Singulair 5 mg chewable tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Singulair 5mg chewable tablets
montelukast
Read the entire leaflet carefully before you or your child start taking this medicine, because it contains important information for you or your child.
- 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 or your child only, and you must not give it to others, even if they have the same symptoms as you or your child, because it could harm them.
- If you or your child 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. By blocking leukotrienes, Singulair improves asthma symptoms and helps control asthma.
When Singulair should be used
Your doctor has prescribed Singulair to treat asthma and to prevent asthma symptoms during the day and night.
- Singulair is used for the treatment of pediatric patients aged 6 to 14 years who are not adequately controlled with their current medication and require additional treatment.
- Singulair is also used as an alternative to inhaled corticosteroids in patients aged 6 to 14 years who have not recently taken oral corticosteroids for the treatment of their asthma and who have shown inability to use inhaled corticosteroids.
- Singulair also helps prevent exercise-induced narrowing of the airways.
Depending on the symptoms and severity of your asthma or your child's asthma, your doctor will determine how Singulair should be used.
What is asthma?
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.
2. What you need to know before taking Singulair
Inform your doctor of any allergies or medical conditions you or your child currently have or have had in the past.
Do not take Singulair
- if you or your child are allergic to montelukast or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before you or your child start taking Singulair.
- If your asthma or breathing, or that of your child, worsens, inform your doctor immediately.
- Oral Singulair is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions your doctor has given you for you or your child. Always have your rescue inhaled medication available for asthma attacks.
- It is important that you or your child use all asthma medications prescribed by your doctor. Singulair should not be used instead of other asthma medications prescribed by your doctor for you or your child.
- 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.
- You or your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.
Several neuropsychiatric events (e.g., behavioral and mood-related changes, depression, and suicidal tendencies) 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 6 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
Tell your doctor or pharmacist if you or your child 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 work.
Before taking Singulair, inform your doctor if you or your child are taking the following medicines:
- phenobarbital (used to treat epilepsy)
- phenytoin (used to treat epilepsy)
- rifampicin (used to treat tuberculosis and certain other infections)
Taking Singulair with food and drink
Singulair 5 mg chewable tablets should not be taken with food; they should be taken at least 1 hour before or 2 hours after meals.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan 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 not known whether Singulair passes into breast milk. If you are breastfeeding or plan 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 5 mg chewable tablets contain aspartame, sodium, and benzyl alcohol
This medicine contains 1.5 mg of aspartame in each 5 mg chewable tablet, equivalent to 0.842 mg of phenylalanine. Aspartame contains a source of phenylalanine which may be harmful if you or your child have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.
This medicine contains less than 23 mg of sodium (1 mmol) per tablet, i.e., essentially “sodium-free”.
This medicine contains up to 0.45 mg of benzyl alcohol in each tablet. Benzyl alcohol may cause allergic reactions.
Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).
Consult your doctor or pharmacist if you or your child have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (metabolic acidosis).
3. How to take Singulair
Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
- You or your child should take only one Singulair chewable tablet once daily, as prescribed by your doctor.
- It should be taken even when you or your child do not have symptoms or during an acute asthma attack.
For children aged 6 to 14 years:
The recommended dose is one 5 mg chewable tablet taken once daily in the evening.
If you or your child are taking Singulair, make sure that neither you nor your child take any other product containing the same active substance, montelukast.
This medicine is taken orally.
The tablets should be chewed before swallowing.
Singulair 5 mg chewable tablets should not be taken with food; they should be taken at least 1 hour before or 2 hours after eating.
If you or your child take more Singulair than you should
Seek immediate help from your doctor.
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 Poison Information Service at telephone number 91.562.04.20 immediately, stating the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.
If you or your child forget to take Singulair
Try to take Singulair as prescribed. However, if you or your child miss a dose, simply resume the usual regimen of one chewable tablet once daily.
Do not take a double dose to make up for missed doses.
If you or your child stop taking Singulair
Singulair can treat your asthma or your child's asthma only if you or your child continue taking it. It is important that you continue taking Singulair for as long as your doctor prescribes it. It will help control your asthma or your child's 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 with Singulair 5 mg chewable tablets, the adverse effects related to the administration of the medicine and reported most frequently (may affect up to 1 in 10 people) were:
- headache
In addition, the following adverse effects were reported in clinical trials with Singulair 10 mg film-coated tablets:
- abdominal pain
These adverse effects were generally mild and occurred more frequently in patients treated with Singulair than with placebo (a pill containing no active ingredient).
Serious adverse effects
Contact your doctor immediately if you notice any of the following adverse effects, which may be serious and may require urgent medical treatment for you or your child.
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: agitation, 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 in 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
- severe skin reactions (erythema multiforme) that may occur without warning
- inflammation of the liver (hepatitis)
Other adverse effects reported during post-marketing of the medicine
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
- 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/fatigue, 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, most commonly appearing on the shins (erythema nodosum)
- changes related to behaviour and mood: obsessive-compulsive symptoms, stuttering
Reporting of adverse effects:
If you or your child experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Singulair
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date stated on the blister 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 shown.
- Store in the original packaging to protect from light and moisture.
- Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Singulair
- The active substance is montelukast. Each chewable tablet contains montelukast sodium equivalent to 5 mg of montelukast.
- The other components are:
Mannitol (E-421), microcrystalline cellulose, hypromellose (E-463), iron oxide red (E-172), sodium croscarmellose, cherry flavour containing benzyl alcohol (E-1519), aspartame (E-951) and magnesium stearate.
Description of the product and contents of the pack
Singulair 5 mg chewable tablets are pink, round, biconvex, with one smooth face and the number 275 on the other.
Blister packs in pack sizes of: 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 100, 140 and 200 tablets.
Unit dose blisters in pack sizes of: 49x1, 50x1 and 56x1 tablets.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Organon Salud, S.L.
Paseo de la Castellana, 77
28046 Madrid
Spain
Tel.: 915911279
Manufacturer
Merck Sharp & Dohme B.V.
Waarderweg 39
Haarlem 2031 BN
The Netherlands
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium
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 authorised 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 revision 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 Medical Devices (AEMPS) http://www.aemps.gob.es/