MONTELUKAST COMBIX 5 mg CHEWABLE TABLETS

Introduction

Package Leaflet: Information for the User

Montelukast Combix 5 mg Chewable Tablets EFG

Read all of this leaflet carefully before you or your child start taking this medicine.

• Keep this leaflet, 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 or your child. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours or your child's.
• If you think any of the side effects that you or your child are getting are serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Contents of the Package Leaflet:

1. What is Montelukast Combix and what is it used for
2. Before taking Montelukast Combix
3. How to take Montelukast Combix
4. Possible side effects
5. Storage of Montelukast Combix
6. Further 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 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 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 between 6 and 14 years of age who have not recently taken oral corticosteroids for the treatment of their asthma and have demonstrated that they are unable to use inhaled corticosteroids.
• Montelukast Combix also helps prevent narrowing of the airways caused by exercise.

Depending on the symptoms and severity of your asthma or your child's asthma, your doctor will determine how you or your child 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 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: Cough, wheezing, and chest congestion.

2. Before taking Montelukast Combix

Tell your doctor about any allergy or medical problem that 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 any of the other ingredients of Montelukast Combix (see section 6. Further information).

Be careful with Montelukast Combix

• If your asthma or breathing or your child's asthma or breathing worsen, tell your doctor immediately.
• Montelukast oral is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions that your doctor has given you for you or your child. 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 Combix should not be used instead of other asthma medications that your doctor has prescribed 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 lung 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 non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.

Use in children

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

For children from 6 to 14 years of age, 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 that you or your child are using.

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

Before taking Montelukast Combix, tell your doctor if you or your child 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 Combix with food and drinks

Montelukast Combix 5 mg chewable tablets should not be taken with meals; 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 plan to become pregnant should consult their doctor before taking Montelukast Combix. Their doctor will assess whether they can take Montelukast Combix during this period.

Use during breastfeeding:

It is not known whether Montelukast Combix appears in breast milk. If you are breastfeeding or plan 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 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.

Important information about some of the ingredients of Montelukast Combix

The chewable tablets of Montelukast Combix contain aspartame, a source of phenylalanine. If your child has phenylketonuria (a rare, inherited disorder of metabolism), you should note 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 only take 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 when you or your child have an acute asthma attack.
• Always take Montelukast Combix as your doctor has told you. Consult your doctor or pharmacist if you are unsure.
• It should be taken orally.

For children from 6 to 14 years of age

One 5 mg chewable tablet should be taken daily in the evening. Montelukast Combix 5 mg chewable tablets should not be taken with meals; 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 that contains the same active ingredient, montelukast.

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

Seek immediate medical attention from your doctor.

In most cases of overdose, no side effects were reported. The symptoms that occurred most frequently in overdose in adults and children were abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.

If you or your child forget to take Montelukast Combix

Try to take Montelukast Combix as you have been prescribed. However, if you or your child forget a dose, just resume your usual schedule of one tablet once a day.

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

If you or your child stop taking Montelukast Combix

Montelukast Combix will only treat your asthma or your child's asthma if you or your child continue to take it. It is essential that you 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 other questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

In clinical trials 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

Additionally, 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 with a higher frequency in patients treated with Montelukast Combix 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 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, including aggressive or hostile behavior, tremor, depression, sleep problems, sleepwalking, suicidal thoughts and actions, stuttering (in very rare cases)]
• dizziness, drowsiness, tingling/numbness, seizures
• palpitations
• nosebleeds
• diarrhea, dry mouth, indigestion, nausea, vomiting
• hepatitis (inflammation of the liver)
• bruises, itching, hives, 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 patients with asthma 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.

Ask your doctor or pharmacist for more information about side effects. If you think any of the side effects that you or your child are getting are serious, or if you notice any side effects not listed in this leaflet, please tell 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 expiry date which is stated on the blister after CAD. The first two numbers indicate the month; the last four numbers indicate the year. The expiry date is the last day of the month stated.

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

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 Combix 5 mg

• The active ingredient is montelukast. This tablet contains montelukast sodium equivalent to 5 mg of montelukast.
• The other ingredients 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 packaging contents

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

Blisters in packs of 28 tablets.

Single-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