Leaflet: information for the user

Montelukast Combix 5 mg chewable tablets EFG

Read this leaflet carefully before you or your child start taking the 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 you or your child and should not be given to others, even if they have the same symptoms as you or your child, as it may harm them.

- If you consider that any of the side effects you are experiencing are serious or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

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

2. Before taking Montelukast Combix

3. How to take Montelukast Combix

4. Possible side effects

5. Storage of Montelukast Combix

6. Additional information

Montelukast Combix is a leukotriene receptor antagonist that blocks certain substances called leukotrienes. Leukotrienes produce narrowing and swelling of the airways in the lungs. By blocking leukotrienes, Montelukast Combix improves asthma symptoms and helps control asthma.

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 is also used as an alternative treatment to inhaled corticosteroids in patients aged 6 to 14 years who have not recently taken oral corticosteroids for the treatment of their asthma and who have demonstrated that they are unable to use inhaled corticosteroids.
• Montelukast Combix also helps prevent airway constriction caused by exercise.

The use of Montelukast Combix will depend on your symptoms and the severity of your asthma or your child's 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, cold air, or exercise.
• Swelling (inflammation) of the inner lining of the airways.

Asthma symptoms include: Coughing, wheezing, and congestion in the chest.

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

Do not take Montelukast Combix if you or your child

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

Be especiallycareful with Montelukast Combix

• If your asthma or breathing or your child's 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 your doctor has given you or your child. 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 Combix should not be used in place of other asthma medications prescribed by your doctor for you or your child.
• 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.
• You or your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as nonsteroidal anti-inflammatory drugs or 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.

Use of 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 or your child are using or have recently used other medications, including those obtained without a prescription.

Before taking Montelukast Combix, inform your doctor if you or your child 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).

Taking Montelukast Combix with food and beverages

Montelukast Combix 5 mg chewable tablets should not be taken with meals; it should be taken at least 1 hour before or 2 hours after meals.

Pregnancy and breastfeeding

Use during pregnancy:

Women who are pregnant or intend 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 intend to breastfeed, you should 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.

Important information about some of the components of Montelukast Combix

The chewable tablets of Montelukast Combix contain aspartame, a source of phenylalanine. If your child has phenylketonuria (a rare hereditary disorder of metabolism), you should be aware that each 5 mg chewable tablet of Montelukast Combix contains phenylalanine (equivalent to 0.67 mg of phenylalanine in each 5 mg chewable tablet of Montelukast Combix).

• You or your child should only take one Montelukast Combix tablet once a day as directed by your doctor.
• Take it even when you or your child do not have symptoms or when having an acute asthma attack.
• Always take Montelukast Combix as directed by your doctor. Consult your doctor or pharmacist if you have any doubts.
• Take it orally.

For children aged 6 to 14 years

Take one chewable tablet of 5 mg daily at night. Montelukast Combix 5 mg chewable tablets should not be taken with meals; take it at least 1 hour before or 2 hours after eating.

If you or your child are taking Montelukast Combix, make sure neither you nor your child take any other product containing the same active ingredient, montelukast.

If you or your child take more Montelukast Combix than you should

Seek help from your doctor immediately.

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 forgot to take Montelukast Combix or forgot to give Montelukast Combix to your child

Try to take Montelukast Combix as directed. However, if you or your child forget a dose, simply resume the usual regimen of one tablet once a day.

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

If you or your child stop taking Montelukast Combix

Montelukast Combix can only treat your asthma or your child's asthma if you or your child continue to take it. It is essential to continue taking Montelukast Combix for the time your doctor prescribes. It will help control your asthma or your child's 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 5 mg chewable 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:

• headache

In addition, the following side effects were reported in clinical trials with Montelukast 10 mg film-coated tablets:

• abdominal pain

These side effects were generally mild and occurred more frequently in patients treated with Montelukast Combix than with placebo (a tablet that does not contain medication).

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

• upper respiratory tract infection
• increased risk of bleeding
• allergic reactions that include skin rash, swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing
• behavioral and mood changes [sleep disturbances, including nightmares, hallucinations, irritability, anxiety, restlessness, excitement including aggressive or hostile behavior, tremor, depression, sleep problems, somnambulism, suicidal thoughts and actions, stuttering (in very rare cases)]
• dizziness, somnolence, paresthesia, seizures
• palpitations
• nasal bleeding
• diarrhea, dry mouth, indigestion, nausea, vomiting
• hepatitis (inflammation of the liver)
• hematomas, pruritus, urticaria, painful red nodules under the skin that more frequently appear on the skin (erythema nodosum)
• musculoskeletal pain or muscle cramps
• fatigue, malaise, swelling, fever

In patients with asthma treated with montelukast, rare cases of a combination of symptoms such as flu-like illness, paresthesia or numbness of arms and legs, worsening of respiratory symptoms, and/or skin rash (Churg-Strauss syndrome) have been reported. Inform your doctor immediately if you experience one or more of these symptoms.

Ask your doctor or pharmacist for more information about side effects. If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this prospectus, report it to your doctor or pharmacist.

Keep out of reach and sight of children.

Do not use this medication after the date represented by the six numbers following CAD that appears on the blister. The first two digits indicate the month; the last four digits indicate the year. 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. Ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

Composition of Montelukast Combix 5 mg

- The active ingredient is montelukast. This tablet contains montelukast sodium corresponding to 5 mg of montelukast.

- The other components are: mannitol (E421), microcrystalline cellulose, red iron oxide (E172), sodium croscarmellose, hydroxypropylcellulose (E463), crospovidone, cherry flavor, aspartame (E951), and magnesium stearate.

Appearance of the product and contents of the package

The chewable tablets of 5 mg are pink speckled, round, and smooth on both sides.

Blister packs in packages of 28 tablets.

Blister packs (single dose) in packages of 28 tablets.

Marketing Authorization Holder:

LABORATORIOS COMBIX, S.L.U

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcon (Madrid), Spain

Responsible for manufacturing:

Zydus France

25, parc d’activités des Peupliers, Building L

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC Du Suzot

35 Rue de la Chapelle

63450 Saint-Amant Tallende

France

This leaflet was approved in March 2025