MONTELUKAST COMBIX 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Montelukast Combix 10 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms of illness as you, as it may harm them.

if they present the same symptoms of illness as you, as it may harm them.

• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What is Montelukast Combix and what is it used for
2. What you need to know before taking Montelukast Combix
3. How to take Montelukast Combix
4. Possible side effects
5. Storage of Montelukast Combix
6. Package contents and additional information

1. What is Montelukast Combix and what is it used for

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

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

• Montelukast Combix is used to treat patients who are not adequately controlled with their medication and need additional treatment.
• Montelukast Combix also helps prevent airway narrowing caused by exercise.
• In asthmatic patients for whom Montelukast Combix 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 Combix.

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 seasonal allergic rhinitis) are an allergic response often caused by airborne pollen from trees, grass, and weeds. Seasonal allergy symptoms typically may include: stuffy nose, runny nose; sneezing; itchy, watery, swollen, red, and painful eyes.

2. What you need to know before taking Montelukast Combix

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

Do not take Montelukast Combix

• if you are allergic (hypersensitive) to montelukast or any of the other ingredients of Montelukast Combix (see section 6. Additional information).

Warnings and precautions

• If your asthma or breathing worsens, inform your doctor immediately.
• Oral montelukast is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions your doctor has given you. Always have your rescue inhalation 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 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 acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.

Use in children

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

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

Interaction of Montelukast Combix with other medications

Some medications may affect the functioning of Montelukast Combix, or Montelukast Combix 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, including those obtained without a prescription.

Before taking Montelukast Combix, inform 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).

Montelukast Combix with food, drinks, and alcohol

Montelukast Combix 10 mg can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Use during pregnancy:

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

Use during breastfeeding:

It is unknown whether Montelukast Combix appears in breast milk. If you are breastfeeding or plan to breastfeed, consult your doctor before taking Montelukast Combix.

Driving and using machines

Montelukast Combix 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 Combix may affect the patient's ability to drive or operate machinery.

Montelukast Combix contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Montelukast Combix

• You should only take one Montelukast Combix 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.
• Always take Montelukast Combix as your doctor has told you. Consult your doctor or pharmacist if you have any questions.
• It should be taken orally.

For adults 15 years of age and older:

One 10 mg tablet should be taken daily in the evening. Montelukast Combix 10 mg can be taken with or without food.

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

If you take more Montelukast Combix than you should

Seek immediate help from your doctor.

In most cases of overdose, no side 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.

If you forget to take Montelukast Combix

Try to take Montelukast Combix 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 Combix

Montelukast Combix will only treat your asthma if you continue to take it. It is essential that you continue taking Montelukast Combix for the time your doctor prescribes. It will help control your asthma.

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

4. Possible side effects

Like all medications, Montelukast Combix can cause side effects, although not everyone gets them.

In clinical trials conducted with Montelukast Combix 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).

The frequency of possible side effects, indicated below, is defined using the following convention:

Very common (affects at least 1 in 10 people)

Common (affects between 1 and 10 in 100 people)

Uncommon (affects between 1 and 10 in 1,000 people)

Rare (affects between 1 and 10 in 10,000 people)

Very rare (affects less than 1 in 10,000 people)

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

• upper respiratory infection (Very common)
• increased risk of bleeding (Rare)
• allergic reactions including skin rash, swelling of the face, lips, tongue, and/or throat that can cause difficulty breathing or swallowing (Uncommon)
• behavioral and mood changes [sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, feeling anxious, restlessness, excitement including aggressive or hostile behavior, depression (Uncommon) tremor, (Rare); hallucinations, suicidal thoughts and actions (Very rare)]
• dizziness, drowsiness, tingling/numbness, seizures (Uncommon)
• palpitations (Rare)
• nasal bleeding (Uncommon)
• diarrhea, nausea, vomiting (Common); dry mouth, indigestion (Uncommon)
• hepatitis (inflammation of the liver) (Very rare)
• bruises, itching, hives (Uncommon); painful red lumps under the skin that most frequently appear on the shins (erythema nodosum) (Very rare)
• joint or muscle pain, muscle cramps (Uncommon)
• fever (Common); fatigue, malaise, swelling (Uncommon)
• stuttering (Very rare)

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 lung 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.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Montelukast Combix

Keep out of sight and reach of children.

Do not use this medication after the expiration date stated on the package. The expiration date is the last day of the month indicated.

Store in the original packaging to protect from light and moisture.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Montelukast Combix

• The active ingredient is montelukast. Each tablet contains montelukast sodium equivalent to 10 mg of montelukast.
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hypromellose (E463), magnesium stearate, coating agent (hypromellose - E464-, hypromellose - E463-, titanium dioxide - E171-, yellow iron oxide - E172-, and red iron oxide - E172-)

Appearance of the product and package contents

Montelukast Combix 10 mg tablets are yellow, round, film-coated tablets with a beveled edge, marked with "285" on one side and smooth on the other.

Blisters in packages of 28 tablets

Marketing authorization holder:

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer:

Zydus France

25, parc d’activités des Peupliers

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

Date of the last revision of this package leaflet March 2025

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/