Package Leaflet: Information for the User

MONTELUKAST TARBIS 5 mg

Oral Dispersible Tablets EFG

montelukast

Read this leaflet carefully before you or your child start taking the 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 and should not be given to others, even if they have the same symptoms as your child, as it may harm them.
• If you think any of the side effects get serious or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

1. What MONTELUKAST TARBIS 5 mg is and what it is used for

2. Before taking MONTELUKAST TARBIS 5 mg

3. How to take MONTELUKAST TARBIS 5 mg

4. Possible side effects

5. Storage of MONTELUKAST TARBIS 5 mg

6. Further information

MONTELUKAST TARBIS 5 mg is a leukotriene receptor antagonist that blocks certain substances called leukotrienes. Leukotrienes cause narrowing and swelling of the airways in the lungs. By blocking leukotrienes, MONTELUKAST TARBIS 5 mg improves asthma symptoms and helps control asthma.

Your doctor has prescribed MONTELUKAST TARBIS 5 mg to treat asthma and prevent asthma symptoms during the day and night.

• MONTELUKAST TARBIS 5 mg is used for the treatment of patients who are not adequately controlled with their medication and need additional treatment.
• MONTELUKAST TARBIS 5 mg is 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 who have demonstrated that they are unable to use inhaled corticosteroids.
• MONTELUKAST TARBIS 5 mg also helps prevent airway constriction caused by exercise.

The use of MONTELUKAST TARBIS 5 mg will depend on your symptoms and the severity of your asthma or your child's asthma, as determined by your doctor.

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 conditions.
• 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 congestion in the chest.

Inform your doctor about any allergy or medical condition you or your child have now or have had.

Do not take MONTELUKAST TARBIS 5 mg if you or your child

• are allergic (hypersensitive) to montelukast or to any of the other components of MONTELUKAST TARBIS 5 mg. (see 6. ADDITIONAL INFORMATION).

Be especially careful with MONTELUKAST TARBIS 5 mg

• If your asthma or breathing or your child's asthma or breathing worsens, inform your doctor immediately.
• MONTELUKAST TARBIS oral is not indicated for treating acute asthma attacks. If an attack occurs, follow the instructions your doctor has given you or for your child. Always have your rescue inhaler medication for asthma attacks.
• It is essential that you or your child use all medications for asthma prescribed by your doctor. MONTELUKAST TARBIS 5 mg should not be used in place 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 respiratory symptoms, and/or skin rash, they should consult their doctor.
• You or your child should not take aspirin or anti-inflammatory medications (also known as nonsteroidal anti-inflammatory drugs or NSAIDs) if they make your asthma worse.
• Patients should be aware that several neuropsychiatric events have been reported with MONTELUKAST TARBIS (for example, changes in behavior and mood-related changes) in adults, adolescents, and children (see section 4). If your child develops these symptoms while taking MONTELUKAST TARBIS, they should consult their child's doctor.

Use in children

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

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

Use of other medications

Some medications may affect the functioning of MONTELUKAST TARBIS 5 mg, or MONTELUKAST TARBIS 5 mg may affect the functioning of other medications you are using.

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

Before taking MONTELUKAST TARBIS 5 mg, inform your doctor if you or your child are taking the following medications:

Taking MONTELUKAST TARBIS 5 mg with food and beverages

MONTELUKAST TARBIS 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 intend to become pregnant should consult their doctor before taking MONTELUKAST TARBIS. Your doctor will evaluate whether you can take MONTELUKAST TARBIS during this period.

Use during breastfeeding

The safety of MONTELUKAST TARBIS in breastfeeding women is unknown. If you are breastfeeding or intend to breastfeed, you should consult your doctor before taking MONTELUKAST TARBIS.

Driving and operating machinery

MONTELUKAST TARBIS is not expected to affect your ability to drive a car or operate machinery. However, individual responses to the medication may vary. Certain adverse effects (such as dizziness and somnolence) that have been reported rarely with MONTELUKAST TARBIS may affect the patient's ability to drive or operate machinery.

Important information about some of the components of MONTELUKAST TARBIS 5 mg

MONTELUKAST TARBIS 5 mg chewable tablets contain aspartame, a source of phenylalanine. If your child has phenylketonuria (a rare inherited metabolic disorder), they should be aware that each 5 mg chewable tablet contains 1.68 mg of phenylalanine.

For children aged 6 to 14 years:

A daily chewable tablet of 5 mg should be taken at night. MONTELUKAST TARBIS 5 mg chewable tablets should not be taken with meals; it should be taken at least 1 hour before or 2 hours after eating.

If you or your child are taking MONTELUKAST LEVI 5 mg, ensure that neither you nor your child take any other product containing the same active ingredient, montelukast.

If you or your child take more MONTELUKAST TARBIS 5 mg than you should

Seek immediate help from your doctor.

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

If you forgot to take MONTELUKAST TARBIS 5 mg or forgot to give MONTELUKAST TARBIS 5 mg to your child

Try to take MONTELUKAST TARBIS 5 mg as directed. However, if you or your child forget a dose, simply resume the regular regimen of one tablet once a day.

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

If you or your child stop taking MONTELUKAST TARBIS 5 mg

MONTELUKAST TARBIS 5 mg will only treat your asthma or your child's asthma if you or your child continue to take it. It is essential to continue taking MONTELUKAST TARBIS 5 mg for the duration prescribed by your doctor. 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.

Like all medicines, MONTELUKAST TARBIS 5 mg can cause side effects, although not everyone will experience them.

In clinical trials conducted with 5 mg chewable tablets, the side effects related to the administration of the medication and reported most frequently (in more than 1 in 100, or less than 1 in 10 treated patients), were:

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

These side effects were generally mild and occurred more frequently in patients treated with montelukast tablets than with placebo (a tablet that does not contain medication).

Since the medication has been marketed, the following side effects have been reported:

In patients with asthma treated with montelukast, rare cases of a combination of symptoms such as flu-like illness, tingling or numbness of arms and legs, worsening of respiratory symptoms, and/or skin rash (Churg-Strauss syndrome) have been reported. Inform your doctor immediately if you experience one or more of these symptoms.

Ask your doctor or pharmacist for more information about side effects. If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medication.

Composition of MONTELUKAST TARBIS 5 mg:

• The active ingredient is: montelukast. Each tablet contains montelukast sodium equivalent to 5 mg of montelukast.
• The other components are: Mannitol, microcrystalline cellulose, hydroxypropyl cellulose, iron oxide red (E 172), sodium croscarmellose, strawberry flavor, aspartame (E 951) and magnesium stearate.

Appearance of the product and contents of the package

The 5 mg chewable tablets are pink, round, biconvex, and have the inscription "5" on one face.

They are presented in packages of 28 tablets.

Marketing Authorization Holder

TARBIS FARMA, S.L.

Gran Via Carlos III, 94

(Barcelona) - 08028 - Spain

Responsible for manufacturing

Neuraxpharm Pharmaceuticals, S.L.

Avda. de Barcelona, 69

(Sant Joan Despi (Barcelona)) - 08970 - Spain

This leaflet was approved in July 2019

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/