Singulair 4 mg chewable tablets
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Singulair 4mg Chewable Tablets
montelukast
Read the entire leaflet carefully before giving this medicine to your child, as it contains important information.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for your child only. Do not give it to others, even if they have the same symptoms as your child, as it could harm them.
- If your child experiences any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Singulair is and what it is used for
- What you need to know before your child takes 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 your child's asthma and to prevent asthma symptoms during the day and night.
- Singulair is used to treat patients aged 2 to 5 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 2 to 5 years who have not recently taken oral corticosteroids for their asthma and who have demonstrated inability to use inhaled corticosteroids.
- Singulair also helps prevent exercise-induced narrowing of the airways in patients aged 2 years and older.
Depending on your child's symptoms and the severity of their asthma, your doctor will determine how Singulair should be used.
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.
2. What you need to know before your child takes Singulair
Inform your doctor of any allergies or medical conditions your child currently has or has had in the past.
Do not give Singulair to your child
- if he or she is allergic to montelukast or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before giving Singulair to your child.
- If your child's asthma or breathing worsens, inform your doctor immediately.
- Oral Singulair is not intended to treat acute asthma attacks. If an attack occurs, follow the instructions your doctor has given you for your child. Always keep your child’s rescue inhaler medication available for asthma attacks.
- It is important that your child uses all asthma medications prescribed by the doctor. Singulair should not be used instead of other asthma medications prescribed by your doctor for your child.
- If your child is being treated with asthma medications, you should be aware that if he or she develops a combination of symptoms such as flu-like illness, tingling or numbness in arms or legs, worsening of lung symptoms, and/or skin rash, you should consult your doctor.
- 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 his or her asthma.
Various 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 these symptoms develop while taking montelukast, you must contact your doctor.
Children and adolescents
Do not give this medicine to children under 2 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 your child is taking, has 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 your child is taking work.
Before taking Singulair, inform your doctor if your child is 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 drinks
Singulair 4 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
This section does not apply to Singulair 4 mg chewable tablets, as this medicine is indicated for use in children aged between 2 and 5 years.
Driving and using machines
This section does not apply to Singulair 4 mg chewable tablets, as this medicine is indicated for use in children aged between 2 and 5 years. However, the following information is important regarding the active substance, montelukast.
Singulair is not expected to affect the 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 4 mg chewable tablets contain aspartame, sodium, and benzyl alcohol
This medicine contains 1.2 mg of aspartame in each 4 mg chewable tablet, equivalent to 0.674 mg of phenylalanine. Aspartame is a source of phenylalanine, which may be harmful if your child has 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; therefore, it is essentially “sodium-free.”
This medicine contains up to 0.36 mg of benzyl alcohol in each tablet. Benzyl alcohol may cause allergic reactions.
Consult your doctor or pharmacist if your child has 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 given by your child's doctor or pharmacist. If in doubt, consult your child's doctor or pharmacist again.
- This medicine should be administered to children under the supervision of an adult. For children who have difficulty taking a chewable tablet, an oral granule formulation is available.
- Your child should only take one Singulair chewable tablet once daily, as prescribed by the doctor.
- It should be taken even when your child has no symptoms or during an acute asthma attack.
For children aged 2 to 5 years:
The recommended dose is one 4 mg chewable tablet daily, taken in the evening.
If your child is taking Singulair, make sure they do not take any other medicine containing the same active substance, montelukast.
This medicine is taken by mouth.
The tablets should be chewed before swallowing.
Singulair 4 mg chewable tablets should not be taken with food; they should be taken at least 1 hour before or 2 hours after meals.
If your child takes more Singulair than they should
Seek immediate help from your child's 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 Toxicology Information Service at 91.562.04.20 immediately, stating the name of the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.
If you forget to give Singulair to your child
Try to give Singulair as prescribed. However, if your child misses a dose, simply resume the usual regimen of one chewable tablet once daily.
Do not give a double dose to make up for missed doses.
If your child stops taking Singulair
Singulair can only treat your child's asthma if treatment is continued.
It is important that your child continues to take Singulair for the length of time prescribed by the doctor. It will help control your child's asthma.
If you have any further questions about the use of this medicine, ask your child's 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 4 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:
- abdominal pain
- thirst
Additionally, the following adverse effects were reported in clinical trials with Singulair 10 mg film-coated tablets and 5 mg chewable tablets:
- headache
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 in your child, as they may be serious and your child 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 in behavior and mood: excitation including aggressive behavior or hostility, depression
- seizures
Rare (may affect up to 1 in 1,000 people):
- increased tendency to bleed
- 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 pulmonary symptoms and/or skin rash (Churg-Strauss syndrome) (see section 2)
- low platelet count
- changes in behavior 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 use 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):
- diarrhea, nausea, vomiting
- skin rash
- fever
- elevated liver enzymes
Uncommon (may affect up to 1 in 100 people):
- changes in behavior and mood: sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, anxiety, restlessness
- dizziness, somnolence, tingling/numbness
- nosebleeds
- dry mouth, indigestion
- bruising, itching, hives
- joint or muscle pain, muscle cramps
- bedwetting (in children)
- weakness/fatigue, malaise, swelling
Rare (may affect up to 1 in 1,000 people):
- changes in behavior 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, appearing most frequently on the shins (erythema nodosum)
- changes in behavior and mood: obsessive-compulsive symptoms, stuttering
Reporting of adverse effects:
If your child experiences any 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
- 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 indicated month.
- Store in the original packaging to protect it from light and moisture.
- Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE point in 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 chewable tablet contains montelukast sodium equivalent to 4 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.
Nature and contents of the container
Singulair 4 mg chewable tablets are pink, oval, biconvex, with one smooth side and the number 711 on the other.
Blister packs in pack sizes of: 7, 10, 14, 20, 28, 30, 50, 56, 98, 100, 140 and 200 tablets.
Unit-dose blisters in pack sizes of: 49x1, 50x1 and 56x1 tablets.
Only some 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 with the following names:
Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Luxembourg, The Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Spain, Sweden
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/