Montelukast 10 Mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Montelukast 10 mg film-coated tablets For patients aged 15 years and above Montelukast
Read all of this leaflet carefully before you start taking this medicine.
- 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 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.
What is in this leaflet:
1. What Montelukast is and what it is used for
2. What you need to know before you use 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 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 Montelukast to treat asthma, preventing your asthma symptoms during the day and night.
- Montelukast 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.
- 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 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 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 use Montelukast
Do not take Montelukast
- if you are allergic to montelukast or any of the other ingredients in this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Montelukast
- If your asthma or breathing gets worse, tell your doctor immediately.
- Oral Montelukast is not meant to treat acute asthma attacks. If an asthma 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.
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 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 acetyl-salicylic acid (aspirin) or other anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they make your asthma worse.
Children and adolescents
Montelukast is not intended to be used in patients aged below 15 years.
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, 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 epilepsy)
- rifampicin (used to treat tuberculosis and some other infections)
Montelukast with food and drink
Montelukast 10 mg may be taken with or without food.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think that you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
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 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 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 contains lactose
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
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.
Check with your doctor or pharmacist if you are not sure.
The recommended dose is one tablet once a day.
This medicine should be taken by mouth.
For patients aged 15 years and above:
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 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 recommended. 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 treat your symptoms only if you take it regularly.
If you have any further questions on the use of this medicine, 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 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).
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 more than 1 in 100 people)
- diarrhoea, nausea, vomiting
- changes in the liver enzymes in the blood
- rash
- fever
Uncommon (may affect more than 1 in 1000 people)
- allergic reactions, also anaphylaxis, which symptoms may include: low blood pressure, breathing problems and skin symptoms such as hives and swelling
- behaviour and mood related changes (dream abnormalities including nightmares, trouble sleeping, sleepwalking, irritability, feeling anxious, restlessness, agitation including aggressive behaviour or hostility, depression)
- 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
- tremor
- palpitations
- swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing
(angioedema)
Very rare (may affect up to 1 in 10,000 people)
- hallucinations, disorientation, suicidal thoughts and actions
- combination of symptoms such as flu-like illness, pins and needles or numbness of arms and legs, worsening of pulmonary symptoms and/or rash (so called Churg-Strauss syndrome). You must tell your doctor right away if your child gets one or more of these symptoms
- tender red lumps under the skin most commonly on your shins (erythema nodosum, erythema multiforme)
- hepatic disorder (hepatic eosinophilic infiltration), hepatitis (inflammation of the liver)
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/yellowcard . By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Montelukast
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry which is stated on the blister, after <EXP>. The expiry date is shown by the six numbers. The first two numbers indicate the months; the last four numbers indicate the year. 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 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 protect the environment.
6. Contents of the pack and other information What Montelukast contains
- The active substance is montelukast. Each tablet contains montelukast sodium which corresponds to 5 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 contents 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
PharmaSwiss Ceska republika s.r.o.
Jankovcova 1569/2c 170 00 Prague 7
Manufacturer:
ICN Polfa Rzeszow S.A. ul. Przemyslowa 2 35-959 Rzeszow Poland
This medicinal product is authorised in the Member States of the EEA under the following names:
Poland: Montexal Slovakia: Montexal 10 mg
05/02/2016