MONTELUKAST CINFA 4 mg GRANULES

2. What you need to know before your child takes montelukast cinfa

Tell your doctor about any allergy or medical problem your child has now or has had.

Do not give montelukast cinfa to your child

• If they are allergic to montelukast or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Ask your doctor or pharmacist before starting to give montelukast cinfa to your child.

• If your child's asthma or breathing worsens, tell 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 your child. 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 instead of other asthma medications prescribed by your doctor for your child.
• If your child is being treated with asthma medications, they should be aware that if they develop a combination of symptoms such as flu-like illness, tingling or numbness of arms or legs, worsening of lung 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 non-steroidal anti-inflammatory drugs or NSAIDs) if they make their asthma worse.

Various neuropsychiatric events (e.g., changes in behavior and mood, depression, and suicidal tendencies) have been reported in patients of all ages treated with montelukast (see section 4). If your child develops these symptoms while taking montelukast, they should consult their 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 presentations of this medicine are available based on the age range.

Taking montelukast cinfa with other medicines

Tell your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines, including those obtained without a prescription.

Some medicines may affect the way montelukast works, or montelukast may affect the way other medicines your child is using work.

Before taking montelukast, tell 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 drinks

montelukast cinfa granules can be taken without regard to meals.

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 using 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 substance, montelukast.

Montelukast is not expected to affect your child's ability to drive a car or operate machinery. However, individual responses to the medicine may vary. Certain side effects (such as dizziness and drowsiness) that have been reported with montelukast may affect the patient's ability to drive or operate machinery.

montelukast cinfa contains sodium.This medicine contains less than 23 mg of sodium (1 mmol) per dose; this is essentially "sodium-free".

3. How to take montelukast cinfa granules

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

This medicine should be administered to children under adult supervision.

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

For children from 6 months to 5 years of age

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

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

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

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

The formulation of montelukast cinfa 4 mg granules is not recommended in 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 the time of use.
• montelukast cinfa granules can be administered:
• directly into the mouth;
• or mixed with a spoonful of soft, cold, or room-temperature food (e.g., apple sauce, ice cream, carrots, and rice).
• Mix the entire contents of montelukast cinfa granules in a spoonful of soft, cold, or room-temperature food, taking care to ensure that the entire dose is mixed with the food.
• Make sure to give the entire spoonful of the food/granule mixture to the child immediately (within 15 minutes). IMPORTANT: Never save any leftover food/granule mixture for later use.
• montelukast cinfa granules are not intended to be dissolved in liquids. However, your child can drink liquids after swallowing montelukast cinfa granules.
• montelukast cinfa granules can be taken without regard to meals.

If your child takes more montelukast cinfa than they should

Ask your child's doctor for help immediately.

In most cases of overdose, no side effects were reported. The symptoms that occurred most frequently reported in overdose 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to give montelukast cinfa to your child

Try to give montelukast as prescribed. However, if your child forgets a dose, just resume the usual routine of one sachet once a day.

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

If your child stops taking montelukast cinfa

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In clinical trials conducted with montelukast granules, the side 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

Additionally, 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
• thirst

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

Serious side effects

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

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

• allergic reactions that include swelling of the face, lips, tongue, and/or throat that can cause difficulty breathing or swallowing
• behavior and mood changes: excitement including aggressive or hostile behavior, depression
• seizures

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

• increased risk of bleeding
• tremors
• palpitations

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

• a combination of symptoms such as flu-like illness, tingling or numbness of arms and legs, worsening of lung symptoms, and/or skin rash (Churg-Strauss syndrome) (see section 2)
• low platelet count
• behavior and mood changes: hallucinations, disorientation, suicidal thoughts and actions
• inflammation (inflammation) of the lungs
• severe skin reactions (erythema multiforme) that can occur without warning
• inflammation of the liver (hepatitis)

Other side 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):

• diarrhea, nausea, vomiting
• skin rash
• fever
• elevated liver enzymes

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

• behavior and mood changes: sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, feeling anxious, restlessness
• dizziness, drowsiness, tingling/numbness
• nosebleeds
• dry mouth, indigestion
• bruises, 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 changes: attention disturbance, memory disturbance, uncontrolled muscle movements

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

• painful red lumps under the skin that most frequently appear on the shins (erythema nodosum)
• behavior and mood changes: obsessive-compulsive symptoms, stuttering

Reporting of side effects

If your child experiences any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's (AEMPS) website: https://www.notificaram.es. By reporting side 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 packaging after "EXP". The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further 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 ingredients are: mannitol (E-421), hypromellose, and magnesium stearate.

Appearance and packaging of the product

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

Not all pack sizes may be marketed.

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 last revision of this package leaflet:April 2024

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

You can access detailed and updated information about this medicine by scanning the QR code included in the package 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