Package Leaflet: Information for the User

montelukast cinfa 5 mg chewable tablets EFG

montelukast sodium

Read this leaflet carefully before you or your child start taking this medicine because it contains important information for you or your child.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you or your child alone. Do not give it to others, even if they have the same symptoms as you or your child, as it may harm them.
• If you or your child experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

How montelukast cinfa works

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

• Montelukast is used to treat pediatric patients aged 6 to 14 years who are not adequately controlled with their medication and require additional treatment.
• Montelukast is also used as an alternative treatment to inhaled corticosteroids in patients aged 6 to 14 years 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.

The use of montelukast cinfa will depend on your symptoms and the severity of your asthma or your child's 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.
• Swelling (inflammation) of the inner layer of the airways. Asthma symptoms include: Coughing, wheezing, and congestion in the chest.

Inform your doctor about any allergy or medical condition you or your child have now or have had.

Do not take montelukast cinfa

If you or your child

• are allergic to montelukast or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist beforeyou or your child start takingmontelukast cinfa.

• If your asthma or breathing or your child's asthma or breathing worsens, inform your doctor immediately.
• montelukast cinfa is not indicated for treating acute asthma attacks. If an attack occurs, follow the instructions your doctor has given you or for your child. Always have your rescue inhaler medication for asthma attacks.
• It is essential that you or your child use all medications for asthma prescribed by your doctor. montelukast cinfa should not be used in place of other asthma medications prescribed by your doctor for you or your child.
• Any patient being treated with asthma medications 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 respiratory symptoms, and/or skin rash, they should consult their doctor.
• You or your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as nonsteroidal anti-inflammatory drugs or NSAIDs) if they make your 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, you should consult your doctor.

Children and adolescents

Do not give this medication to children under 6 years of age.For children aged 2 to 5 years, montelukast cinfa 4 mg 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.

Taking montelukast cinfa with other medications

Inform your doctor or pharmacist if you or your child are taking, have taken recently, or may need to take any other medication.

Some medications may affect the functioning of montelukast, or montelukast may affect the functioning of other medications you are using.

Before taking montelukast, inform your doctor if you or your child are taking the following medications:

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

Taking montelukast cinfa with food and drinks

montelukast cinfa 5 mg chewable tablets should not be taken with meals; it should be taken at least 1 hour before or 2 hours after meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Your doctor will evaluate whether you can take montelukast during this period.

Breastfeeding

The safety of montelukast in breastfeeding women is unknown. If you are breastfeeding or plan to breastfeed, you should consult your doctor before taking montelukast cinfa.

Driving and operating machinery

montelukast is not expected to affect your ability to drive a vehicle or operate machinery. 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 machinery.

montelukast cinfa contains aspartame (E-951)

This medication contains 1.50 mg of aspartame in each tablet.

Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable 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 for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

• You or your child should only take one chewable tablet of montelukast cinfa once a day, as prescribed by your doctor. It should be taken even when you or your child do not have symptoms or when they have an acute asthma attack.
• It should be taken orally.

For children aged 6 to 14 years:

The recommended dose is one chewable tablet of 5 mg daily at night.

Montelukast cinfa 5 mg chewable tablets should not be taken with meals; it should be taken at least 1 hour before or 2 hours after food. The tablets should be chewed before swallowing.

If you or your child are taking montelukast cinfa, make sure that neither you nor your child take any other medication that contains the same active ingredient, montelukast.

If you or your child take more montelukast cinfa than you should

Seek help from your 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, drowsiness, 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 take montelukast cinfa or forgot to give montelukast cinfa to your child

Try to take montelukast cinfa as prescribed. However, if you or your child forget a dose, simply resume the usual regimen of one chewable tablet once a day.

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

If you or your child interrupt treatment with montelukast cinfa

Montelukast cinfa can only treat your asthma or your child's asthma if you or your child continue to take it. It is essential to continue taking montelukast for the time your doctor prescribes. It will help control your asthma or your child's asthma.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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

In clinical trials conducted with montelukast 5 mg chewable tablets, the side effects related to the administration of the drug and reported most frequently (may affect more than 1 in 10 people), were:

• headache

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

• abdominal pain

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.

Infrequent (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
• swelling (inflammation) of the lungs
• 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 frequent (may affect more than 1 in 10 people):

• upper respiratory tract infection

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

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

Infrequent (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
• bruising, 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 lumps 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 you or your child experience 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 5 mg tablet contains 5 mg of montelukast base (as 5.20 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 content of the packaging

The tablets are reddish in color, cylindrical, biconvex, and have the code “MO2” 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.

Holder of the marketing authorization 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 medication 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 medication 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/74196/P_74196.html

QR code to:https://cima.aemps.es/cima/dochtml/p/74196/P_74196.html