Active ingredient
- montelukast sodium
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL14894/0580 .
Montelukast 10 mg film-coated tablets
Package leaflet: Information for the patient
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.
What is in this leaflet
1. What Montelukast 10 mg film-coated tablets are and what they are 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 are and what they are 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, this medicine improves asthma symptoms, helps 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.
Your doctor will determine how these tablets should be used depending on the symptoms and severity of your asthma.
What is asthma?
Asthma is a long-term disease.
Asthma includes:
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 air borne 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
Warnings and precautions
Talk to your doctor or pharmacist before taking Montelukast 10 mg film-coated tablets
Children and adolescents
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 10 mg film-coated tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines may affect how Montelukast works, or Montelukast may affect how other medicines work.
Tell your doctor if you are taking the following medicines before starting Montelukast 10 mg film-coated tablets:
Montelukast 10 mg film-coated tablets with food and drink
These tablets 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 this medicine. Your doctor will assess whether you can take this tablet during this time.
Breast-feeding
It is not known if this medicine appears in breast milk. You should consult your doctor before taking this tablet 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 a car or operate machinery. However, individual responses to medication may vary.
Certain side effects (such as dizziness and drowsiness) that have been reported 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 an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Montelukast 10 mg film coated tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
For adults 15 years of age and older:
One 10 mg tablet to be taken daily in the evening. This 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.
This medicine is for oral use.
You can take Montelukast 10 mg film-coated tablets with or without food.
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 over dose 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 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 10 mg film-coated tablets
This medicine can treat your asthma only if you continue to take it.
It is important to continue taking this medicine for as long as your doctor prescribes. It will help control your asthma.
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 (may affect up to 1 in 10 people) thought to be related to Montelukast were:
These were usually mild and occurred at a greater frequency in patients treated with Montelukast than placebo (a pill containing no medication).
Serious side effects
Talk with your doctor immediately if you notice any of the following side effects, which may be serious, and for which you may need urgent medical treatment.
Uncommon: the following may affect up to 1 in 100 people
Rare: the following may affect up to 1 in 1,000 people
Very rare: the following may affect up to 1 in 10,000 people
Other side effects while the medicine has been on the market
Very common: the following may affect more than 1 in 10 people
Common: the following may affect up to 1 in 10 people
Uncommon: the following may affect up to 1 in 100 people
Rare: the following may affect up to 1 in 1,000 people
Very Rare: the following may affect up to 1 in 10,000 people
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 or search for MHRA Yellow Card in the Google Play or Apple App Store. 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.
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 10-mg film-coated tablets contain
What Montelukast 10-mg film-coated tablets look like and contents of the pack
Montelukast 10 mg film-coated tablets are beige to light yellow coloured, rounded square, film-coated tablets, engraved with “M10” on one side and plain on the other side.
Blisters in packages of: 14, 28, 30, 50, 56, 98 tablets.
Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Manufacturers:
This leaflet was last revised in August 2019.
V015 & V018
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+44 (0) 208 848 8688
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