MONTELUKAST CINFA 5 mg CHEWABLE TABLETS

Introduction

Package Leaflet: Information for the User

montelukast cinfa 5 mg chewable tablets EFG

montelukast sodium

Read the entire package leaflet carefully before you or your child start taking this medicine, as it contains important information for you or your child.

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

Contents of the Package Leaflet

1. What is montelukast cinfa and what is it used for
2. What you need to know before taking montelukast cinfa
3. How to take montelukast cinfa
4. Possible side effects
5. Storage of montelukast cinfa
6. Contents of the pack and further information

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

Montelukast is a leukotriene receptor antagonist that blocks 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 between 6 and 14 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 6 and 14 years of age who have not recently taken oral corticosteroids for their asthma and have demonstrated that they are unable to use inhaled corticosteroids.
• Montelukast also helps prevent exercise-induced narrowing of the airways.

Depending on the symptoms and severity of your asthma or 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.
• airways that are sensitive and 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 chest congestion.

2. What you need to know before taking montelukast cinfa

Tell your doctor about any allergy or medical problem that you or your child have now or have had.

Do not take montelukast cinfa

If you or your child

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

Warnings and precautions

Consult your doctor or pharmacist before you or your child start taking montelukast cinfa.

• If your asthma or breathing or your child's asthma or breathing worsen, inform your doctor immediately.
• Montelukast cinfa is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions given by your doctor for you or your child. Always have your rescue inhaler medication for asthma attacks.
• It is essential that you or your child use all asthma medications prescribed by your doctor. Montelukast cinfa should not be used instead of other asthma medications that your doctor has prescribed 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 lung 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 non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.

Neuropsychiatric events have been reported in patients of all ages treated with montelukast (see section 4). If you develop these symptoms while taking montelukast, consult your doctor.

Children and adolescents

Do not give this medicine to children under 6 years of age. For children from 2 to 5 years of age, montelukast cinfa 4 mg chewable tablets and montelukast cinfa 4 mg granules are available.

For children from 6 to 14 years of age, montelukast cinfa 5 mg chewable tablets are available.

Taking montelukast cinfa with other medicines

Tell your doctor or pharmacist if you or your child are taking, have recently taken, or might take any other medicines.

Some medicines may affect the way montelukast works, or montelukast may affect the way other medicines work.

Before taking montelukast, tell your doctor if you or your child are 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 5 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

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

Pregnancy

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

Breastfeeding

It is not known whether montelukast appears in breast milk. If you are breastfeeding or plan to breastfeed, consult your doctor before taking montelukast cinfa.

Driving and using machines

Montelukast is not expected to affect your 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 the patient's ability to drive or operate machinery.

Montelukast cinfa contains aspartame (E-951)

This medicine contains 1.50 mg of aspartame in each tablet.

Aspartame is a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disease 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; it is essentially "sodium-free".

3. How to take montelukast cinfa

Follow the exact instructions for administration of this medicine indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

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

For children from 6 to 14 years of age:

The recommended dose is one 5 mg chewable tablet daily in the evening.

Montelukast cinfa 5 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 you or your child are taking montelukast cinfa, ensure that neither you nor your child take any other medicine 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 side effects were reported. The symptoms that occurred most frequently 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 or your child forget to take montelukast cinfa

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

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

If you or your child stop taking montelukast cinfa

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

If you have any further questions about the use of this medicine, ask your 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 5 mg chewable tablets, the side effects related to the administration of the medicine 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 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 observe any of the following side effects, as they may be serious and 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 you or your child experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) at 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 the packaging and any unused medicine to a pharmacy for proper disposal. This will help protect the environment.

6. Contents of the pack and further information

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 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 packaging contents

The tablets are reddish, cylindrical, biconvex, and have the code "MO2" on one side. 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 the last revision of this package leaflet:April 2024

Detailed and up-to-date 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 up-to-date 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/74196/P_74196.html

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