Leaflet: information for the user

Montelukast Combix 10 mg film-coated tablets EFG

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, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms of illness as you, as it may harm them.

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

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

Montelukast Combix is a leukotriene receptor antagonist that blocks certain substances called leukotrienes. Leukotrienes produce bronchospasm and inflammation 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).

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

• Montelukast Combix is used for the treatment of patients who are not adequately controlled with their medication and need additional treatment.
• Montelukast Combix also helps prevent airway constriction 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 symptoms and the severity of your asthma, your doctor will determine how to use Montelukast Combix.

What is asthma?

Asthma is a chronic disease.

Asthma includes:

• Difficulty breathing due to bronchospasm. This bronchospasm worsens and improves in response to various diseases.
• Respiratory airways that are sensitive and react to many things, such as cigarette smoke, pollen, cold air, or exercise.
• Inflammation (inflammation) of the inner layer of the respiratory 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, nasal itching; sneezing; watery, swollen, red, and itchy eyes.

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

Do not take Montelukast Combix

- if you are allergic (hypersensitive) to montelukast or to any of the other components of Montelukast Combix (See section 6. Additional information).

Warnings and precautions

• If your asthma or breathing worsens, inform your doctor immediately.

• Montelukast 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 asthma medications prescribed by your doctor. Montelukast 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, tingling or numbness of arms or legs, worsening of respiratory symptoms, and/or skin rash, they should consult their doctor.

• Do not take acetylsalicylic acid (aspirin) or nonsteroidal anti-inflammatory drugs (also known as NSAIDs) if they make your asthma worse.

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.

Inform 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 for the treatment of epilepsy).

- Phenytoin (used for the treatment of epilepsy).

- Rifampicin (used for the treatment of 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 planning to become pregnant should consult their doctor before taking Montelukast Combix. Your doctor will evaluate whether you can take Montelukast Combix during this period.

Use during breastfeeding:

The safety of Montelukast Combix in breastfeeding women is unknown. If you are breastfeeding or plan to breastfeed, consult your doctor before taking Montelukast Combix.

Driving and operating machinery

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 adverse effects (such as dizziness and somnolence) that have been reported rarely with Montelukast Combix may affect the patient's ability to drive or operate machinery.

Montelukast Combix contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

• You should only take one Montelukast Combix tablet 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 Combix as instructed by your doctor. 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 at night. 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 adverse effects were reported. The symptoms that occurred most frequently reported in overdose in adults and children were abdominal pain, drowsiness, drowsiness, headache, vomiting, and hyperactivity.

If you forget to take Montelukast Combix

Try to take Montelukast Combix 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 the missed doses.

If you interrupt treatment with Montelukast Combix

Montelukast Combix can 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.

Like all medicines, Montelukast Combix can cause side effects, although not everyone will experience 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 tablet 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 tract infection (Very common)
• increased risk of bleeding (Rare)
• allergic reactions that include skin rash, facial swelling, lips, tongue, and/or throat that may cause difficulty breathing or swallowing (Uncommon)
• behavioral and mood changes [sleep disturbances, including nightmares, sleep problems, somnambulism, irritability, anxiety, restlessness, excitement including aggressive or hostile behavior, depression (Uncommon) tremors, (Rare); hallucinations, suicidal thoughts and actions (Very rare)]
• dizziness, somnolence, paresthesia, convulsions (Uncommon)
• palpitations (Rare)
• nasal bleeding (Uncommon)
• diarrhea, nausea, vomiting (Common); dry mouth, indigestion (Uncommon)
• hepatitis (liver inflammation) (Very rare)
• hematomas, pruritus, urticaria (Uncommon); red painful bumps under the skin that more frequently appear on the face (erythema nodosum) (Very rare)
• musculoskeletal pain or cramps (Uncommon)
• fever (Common); fatigue, malaise, swelling (Uncommon)
• stuttering (Very rare)

In patients with asthma treated with montelukast, 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. Inform your doctor immediately if you experience one or more of these symptoms.

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 prospectus. 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 medication.

Keep out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Montelukast Combix

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

- The other components are: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hydroxypropylcellulose (E463), magnesium stearate, coating agent (hypromellose –E464-, hydroxypropylcellulose -E463-, titanium dioxide-E171-, yellow iron oxide –E172- and red iron oxide -E172-)

Appearance of the product and contents of the packaging

The Montelukast Combix 10 mg tablets are yellow-coated, round, beveled-edge tablets with the mark “285” on one face and smooth on the other.

Blister packs in packs of 28 tablets

Holder of the marketing authorization:

Combix, S.L.U. Laboratories

C/ Badajoz 2, Building 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing:

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

Last review date of this leaflet March 2025

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/