MONTELUKAST CINFA 4 mg CHEWABLE TABLETS

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 giving montelukast cinfa to your child.

• If your child's asthma or breathing worsens, tell 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 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 cinfa should not be used instead of other asthma medications prescribed by your child's doctor.
• If your child is being treated with asthma medications, 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 (such as 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 2 years of age.

For pediatric patients under 18 years of age, other formulations 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.

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 4 mg chewable tablets should not be taken with food; they should be taken at least 1 hour before or 2 hours after food.

Pregnancy and breastfeeding

This subsection is not applicable to montelukast cinfa 4 mg chewable tablets, as their use is indicated in children between 2 and 5 years of age.

Driving and using machines

This subsection is not applicable to montelukast cinfa 4 mg chewable tablets, as their use is indicated in children between 2 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 vehicle 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 your child's ability to drive or operate machinery.

Montelukast cinfa contains aspartame (E-951)

This medicine contains 1.20 mg of aspartame in each tablet.

Aspartame is a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

Montelukast cinfa contains sodium

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

3. How to take montelukast cinfa

Follow the exact instructions for administering this medicine indicated by your doctor or pharmacist for your child. If in doubt, consult your child's doctor or pharmacist again.

• This medicine should be administered to children under adult supervision. For children who have problems taking a chewable tablet, an oral granule formulation is available.
• Your child should only take one montelukast cinfa chewable tablet once a day, as prescribed by their doctor.
• 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 2 to 5 years of age:

The recommended dose is one 4 mg chewable tablet 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 food. The tablets should be chewed before swallowing.

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

For children from 2 to 5 years of age, montelukast cinfa 4 mg chewable tablets and montelukast cinfa 4 mg oral granules are available. For children from 6 to 14 years of age, montelukast cinfa 5 mg chewable tablets are available. The 4 mg chewable tablet of montelukast cinfa is not recommended in children under 2 years of age.

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 cinfa as prescribed. However, if your child forgets a dose, simply resume the usual routine of one chewable tablet once a day.

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

If your child stops taking montelukast cinfa

Montelukast cinfa can 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 with montelukast chewable tablets, the side effects related to the administration of the medicine and most frequently reported (may affect more than 1 in 10 people) were:

• abdominal pain
• thirst

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

• headache

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

Ask your doctor immediatelyif you observe 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 including 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
• 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 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
• bruising, itching, hives
• joint or muscle pain, muscle cramps
• bedwetting (in children)
• weakness/tiredness, 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, ask your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines and Health Products Agency's 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. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of montelukast cinfa

• The active substance is montelukast. Each montelukast cinfa 4 mg tablet contains 4 mg of montelukast (as 4.16 mg of montelukast sodium).
• The other ingredients 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 pack contents

The tablets are reddish, cylindrical, biconvex, and have the code "MO3" on one face. They are presented in aluminum/aluminum blisters. Each pack contains 28 or 200 (EC) tablets.

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.

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 Health 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/74195/P_74195.html

QR code to: https://cima.aemps.es/cima/dochtml/p/74195/P_74195.html