Montelukast Combix 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Montelukast Combix 10 mg film-coated tablets EFG

Read the entire 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, ask your doctor, pharmacist or nurse.

• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.

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

Leaflet contents:

1. What Montelukast Combix is and what it is used for
2. What you need to know before taking Montelukast Combix
3. How to take Montelukast Combix
4. Possible side effects
5. How to store Montelukast Combix
6. Contents of the pack and other 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 and may 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 to prevent asthma symptoms during the day and night.

• Montelukast Combix is used for the treatment of patients whose condition is not adequately controlled with their current medication and who require additional therapy.
• Montelukast Combix also helps prevent airway narrowing caused by exercise.
• In those 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 triggers.
• 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 chest tightness.

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. Symptoms of seasonal allergies typically may include: nasal congestion, runny nose, itchy nose; sneezing; watery, swollen, red, and itchy eyes.

2. What you need to know before starting to take Montelukast Combix

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

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.
• 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. Always keep your inhaled rescue medication for asthma attacks on hand.
• It is important 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 in arms or legs, worsening of pulmonary symptoms, and/or skin rash, they must consult their doctor.
• You should not take acetylsalicylic acid (aspirin) or anti-inflammatory medicines (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 medicines

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

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

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

• Phenobarbital (used for the treatment of epilepsy).
• Phenytoin (used for the treatment of epilepsy).
• Rifampicin (used for the treatment of tuberculosis and certain other infections).

Montelukast Combix with food, drinks and alcohol

Montelukast Combix 10 mg may 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 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 use of 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 somnolence), which have been reported very rarely with Montelukast Combix, may affect a patient's ability to drive or operate machinery.

Montelukast Combix contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Montelukast Combix

• You should take only one tablet of Montelukast Combix once daily, as prescribed by your doctor.
• It should be taken even when you 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 orally.

For adults aged 15 years and older:

One 10 mg tablet should be taken daily at night. Montelukast Combix 10 mg may be taken with or without food.

If you are taking Montelukast Combix, make sure you do not take any other product containing the same active substance, 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 most frequently reported symptoms in cases of 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, simply resume your regular schedule of one tablet once daily.

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

If you stop taking Montelukast Combix

Montelukast Combix can only treat your asthma if you continue taking it. It is important that you continue taking Montelukast Combix for as long as your doctor has prescribed it. It will help control your 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 can cause adverse effects, although not everyone experiences them.

In clinical trials with Montelukast Combix 10 mg film-coated tablets, the adverse effects related to the administration of the medicine and reported most frequently (occurring in at least 1 in every 100 patients and in fewer than 1 in every 10 patients treated) were:

• abdominal pain
• headache

These adverse effects were generally mild and occurred more frequently in patients treated with montelukast than with placebo (a tablet containing no active ingredient).

The frequency of the possible adverse effects listed below is defined using the following convention:

Very common (affects at least 1 in every 10 people)
Common (affects between 1 and 10 in every 100 people)
Uncommon (affects between 1 and 10 in every 1,000 people)
Rare (affects between 1 and 10 in every 10,000 people)
Very rare (affects fewer than 1 in every 10,000 people)

Additionally, since the medicine has been marketed, the following adverse effects have been reported:

• upper respiratory tract infection (Very common)
• increased tendency to bleeding (Rare)
• allergic reactions including skin rash, swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing (Uncommon)
• changes in behaviour and mood [sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, anxious feelings, restlessness, excitement including aggressive behaviour or hostility, depression (Uncommon), tremor (Rare); hallucinations, suicidal thoughts and actions (Very rare)]
• dizziness, drowsiness, tingling/numbness, seizures (Uncommon)
• palpitations (Rare)
• nosebleeds (Uncommon)
• diarrhoea, nausea, vomiting (Common); dry mouth, indigestion (Uncommon)
• hepatitis (inflammation of the liver) (Very rare)
• bruising, itching, urticaria (Uncommon); painful red lumps under the skin, most commonly appearing 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 in arms and legs, worsening of pulmonary symptoms and/or skin rash (Churg-Strauss syndrome) have been reported. You must inform your doctor immediately if you experience one or more of these symptoms.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Montelukast Combix

Keep out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging. 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. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Montelukast Combix

• The active substance is montelukast. Each tablet contains montelukast sodium equivalent 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 pack

Montelukast Combix 10 mg tablets are yellow, film-coated, round tablets with bevelled edges, marked “285” on one side and plain on the other.

Blister packs in packages containing 28 tablets.

Marketing Authorization Holder:

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer 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

Date of the most recent revision of this package leaflet: March 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/