Montelukast Cinfa 4 mg granules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

montelukast cinfa 4 mg granules EFG

Montelukast sodium

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 and must 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What montelukast cinfa is and what it is used for
2. What you need to know before your child takes montelukast cinfa
3. How to take montelukast cinfa
4. Possible side effects
5. How to store montelukast cinfa

Contents of the pack and other information

1. What is montelukast cinfa and what is it used for?

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

How does montelukast cinfa work?

Leukotrienes cause 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 to prevent asthma symptoms during the day and night.

• Montelukast is used to treat patients aged 6 months 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 their asthma and who have been shown to be unable to use inhaled corticosteroids.
• Montelukast 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 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 coughing, 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 had in the past.

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 starting to give montelukast cinfa to your child.

• If your child's asthma or breathing worsens, inform your doctor immediately.
• Montelukast 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 inhaled rescue medication available for asthma attacks.
• It is important that your child uses all asthma medications prescribed by the doctor. Montelukast should not be used instead of other asthma medications prescribed for your child.
• 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 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 (for example, changes in behaviour and mood, depression, and suicidal thoughts) have been reported in patients of all ages treated with montelukast (see section 4). If your child develops these symptoms while taking montelukast, you should consult 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.

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, including those obtained without a prescription.

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 granules can be taken regardless of meal times.

Pregnancy and breastfeeding

This section does not apply to montelukast cinfa granules, as it is indicated for use in children between 6 months and 5 years of age.

Driving and using machines

This section does not apply to montelukast cinfa 4 mg granules, as it is indicated for use in children between 6 months and 5 years of age. However, the following information is important regarding the active substance, montelukast.

Montelukast 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 montelukast may affect a patient's ability to drive or operate machinery.

montelukast cinfa contains sodium. This medicine contains less than 23 mg of sodium (1 mmol) per sachet; therefore, it is essentially “sodium-free”.

3. How to take montelukast cinfa granules

Follow exactly the dosing instructions provided 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.

• Your child should take montelukast every night.
• It should be taken even when your child has no symptoms or during an acute asthma attack.
• It must be taken orally.

For children aged 6 months to 5 years

One 4 mg sachet of montelukast cinfa granules should be taken orally every night.

If your child is taking montelukast, make sure they do not take any other medication containing the same active substance, montelukast.

For children aged 6 months to 2 years, montelukast cinfa 4 mg granules are available.

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

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

How should I give montelukast cinfa granules to my child?

This medicine is taken orally.

• Do not open the sachet until ready to use.
• montelukast cinfa 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, mashed carrots and rice).
• Mix the entire contents of the montelukast cinfa granules sachet with one 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 of the food/granules mixture to the child immediately (within 15 minutes). IMPORTANT: Never store any leftover mixture of food/granules for later use.
• montelukast cinfa granules are not intended to be dissolved in liquids. However, your child may drink liquids after swallowing the montelukast cinfa granules.
• montelukast cinfa granules may be taken regardless of meal times.

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 commonly 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, pharmacist, or the Toxicology Information Service immediately at telephone number: 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 as prescribed. However, if your child misses a dose, simply resume the usual regimen of one sachet daily.

Do not give a double dose to make up for a missed dose.

If your child stops treatment with montelukast cinfa

Montelukast will only help control your child's asthma if taken regularly. It is important that your child continues taking montelukast for as long as prescribed by the doctor.

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 granules, the adverse effects related to the administration of the medicine and reported most frequently (may affect up to 1 in 10 people) were:

• diarrhoea
• hyperactivity
• asthma
• itchy or scaly skin
• rash

Additionally, the following adverse 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 adverse effects were generally mild and occurred more frequently in patients treated with montelukast than in those receiving placebo (a tablet containing no active ingredient).

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: excitation 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 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
• severe skin reactions (erythema multiforme) which 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 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/tiredness, malaise, swelling

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

• changes in behaviour and mood: attention disturbance, memory disturbance, 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 adverse effect, consult 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 montelukast cinfa

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

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the container 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 containers and medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of montelukast cinfa

• The active substance is montelukast. Each sachet of granules 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 pack

montelukast cinfa 4 mg is a white or almost white granule. It is supplied in single-dose sachets. Each pack contains 28 or 200 sachets (hospital pack).

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

OTHER PRESENTATIONS

montelukast cinfa 4 mg chewable tablets EFG

montelukast cinfa 5 mg chewable tablets EFG

Date of the most recent review of this leaflet: April 2024

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/

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 outer packaging. 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