Montelukast Tarbis 4 mg chewable tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

MONTELUKAST TARBIS 4 mg

chewable tablets EFG

montelukast

Read all of this 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 should not be given to other people, even if they have the same symptoms as your child, because it could harm them.
• If you think any of the side effects your child experiences is severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

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. How to store MONTELUKAST TARBIS 4 mg
6. Further information

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

MONTELUKAST TARBIS 4 mg 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 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 to prevent asthma symptoms during the day and night.

• MONTELUKAST TARBIS 4 mg is used to treat patients aged 2 to 5 years who are not adequately controlled with their current medication and require additional treatment.
• MONTELUKAST TARBIS 4 mg 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 their asthma treatment and who have demonstrated inability to use inhaled corticosteroids.
• MONTELUKAST TARBIS 4 mg 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 TARBIS 4 mg 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 TARBIS 4 mg

Inform your doctor of any allergies or medical conditions your child currently has or has had in the past.

Do not give MONTELUKAST TARBIS 4 mg to your child if

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

Take special care with MONTELUKAST TARBIS 4 mg

• 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 inhaler medication available for asthma attacks.
• It is important that your child uses all asthma medications prescribed by the doctor. MONTELUKAST TARBIS 4 mg should not be used instead of other asthma medications prescribed 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 lung symptoms, and/or skin rash, you should consult your doctor.
• Your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen his or her asthma.
• Patients should be aware that various neuropsychiatric events (e.g., changes in behavior and mood-related events) have been reported with MONTELUKAST TARBIS 4 mg in adults, adolescents, and children (see section 4). If your child develops these symptoms while taking MONTELUKAST TARBIS 4 mg, you should consult your child's doctor.

Use of other medicines

Some medicines may affect how MONTELUKAST TARBIS 4 mg works, or MONTELUKAST TARBIS 4 mg may affect how other medicines your child is taking work.

Tell 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 TARBIS 4 mg, 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 some other infections)

Taking MONTELUKAST TARBIS 4 mg with food and drink

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

Pregnancy and breast-feeding

This section does not apply to MONTELUKAST TARBIS 4 mg, as it is indicated for use in children aged 2 to 5 years. However, the following information is important regarding the active substance, montelukast.

Use during pregnancy

Women who are pregnant or planning to become pregnant should consult their doctor before taking MONTELUKAST TARBIS. Your doctor will assess whether you can take MONTELUKAST TARBIS during pregnancy.

Use during breast-feeding

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

Driving and using machines

This section does not apply to MONTELUKAST TARBIS 4 mg chewable tablets, as it is indicated for use in children aged 2 to 5 years. However, the following information is important regarding the active substance, montelukast.

MONTELUKAST TARBIS 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), which have been reported very rarely with MONTELUKAST TARBIS, may affect a 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 inherited metabolic disorder), you should be aware that each 4 mg chewable tablet contains 1.35 mg of phenylalanine.

3. HOW TO TAKE MONTELUKAST TARBIS 4 mg

• This medicine should be given to children under the supervision of an adult.
• Your child should take only one tablet of MONTELUKAST TARBIS 4 mg once daily, as prescribed by the doctor.
• It should be taken even when your child has no symptoms or during an acute asthma attack.
• Always ensure your child takes MONTELUKAST TARBIS 4 mg exactly as directed by the doctor.

If you have any doubts, consult your child's doctor or pharmacist.

• This medicine is for oral use.

For children aged 2 to 5 years:

One 4 mg chewable tablet should be taken daily at night. MONTELUKAST TARBIS 4 mg chewable tablets should not be taken with food; 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 medicine containing the same active substance, 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 immediate medical help from your child's doctor.

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.

If you forget to give your child MONTELUKAST TARBIS 4 mg

Try to give MONTELUKAST TARBIS 4 mg as prescribed. However, if your child misses a dose, simply resume the usual schedule of one tablet once daily.

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 treatment is continued.

It is important that your child continues to take MONTELUKAST TARBIS 4 mg for as long as the doctor prescribes it. 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 adverse effects

Like all medicines, MONTELUKAST TARBIS 4 mg may produce adverse effects, although not everyone experiences them.

In clinical trials with 4 mg chewable tablets, the adverse 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 adverse effects were reported in clinical trials with montelukast 10 mg film-coated tablets and 5 mg chewable tablets:

• headache

These adverse effects were generally mild and occurred more frequently in patients treated with montelukast tablets than in those treated with placebo (a pill containing no active ingredient).

Furthermore, since the medicine has been marketed, the following adverse effects have been reported:

• allergic reactions including skin rash, swelling of the face, lips, tongue, and/or throat which may cause difficulty breathing or swallowing, itching, and hives;
• fatigue, restlessness, agitation including aggressive behavior, irritability, tremor, depression, suicidal thoughts and actions (in very rare cases), dizziness, somnolence, hallucinations, sleep disorders, including nightmares and sleep problems, tingling/numbness, seizures;
• malaise, joint or muscle pain, muscle cramps, dry mouth, nausea, vomiting, indigestion, diarrhea, hepatitis;
• increased tendency to bleeding, bruising, painful red lumps under the skin which more frequently appear on the shins (erythema nodosum), palpitations;
• swelling
• stuttering (very rare – may affect up to 1 in 10,000 people).

In asthmatic patients 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 pulmonary symptoms and/or skin rash (Churg-Strauss syndrome) have been reported. You must inform your doctor immediately if your child experiences one or more of these symptoms.

Ask your doctor or pharmacist for more information about adverse effects. If you consider any of the adverse effects experienced to be severe or if you notice any adverse effects not mentioned in this leaflet, inform your child’s doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of MONTELUKAST TARBIS 4 mg

• 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 indicated.
• Store in the original packaging to protect it from light and moisture.
• Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of MONTELUKAST TARBIS 4 mg:

• The active substance is montelukast. Each tablet contains montelukast sodium equivalent to 4 mg of montelukast.
• The other components are: Mannitol, microcrystalline cellulose, hydroxypropylcellulose, iron oxide red (E 172), sodium croscarmellose, strawberry flavor, aspartame (E 951), and magnesium stearate.

Appearance of the medicinal product and contents of the pack

The 4 mg chewable tablets are pink, oval-shaped, biconvex, and marked with the number "4" on one side.

Packaged in containers of 28 tablets.

Marketing Authorization Holder

TARBIS FARMA, S.L.

Gran Via Carlos III, 94

(Barcelona) - 08028 - Spain

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. de Barcelona, 69

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

This leaflet was approved in July 2019

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/