Montelukast 10 Mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Montelukast 10 mg film-coated tablets Montelukast
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 10 mg film-coated tablets is and what it is used for
2. What you need to know before you take Montelukast 10 mg film-coated tablets
3. How to take Montelukast 10 mg film-coated tablets
4. Possible side effects
5. How to store Montelukast 10 mg film-coated tablets
6. Contents of the pack and other information
1. What Montelukast 10 mg film-coated tablets 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 the 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 /.../ to treat asthma, preventing your asthma symptoms during the day and night.
• Montelukast 10 mg film-coated tablets is used for the treatment of patients aged 15 years and older who are not adequately controlled on their medication and need additional therapy.
• Montelukast 10 mg film-coated tablets also helps prevent the narrowing of airways triggered by exercise.
• In those asthmatic patients in whom Montelukast 10 mg film-coated tablets is indicated in asthma, Montelukast 10 mg film-coated tablets can also provide symptomatic relief of seasonal allergic rhinitis.
Your doctor will determine how Montelukast 10 mg film-coated tablets 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 10 mg film-coated tablets
Tell your doctor about any medical problems or allergies you have now or have had.
Do not take Montelukast 10 mg film-coated tablets
• If you are allergic (hypersensitive) 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 10 mg film-coated tablets:
• If your asthma or breathing gets worse, tell your doctor immediately.
• Oral Montelukast 10 mg film-coated tablets 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 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-salicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they make your asthma worse.
Children and adolescents
Montelukast 10 mg film-coated tablets is not suitable for children and adolescents under 15 years of
age for whom alternative products available in lower strengths are recommended.
Other medicines and Montelukast Warren
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines may affect how Montelukast 10 mg film-coated tablets works or Montelukast 10 mg film-coated tablets may affect how other medicines work.
Tell your doctor if you are taking the following medicines before starting Montelukast Warren:
• 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)
Montelukast 10 mg film-coated tablets with food and drink
Montelukast may be taken with or without food.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Women who are pregnant or intend to become pregnant should consult their doctor before taking Montelukast Warren. Your doctor will assess whether you can take Monte lukast 10 mg film-coated tablets during this time.
Breast-feeding
It is not known if montelukast appears in breast milk. You should consult your doctor before taking Montelukast 10 mg film-coated tablets 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 10 mg film-coated tablets contain lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Montelukast Warren
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
• The recommended dose is only one tablet of Montelukast 10 mg film-coated tablets once a day as prescribed by your doctor.
• It should be taken even when you have no symptoms or have an acute asthma attack.
• To be taken by mouth.
Use in adults and adolescent 15 years of age and older
The recommended dose is one 10 mg tablet to be taken daily in the evening. Montelukast 10 mg film-coated tablets may be taken with or without food.
Use in children and adolescents younger than 15 years
This product is not suitable for children and adolescents under 15 years of age for whom alternative products available in lower strengths are recommended.
If you are taking Montelukast Warren, be sure that you do not take any other products that contain the same active ingredient, montelukast.
If you take more Montelukast 10 mg film-coated tablets 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 10 mg film-coated tablets
Try to take Montelukast 10 mg film-coated tablets 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 10 mg film-coated tablets
Montelukast 10 mg film-coated tablets can treat your asthma only if you continue to take it.
It is important to continue taking Montelukast 10 mg film-coated tablets 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, the most commonly reported side effects (occurring in at least 1 of 100 patients and less than 1 of 10 patients treated) 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 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)
• nose bleed (Uncommon)
• 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 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 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 10 mg film-coated tablets Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
Do not store above 30 °C.
Store in the original package in order to protect from moisture and light.
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 What Montelukast 10 mg film-coated tablets contains
- The active substance is montelukast. Each film-coated tablet contains montelukast sodium which corresponds to 10 mg of montelukast.
- The other ingredients are: cellulose, microcrystalline (E460), lactose monohydrate, hydroxypropylcellulose, low substituted (E463), croscarmellose sodium (E468), magnesium stearate (E572).
Film coating: hypromellose, type 2910 (E464), hydroxypropylcellulose (E463), titanium dioxide (E171), carnauba wax (E903), iron oxide yellow (E172), iron oxide red (E172).
What Montelukast 10 mg film-coated tablets looks like and contents of the pack
Montelukast 10 mg film-coated tablets are beige coloured, rounded square, film coated, biconvex tablets, 8.1 mm x 8.1 mm, plain on both sides.
Packaged in OPA-Al-PVC/Al blister in following pack sizes 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 100, 140 and 200 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder WARREN GENERICS s.r.o.
U Stare tvrze 285/21 196 00 Prague Czech Republic
Manufacturer
Indoco Remedies Limited
L-32, 33, 34, Plant III, Verna Industrial Area
403722 Verna, Goa,
India
This medicinal product is authorised in the Member States of the EEA under the following
names:
United Kingdom The Netherlands Germany
Montelukast 10 mg film-coated tablets Montelukast Warren 10 mg filmomhulde tabletten Montelukast Warren 10 mg Filmtabletten
This leaflet was last revised in 02/2015.
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