Montelukast Combix 5 mg chewable tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Montelukast Combix 5 mg chewable tablets EFG

Read the entire leaflet carefully before you or your child start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you or your child; do not give it to other people, even if they have the same symptoms as you or your child, as it may harm them.
• If you consider any of the side effects you experience 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 Combix is and what it is used for
2. Before you take Montelukast Combix
3. How to take Montelukast Combix
4. Possible side effects
5. How to store Montelukast Combix
6. Further information

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

Montelukast Combix is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause 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 to prevent asthma symptoms during the day and night.

• Montelukast Combix is used for the treatment of patients who are not adequately controlled with their current medication and require additional therapy.
• Montelukast Combix is also used as an alternative to inhaled corticosteroids in patients aged 6 to 14 years who have not recently taken oral corticosteroids for treatment of their asthma and who have demonstrated inability to use inhaled corticosteroids.
• Montelukast Combix also helps prevent airway narrowing caused by exercise.

Depending on the symptoms and severity of your asthma or your child's asthma, your doctor will determine how Montelukast Combix should be used.

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 stimuli, 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.

2. BEFORE TAKING MONTELUKAST COMBIX

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

Do not take Montelukast Combix if you or your child

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

Take special care with Montelukast Combix

• If your asthma or breathing, or that of your child, worsens, inform your doctor immediately.
• Oral montelukast is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions given to you by your doctor for you or your child. 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 Combix should not be used instead 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 in arms or legs, worsening of pulmonary symptoms, and/or skin rash, they should consult their doctor.
• You or your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they cause your asthma to worsen.

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 medicines

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

Inform your doctor or pharmacist if you or your child are using or have recently used any other medicines, including those obtained without a prescription.

Before taking Montelukast Combix, inform your doctor if you or your child are taking the following medicines:

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

Taking Montelukast Combix with food and drinks

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

Pregnancy and breastfeeding

Use during pregnancy:

Women who are pregnant or planning 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 passes into breast milk. If you are breastfeeding or planning to breastfeed, you should 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 medicine may vary. Certain adverse effects (such as dizziness and drowsiness), which have been reported very rarely with Montelukast Combix, may affect the patient's ability to drive or operate machinery.

Important information about some of the ingredients of Montelukast Combix

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

3. HOW TO TAKE MONTELUKAST COMBIX

• You or your child should take only one Montelukast Combix tablet once a day, as prescribed by your doctor.
• It should be taken even when you or your child do not have symptoms or during an acute asthma attack.
• Always take Montelukast Combix exactly as your doctor has instructed. Consult your doctor or pharmacist if you have any doubts.
• It must be taken by mouth.

For children aged 6 to 14 years

One 5 mg chewable tablet should be taken daily at night. Montelukast Combix 5 mg chewable tablets must not be taken with food; they should be taken at least 1 hour before or 2 hours after meals.

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

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

Seek medical help immediately.

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.

If you or your child forget to take Montelukast Combix or forget to give it to your child

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

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

If you or your child stop taking Montelukast Combix

Montelukast Combix can only control your asthma or your child's asthma if you or your child continue taking it. It is important to continue taking Montelukast Combix for as long as your doctor prescribes it. It will help control your asthma or your child's 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 Combix may cause adverse effects, although not everyone experiences them.

In clinical trials with Montelukast Combix 5 mg chewable 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 fewer than 1 in 10 patients treated) were:

• headache

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

• abdominal pain

These adverse effects were generally mild and occurred more frequently in patients treated with Montelukast Combix than in those treated with placebo (a tablet without active ingredient).

Furthermore, 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 breathing or swallowing
• changes in behavior and mood [sleep disturbances, including nightmares, hallucinations, irritability, anxiety, restlessness, agitation including aggressive behavior or hostility, tremor, depression, sleep problems, sleepwalking, suicidal thoughts and actions, stuttering (in very rare cases)]
• dizziness, somnolence, tingling/numbness, seizures
• palpitations
• nosebleeds
• diarrhea, dry mouth, indigestion, nausea, vomiting
• hepatitis (inflammation of the liver)
• bruising, itching, hives, painful red lumps under the skin which more commonly 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 in arms and legs, worsening of pulmonary symptoms and/or skin rash (Churg-Strauss syndrome) have been reported. You should contact your doctor immediately if you experience one or more of these symptoms.

Ask your doctor or pharmacist for further 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 mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of MONTELUKAST COMBIX

Keep out of the reach and sight of children.

Do not use this medicine after the date represented by the six numbers following CAD shown 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 indicated.

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

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 Combix 5 mg

• The active substance is montelukast. This tablet contains montelukast sodium equivalent 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 medicinal product and contents of the pack

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

Blister packs in packs of 28 tablets.

Unit-dose blisters in packs of 28 tablets.

Marketing Authorization Holder:

LABORATORIOS COMBIX, S.L.U

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcon (Madrid), Spain

Manufacturer:

Zydus France

25, parc d’activités des Peupliers, Bâtiment 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