Package Leaflet: Information for the User

Montelukast Cinfa 4 mg Chewable Tablets EFG

Montelukast Sodium

Read this leaflet carefully before 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 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 is a leukotriene receptor antagonist that blocks certain substances called leukotrienes.

How montelukast cinfa works

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

When to use montelukast cinfa

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

• Montelukast is used to treat patients between 2 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.

Depending on symptoms and the severity of your child's asthma, your doctor will determine how to use montelukast cinfa.

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 diseases.
• Sensitive airways that react to many things, such as cigarette smoke, pollen, cold air, or exercise
• Swelling (inflammation) of the inner layer 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 any of the other components of this medication (listed in section 6).

Warnings and precautions

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

• If your child's asthma or breathing worsens, inform your child's doctor immediately.
• Montelukast cinfa 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 medications for asthma prescribed by their doctor. Montelukast cinfa 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 they develop a combination of symptoms such as flu-like illness, tingling or numbness in 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.

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

Children and adolescents

Do not give this medication to children under 2 years of age.

For pediatric patients under 18 years, 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 recently given, or may need to give any other medication.

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 child's 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 4 mg chewable tablets should not be taken with meals; it should be taken at least 1 hour before or 2 hours after eating.

Pregnancy and breastfeeding

This subsection is not applicable to montelukast cinfa 4 mg chewable tablets, as its use is indicated in children aged 2 to 5 years.

Driving and operating machines

This subsection is not applicable to montelukast cinfa 4 mg chewable tablets, as its use is indicated in children aged 2 to 5 years, however, the following information is important for the active ingredient, montelukast.

Montelukast is not expected to affect your ability to drive a vehicle 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 aspartame (E-951)

This medication contains 1.20 mg of aspartame in each tablet.

Aspartame contains a source of phenylalanine that may be detrimental in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates due to the body's inability to eliminate it correctly.

montelukast cinfa contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; 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. For children who have problems taking a chewable tablet, an oral granule formulation is available.
• Your child should only take one chewable tablet of montelukast cinfa 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 aged 2 to 5 years:

The recommended dose is one chewable tablet of 4 mg daily at night. Montelukast cinfa 4 mg chewable tablets should not be taken with meals; 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, make sure they are not taking any other medication that contains the same active ingredient, montelukast.

For children aged 2 to 5 years, montelukast cinfa 4mg 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 4 mg chewable tablet of montelukast cinfa is not recommended for children under 2 years of age.

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, sedation, 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 montelukast cinfa to your child:

Try to give montelukast cinfa as prescribed. However, if your child forgets a dose, limit yourself to resuming the usual regimen of one chewable tablet once a day.

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

If your child interrupts treatment with montelukast cinfa:

Montelukast cinfa can only treat your child's asthma if they continue to take it.

It is essential that your child continues to take montelukast for the time their doctor prescribes.

This will help control your child's asthma.

If you have any other questions 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 chewable montelukast tablets, the side effects related to the administration of the drug and reported most frequently (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 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 observe any of the following side effects, as they may be severe and require urgent medical treatment.

Not common (may affect up to 1 in 100 people):

• allergic reactions that include swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing
• behavioral 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 respiratory symptoms and/or skin rash (Churg-Strauss syndrome) (see section 2)
• low platelet count
• behavioral and mood changes: hallucinations, disorientation, suicidal thoughts and actions
• lung inflammation
• severe skin reactions (erythema multiforme) that may occur without warning
• inflammation of the liver (hepatitis)

Other side effects reported during the marketing of the drug

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
• enzymes elevated in the liver

Not common (may affect up to 1 in 100 people):

• behavioral and mood changes: sleep disturbances, including nightmares, sleep problems, somnambulism, irritability, anxiety, restlessness
• dizziness, somnolence, tingling/numbness
• nasal bleeding
• dry mouth, indigestion
• bruises, 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):

• behavioral and mood changes: attention alteration, memory alteration, uncontrolled muscle movements

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

• red, painful bumps under the skin that more frequently appear on the face (erythema nodosum)
• behavioral and mood changes: obsessive-compulsive symptoms, stuttering

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 Pharmacovigilance of Medicines 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 of 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 montelukast cinfa 4 mg 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 carboxymethylcellulose (type A) (from potato), aspartame (E-951), magnesium stearate (E-572), cherry aroma, and iron oxide red (E-172).

Appearance of the product and contents of the packaging

The tablets are reddish in color, cylindrical, biconvex, and have the code “MO3” on one side. They are presented in aluminum/aluminum blisters. Each package contains 28 or 200 (EC) tablets.

Only some package sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer:

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate.

31620 Huarte (Navarra) - Spain.

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/74195/P_74195.html

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