcrystalline (E460), croscarmellose sodium (E468), hydroxypropylcellulose (E463), magnesium stearate (E572).
Film-coating: hypromellose (E 464), titanium dioxide (E171), macrogol 400, iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E172).
What Montelukast film-coated tablets look like and contents of the pack
Brown coloured rounded square shaped, film coated tablets debossed with ‘MTS' on one side and ‘10' on the other side.
Blister in pack sizes of: 14, 20, 28, 49, 50, 100 film-coated tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Dr. Reddy's Laboratories (UK) Ltd., 6 Riverview Road, Beverley, HU17 0LD
This leaflet was last updated in 09/2012.