Montelukast 10 Mg Film-Coated Tablets
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Montelukast 10mg film-coated tablets
Montelukast
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, ask your doctoror 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 10 mg is and what it is used for
2. Before you take Montelukast 10 mg
3. How to take Montelukast 10 mg
4. Possible side effects
5. How to store Montelukast 10 mg
6. Further information
1. WHAT MONTELUKAST 10 MG IS AND WHAT IT IS USED FOR
Montelukast 10 mg 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 10 mg 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 10 mg to treat asthma, preventing your asthma symptoms during the day and night.
• Montelukast 10 mg is used for the treatment of patients who are not adequately controlled on their medication and need additional therapy.
• Montelukast 10 mg also helps prevent the narrowing of airways triggered by exercise.
• In those asthmatic patients in whom Montelukast 10 mg is indicated in asthma, Montelukast 10 mg can also provide symptomatic relief of seasonal allergic rhinitis.
Your doctor will determine how Montelukast 10 mg 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 YOU TAKE MONTELUKAST 10 MG Do not take Montelukast 10 mg
- if you are allergic (hypersensitive) to montelukast or any of the other ingredients of Montelukast 10 mg. Take special care with Montelukast 10 mg
• If your asthma or breathing gets worse, tell your doctor immediately.
• Oral Montelukast 10 mg 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 10 mg 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 lung (pulmonary) problems, and/or rash, you should consult your doctor.
• You should not take aspirin or anti-inflammatory medicines (also known as non-steroidal antiinflammatory drugs or NSAIDs) if they make your asthma worse.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Some medicines may affect how Montelukast 10 mg works, or Montelukast 10 mg may affect how other medicines work.
Tell your doctor if you are taking the following medicines before starting Montelukast 10 mg:
• phenobarbital (used for treatment of epilepsy)
• phenytoin (used for treatment of epilepsy)
• rifampicin (used to treat tuberculosis and some other infections)
Taking Montelukast 10 mg 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 intend to become pregnant should consult their doctor before taking Montelukast 10 mg. Your doctor will assess whether you can take Montelukast 10 mg during this time.
Use in breast-feeding
It is not known if Montelukast 10 mg appears in breast milk. You should consult your doctor before taking Montelukast 10 mg if you are breast-feeding or intend to breast-feed.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Montelukast 10 mg 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 10 mg may affect some patients’ ability to drive or operate machinery.
Important information about some of the ingredients of Montelukast 10 mg
Montelukast 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 10 MG
Always take Montelukast 10 mg as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
• You should take only one tablet of Montelukast 10 mg 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.
The usual dose is
For adults and adolescents 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 10 mg, be sure that you do not take any other products that contain the same active ingredient, montelukast.
Montelukast 10 mg should not be used in children below 15 years of age due to the high content of active substance.
Other dosage forms with appropriate strengths are available for younger children.
If you take more Montelukast 10 mg 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
Try to take Montelukast 10 mg 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
Montelukast 10 mg can treat your asthma only if you continue to take it. It is important to continue taking Montelukast 10 mg 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 10 mg can cause side effects, although not everybody gets them.
In clinical studies with Montelukast 10 mg film-coated tablets, the most commonly (affects 1 to 10 users in 100 ) reported side effects thought to be related to Montelukast 10 mg were:
• abdominal pain
• headache
Additionally, while the drug has been on the market, the following have been reported:
• allergic reactions including rash, swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing, itching, and hives
• tiredness, restlessness, agitation including aggressive behavior, irritability, tremor, depression, dizziness, drowsiness, hallucinations, dream abnormalities, including nightmares and trouble sleeping, pins and needles/numbness, seizure
• feeling unwell, joint or muscle pain, muscle cramps, dry mouth, nausea, vomiting, indigestion, diarrhoea, hepatitis
• increased bleeding tendency, bruising, palpitations
• swelling
In asthmatic patients treated with montelukast, very rare cases (affects less than 1 user in 10,000) of a combination of symptoms such as flulike illness, pins and needles or numbness of arms and legs, worsening of lung (pulmonary) problems 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.
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 10 MG
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the container. 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.
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 10 mg contains
The active substance is montelukast.
One tablet contains 10.4 mg montelukast sodium which corresponds to 10 mg of montelukast.
The other ingredients are:
Core: Lactose monohydrate, hydroxypropylcellulose type EF, cellulose, microcrystalline, croscarmellose sodium, magnesium stearat,
Coating: Hypromellose 6 cps, titanium dioxide (E 171), macrogol 400, ferric oxide, yellow (E 172), ferric oxide, red (E 172)
What Montelukast 10 mg looks like and contents of the pack
Beige, squared, biconvex, film-coated tablet, encoded 10 on one side
Packaged in
OPA/Al/PVC/Al blisters:
7, 10, 14, 20, 21, 28, 30, 49, 50, 56, 84, 90, 98, 100, 140, 200 tablets Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Hexal AG, Industriestrasse 25, 83607 Holzkirchen, Germany Manufacturers:
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany or Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana, Slovenia or LEK S.A., ul. Domaniewska 50 C, 02-672 Warszawa, Poland or S.C. Sandoz S.R.L, Str. Livezeni nr7A, 540472 Targu-Mures, Romania.