Montelukast Asthmapharma 4 mg chewable tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Montelukast ASTHMAPHARMA 4 mg chewable tablets EFG

Montelukast sodium

Read the entire leaflet carefully before your child starts 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 your child and must not be given to other people, even if they have the same symptoms as your child, as it may harm them.
• If you consider any of the side effects your child experiences 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 ASTHMAPHARMA is and what it is used for
2. Before taking Montelukast ASTHMAPHARMA
3. How to take Montelukast ASTHMAPHARMA
4. Possible side effects
5. How to store Montelukast ASTHMAPHARMA
6. Further information

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

Montelukast 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 improves asthma symptoms and helps control asthma.

Your doctor has prescribed Montelukast to treat your child's asthma and to prevent asthma symptoms during the day and night.

• Montelukast is used for the treatment of patients aged 2 to 5 years who are not adequately controlled with their current medication and require additional treatment.

• Montelukast is also used as an alternative treatment to inhaled corticosteroids in patients aged 2 to 5 years who have not recently taken oral corticosteroids for the treatment of their asthma and who have demonstrated inability to use inhaled corticosteroids.

• Montelukast also helps prevent exercise-induced narrowing of the airways in patients aged 2 years and older.

• Depending on your child's symptoms and the severity of their asthma, your doctor will determine how Montelukast 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 things, 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 ASTHMAPHARMA

Inform your doctor of any allergies or current or past medical conditions your child may have.

Do not give MONTELUKAST ASTHMAPHARMA to your child if

• He or she is allergic (hypersensitive) to montelukast or to any of the other components of Montelukast (see section 6.).

Take special care with MONTELUKAST ASTHMAPHARMA

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

• Oral montelukast is not indicated for the treatment of acute asthma attacks. If an asthma attack occurs, follow the instructions your doctor has given you for your child. Always keep your child's rescue inhaled medication available for asthma attacks.

• It is important that your child uses all asthma medications prescribed by the doctor.

Montelukast should not be used instead of other asthma medications prescribed by your doctor for your child.

• If your child is being treated with asthma medications, be aware that if he or she develops a combination of symptoms such as flu-like illness, tingling or numbness in arms or legs, worsening of pulmonary symptoms, and/or skin rash, you should consult your doctor.

• Your child should not take acetylsalicylic acid (aspirin) or non-steroidal anti-inflammatory drugs (also known as NSAIDs) if these worsen his or her asthma.

• Various neuropsychiatric events (e.g., behavioral and mood-related changes, depression, and suicidal tendencies) have been reported in patients of all ages (see section 4). If such symptoms develop while taking Montelukast, contact your doctor.

Use of other medicines

Some medicines may affect how Montelukast ASTHMAPHARMA works, or Montelukast ASTHMAPHARMA may affect how other medicines your child is taking work.

Inform your doctor or pharmacist if your child is taking or has recently taken any other medicines, including those obtained without a prescription.

Before taking Montelukast, inform your doctor if your child is 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)

Taking MONTELUKAST ASTHMAPHARMA with food and drinks

Montelukast ASTHMAPHARMA 4 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

This subsection does not apply to Montelukast 4 mg chewable tablets, as it is indicated for use in children aged 2 to 5 years. However, the following information is relevant for the active substance, montelukast.

Use during pregnancy

Women who are pregnant or planning to become pregnant should consult their doctor before taking Montelukast. Your doctor will assess whether you can take Montelukast during this period.

Use during breastfeeding

It is unknown whether Montelukast passes into breast milk. If you are breastfeeding or planning to breastfeed, you should consult your doctor before taking Montelukast.

Driving and use of machines

This subsection does not apply to Montelukast 4 mg chewable tablets, as it is indicated for use in children aged 2 to 5 years. However, the following information is relevant for the active substance, montelukast.

Montelukast is not expected to affect your ability to drive 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, may affect a patient's ability to drive or operate machinery.

Important information about some of the components of MONTELUKAST ASTHMAPHARMA

This medicine may be harmful to people with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

If your child has phenylketonuria (a rare inherited metabolic disorder), you should be aware that each 4 mg chewable tablet contains phenylalanine (equivalent to 0.135 mg of phenylalanine per 4 mg chewable tablet).

3. HOW TO TAKE MONTELUKAST ASTHMAPHARMA

• This medicine should be given to children under the supervision of an adult.

• Your child should take only one Montelukast tablet per day, exactly as prescribed by the doctor.

• It must be taken even when your child has no symptoms or during an acute asthma attack.

• Always ensure your child takes Montelukast exactly as directed by the doctor. Consult your child’s doctor or pharmacist if you have any doubts.

• It must be taken by mouth.

For children aged 2 to 5 years:

One 4 mg chewable tablet should be taken daily at night. Montelukast should not be taken with food; it should be taken at least 1 hour before or 2 hours after eating.

If your child is taking Montelukast ASTHMAPHARMA, make sure they do not take any other medication containing the same active substance, montelukast.

For children aged 2 to 5 years, Montelukast ASTHMAPHARMA 4 mg chewable tablets are available.

For children aged 6 to 14 years, Montelukast ASTHMAPHARMA 5 mg chewable tablets are available. The Montelukast ASTHMAPHARMA 4 mg chewable tablet is not recommended for children under 2 years of age.

If your child takes more MONTELUKAST ASTHMAPHARMA than they should

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.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Poison Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to give MONTELUKAST ASTHMAPHARMA to your child

Try to give Montelukast as prescribed. However, if your child misses a dose, simply resume the usual regimen of one tablet per day.

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

If your child stops taking MONTELUKAST ASTHMAPHARMA

Montelukast will only treat your child’s asthma if treatment is continued.

It is important that your child continues taking Montelukast for as long as prescribed by the doctor.

It will help control your child’s asthma.

If you have any further questions about the use of this product, ask your child’s doctor or pharmacist.

4. Possible side effects

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

In clinical trials with Montelukast 4 mg chewable tablets, the side effects related to the administration of the medicine and reported most frequently (occurring in at least 1 in 100 patients and in fewer than 1 in 10 patients treated) were:

• Abdominal pain
• Thirst

Additionally, the following side effects were reported in clinical trials with Montelukast 10 mg film-coated tablets and 5 mg chewable tablets:

• Headache

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

Furthermore, since the medicine has been marketed, the following side 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 behaviour and mood [sleep disturbances, including nightmares, hallucinations, irritability, anxiety, restlessness, excitement including aggressive or hostile behaviour, tremor, depression, sleep problems, sleepwalking, suicidal thoughts and actions (in very rare cases)]
• Dizziness, drowsiness, tingling/numbness, seizures
• Palpitations
• Nosebleeds
• Diarrhoea, dry mouth, indigestion, nausea, vomiting
• Hepatitis (inflammation of the liver)
• Bruising, itching, urticaria, painful red lumps under the skin most frequently appearing on the shins (erythema nodosum)
• Joint or muscle pain, muscle cramps
• Tiredness, 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 inform your doctor immediately if your child experiences one or more of these symptoms. Very rare cases (may affect up to 1 in 10,000 people) of stuttering have also been reported.

Ask your doctor or pharmacist for more information about side effects. If you consider any of the side effects your child experiences to be severe, or if you notice any side effects not listed in this leaflet, please inform your child's doctor or pharmacist.

5. Storage of MONTELUKAST ASTHMAPHARMA

• Keep out of the reach and sight of children.

• Do not use this medicinal product after the date indicated by the six numbers following "CAD" on the blister. The first two numbers indicate the month; the last four numbers indicate the year. The expiration date refers to the last day of the month indicated.

• Store in the original packaging.

• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of MONTELUKAST ASTHMAPHARMA

• The active substance is montelukast. Each tablet contains montelukast sodium equivalent to 4 mg of montelukast.

• The other components are:

Mannitol, microcrystalline cellulose, sodium croscarmellose, L-hydroxypropyl cellulose, ferric oxide red (E172), cherry flavor, aspartame (E 951), magnesium stearate.

Appearance of the medicinal product and contents of the container

Montelukast ASTHMAPHARMA 4 mg chewable tablets are pink, oval-shaped, biconvex tablets, packaged in PA/AL/PVC-aluminum blisters in pack sizes of: 7, 10, 14, 20, 28, 30, 50, 56, 98, 100, 140 and 200 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

FARMALIDER S.A.
C/ Aragoneses 15
28108 Alcobendas (Madrid)
Spain

Manufacturers

PHARMATEN, S.A.
6 Dervenakion Street
Pallini 15351 – Athens
Greece

or

PHARMATEN INTERNATIONAL, S.A.
Sapes Industrial Park Block 5
69300 Rodopi
Greece

or

FARMALIDER S.A.
C/ Aragoneses 15
28108 Alcobendas (Madrid)
Spain

This leaflet was approved in March 2025