MONTELUKAST ASTHMAPHARMA 10 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

MONTELUKAST ASTHMAPHARMA 10 mg film-coated tablets

Montelukast sodium

Read all of this leaflet carefully before your child starts taking this medicine.

• Keep this 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 for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as your child's.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

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

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

Montelukast is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause the airways in the lungs to narrow and swell, and can also cause allergy symptoms. By blocking leukotrienes, Montelukast improves asthma symptoms, helps control asthma, and relieves symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).

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

• Montelukast is used to treat patients who are not adequately controlled with their medication and need additional treatment.
• Montelukast also helps prevent airway narrowing caused by exercise.
• In asthmatic patients for whom Montelukast is indicated for asthma, Montelukast may also provide symptomatic relief of seasonal allergic rhinitis.

Depending on the symptoms and 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 diseases.
• 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.

The symptoms of asthma include: Coughing, wheezing, and chest congestion.

What are seasonal allergies?

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

2. Before taking MONTELUKAST ASTHMAPHARMA

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

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

Be careful with MONTELUKAST ASTHMAPHARMA

• If your asthma or breathing gets worse, tell your doctor immediately.
• Montelukast 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 essential 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 ... Montelukast should not replace other asthma medications prescribed by your doctor.
• You should not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they make your asthma worse.
• Several neuropsychiatric events (such as changes in behavior and mood, depression, and suicidal tendencies) have been reported in patients of all ages (see section 4). If you develop these symptoms while taking Montelukast, you should contact your doctor.

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 medications

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

Tell your doctor or pharmacist if you are using or have recently used other medications, even those obtained without a prescription.

Before taking Montelukast, tell your doctor if you are taking the following medications:

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

Taking MONTELUKAST ASTHMAPHARMA with food and drinks

Montelukast 10 mg can be taken with or without food.

Pregnancy and breastfeeding

Use during pregnancy

Women who are pregnant or plan 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 appears in breast milk. If you are breastfeeding or plan 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 medication may vary. Certain side effects (such as dizziness and drowsiness) that have been reported very rarely with Montelukast may affect the patient's ability to drive or operate machinery.

Important information about some of the ingredients of MONTELUKAST ASTHMAPHARMA

The 10 mg film-coated tablets of Montelukast contain lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medication.

3. How to take MONTELUKAST ASTHMAPHARMA

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

• You should take it even when you do not have symptoms or when you have an acute asthma attack.

• Always take Montelukast as your doctor has told you. Consult your doctor or pharmacist if you have any doubts.

• It should be taken orally.

For adults 15 years of age and older:

You should take one 10 mg tablet daily in the evening. Montelukast ASTHMAPHARMA 10 mg can be taken with or without food.

If you are taking Montelukast, make sure you do not take any other product that contains the same active ingredient, montelukast.

If you take more MONTELUKAST ASTHMAPHARMA than you should

In most cases of overdose, no adverse 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 medication and the amount ingested.

If you forget to take MONTELUKAST ASTHMAPHARMA

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

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

If you stop taking MONTELUKAST ASTHMAPHARMA

Montelukast can only treat your asthma if you continue to take it. It is essential 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 about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Montelukast can cause side effects, although not everybody gets them.

In clinical trials with Montelukast 10 mg film-coated tablets, the side effects related to the administration of the medication and reported most frequently (occurring in at least 1 in 100 patients and less than 1 in 10 patients treated) 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 medication).

Additionally, since the medication has been marketed, the following side effects have been reported:

• Upper respiratory tract infection

• Increased risk of bleeding

• Allergic reactions including skin rash, swelling of the face, lips, tongue, and/or throat that can cause difficulty breathing or swallowing

• Behavioral and mood changes [sleep disturbances, including nightmares, hallucinations, irritability, feeling anxious, restlessness, excitement including aggressive or hostile behavior, tremors, depression, sleep problems, somnambulism, thoughts, and suicidal actions (in very rare cases)]

• Dizziness, drowsiness, tingling/numbness, seizures

• Palpitations

• Nosebleeds

• Diarrhea, dry mouth, indigestion, nausea, vomiting

• Hepatitis (inflammation of the liver)

• Bruises, itching, urticaria, painful red lumps under the skin that most frequently appear on the shins (erythema nodosum)

• Joint or muscle pain, muscle cramps

• Fatigue, discomfort, 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 should immediately inform your doctor if you have 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 side effects. If you think any of the side effects you are suffering from is serious, or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.

5. Storage of MONTELUKAST ASTHMAPHARMA

• Keep out of the reach and sight of children.

• Do not use this medication after the expiry date stated on the blister. The first two numbers indicate the month; the last four numbers indicate the year. The expiry date is the last day of the month indicated.

• Store in the original package.

• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. FURTHER INFORMATION

Composition of MONTELUKAST ASTHMAPHARMA

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

The other ingredients 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 packaging contents

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

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

Not all 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