Package Leaflet: Information for the User

MONTELUKAST TARBIS 4 mg

Chewable tablets EFG

montelukast

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

1. What MONTELUKAST TARBIS 4 mg is and what it is used for

2. Before taking MONTELUKAST TARBIS 4 mg

3. How to take MONTELUKAST TARBIS 4 mg

4. Possible side effects

5. Storage of MONTELUKAST TARBIS 4 mg

6. Further information

MONTELUKAST TARBIS 4 mg is a leukotriene receptor antagonist that blocks certain substances called leukotrienes. Leukotrienes produce narrowing and swelling of the airways in the lungs. By blocking leukotrienes, MONTELUKAST TARBIS 4 mg improves asthma symptoms and helps control asthma.

Your doctor has prescribed MONTELUKAST TARBIS 4 mg to treat your child's asthma and prevent asthma symptoms during the day and night.

• MONTELUKAST TARBIS 4 mg is used for the treatment of patients between 2 and 5 years of age who are not adequately controlled with their medication and need additional treatment.
• MONTELUKAST TARBIS 4 mg is also used as an alternative treatment to inhaled corticosteroids in patients between 2 and 5 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 4 mg also helps prevent airway constriction caused by exercise in patients 2 years of age and older.

The dosage of MONTELUKAST TARBIS 4 mg will depend on your child's symptoms and the severity of their 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.
• inflammation of the inner lining of the airways.

Asthma symptoms include: Coughing, wheezing, and congestion in the chest.

Inform your child's doctor about any allergy or medical condition your child has now or has had.

Do not give MONTELUKAST TARBIS 4 mg to your child if

• he is allergic (hypersensitive) to montelukast or to any of the other components of MONTELUKAST TARBIS 4 mg. (see 6. ADDITIONAL INFORMATION).

Be especially careful with MONTELUKAST TARBIS 4 mg

• If your child's asthma or breathing worsens, inform your doctor immediately.
• MONTELUKAST oral is not indicated for treating acute asthma attacks. If an attack occurs, follow the instructions your doctor has given for your child. Always have your child's rescue inhaler medication available for asthma attacks.
• It is essential that your child uses all asthma medications prescribed by your doctor. MONTELUKAST TARBIS 4 mg should not be used in place 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 develops a combination of symptoms such as flu-like illness, tingling or numbness of arms or legs, worsening respiratory symptoms, and/or skin rash, he should consult his doctor.
• Your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as nonsteroidal anti-inflammatory drugs or NSAIDs) if they worsen his asthma.
• Patients should be aware that several neuropsychiatric events have been reported with MONTELUKAST TARBIS 4 mg (e.g., 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 4 mg, he should consult his doctor.

Use of other medications

Some medications may affect the functioning of MONTELUKAST TARBIS 4 mg, or MONTELUKAST TARBIS 4 mg may affect the functioning of other medications your child is using.

Inform your doctor or pharmacist if your child is using or has recently used other

medications, including those obtained without a prescription.

Before taking MONTELUKAST TARBIS 4 mg, inform your doctor if your child is taking the following medications:

• 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 TARBIS 4 mg with food and beverages

MONTELUKAST TARBIS 4 mg chewable tablets should not be taken with meals; it should be taken at least 1 hour before or 2 hours after meals.

Pregnancy and breastfeeding

This subsection is not applicable to MONTELUKAST TARBIS 4 mg since its use is indicated in children between 2 and 5 years of age, however, the following information is important for the active ingredient, montelukast.

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 your child can take MONTELUKAST TARBIS during this period.

Use during breastfeeding

The passage of MONTELUKAST TARBIS into breast milk is unknown. If you are breastfeeding or intend to breastfeed, you should consult your doctor before taking MONTELUKAST TARBIS.

Driving and operating machinery

This subsection is not applicable to MONTELUKAST TARBIS 4 mg chewable tablets, since its use is indicated in children between 2 and 5 years of age, however, the following information is important for the active ingredient, montelukast.

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 4 mg

MONTELUKAST TARBIS 4 mg chewable tablets contain aspartame, a source of phenylalanine. If your child has phenylketonuria (a rare hereditary metabolic disorder), note that each 4 mg chewable tablet contains 1.35 mg of phenylalanine.

Consult with your child's doctor or pharmacist if you have any doubts.

For children aged 2 to 5 years:

A daily chewable tablet of 4 mg should be taken at night. Montelukast Tarbis 4 mg chewable tablets should not be taken with meals; they should be taken at least 1 hour before or 2 hours after eating.

If your child is taking Montelukast Tarbis 4 mg, make sure they do not take any other medication that contains the same active ingredient, montelukast.

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.

The Montelukast Tarbis 4 mg chewable tablet is not recommended for children under 2 years of age.

If your child takes more Montelukast Tarbis 4 mg than they should:

Seek help from your child's doctor immediately.

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

If you forget to give Montelukast Tarbis 4 mg to your child:

Try to give Montelukast Tarbis 4 mg as instructed. However, if your child forgets a dose, simply resume the usual once-daily tablet.

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

If your child stops taking Montelukast Tarbis 4 mg:

Montelukast Tarbis 4 mg can only treat your child's asthma if they continue to take it.

It is essential that your child continues to take Montelukast Tarbis 4 mg for the duration prescribed by their doctor. This will help control your child's asthma.

If you have any other questions about using this product, ask your child's doctor or pharmacist.

Like all medicines, MONTELUKAST TARBIS 4 mg can cause side effects, although not everyone will experience them.

In clinical trials conducted with 4 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:

In addition, the following side effects were reported in clinical trials with 10 mg film-coated tablets and 5 mg chewable 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 a medication).

In addition, 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 your child has 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 are experiencing is 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 4 mg:

Appearance of the product and contents of the package

The chewable tablets of 4 mg are pink, oval, biconvex, and have the inscription "4" 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/