10 mg film-coated tablets
montelukast
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
Leukotriene er causes constriction and swelling of the airways in the lungs and also causes allergic symptoms. By blocking the leukotrienes, Singulair improves the symptoms of asthma, helps control asthma, and improves the symptoms of seasonal allergies (so-called hay fever or seasonal allergic rhinitis ).
When to use Singulair
Your doctor has prescribed Singulair to treat asthma and thus prevent asthma symptoms during the day and night.
- Singulair is used for the treatment of adults and adolescents, 15 years of age and older, who have not been adequately controlled with previous asthma medication and therefore need additional treatment.
- Singulair also prevents constriction of the airways associated with physical exertion.
- Singulair can also be used for seasonal allergic rhinitis in those patients where Singulair is used to treat asthma.
Depending on your symptoms and the severity of your asthma, your doctor will decide how Singulair should be used.
What is asthma?
Asthma is a chronic disease.
Asthma includes:
- Difficulty breathing due to constriction of the airways. This constriction of the airways worsens and improves depending on different conditions.
- Sensitive airways that react to different things such as cigarette smoke, pollen, cold air, or exertion.
- Swelling ( inflammation ) of the mucous membranes of the respiratory tract.
Symptoms of asthma include coughing, wheezing, and chest tightness.
What is a seasonal allergy?
Seasonal allergy (also called hay fever or seasonal allergic rhinitis ) is an allergic reaction that is often caused by airborne pollen from trees, grass, or weeds. The symptoms of seasonal allergy are characterized by; a stuffy, runny, and itchy nose; sneezing; watery, swollen, red, and itchy eyes.
What you need to know before you take Singulair
Tell your doctor about any medical or allergy problems you have or have had.
Do not take Singulair
- if you are allergic to montelukast or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Singulair.
- If asthma symptoms or breathing worsen, contact your doctor immediately.
- Singulair is not intended for the treatment of acute asthma attacks. If an attack occurs, follow the instructions given by the doctor for this situation. Always carry your inhaled bronchodilator asthma medicine with you for acute asthma attacks.
- You or your child must take any other asthma medicines prescribed by the doctor. Singulair is not intended to replace other asthma medicines prescribed by the doctor for concomitant treatment.
- During treatment with asthma medication, you should know that if you get a combination of different symptoms, such as flu-like symptoms, tingling or numbness in the arms or legs, worsening respiratory symptoms, and/or skin rashes, a doctor should be contacted.
- If you know that your asthma is worsened by aspirin or other anti-inflammatory agents (so-called NSAIDs ), then do not use these drugs.
Patients should be aware that various neuropsychiatric events (eg, behavior and mood-related changes) have been reported in adults, adolescents, and children with Singulair (see section 4). If you develop such symptoms while using Singulair, you should contact your doctor.
Children and young people
Do not give this medicine to children younger than 15 years of age.
There are other formulations of this medicine available for children and adolescents under the age of 18 that are based on age group.
Other medicines and Singulair
Tell your doctor or pharmacist if you have recently taken, or might take any other medicines, even those without a prescription.
Some medicines can affect how Singulair works and Singulair can affect how other medicines work.
Tell your doctor if you are using the following medications before you start taking Singulair:
- phenobarbital ( antiepileptic )
- phenytoin (medicine for epilepsy )
- rifampicin (medicine against tuberculosis and other infections )
- gemfibrozil (medicine for high blood fat levels)
Singulair with food and drink
Singulair 10 mg film-coated tablets can be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using Singulair.
Pregnancy
Your doctor will decide if you can take Singulair during this time.
Breastfeeding
It is unknown whether Singulair passes into breast milk. Therefore, consult a doctor before using Singulair during breastfeeding or planned breastfeeding.
Driving ability and use of machinery
Singulair is not expected to affect your ability to drive or operate machinery. However, individual reactions to drugs can vary. However, dizziness and drowsiness have been reported which may affect some patients’ ability to drive or operate machinery.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Singulair 10 mg film-coated tablets contain lactose and sodium
If you have an intolerance to some sugars, you should consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost “sodium-free”.
How to take Singulair
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
- Take only one Singulair tablet a day as directed by your doctor.
- You must continue to take Singulair both during symptom-free periods and during an acute asthma attack.
Adults and adolescents, 15 years and older
The recommended dose is one 10 mg tablet taken once daily in the evening.
Singulair should not be used with any other product that contains the same active ingredient, montelukast.
This medicine should be taken by mouth.
Singulair 10 mg can be taken with or without food.
If you have taken too much Singulair
Contact a doctor immediately for advice.
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
In the majority of the reports that exist of overdose, no side effects have been reported. The most common symptoms reported in overdose in adults and children included abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.
If you forget to take Singulair
Try to take Singulair as prescribed. If you have missed a dose, then return to the usual schedule of one tablet a day.
Do not take a double dose to make up for a missed dose.
If you stop taking Singulair
Singulair can only treat your asthma if you keep taking it.
It is important to keep taking Singulair as long as your doctor prescribes it. It helps you control your asthma.
If you have further questions about this medicine, contact your doctor or pharmacist.
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 (which may affect up to 1 in 10 users) where a probable relationship exists were:
- stomach ache
- headache
These were usually mild and occurred more often in patients treated with Singulair than with a placebo (a pill that does not contain any medicine).
Serious side effects are
Talk to your doctor immediately if you notice any of the following side effects which may be serious and may require urgent medical treatment.
Uncommon: may affect up to 1 in 100 users
- allergic reactions including swelling of the face, lips, tongue, and/or throat, which may cause breathing or swallowing difficulties
- behavioral and mood changes: anxiety/agitation including aggressive behavior or hostility, depression
- convulsions
Rare: may affect up to 1 in 1,000 users
- increased tendency to bleed
- tremors
- palpitation
Very rare: may affect up to 1 in 10,000 users
- combination of symptoms, such as flu-like symptoms, tingling or numbness in the arms and legs, worsening respiratory symptoms, and/or skin rash (Churg-Strauss syndrome) (see section 2)
- decreased number of platelets
- behavioral and mood changes: hallucinations, disorientation, suicidal thoughts and actions
- swelling ( inflammation ) in the lungs
- serious skin reactions (erythema multiforme) which may appear without warning
- inflammation of the liver ( hepatitis )
Other side effects were reported during the time the medicine has been on the market
Very common: may affect more than 1 in 10 users
- upper respiratory tract infection
Common: may affect up to 1 in 10 users
- diarrhea, nausea, vomiting
- rash
- fever
- elevated liver enzymes
Uncommon: may affect up to 1 in 100 users
- behavioral and mood changes: altered dream patterns including nightmares, insomnia, sleepwalking, irritability, anxiety, restlessness
- dizziness, drowsiness, numbness, and tingling
- nosebleed
- dry mouth, indigestion
- bruises, itching, hives
- joint or muscle pain, muscle cramps
- bedwetting in children
- weakness/fatigue, general malaise, swelling
Rare: may affect up to 1 in 1,000 users
- behavioral and mood changes: impaired attention, impaired memory, involuntary muscle movements
Very rare: may affect up to 1 in 10,000 users
- painful red bumps under the skin, preferably on the shins (erythema nodosum)
- behavioral and mood changes: obsessive-compulsive symptoms, stuttering
How to store Singulair
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the blister and carton after EXP. The first two digits indicate the month and the last four digits indicate the year. The expiration date is the last day of the specified month.
Store in the original packaging. Light sensitive. Moisture sensitive.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is montelukast. One tablet contains montelukast sodium equivalent to 10 mg montelukast.
- Other ingredients are lactose monohydrate (89.3 mg), microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose (E463), and magnesium stearate.
Film coating: Hypromellose, hydroxypropyl cellulose (E463), titanium dioxide (E171), red and yellow iron oxide (E172), and carnauba wax.
Appearance and package sizes of the medicine
Singulair 10 mg tablet is beige, rounded square, film-coated, marked SINGULAIR on one side and MSD 117 on the other.
Blisters in packs of: 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 100, 140, 200 tablets.
Blisters (single-dose) in packs of: 49×1, 50×1 and 56×1 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
NV Organon
Kloosterstraat 6
5349 AB Us
Netherlands
Manufacturer
Merck Sharp & Dohme BV
PO Box 581
2003 PC Haarlem
Netherlands
Schering-Plough Labo NV
Industriepark 30
Heist-op-den-Berg, 2220
Belgium