MONTELUKAST CINFA 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

montelukast cinfa 10 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is montelukast cinfa and what is it used for
2. What you need to know before you take montelukast cinfa
3. How to take montelukast cinfa
4. Possible side effects
5. Storage of montelukast cinfa

Contents of the pack and additional 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 the airways in the lungs to narrow and swell, and can also cause allergy symptoms. By blocking the leukotrienes, montelukast improves asthma symptoms, helps control asthma, and improves symptoms of seasonal allergies (also known as hay fever or allergic rhinitis).

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 adults and adolescents 15 years of age and older who are not adequately controlled with their medication and need additional treatment.
• Montelukast also helps prevent airway narrowing caused by exercise.
• In patients with asthma who are indicated for montelukast, montelukast may also provide symptomatic relief of seasonal allergic rhinitis.

Depending on your symptoms and the severity of your asthma, your doctor will determine how you should 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.

What are seasonal allergies?

Seasonal allergies (also known as hay fever or allergic rhinitis) are an allergic reaction often caused by airborne pollen from trees, grass, and weeds. Symptoms of seasonal allergies typically include: congested nose, runny nose; sneezing; itchy, watery, swollen, red, and painful eyes.

2. What you need to know before you take montelukast cinfa

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

Do not take montelukast cinfa

• if you 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 starting to take montelukast cinfa.

• If your asthma or breathing gets worse, tell your doctor immediately.
• montelukast cinfa oral is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions given by your doctor. Always have your rescue inhaler medication for asthma attacks.
• It is important that you or your child use all asthma medications prescribed by your doctor. montelukast cinfa should not replace other asthma medications that your doctor has prescribed.
• 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.
• Do not take aspirin or non-steroidal anti-inflammatory drugs (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they make your 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 you develop these symptoms while taking montelukast, you should consult your doctor.

Children and adolescents

Do not give this medicine to children under 15 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 are taking, have 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 work.

Before taking montelukast, tell your doctor if you are taking the following medicines:

• phenobarbital (used to treat epilepsy)
• phenytoin (used to treat epilepsy)
• rifampicin (used to treat tuberculosis and some other infections)
• gemfibrozil (used to treat high lipid levels in plasma)

Taking montelukast cinfa with food and drinks

montelukast cinfa 10 mg film-coated tablets can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking 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 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 lactose.If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

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

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

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

Adults and adolescents 15 years of age and older:

The recommended dose is one 10 mg tablet daily in the evening. If you are taking montelukast cinfa, make sure you do not take any other product that contains the same active ingredient, montelukast.

This medicine is taken orally.

You can take montelukast with or without food.

If you take more montelukast cinfa than you should

Seek immediate medical attention.

In most cases of overdose, no adverse 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, telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take montelukast cinfa

Try to take montelukast cinfa as prescribed. However, if you miss a dose, just resume your regular schedule of one tablet once a day.

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

If you stop taking montelukast cinfa

montelukast cinfa may only treat your asthma if you continue to take it. It is important that you continue to take montelukast for as long as your doctor prescribes it. It will help control your asthma.

If you have any further questions on 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 conducted with montelukast 10 mg film-coated tablets, the adverse effects related to the administration of the medicine and most frequently reported (may affect up to 1 in 10 people), were:

• abdominal pain
• headache

These side effects were generally mild and occurred more frequently 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 including swelling of the face, lips, tongue and/or throat which may cause difficulty in breathing or swallowing
• mood-related changes: excitement including aggressive behavior or hostility, 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
• mood-related changes: hallucinations, disorientation, suicidal thoughts and actions
• inflammation (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 medicine

Very common(may affect more than 1 in 10 people):

• upper respiratory 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):

• mood-related 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):

• mood-related 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, most frequently appearing on the shins (erythema nodosum)
• mood-related changes: obsessive-compulsive symptoms, stuttering

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) through the 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 use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of the month shown.

Do not store above 30°C.

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 additional information

Composition of montelukast cinfa

• The active substance is montelukast. Each tablet contains 10.4 mg of montelukast sodium, equivalent to 10 mg of montelukast.

• The other ingredients are:

Core of the tablet: microcrystalline cellulose, lactose monohydrate, sodium carboxymethyl starch (type A) (from potato), low-substituted hydroxypropylcellulose, hydroxypropylcellulose, magnesium stearate.

Coating: hypromellose, macrogol 6000, titanium dioxide (E-171), talc, red iron oxide (E-172), and yellow iron oxide (E-172).

Appearance and packaging

The tablets are cream-colored, round, biconvex, and marked with the code ”M” on one side.

They are presented in aluminum-aluminum-polyamide-PVC blisters. Each pack contains 28 or 100 (clinical pack) 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

Other presentations

Montelukast cinfa 4 mg granules EFG

Montelukast cinfa 4 mg chewable tablets EFG

Montelukast cinfa 5 mg chewable tablets EFG

Date of last revision of this 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) www.aemps.gob.es/

You can access detailed and up-to-date information about 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/75831/P_75831.html

QR code to: https://cima.aemps.es/cima/dochtml/p/75831/P_75831.html