Montelukast 10 Mg Film-Coated Tablets
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MONTELUKAST 10 mg FILM-COATED TABLETS
For adolescents and adults from 15 years 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 later.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for your child. Do not pass it on to others. It may harm them, even if their symptoms are the same as your child’s.
- 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. See Section 4.
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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. Content 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 the lungs and also cause allergy symptoms. By blocking leukotrienes, Montelukast improves asthma symptoms, helps to control asthma and improves seasonal allergy symptoms (also known as hay fever or seasonal allergic rhinitis).
Your doctor has prescribed this medicine to treat asthma, preventing your asthma symptoms during the day and night.
- This medicine is used for the treatment of adolescents and adults from 15 years of age who are not adequately controlled on their medication and need additional therapy.
- This medicine also helps prevent the narrowing of airways triggered by exercise.
- In those asthmatic patients in whom this medicine is indicated in asthma, these tablets can also provide symptomatic relief of seasonal allergic rhinitis.
Your doctor will determine how this medicine 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.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Do not take Montelukast if you
- are allergic (hypersensitive) to montelukast or any of the other ingredients in this medicine (see 6. FURTHER INFORMATION).
Warnings and precautions
Take special care with Montelukast
- If your asthma or breathing gets worse, tell your doctor immediately.
- These oral tablets are 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 medicines prescribed by your doctor.
These tablets 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 flu-like illness, pins and needles or numbness of arms or legs, worsening of pulmonary symptoms, and/or rash occur, you should consult your doctor.
- You should not take aspirin (acetyl-salicylic acid) or other anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they make your asthma worse.
Use in children
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 your tablets work, or these tablets may affect how 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 or have recently taken the following medicines before starting this medicine:
- 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 with food and drink
These tablets 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 this medicine. Your doctor will assess whether you can take this medicine during this time.
Use in breast-feeding
It is not known if montelukast appears in breast milk. You should consult your doctor before taking this medicine if you are breast-feeding or intend to breast-feed.
Driving and using machines
This medicine is not expected to affect your ability to drive 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 these tablets may affect some patients' ability to drive or operate machinery.
Important information about some of the ingredients of Montelukast
These 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.
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3. HOW TO TAKE MONTELUKAST
- You should take only one tablet of this medicine 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 the tablets 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 Montelukast 10 mg tablet to be taken daily in the evening. The tablet may be taken with or without food.
If you are taking this medicine, 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 this medicine 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
This medicine can treat your asthma only if you continue to take it.
It is important to continue taking the 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.
Seek immediate medical advice if you experience allergic reactions including swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing (Uncommon).
Tell your doctor right away if you experience any behaviour and mood related changes such as:
Uncommon (may affect up to 1 in 100 people) dream abnormalities, including nightmares, sleepwalking, trouble sleeping, hallucinations, irritability, feeling anxious, restlessness, agitation including aggressive behaviour or hostility, depression
Rare (may affect up to 1 in 1,000 people) tremor, disturbance in attention, memory impairment
Very rare (may affect up to 1 in 10,000 people) hallucinations, disorientation, suicidal thoughts and actions
In asthmatic patients treated with montelukast, very rare cases of a combination of symptoms such as flulike 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.
In clinical studies with these tablets, 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 the medicine 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).
Additionally, while the medicine has been on the market, the following have been reported:
Very common (may affect more than 1 in 10 people):
- upper respiratory infection
Common (may affect up to 1 in 10 people):
- diarrhoea, nausea, vomiting; rash; fever
Uncommon (may affect up to 1 in 100 people):
- dizziness, drowsiness, pins and needles/numbness, seizure
- nosebleed
- dry mouth, indigestion
- bruising, itching, hives
- joint or muscle pain, muscle cramps
- tiredness, feeling unwell, swelling
Rare (may affect up to 1 in 1,000 people):
- increased bleeding tendency
- palpitations
Very rare (may affect up to 1 in 10,000 people):
- 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
Reporting of side effects
If you get any side effects talk to your doctor, pharmacist or nurse. 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 the side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE MONTELUKAST
- Keep out of 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.
- Do not store above 30°C.
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 dispose of medicines no longer required. These measures will help protect the environment.
6. CONTENT OF THE PACK AND OTHER INFORMATION
What Montelukast contains
- The active substance is montelukast. Each tablet contains montelukast sodium which corresponds to 10 mg of montelukast.
- The other ingredients are:
Microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, hyprolose (E 463) and magnesium stearate
Film coating: Black Iron oxide (E172), Hypromellose, Red Iron Oxide (E172),
Polyethylene Glycol, Titanium Dioxide (E171), Yellow Iron Oxide (E172), Macrogol (6000).
What Montelukast looks like and content of the pack
Montelukast 10 mg film-coated tablets are beige, square and biconvex with MOK 10 engraved on one side and PHD471 on the other.
Blister in packages of: 14, 20, 28, 30, 50, 98, 100 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Dexcel Pharma Ltd., 7 Sopwith Way, Drayton Fields, Daventry, Northamptonshire, NN11 8PB UK.
Manufacturer:
MC Pharma AD
35, Zemliane Str., 1618 Sofia, Bulgaria.
This medicinal product is authorised in the Member States of the EEA under the following names:
United Kingdom: Montelukast 10 mg film-coated tablets