Singulair 10 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Singulair 10mg film-coated tablets
montelukast
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Singulair is and what it is used for
- What you need to know before taking Singulair
- How to take Singulair
- Possible side effects
- How to store Singulair
- 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 the airways in the lungs and can also cause allergy symptoms. By blocking leukotrienes, Singulair improves asthma symptoms, helps control asthma, and improves symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).
When Singulair should be used
Your doctor has prescribed Singulair to treat your asthma and to 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 are not adequately controlled with their current medication and require additional treatment.
- Singulair also helps prevent airway narrowing caused by exercise.
- In those patients with asthma for whom Singulair is indicated for asthma, Singulair may also provide symptomatic relief of seasonal allergic rhinitis.
Depending on your symptoms and the severity of your asthma, your doctor will determine how you should use Singulair.
What asthma is
Asthma is a chronic disease.
Asthma includes:
- difficulty breathing due to narrowing of the airways. This narrowing of the airways worsens and improves in response to various triggers.
- sensitive airways that react to many things, such as cigarette smoke, pollen, cold air, or exercise.
- swelling (inflammation) of the inner lining of the airways.
Asthma symptoms include: coughing, wheezing, and chest tightness.
What seasonal allergies are
Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are an allergic response often caused by airborne pollen from trees, grass, and weeds. Symptoms of seasonal allergies typically include: stuffy nose, runny nose, itchy nose; sneezing; watery, swollen, red, and itchy eyes.
2. What you need to know before taking Singulair
Inform your doctor of any allergies or medical conditions you currently have or have had in the past.
Do not take Singulair
- if you are allergic to montelukast or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to take Singulair.
- If your asthma or breathing worsens, inform your doctor immediately.
- Oral Singulair is not indicated for the treatment of acute asthma attacks. If an asthma attack occurs, follow the instructions given by your doctor. Always keep your inhaled rescue medication available for asthma attacks.
- It is important that you or your child use all asthma medications prescribed by your doctor. Singulair should not replace other asthma medications prescribed by your doctor.
- Any patient being treated with asthma medications should be aware that if they develop a combination of symptoms such as flu-like illness, tingling or numbness in arms or legs, worsening of lung symptoms, and/or skin rash, they should consult their doctor.
- Do not take acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.
Neuropsychiatric events (e.g., behavioral and mood-related changes, depression, and suicidal thoughts) have been reported in patients of all ages treated with montelukast (see section 4). If you develop these symptoms while taking montelukast, you must contact your doctor.
Children and adolescents
Do not give this medicine to children under 15 years of age.
For pediatric patients under 18 years of age, other formulations of this medicine are available depending on age range.
Other medicines and Singulair
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.
Some medicines may affect how Singulair works, or Singulair may affect how other medicines you are taking work.
Before taking Singulair, inform your doctor if you are taking the following medicines:
- phenobarbital (used to treat epilepsy)
- phenytoin (used to treat epilepsy)
- rifampicin (used to treat tuberculosis and some other infections)
- gemfibrozil (used to treat high plasma lipid levels)
Taking Singulair with food and drinks
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 become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
Your doctor will assess whether you can take Singulair during this period.
Breastfeeding
It is unknown whether Singulair passes into breast milk. If you are breastfeeding or planning to breastfeed, you should consult your doctor before taking Singulair.
Driving and using machines
Singulair is not expected to affect your ability to drive a car or operate machinery. However, individual responses to the medicine may vary. Certain adverse effects (such as dizziness and drowsiness) reported with Singulair may affect a patient's ability to drive or operate machinery.
Singulair 10 mg film-coated tablets contain lactose and sodium
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.
3. How to take Singulair
Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
- You should take only one Singulair tablet once daily, as prescribed by your doctor.
- It should be taken even when you do not have symptoms or during an acute asthma attack.
For adults and adolescents aged 15 years and older:
The recommended dose is one 10 mg tablet taken once daily in the evening.
If you are taking Singulair, make sure you do not take any other product containing the same active substance, montelukast.
This medicine is taken orally.
You may take Singulair 10 mg with or without food.
If you take more Singulair than you should
Seek medical help immediately.
In most overdose cases, no adverse effects were reported. The most frequently reported symptoms in cases of overdose in adults and children were abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.
Contact your doctor, pharmacist, or call the Toxicology Information Service at 91.562.04.20 immediately, indicating the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.
If you forget to take Singulair
Try to take Singulair as prescribed. However, if you miss a dose, simply resume your usual regimen of one tablet once daily.
Do not take a double dose to make up for missed doses.
If you stop taking Singulair
Singulair can only treat your asthma if you continue taking it. It is important that you continue taking Singulair for the duration prescribed by your doctor. It will help control your asthma.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
In clinical trials conducted with Singulair 10 mg film-coated tablets, the adverse effects related to the administration of the medicine and reported most frequently (may affect up to 1 in 10 people) were:
- abdominal pain
- headache
These adverse effects were generally mild and occurred more frequently in patients treated with Singulair than with placebo (a pill containing no active medicine).
Serious adverse effects
Consult your doctor immediately if you experience any of the following adverse effects, which may be serious and may require urgent medical treatment.
Uncommon (may affect up to 1 in 100 people):
- allergic reactions including swelling of the face, lips, tongue and/or throat which may cause difficulty breathing or swallowing
- changes related to behaviour and mood: excitement including aggressive behaviour or hostility, depression
- seizures
Rare (may affect up to 1 in 1,000 people):
- increased tendency to bleeding
- tremor
- palpitations
Very rare (may affect up to 1 in 10,000 people):
- combination of symptoms such as flu-like illness, tingling or numbness of arms and legs, worsening of lung symptoms and/or skin rash (Churg-Strauss syndrome) (see section 2)
- low platelet count
- changes related to behaviour and mood: hallucinations, disorientation, suicidal thoughts and actions
- swelling (inflammation) of the lungs
- serious skin reactions (erythema multiforme) which may occur without warning
- inflammation of the liver (hepatitis)
Other adverse effects reported during the medicine's marketing
Very common (may affect more than 1 in 10 people):
- upper respiratory tract infection
Common (may affect up to 1 in 10 people):
- diarrhoea, nausea, vomiting
- skin rash
- fever
- elevated liver enzymes
Uncommon (may affect up to 1 in 100 people):
- changes related to behaviour and mood: sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, feeling anxious, restlessness
- dizziness, somnolence, tingling/numbness
- nosebleeds
- dry mouth, indigestion
- bruising, itching, urticaria
- joint or muscle pain, muscle cramps
- bed-wetting (in children)
- weakness/tiredness, malaise, swelling
Rare (may affect up to 1 in 1,000 people):
- changes related to behaviour and mood: attention disturbance, memory impairment, uncontrolled muscle movements
Very rare (may affect up to 1 in 10,000 people):
- painful red lumps under the skin which most commonly appear on the shins (erythema nodosum)
- changes related to behaviour and mood: obsessive-compulsive symptoms, stuttering
Reporting of adverse effects:
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Singulair
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Keep this medicine out of the sight and reach of children.
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Do not use this medicine after the expiry date stated on the blister pack after EXP. The first two digits indicate the month; the last four digits indicate the year. The expiry date refers to the last day of the month indicated.
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Store in the original packaging to protect from light and moisture.
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Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Singulair
- The active substance is montelukast. Each tablet contains montelukast sodium equivalent to 10 mg of montelukast.
- The other components are:
Microcrystalline cellulose, monohydrate lactose (89.3 mg), sodium croscarmellose, hypromellose (E-463), and magnesium stearate.
Coating: hypromellose, hypromellose (E-463), titanium dioxide (E-171), red and yellow iron oxide (E-172), and carnauba wax.
Appearance of the product and contents of the pack
Singulair 10 mg tablets are beige, rounded square-shaped, film-coated tablets, with one smooth face and the number "117" on the other.
Blister packs in containers of: 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 100, 140 and 200 tablets.
Unit-dose blister packs (single-dose) in containers of: 49x1, 50x1 and 56x1 tablets.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Organon Salud, S.L.
Paseo de la Castellana, 77
28046 Madrid
Spain
Tel.: 915911279
Manufacturer
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium
Merck Sharp & Dohme B.V.
Waarderweg 39
Haarlem 2031 BN
The Netherlands
Vianex S.A.
Plant A 12th Km National Road Athens-Lamia
Metamorfossi 144 51
Greece
Vianex S.A.
Plant B 15th Km Marathonos Avenue
Pallini, Attiki, 153 51
Greece
This medicinal product is authorized in the European Economic Area member states under the following names:
Austria, Belgium, Denmark, Finland, France, Greece, Spain, Sweden, Germany, Ireland, Italy, Luxembourg, The Netherlands, Portugal
Singulair
Date of the most recent review of this leaflet: 10/2025.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/