Montelukast Asthmapharma 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

MONTELUKAST ASTHMAPHARMA 10 mg film-coated tablets

Montelukast sodium

Read the entire leaflet carefully before your child starts taking this medicine.

• 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 others, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects your child experiences to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Montelukast ASTHMAPHARMA is and what it is used for
2. Before you take Montelukast ASTHMAPHARMA
3. How to take Montelukast ASTHMAPHARMA
4. Possible side effects
5. How to store Montelukast ASTHMAPHARMA
6. Further information

1. What MONTELUKAST ASTHMAPHARMA is and what it is used for

Montelukast is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause 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 symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).

Your doctor has prescribed Montelukast to treat your asthma and to prevent asthma symptoms during the day and night.

• Montelukast is used to treat patients whose asthma is not adequately controlled with their current medication and who require additional treatment.
• Montelukast also helps prevent airway narrowing caused by exercise.
• In those asthmatic patients for whom Montelukast is indicated for asthma, 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.

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 triggers.
• Sensitive airways that react to many things, such as cigarette smoke, pollen, cold air, or exercise.
• Swelling (inflammation) of the inner lining of the airways.

Asthma symptoms include: Cough, wheezing, and chest tightness.

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. Symptoms of seasonal allergies typically include: nasal congestion, runny nose, itchy nose; sneezing; and watery, swollen, red, and itchy eyes.

2. BEFORE TAKING MONTELUKAST ASTHMAPHARMA

Inform your doctor of any allergies or medical conditions you currently have or have had in the past.

Do not take MONTELUKAST ASTHMAPHARMA if you are allergic (hypersensitive) to montelukast or to any of the other ingredients of Montelukast (see section 6.).

Take special care with MONTELUKAST ASTHMAPHARMA

• If your asthma or breathing worsens, inform your doctor immediately.
• Oral montelukast is not indicated for the treatment of acute asthma attacks. If an asthma attack occurs, follow the instructions given by your doctor. Always keep your rescue inhaled medication available for asthma attacks.
• It is important that you or your child use all asthma medications prescribed by your doctor. Montelukast should not replace other asthma medications prescribed by your doctor.
• Any patient who is advised by their doctor not to take acetylsalicylic acid (aspirin) or non-steroidal anti-inflammatory drugs (NSAIDs) because they worsen asthma should avoid these medications.
• Various neuropsychiatric events (e.g., behavioral and mood-related changes, depression, and suicidal thoughts) have been reported in patients of all ages (see section 4). If you develop these symptoms while taking Montelukast, contact your doctor immediately.

Use in children

For children aged 2 to 5 years, Montelukast ASTHMAPHARMA 4 mg chewable tablets are available.

For children aged 6 to 14 years, Montelukast ASTHMAPHARMA 5 mg chewable tablets are available.

Use of other medicines

Some medicines may affect how Montelukast works, or Montelukast may affect how other medicines work.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Before taking Montelukast, inform your doctor if you are taking any of the following medicines:

• Phenobarbital (used to treat epilepsy)
• Phenytoin (used to treat epilepsy)
• Rifampicin (used to treat tuberculosis and certain other infections)

Taking MONTELUKAST ASTHMAPHARMA with food and drink

Montelukast 10 mg may be taken with or without food.

Pregnancy and breastfeeding

Use during pregnancy

Women who are pregnant or planning to become pregnant should consult their doctor before taking Montelukast. Your doctor will assess whether you can take Montelukast during this period.

Use during breastfeeding

It is unknown whether Montelukast passes into breast milk. If you are breastfeeding or planning to breastfeed, you should consult your doctor before taking Montelukast.

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 adverse effects (such as dizziness and somnolence), which have been reported very rarely with Montelukast, may affect a patient's ability to drive or operate machinery.

Important information about some of the ingredients of MONTELUKAST ASTHMAPHARMA

Montelukast 10 mg film-coated tablets contain lactose. If your doctor has informed you of an intolerance to certain sugars, consult your doctor before taking this medicine.

3. HOW TO TAKE MONTELUKAST ASTHMAPHARMA

• You should take only one tablet of Montelukast once a day, as prescribed by your doctor.

• It should be taken even when you do not have symptoms or during an acute asthma attack.

• Always take Montelukast exactly as directed by your doctor. Consult your doctor or pharmacist if you have any doubts.

• It must be taken orally.

For adults aged 15 years and older:

One 10 mg tablet should be taken daily at night. Montelukast ASTHMAPHARMA 10 mg may be taken with or without food.

If you are taking Montelukast, make sure you do not take any other product containing the same active substance, montelukast.

If you take more MONTELUKAST ASTHMAPHARMA than you should

In most overdose cases, no adverse effects were reported. The most frequently reported symptoms in cases of 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 at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take MONTELUKAST ASTHMAPHARMA

Try to take Montelukast as prescribed. However, if you miss a dose, simply resume your usual regimen of one tablet daily.

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

If you stop taking MONTELUKAST ASTHMAPHARMA

Montelukast can only treat your asthma if you continue taking it. It is important that you continue taking Montelukast for the duration prescribed by your doctor. It will help control your asthma.

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

4. Possible adverse effects

Like all medicines, Montelukast may cause adverse effects, although not everyone experiences them.

In clinical trials with Montelukast 10 mg film-coated tablets, the adverse effects related to the administration of the medicine and reported more frequently (occurring in at least 1 in 100 patients and in less than 1 in 10 patients treated) were:

• Abdominal pain
• Headache

These adverse effects were generally mild and occurred more frequently in patients treated with Montelukast than in those treated with placebo (a tablet containing no active ingredient).

In addition, since the medicine has been marketed, the following adverse effects have been reported:

• Upper respiratory tract infection
• Increased tendency to bleeding
• Allergic reactions including skin rash, swelling of the face, lips, tongue, and/or throat, which may cause difficulty in breathing or swallowing
• Changes in behavior and mood [sleep disturbances, including nightmares, hallucinations, irritability, anxious feelings, restlessness, agitation including aggressive behavior or hostility, tremor, depression, sleep problems, sleepwalking, suicidal thoughts and actions (in very rare cases)]
• Dizziness, drowsiness, tingling/numbness, seizures
• Palpitations
• Nasal bleeding
• Diarrhea, dry mouth, indigestion, nausea, vomiting
• Hepatitis (inflammation of the liver)
• Bruising, itching, urticaria, painful red lumps under the skin which more frequently appear on the shins (erythema nodosum)
• Joint or muscle pain, muscle cramps
• Fatigue, malaise, swelling, fever

In asthmatic patients treated with montelukast, very rare cases of a combination of symptoms such as flu-like illness, tingling or numbness of arms and legs, worsening of pulmonary symptoms and/or skin rash (Churg-Strauss syndrome) have been reported. You must inform your doctor immediately if you experience one or more of these symptoms. Very rare cases (may affect up to 1 in 10,000 people) of stuttering have also been reported.

Ask your doctor or pharmacist for more information about adverse effects. If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of MONTELUKAST ASTHMAPHARMA

• Keep out of the reach and sight of children.

• Do not use this medicine after the date indicated by the six numbers following CAD on the blister. The first two numbers indicate the month; the last four numbers indicate the year. The expiry date refers to the last day of the month shown.

• Store in the original packaging.

• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of MONTELUKAST ASTHMAPHARMA

The active substance is montelukast. Each tablet contains montelukast sodium corresponding to 10 mg of montelukast.

The other components are:

Core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hydroxypropyl cellulose, magnesium stearate.

Coating: polyvinyl alcohol, titanium dioxide (E-171), talc, yellow iron oxide (E-172), lecithin, xanthan gum, red iron oxide (E-172), and black iron oxide (E-172).

Appearance of the product and contents of the pack

The 10 mg tablets are beige, round, biconvex, film-coated tablets.

Blister packs in packages containing: 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 100, 140 and 200 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

FARMALIDER S.A.

C/ Aragoneses 15

28108 Alcobendas (Madrid)

Spain

Manufacturers

PHARMATEN, S.A.

6 Dervenakion Street

Pallini 15351 – Athens

Greece

or

PHARMATEN INTERNATIONAL, S.A.

Sapes Industrial Park Block 5

69300 Rodopi

Greece

or

FARMALIDER S.A.

C/ Aragoneses 15

28108 Alcobendas (Madrid)

Spain

This leaflet was approved in March 2025