MONTELUKAST ASTHMAPHARMA 5 mg CHEWABLE TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Montelukast ASTHMAPHARMA 5 mg chewable tablets EFG

Montelukast sodium

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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What is Montelukast ASTHMAPHARMA and what is it used for
2. Before taking Montelukast ASTHMAPHARMA
3. How to take Montelukast ASTHMAPHARMA
4. Possible side effects
5. Storage of Montelukast ASTHMAPHARMA
6. Further information

1. What is MONTELUKAST ASTHMAPHARMA and what is it 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 prevent asthma symptoms during the day and night.

• Montelukast is used for the treatment of patients who are not adequately controlled with their medication and need additional treatment.

• Montelukast 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 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 to use Montelukast.

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.

Asthma symptoms include: Cough, wheezing, and chest congestion.

2. Before taking MONTELUKAST ASTHMAPHARMA

Tell your doctor about any allergy or medical problem that you or your child have now or have had.

Do not take MONTELUKAST ASTHMAPHARMA if you or your child

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

Be careful with MONTELUKAST ASTHMAPHARMA

• If your asthma or breathing or your child's worsen, tell your doctor immediately.

• Montelukast oral is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions given by your doctor for you or your child. Always have your rescue inhalation medication for asthma attacks.

• It is essential that you or your child use all asthma medications prescribed by your doctor. Montelukast 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 medications or NSAIDs) if they worsen your asthma.

• Several neuropsychiatric events (such as changes in behavior and mood-related, depression, and suicidal tendencies) have been reported in patients of all ages (see section 4). If you develop these symptoms while taking Montelukast, you should contact your doctor.

Use in children

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

For children from 6 to 14 years of age, Montelukast 5 mg chewable tablets are available.

Use of other medications

Some medications may affect the functioning of Montelukast, or Montelukast may affect the functioning of other medications you are using.

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

Before taking Montelukast, 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 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 food.

Pregnancy and breastfeeding

Use during pregnancy

Women who are pregnant or plan 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 not known whether Montelukast appears in breast milk. If you are breastfeeding or plan 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 machines. However, individual responses to the medication may vary.

Certain side effects (such as dizziness and drowsiness) that have been reported very rarely with Montelukast may affect the patient's ability to drive or operate machines.

Important information about some of the ingredients of MONTELUKAST ASTHMAPHARMA

This medication 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 disorder of metabolism), you should note 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 only take 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 when you have an acute asthma attack.

• Always take Montelukast as your doctor has told you. Consult your doctor or pharmacist if you have any doubts.

• 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 should not be taken with food; it should be taken at least 1 hour before or 2 hours after food.

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

If you or your child take more MONTELUKAST ASTHMAPHARMA than you should

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.

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

If you or your child forget to take MONTELUKAST ASTHMAPHARMA

Try to take Montelukast as prescribed. However, if you or your child forget a dose, just resume your usual routine 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 ASTHMAPHARMA

Montelukast can 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 for the time your doctor prescribes. 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 side effects

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

In clinical trials with Montelukast 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 more frequently in patients treated with MONTELUKAST 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 tract 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

• Behavior and mood changes [sleep disturbances, including nightmares, hallucinations, irritability, feeling anxious, restlessness, excitement including aggressive or hostile behavior, tremor, depression, sleep problems, somnambulism, suicidal thoughts and actions (in very rare cases)]

• Dizziness, drowsiness, tingling/numbness, convulsions

• 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. 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 experience any side effects that you think are serious or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

5. Storage of MONTELUKAST ASTHMAPHARMA

• Keep out of the reach and sight of children.

• Do not use this medication after the expiry date stated on the blister. The first two numbers indicate the month; the last four numbers indicate the year. The expiry date is the last day of the month indicated.

• Store in the original packaging.

• 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 ASTHMAPHARMA

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

• The other ingredients are:

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

Appearance of the product and packaging contents

Montelukast 5 mg chewable tablets are pink, round, biconvex, packaged in PA/ALL/PVC-Aluminum blisters in packs of: 7, 10, 14, 20, 28, 30, 50, 56, 98, 100, 140, and 200 tablets.

Not all 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