Montelukast Asthmapharma 5 mg chewable tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Montelukast ASTHMAPHARMA 5 mg chewable tablets EFG

Montelukast sodium

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 pass it on to others, 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 serious, 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 you take 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 asthma and to prevent asthma symptoms during the day and night.

• Montelukast is used for the treatment of patients whose asthma is not adequately controlled with their current medication and who require additional therapy.

• Montelukast 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 their asthma and who have demonstrated inability to use inhaled corticosteroids.

• Montelukast also helps prevent exercise-induced narrowing of the airways.

Depending on the symptoms and severity of your asthma or your child's 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: coughing, wheezing, and chest tightness.

2. BEFORE TAKING MONTELUKAST ASTHMAPHARMA

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 ASTHMAPHARMA if you or your child

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

Take special care with MONTELUKAST ASTHMAPHARMA

• 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 your doctor has given you for yourself or for your child. Always have 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 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 drugs (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your 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 you develop these symptoms while taking Montelukast, contact your doctor.

Use in children

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

For children aged 6 to 14 years, Montelukast 5 mg chewable tablets are available.

Use of other medicines

Some medicines may affect how Montelukast works, or Montelukast may affect how other medicines you are taking 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, inform your doctor if you or your child are taking any of 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 some other infections)

Taking MONTELUKAST ASTHMAPHARMA with food and drinks

Montelukast 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. 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 using machines

Montelukast 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) that have been reported very rarely with Montelukast may affect the patient's ability to drive or operate machinery.

Important information about some of the components of MONTELUKAST ASTHMAPHARMA

This medicine may be harmful for 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 5 mg chewable tablet contains phenylalanine (equivalent to 0.168 mg of phenylalanine per 5 mg chewable tablet).

3. HOW TO TAKE MONTELUKAST ASTHMAPHARMA

• You or your child should take only one Montelukast tablet once a day, as prescribed by your doctor.

• It should be taken even when you or your child do not have symptoms or are experiencing an acute asthma attack.

• Always take Montelukast exactly as directed by your doctor. Consult your doctor or pharmacist if you have any doubts.

• It must be taken orally.

For children aged 6 to 14 years:

One 5 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 you or your child are taking Montelukast ASTHMAPHARMA, make sure that neither your child nor you take any other product containing the same active substance, montelukast.

If you or your child take more MONTELUKAST ASTHMAPHARMA than you 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, somnolence, thirst, headache, vomiting, and hyperactivity.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take MONTELUKAST ASTHMAPHARMA or forget to give it to your child

Try to take Montelukast as prescribed. However, if you or your child miss a dose, simply resume your regular schedule 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 ASTHMAPHARMA

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

In clinical trials with Montelukast 5 mg chewable tablets, the adverse effects related to 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:

• Headache

Additionally, 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 than in those treated with placebo (a tablet containing no 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 behaviour and mood [sleep disturbances, including nightmares, hallucinations, irritability, anxious feelings, restlessness, agitation including aggressive behaviour or hostility, 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, hives, painful red lumps under the skin which most frequently appear 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 you experience 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 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, please inform your doctor or pharmacist.

5. Storage of MONTELUKAST ASTHMAPHARMA

• Keep out of the reach and sight of children.

• Do not use this medicine 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 shown.

• Store in the original packaging.

• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of MONTELUKAST ASTHMAPHARMA

• The active substance is montelukast. This tablet contains montelukast sodium equivalent to 5 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 5 mg chewable tablets are pink, round, biconvex, 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 commercially available.

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