Montelukast Cinfa 4 mg chewable tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
montelukast cinfa 4 mg chewable tablets EFG
montelukast sodium
Read the entire leaflet carefully before you start giving this medicine to your child, as it contains important information for your child.
- 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 and must not be given to other people, even if they have the same symptoms as your child, since it could harm them.
- If your child experiences any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.
Leaflet Contents
- What montelukast cinfa is and what it is used for
- What you need to know before your child takes montelukast cinfa
- How to take montelukast cinfa
- Possible adverse effects
- How to store montelukast cinfa
Pack contents and additional information
1. What is montelukast cinfa and what is it used for
Montelukast is a leukotriene receptor antagonist that blocks substances called leukotrienes.
How montelukast cinfa works
Leukotrienes cause narrowing and swelling of the airways in the lungs. By blocking leukotrienes, montelukast cinfa improves asthma symptoms and helps control asthma.
When montelukast cinfa should be used
Your doctor has prescribed montelukast cinfa to treat your child's asthma and to prevent asthma symptoms during the day and night.
- montelukast is used for the treatment of patients aged 2 to 5 years who are not adequately controlled with their current medication and require additional treatment.
- montelukast is also used as an alternative to inhaled corticosteroids in patients aged 2 to 5 years who have not recently taken oral corticosteroids for the treatment of their asthma and who have demonstrated inability to use inhaled corticosteroids.
- montelukast also helps prevent exercise-induced narrowing of the airways in patients 2 years of age and older.
Depending on your child's symptoms and the severity of their asthma, your doctor will determine how montelukast cinfa 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: cough, wheezing, and chest tightness.
2. What you need to know before your child takes montelukast cinfa
Inform your doctor of any allergies or medical conditions your child currently has or has previously had.
Do not give montelukast cinfa 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 montelukast cinfa to your child.
- If your child's asthma or breathing worsens, inform your doctor immediately.
- montelukast cinfa is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions your doctor has given you for your child. Always keep your child’s rescue inhaled medication available for asthma attacks.
- It is important that your child uses all asthma medications prescribed by the doctor. montelukast cinfa should not be used instead of other asthma medications prescribed by your doctor.
- If your child is being treated with asthma medications, 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. behavioural 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 consult 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.
Taking montelukast cinfa with other medicines
Inform your doctor or pharmacist if your child is taking, has recently taken, or might need to take any other medicines.
Some medicines may affect how montelukast works, or montelukast may affect how other medicines your child is taking work.
Before taking montelukast, 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 some other infections)
Taking montelukast cinfa with food and drink
montelukast cinfa 4 mg chewable tablets should not be taken with food; they should be taken at least 1 hour before or 2 hours after eating.
Pregnancy and breastfeeding
This section does not apply to montelukast cinfa 4 mg chewable tablets, as this medicine is indicated for use in children aged 2 to 5 years.
Driving and using machines
This section does not apply to montelukast cinfa 4 mg chewable tablets, as this medicine is indicated for use in children aged 2 to 5 years. However, the following information is important for the active substance, montelukast.
Montelukast is not expected to affect your ability to drive a vehicle or operate machinery. However, individual responses to the medicine may vary. Certain adverse effects (such as dizziness and drowsiness) reported with montelukast may affect a patient’s ability to drive or operate machinery.
montelukast cinfa contains aspartame (E-951)
This medicine contains 1.20 mg of aspartame per tablet.
Aspartame is a source of phenylalanine, which may be harmful if the patient has phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.
montelukast cinfa contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; hence, it is essentially “sodium-free”.
3. How to take montelukast cinfa
Follow exactly the instructions for administering this medicine as 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 chewable tablet of montelukast cinfa once daily, as prescribed by the doctor.
- It should be taken even when your child has no symptoms or during an acute asthma attack.
- It must be taken by mouth.
For children aged 2 to 5 years:
The recommended dose is one 4 mg chewable tablet taken once daily in the evening. montelukast cinfa 4 mg chewable tablets should not be taken with food; they should be taken at least 1 hour before or 2 hours after meals. The tablets must be chewed before swallowing.
If your child is taking montelukast cinfa, make sure they do not take any other medication containing the same active substance, montelukast.
For children aged 2 to 5 years, montelukast cinfa 4 mg chewable tablets and montelukast cinfa 4 mg granules are available. For children aged 6 to 14 years, montelukast cinfa 5 mg chewable tablets are available. The montelukast cinfa 4 mg chewable tablet is not recommended for children under 2 years of age.
If your child takes more montelukast cinfa 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.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medication and the amount ingested.
If you forget to give montelukast cinfa to your child
Try to give montelukast cinfa 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 treatment with montelukast cinfa
montelukast cinfa can only treat your child's asthma if treatment is continued.
It is important that your child continues taking montelukast 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 conducted with montelukast chewable tablets, the adverse effects related to the administration of the medicine and reported most frequently (may affect more than 1 in 10 people) were:
- abdominal pain
- drowsiness
In addition, the following adverse effects were reported in clinical trials with montelukast 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 montelukast than in those receiving placebo (a tablet containing no active medicine).
Serious adverse effects
Contact your doctor immediately if you notice any of the following adverse effects, as they 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 in behaviour and mood: excitability 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):
- a 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 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 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 in 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
- bedwetting (in children)
- weakness/fatigue, malaise, swelling
Rare (may affect up to 1 in 1,000 people):
- changes in 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 in behaviour and mood: obsessive-compulsive symptoms, stuttering
Reporting of adverse effects
If your child experiences 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 montelukast cinfa
Keep this medicine out of sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of montelukast cinfa
- The active substance is montelukast. Each 4 mg montelukast cinfa tablet contains 4 mg of montelukast base (as 4.16 mg of montelukast sodium).
- The other components are: microcrystalline cellulose (E-460), mannitol (E-421), sodium carboxymethyl starch (type A) (from potato), aspartame (E-951), magnesium stearate (E-572), cherry flavor, and red iron oxide (E-172).
Appearance of the product and contents of the pack
The tablets are reddish in color, cylindrical, biconvex, and marked with the code "MO3" on one side. They are presented in aluminum/aluminum blisters. Each pack contains 28 or 200 (EC) tablets.
Only certain pack sizes may be commercially available.
Marketing Authorization Holder and Manufacturer:
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta.
31620 Huarte (Navarra) - Spain.
Date of the most recent revision of this package leaflet: April 2024
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/
You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/74195/P_74195.html
QR code to: https://cima.aemps.es/cima/dochtml/p/74195/P_74195.html