Package Leaflet: Information for the User

Montelukast Cinfa 10 mg Film-Coated Tablets

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

• 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 only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to 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 and can also cause allergy symptoms. By blocking leukotrienes, montelukast improves asthma symptoms, helps control asthma, and improves seasonal allergy symptoms (also known as hay fever or seasonal 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 for the treatment of 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 constriction caused by exercise.
• In patients with asthma for whom montelukast is indicated, montelukast may also provide symptomatic relief of seasonal allergic rhinitis.

The dosage of montelukast cinfa will depend on your symptoms and the severity of your 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, or cold air, or exercise.
• Inflammation of the inner layer of the airways. Asthma symptoms include: coughing, wheezing, and congestion in the chest.

What are seasonal allergies?

Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are an allergic response often caused by airborne pollen from trees, grass, and weeds. Typical symptoms of seasonal allergies may include: stuffy nose, runny nose, itchy nose; sneezing; or red, itchy, watery eyes.

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

Do not take montelukast cinfa.

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

Warnings and precautions.

Consult your doctor or pharmacist before starting to take montelukast cinfa.

• If your asthma or breathing worsens, inform your doctor immediately.
• montelukast cinfa oral is not indicated for treating acute asthma attacks. If an attack occurs, follow the instructions given by your doctor. Always have your rescue inhaler medication for asthma attacks available.
• It is essential that you or your child use all the asthma medications prescribed by your doctor. montelukast cinfa should not replace other asthma medications prescribed by your doctor.
• Any patient being treated with asthma medications should be aware that if they develop a combination of symptoms such as flu-like illness, numbness or tingling of arms or legs, worsening of respiratory symptoms, and/or skin rash, they should consult their doctor.
• Do not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as nonsteroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.

Various neuropsychiatric events (e.g., changes in behavior and mood, 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, consult your doctor.

Children and adolescents.

Do not give this medication to children under 15 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 are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

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 are taking the following medications:

• phenobarbital (used for epilepsy treatment)
• phenytoin (used for epilepsy treatment)
• rifampicin (used for tuberculosis and some other infections treatment)
• gemfibrozil (used for high plasma lipid levels treatment)

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, or think you may be 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, consult your doctor before taking montelukast cinfa.

Driving and operating machinery.

montelukast is not expected to affect your ability to drive a car 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 lactose.If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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 doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

• 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 at night. If you are taking montelukast cinfa, make sure you do not take any other product containing the same active ingredient, montelukast.

This medication is taken orally.

You can take montelukast with or without food.

If you 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 forget to take montelukast cinfa:

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

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

If you interrupt treatment with montelukast cinfa:

Montelukast cinfa can only treat your asthma if you continue to take it. It is essential that you continue taking montelukast for the time your doctor prescribes. It will help control your 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 10 mg film-coated tablets, the side effects related to the administration of the drug and reported most frequently (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 tablet that does not contain a medicine).

Severe side effects

Consult your doctor immediatelyif you notice any of the following side effects, as they may be severe and require urgent medical treatment.

Uncommon(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 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):

• 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 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 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.

Do not store at a temperature above 30°C.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of montelukast cinfa

• The active ingredient is montelukast. Each tablet contains 10.4 mg of montelukast sodium corresponding to 10 mg of montelukast.

• The other components are:

Tablet core:microcrystalline cellulose, lactose monohydrate, sodium carboxymethylcellulose (type A) (potato), low-substituted hydroxypropylcellulose, hydroxypropylcellulose, magnesium stearate.

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

Appearance of the product and content of the packaging

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

They are presented in aluminum-aluminum-poliamide-PVC blisters. Each package contains 28 or 100 (clinical package) tablets.

Only some package sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Other Presentations

Montelukast cinfa 4 mg granulated EFG

Montelukast cinfa 4 mg chewable tablets EFG

Montelukast cinfa 5 mg chewable tablets EFG

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)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/75831/P_75831.html

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