Montelukast 10 Mg Film-Coated Tablets
PACKAGE LEAFLET
Package leaflet: Information for the user
Montelukast 10 mg film-coated tablets
Montelukast
For adolescents and adults from 15 years
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. Y ou 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 only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any of the 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 is and what it is used for
2. What you need to know before you take Montelukast
3. How to take Montelukast
4. Possible side effects
5. How to store Montelukast
6. Contents 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 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 who are not adequately controlled on their medication and need additional therapy.
• Montelukast also helps prevent the narrowing of airways triggered by exercise.
• 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. What you need to know before you take Montelukast
Tell your doctor about any medical problems or allergies you have now or have had.
Do not take Montelukast if you
• are allergic to montelukast, soya, peanut or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
• If your asthma or breathing gets worse, tell your doctor immediately.
• Oral 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 or your child take all asthma medications prescribed by your doctor. Montelukast should not be substituted for other asthma medications your doctor has prescribed for you.
• Any patient on anti-asthma medicines should be aware that if you develop 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.
• You should not take acetyl-salicilic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they make your asthma worse.
• If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Children and adolescents
Montelukast 10 mg film-coated tablets are not recommended for use in children and adolescents under the age of 15.
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 Montelukast works or Montelukast may affect how other medicines work.
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
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)
• gemfibrozil (used for treatment of high lipid levels in plasma)
Taking Montelukast with food and drink
Montelukast 10 mg may be taken with or without food.
Pregnancy and Breast-feeding
Use in pregnancy
Women who are pregnant or breast-feeding, think they may be pregnant or are planning to have a baby, should consult their doctor before taking this medicine. Your doctor will assess whether you can take Montelukast 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.
Montelukast 10 mg film-coated tablets contain lactose.
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.
Montelukast contains soya oil. If you are allergic to soja or peanut, do not use this medicinal product.
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 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
For adults 15 years of age and older:
One 10 mg tablet to be taken daily in the evening. Montelukast 10 mg may be taken with or without food.
If you are taking Montelukast, 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 overdosage reports. The most frequently occurring symptoms reported with overdosage 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 to take it.
It is important 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, this medicine can cause side effects, although not everybody gets them.
In clinical studies with Montelukast 10 mg film-coated tablets, the most commonly (in more than 1 in 100, or less than 1 in 10 treated patients) reported side effects thought to be related to Montelukast were:
• abdominal pain
• headache
These were usually mild and occurred at a greater frequency in patients treated with Montelukast or placebo (a pill containing no medication).
Additionally, while the drug has been on the market, the following have been reported:
Very common (affects at least 1 user in 10)
• upper respiratory infection
Common (affects 1 to 10 users in 100)
• diarrhea, nausea, vomiting
• rash
• fever
Uncommon (affects 1 to 10 users in 1,000)
• allergic reactions including swelling of the face, lips , tongue, and/ or throat which may cause difficulty in breathing or swallowing
• behaviour and mood related changes (dream abnormalities, including nightmares, trouble sleeping, sleep walking, irritation, feeling anxious, restlessness, agitation including aggressive behaviour or hostility, depression)
• dizziness, drowsiness, pins and needles/numbness, seizure
• nosebleed
• bruising, itching, hives
• dry mouth, indigestion
• joint or muscle pain, muscle cramps
• weakness/tiredness, feeling unwell, swelling
Rare (affects 1 to 10 users in 10,000)
• increase bleeding tendency
• tremor
• palpitations
• disturbance in attention
• memory impairment
Very rare (affects less than 1 user in 10,000)
• hepatitis (inflammation of the liver)
• tender red lumps under the skin most commonly on your shins(erythema nodosum), severe skin reactions (erythema multiforme) that may occur without warning
• hallucinations, disorientation, suicidal thoughts and actions
In asthmatic patients treated with Montelukast, very rare cases of 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) have been reported. You must tell your doctor right away if you get 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 (Website: 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
• Keep out of the 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 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 contains
• The active substance is: montelukast
10 mg tablet contains 10.4 mg montelukast sodium which corresponds to 10 mg of montelukast.
• The other ingredients are:
Tablet c ore: Microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, Hydroxypropyl cellulose and magnesium stearate.
Film coating: Polyvinyl alcohol, titanium dioxide, talc, iron oxide red, iron oxide black, iron oxide yellow, lecithin and xanthan gum.
What Montelukast looks like and contents of the pack
Montelukast 10 mg tablets are beige, round, biconvex, film-coated tablets.
In packs of 1, 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 100 tablets.
Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Pharmathen S.A., 6 Dervenakion str., Pallini Attiki, 15351 Greece Tel.: +30 210 666 4300 Fax: +30 210 666 6749 E-mail: info@pharmathen.com
Manufacturer:
Pharmathen S.A., 6 Dervenakion str., Pallini Attiki, 15351 Greece Tel.: +30 210 666 4300 Fax: +30 210 666 6749 E-mail: info@pharmathen.com
This m edicinal pr oduct is au thorized in t he M ember St ates of t he E EA unde r t he following names:
UK/H/2691/01/DC:
UK
Czech Republic Germany
Estonia
Iceland
Lithuania
Poland
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