Leaflet: information for the user

montelukast cinfa 4 mg granulatedEFG

Montelukast sodium

Read this 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 only for your child and should not be given to other people, even if they have the same symptoms as your child, as it may harm them.
• If your child experiences any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack and additional information

montelukast cinfa is a leukotriene receptor antagonist that blocks certain substances called leukotrienes.

How does montelukast cinfa work?

Leukotrienes produce narrowing and swelling of the airways in the lungs. By blocking leukotrienes, montelukast improves asthma symptoms and helps control asthma.

When should montelukast cinfa be used?

Your doctor has prescribed montelukast to treat your child's asthma and prevent asthma symptoms during the day and night.

• Montelukast is used to treat patients between 6 months and 5 years of age who are not adequately controlled with their medication and need additional treatment.
• Montelukast is also used as an alternative treatment to inhaled corticosteroids in patients between 2 and 5 years of age who have not recently taken oral corticosteroids for asthma treatment and have demonstrated an inability to use inhaled corticosteroids.
• Montelukast also helps prevent airway constriction caused by exercise in patients 2 years of age and older.

The dosage of montelukast cinfa will depend on your child's symptoms and the severity of their asthma, as determined by your doctor.

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 conditions.
• Sensitive airways that react to many things, such as cigarette smoke, pollen, cold air, or exercise.
• Inflammation of the inner lining of the airways. Asthma symptoms include: coughing, wheezing, and congestion in the chest.

Inform your child's doctor about any allergy or medical condition your child has now or has had.

Do not give montelukast cinfa to your child

• If your child is allergic to montelukast or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your child's doctor or pharmacist before starting to give montelukast cinfa to your child.

• If your child's asthma or breathing worsens, inform your child's doctor immediately.
• Montelukast is not indicated for treating acute asthma attacks. If an attack occurs, follow the instructions given by your child's doctor. Always have your child's rescue inhaler medication for asthma attacks.
• It is essential that your child uses all asthma medications prescribed by their doctor. Montelukast should not be used in place of other asthma medications prescribed by your child's doctor.
• If your child is being treated with asthma medications, be aware that if your child develops a combination of symptoms such as flu-like illness, numbness or tingling of arms or legs, worsening respiratory symptoms, and/or skin rash, they should consult their doctor.
• Your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as nonsteroidal anti-inflammatory drugs or NSAIDs) if they make their asthma worse.

Neuropsychiatric events have been reported (e.g., changes in behavior and mood, depression, and suicidal tendency) in patients of all ages treated with montelukast (see section 4). If you develop these symptoms while taking montelukast, consult your doctor.

Children and adolescents

Do not give this medication to children under 6 months of age.

For pediatric patients under 18 years of age, other presentations of this medication are available based on age range.

Taking montelukast cinfa with other medications

Inform your child's doctor or pharmacist if your child is taking, has taken recently, or may need to take any other medication, including those purchased without a prescription.

Some medications may affect the functioning of montelukast, or montelukast may affect the functioning of other medications your child is using.

Before taking montelukast, inform your doctor if your child is taking the following medications:

• phenobarbital (used for epilepsy treatment)
• phenytoin (used for epilepsy treatment)
• rifampicin (used for tuberculosis and some other infections treatment)

Taking montelukast cinfa with food and drinks

Montelukast cinfa granules can be taken regardless of meal times.

Pregnancy and breastfeeding

This subsection is not applicable to montelukast cinfa granules, as its use is indicated in children between 6 months and 5 years of age.

Driving and operating machines

This subsection is not applicable to montelukast cinfa 4 mg granules, as its use is indicated in children between 6 months and 5 years of age. However, the following information is important for the active ingredient, montelukast.

Montelukast is not expected to affect your ability to drive a car or operate machines. However, individual responses to the medication may vary. Certain adverse effects (such as dizziness and somnolence) reported with montelukast may affect the patient's ability to drive or operate machines.

montelukast cinfa contains sodium.This medication contains less than 23 mg of sodium (1 mmol) per dose; that is, it is essentially "sodium-free".

Follow exactly the administration instructions of this medication indicated by your child's doctor or pharmacist. In case of doubt, consult the doctor or pharmacist again.

This medication should be administered to children under the supervision of an adult.

• Your child must take montelukast every night.
• It should be taken even when your child does not have symptoms or has an acute asthma attack.
• It should be taken orally.

For children aged 6 months to 5 years

Take one packet of montelukast cinfa 4 mg granule orally every night.

Make sure your child does not take any other medication that contains the same active ingredient, montelukast.

For children aged 6 months to 2 years, montelukast cinfa 4 mg granule is available.

For children aged 2 to 5 years, montelukast cinfa 4 mg chewable tablets and montelukast cinfa 4 mg granule are available.

The montelukast cinfa 4 mg granule formulation is not recommended for children under 6 months of age.

How should I give my child montelukast cinfa granule?

This medication is taken orally.

• Do not open the packet until the time of use.
• montelukast cinfa granule can be administered:
• directly in the mouth;
• or mixed with a spoonful of cold or room temperature soft food (e.g., apple sauce, ice cream, carrots, and rice).
• Mix the entire content of montelukast cinfa granule with a spoonful of cold or room temperature soft food, taking care to ensure the complete dose is mixed with the food.
• Make sure to administer the entire spoonful to the child immediately (within 15 minutes). IMPORTANT: Never store any leftover food/granule mixture for later use.
• montelukast cinfa granule is not intended to dissolve in liquids. However, your child may take liquids after swallowing montelukast cinfa granule.
• montelukast cinfa granule can be taken regardless of meal times.

If your child takes more montelukast cinfa than they should

Seek help from your child's doctor immediately.

In most cases of overdose, no adverse effects were reported. The symptoms that were most frequently reported in overdose cases in adults and children were abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to give your child montelukast cinfa

Try to give montelukast as prescribed. However, if your child forgets a dose, limit yourself to resuming the usual once-a-day packet regimen.

Do not give a double dose to compensate for missed doses.

If your child interrupts treatment with montelukast cinfa

Montelukast can only treat your child's asthma if they continue taking it. It is essential that your child continues taking montelukast for the time their doctor prescribes. It will help control your child's asthma.

If you have any other doubts about the use of this medication, ask your child's doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

In clinical trials conducted with montelukast granules, the side effects related to the administration of the drug and reported most frequently (may affect up to 1 in 10 people), were:

• diarrhea
• hyperactivity
• asthma
• skin with itching or scaly skin
• skin eruption

In addition, the following side effects were reported in clinical trials with montelukast 10 mg film-coated tablets and montelukast 5 mg or 4 mg chewable tablets:

• abdominal pain
• headache
• sedation

These side effects were generally mild and occurred more frequently in patients treated with montelukast than with placebo (a tablet that does not contain a medicine).

Severe side effects

Consult your doctor immediatelyif you notice any of the following side effects, as they may be severe and require urgent medical treatment.

Uncommon(may affect up to 1 in 100 people):

Rare(may affect up to 1 in 1,000 people):

Very rare(may affect up to 1 in 10,000 people):

Other side effects reported during the marketing of the drug

Very common(may affect more than 1 in 10 people):

Common(may affect up to 1 in 10 people):

Uncommon(may affect up to 1 in 100 people):

Rare(may affect up to 1 in 1,000 people):

Very rare(may affect up to 1 in 10,000 people):

Reporting of side effects

If your child experiences any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not store at a temperature above 30°C.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of montelukast cinfa

• The active ingredient is montelukast. Each sachet contains montelukast sodium equivalent to 4 mg of montelukast.
• The other components are: mannitol (E-421), hypromellose and magnesium stearate.

Appearance of the product and contents of the packaging

montelukast cinfa 4 mg is a white or almost white granulate. It is presented in single-dose sachets. Each package contains 28 or 200 (clinical package) sachets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

OTHER PRESENTATIONS

montelukast cinfa 4 mg chewable tablets EFG

montelukast cinfa 5 mg chewable tablets EFG

Last review date of this leaflet:April 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/74193/P_74193.html

QR code to:https://cima.aemps.es/cima/dochtml/p/74193/P_74193.html