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: PL 00025/0358.
Singulair 10mg Tablets
Package leaflet: Information for the user
Singulair® 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 Singulair is and what it is used for
2. What you need to know before you take Singulair
3. How to take Singulair
4. Possible side effects
5. How to store Singulair
6. Contents of the pack and other information
1. What Singulair is and what it is used for
What Singulair is
Singulair is a leukotriene receptor antagonist that blocks substances called leukotrienes.
How Singulair works
Leukotrienes cause narrowing and swelling of airways in the lungs and also cause allergy symptoms. By blocking leukotrienes, Singulair improves asthma symptoms, helps control asthma and improves seasonal allergy symptoms (also known as hay fever or seasonal allergic rhinitis).
When Singulair should be used
Your doctor has prescribed Singulair to treat asthma, preventing your asthma symptoms during the day and night.
Your doctor will determine how Singulair 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 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 Singulair
Tell your doctor about any medical problems or allergies you have now or have had.
Do not take Singulair
Warnings and precautions
Talk to your doctor or pharmacist before taking Singulair.
Patients should be aware that various neuropsychiatric events (for example behaviour and mood-related changes) have been reported in adults, adolescents and children with Singulair (see section 4). If you develop such symptoms while taking Singulair, you should consult your doctor.
Children and adolescents
Do not give this medicine to children less than 15 years of age.
There are different form(s) of this medicine available for paediatric patients under 18 years of age based on age range.
Other medicines and Singulair
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines including those obtained without a prescription.
Some medicines may affect how Singulair works, or Singulair may affect how other medicines work.
Tell your doctor if you are taking the following medicines before starting Singulair:
Singulair with food and drink
Singulair 10 mg film-coated tablet 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 Singulair.
Pregnancy
Your doctor will assess whether you can take Singulair during this time.
Breast-feeding
It is not known if Singulair appears in breast milk. You should consult your doctor before taking Singulair if you are breast-feeding or intend to breast-feed.
Driving and using machines
Singulair 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 Singulair may affect some patients’ ability to drive or operate machinery.
Singulair 10 mg film-coated tablets contain lactose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. How to take Singulair
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 and adolescents 15 years of age and older:
The recommended dose is one 10 mg tablet to be taken daily in the evening.
If you are taking Singulair, 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 Singulair 10 mg with or without food.
If you take more Singulair 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 Singulair
Try to take Singulair 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 Singulair
Singulair can treat your asthma only if you continue to take it.
It is important to continue taking Singulair 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 Singulair 10 mg film-coated tablets, the most commonly reported side effects (may affect up to 1 in 10 people) thought to be related to Singulair were:
These were usually mild and occurred at a greater frequency in patients treated with Singulair 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, 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 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 Singulair
6. Contents of the pack and other information
What Singulair contains
What Singulair looks like and contents of the pack
10 mg Singulair tablets are beige, rounded square, film-coated with SINGULAIR engraved on one side, MSD 117 on the other.
Blisters in packages of: 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 100, 140, and 200 tablets.
Blisters (unit dose), in packages of: 49x1, 50x1 and 56x1 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder:
The manufacturer:
Information is given by:
Alternatively phone the Asthma UK Helpline on 0300 222 5800, Monday to Friday, 9 am to 5 pm.
(Asthma UK is an independent charity working to conquer asthma and is not associated with Merck Sharp & Dohme Limited.)
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria, Belgium, Denmark, Finland, France, Greece, Spain, Sweden, Germany, Ireland, United Kingdom, Italy, Luxemburg, Netherlands, Portugal
Singulair
This package leaflet was last revised in May 2020
© Merck Sharp & Dohme Limited 2020. All rights reserved.
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