Montelukast Tarbis 5 mg chewable tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

MONTELUKAST TARBIS 5 mg

chewable tablets EFG

montelukast

Read the entire leaflet carefully before you or 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 you or your child; do not give it 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 you experience is severe or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet:

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. How to store MONTELUKAST TARBIS 5 mg
6. Further information

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

MONTELUKAST TARBIS 5 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 5 mg improves asthma symptoms and helps control asthma.

Your doctor has prescribed MONTELUKAST TARBIS 5 mg to treat asthma and to 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 current medication and require additional therapy.
• MONTELUKAST TARBIS 5 mg is used as an alternative treatment to inhaled corticosteroids in patients aged 6 to 14 years who have not recently taken oral corticosteroids for the treatment of their asthma and who have demonstrated inability to use inhaled corticosteroids.
• MONTELUKAST TARBIS 5 mg 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 TARBIS 5 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: cough, wheezing, and chest tightness.

2. BEFORE TAKING MONTELUKAST TARBIS 5 mg

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 TARBIS 5 mg if you or your child

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

Take special care with MONTELUKAST TARBIS 5 mg

• If your asthma or breathing, or that of your child, worsens, inform your doctor immediately.
• MONTELUKAST TARBIS oral is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions given to you by your doctor for you or your child. Always keep your inhaled rescue medication for asthma attacks.
• It is important that you or your child use all asthma medications prescribed by your doctor. MONTELUKAST TARBIS 5 mg 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 aspirin or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.
• Patients should be aware that several neuropsychiatric events have been reported with MONTELUKAST TARBIS (e.g., behavioral and mood-related changes) in adults, adolescents, and children (see section 4). If your child develops these symptoms while taking MONTELUKAST TARBIS, you should consult your 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 medicines

Some medicines may affect how MONTELUKAST TARBIS 5 mg works, or MONTELUKAST TARBIS 5 mg may affect how other medicines 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 TARBIS 5 mg, inform your doctor if you or your child are 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 5 mg with food and drinks

MONTELUKAST TARBIS 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 TARBIS. Your doctor will assess whether you can take MONTELUKAST TARBIS during this period.

Use during breastfeeding

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 use of machines

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) that 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 5 mg

MONTELUKAST TARBIS 5 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 5 mg chewable tablet contains 1.68 mg of phenylalanine.

3. How to TAKE MONTELUKAST TARBIS 5 mg

• You or your child should take only one tablet of MONTELUKAST TARBIS 5 mg once daily, as prescribed by your doctor.
• It should be taken even when you or your child do not have symptoms or during an acute asthma attack.
• Always take MONTELUKAST TARBIS 5 mg exactly as your doctor has instructed. Consult your doctor or pharmacist if you have any doubts.
• It should be taken orally.

For children aged 6 to 14 years:

One 5 mg chewable tablet should be taken daily in the evening. MONTELUKAST TARBIS 5 mg chewable tablets should not be taken with food; they should be taken at least 1 hour before or 2 hours after meals.

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

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

Seek immediate help from your 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 or your child forget to take MONTELUKAST TARBIS 5 mg or forget to give it to your child

Try to take MONTELUKAST TARBIS 5 mg as prescribed. However, if you or your child miss a dose, simply resume the usual regimen 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 TARBIS 5 mg

MONTELUKAST TARBIS 5 mg can only control your asthma or your child's asthma if you or your child continue taking it. It is important 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 further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, MONTELUKAST TARBIS 5 mg may produce adverse effects, although not everybody gets them.

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

• headache

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

• abdominal pain

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 substance).

In addition, 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 urticaria
• fatigue, restlessness, agitation including aggressive behavior, irritability, tremor, depression, suicidal thoughts and actions (in very rare cases), dizziness, drowsiness, hallucinations, sleep disturbances, 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 you experience one or more of these symptoms.

Ask your doctor or pharmacist for further 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, inform your 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 Medicinal Products: 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 5 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 indicated month.
• Store in the original packaging to protect from light and moisture.
• Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of MONTELUKAST TARBIS 5 mg:

• The active substance is: montelukast. Each tablet contains montelukast sodium equivalent to 5 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 product and contents of the pack

The 5 mg chewable tablets are pink, round, biconvex, and marked with the number "5" 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 patient information leaflet was approved in July 2019

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