MONTELUKAST TARBIS 5 mg CHEWABLE TABLETS

Introduction

Package Leaflet: Information for the User

MONTELUKAST TARBIS 5 mg

chewable tablets EFG

montelukast

Read all of this leaflet carefully before you or your child start taking this medicine.

• Keep this leaflet, as 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, as it may harm them, even if their symptoms are the same as your child's.
• If you think any of the side effects that you or your child are getting are serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Contents of the pack:

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

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 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 have demonstrated that they are unable to use inhaled corticosteroids.
• MONTELUKAST TARBIS 5 mg 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 TARBIS 5 mg.

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 TARBIS 5 mg

Tell your doctor about any allergy or medical problem that 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 any of the other ingredients of MONTELUKAST TARBIS 5 mg. (see 6. Further information).

Be careful with MONTELUKAST TARBIS 5 mg

• If your asthma or breathing or your child's worsen, tell your doctor immediately.
• MONTELUKAST TARBIS oral is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions your doctor has given you for you or your child. Always have your rescue inhaler medication for asthma attacks.
• It is essential 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 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 aspirin or anti-inflammatory medications (also known as non-steroidal 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 (such as changes in behavior and mood-related events) 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 from 2 to 5 years of age, MONTELUKAST TARBIS 4 mg chewable tablets are available.

For children from 6 to 14 years of age, 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.

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

Before taking MONTELUKAST TARBIS 5 mg, 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 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 food.

Pregnancy and breastfeeding

Use during pregnancy

Women who are pregnant or plan 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 appears in breast milk. If you are breastfeeding or plan to breastfeed, you should consult your doctor before taking MONTELUKAST TARBIS.

Driving and using machines

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

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

The 5 mg chewable tablets of MONTELUKAST TARBIS contain aspartame, 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 1.68 mg of phenylalanine.

3. How to take MONTELUKAST TARBIS 5 mg

• You or your child should only take one MONTELUKAST TARBIS 5 mg 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 TARBIS 5 mg 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 TARBIS 5 mg chewable tablets should not be taken with food; they should be taken at least 1 hour before or 2 hours after food.

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 medical attention.

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.

If you or your child forget to take MONTELUKAST TARBIS 5 mg

Try to take MONTELUKAST TARBIS 5 mg as prescribed. However, if you or your child forget a dose, just resume your usual schedule 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 TARBIS 5 mg

MONTELUKAST TARBIS 5 mg 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 TARBIS 5 mg 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 TARBIS 5 mg can cause side effects, although not everybody gets them.

In clinical trials 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 in 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 with a higher frequency in patients treated with montelukast tablets than with placebo (a pill that does not contain medication).

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

• allergic reactions including skin rash, swelling of the face, lips, tongue, and/or throat that can cause difficulty breathing or swallowing, itching, and hives
• fatigue, restlessness, excitement 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
• discomfort, joint or muscle pain, muscle cramps, dry mouth, nausea, vomiting, indigestion, diarrhea, hepatitis
• increased risk of bleeding, bruising, red painful lumps under the skin that most 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 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.

Ask your doctor or pharmacist for more information about side effects. If you think any of the side effects that you or your child are getting are serious, or if you notice any side effects not listed in this leaflet, please tell 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 Medicines and Health Products Agency's (AEMPS) online system: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of MONTELUKAST TARBIS 5 mg

• Keep out of the reach and sight of children.
• Do not use this medication after the expiry date stated on the blister pack. The first two numbers indicate the month; the last four numbers indicate the year. The expiry date is the last day of the month stated.
• Store in the original packaging to protect from light and moisture.
• Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Further information

Composition of MONTELUKAST TARBIS 5 mg:

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

Appearance of the product and packaging contents

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

They are available in packs 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 updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/