Singulair 4 mg granules
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Singulair 4mg granules
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, ask your doctor or pharmacist.
- This medicine has been prescribed only for your child. Do not give it to others, even if they have the same symptoms as your child, as it may harm them.
- If your child experiences any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions 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 adverse 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 between 6 months and 5 years who are not adequately controlled with their current medication and require additional treatment.
- Singulair is also used as an alternative treatment to inhaled corticosteroids in patients aged between 2 and 5 years who have not recently taken oral corticosteroids for the treatment of 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 ingredients 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 have 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 child’s doctor.
- If your child is being treated with asthma medications, you should be aware that if your child develops a combination of symptoms such as flu-like illness, tingling or numbness in the 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.
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 such symptoms develop while taking montelukast, you should contact your doctor.
Children and adolescents
Do not give this medicine to children under 6 months 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 drink
Singulair granules may be taken regardless of meal times.
Pregnancy and breastfeeding
This subsection does not apply to Singulair 4 mg granules, as it is indicated for use in children aged between 6 months and 5 years.
Driving and using machines
This subsection does not apply to Singulair 4 mg granules, as it is indicated for use in children aged between 6 months 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 somnolence) reported with Singulair may affect a patient’s ability to drive or operate machinery.
Singulair contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per sachet; hence, it is essentially “sodium-free”.
3. How to take Singulair
Follow exactly the administration instructions for this medicine as given by your child's doctor or pharmacist. If in doubt, consult your child's doctor or pharmacist again.
- This medicine must be administered to children under the supervision of an adult.
- Your child should take Singulair every night. It should be taken even when your child has no symptoms or during an acute asthma attack.
For children aged 6 months to 5 years:
The recommended dose is one 4 mg sachet of Singulair granules for oral use each night.
If your child is taking Singulair, make sure they do not take any other product containing the same active substance, montelukast.
How should I give Singulair granules to my child?
This medicine is taken orally.
-
Do not open the sachet until the time of use.
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Singulair granules may be administered:
- directly into the mouth; or
- mixed with one spoonful of soft food at cold or room temperature (e.g., apple sauce, ice cream, carrots, or rice).
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Mix the entire contents of the Singulair granules sachet with one spoonful of cold or room-temperature soft food, taking care to ensure the full dose is mixed with the food.
-
Make sure to administer the entire spoonful of the food/granule mixture to the child immediately (within 15 minutes).
IMPORTANT: Never store any leftover mixture of food/granules for later use.
- Singulair granules are not intended to be dissolved in liquids. However, your child may take liquids after swallowing the Singulair granules.
- Singulair granules may be taken regardless of meal times.
If your child takes more Singulair than they 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, stating 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 sachet 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 they continue taking it. It is important that your child continues taking Singulair for the duration prescribed by their 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 granules, the adverse effects related to the administration of the medicine and reported most frequently (may affect up to 1 in 10 people) were:
- diarrhea
- hyperactivity
- asthma
- itchy or scaly skin
- skin rash
In addition, the following adverse effects were reported in clinical trials with Singulair 10 mg film-coated tablets and Singulair 5 mg or 4 mg chewable tablets:
- abdominal pain
- headache
- thirst
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
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
- behavior- and mood-related changes: excitation including aggressive behavior 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
- behavior- and mood-related changes: 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):
- diarrhea, nausea, vomiting
- skin rash
- fever
- elevated liver enzymes
Uncommon (may affect up to 1 in 100 people):
- behavior- and mood-related changes: 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):
- behavior- and mood-related changes: 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)
- behavior- and mood-related changes: 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 foil 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 stated month.
- Do not store above 25 °C. Keep 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 containers at the SIGRE collection point at your pharmacy. If you are unsure, 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 sachet of granules contains sodium montelukast equivalent to 4 mg of montelukast.
- The other components are: Mannitol (E-421), hypromellose (E-463) and magnesium stearate.
Appearance of the product and contents of the pack
Singulair 4 mg granules are white granules.
Packs of 7, 20, 28 and 30 sachets.
Only some 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
Merck Sharp & Dohme, B.V.
Waarderweg 39
2031 BN, Haarlem
The Netherlands
Vianex, S.A. Factory A
12 Km. National Road
Metamorphossi Attiki
Lamia, Athens GR-14451
Greece
This medicinal product is authorized in the Member States of the European Economic Area under 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, Slovakia, Spain, Sweden
Singulair
Date of the most recent review of this leaflet: 04/2023.
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/