MONTELUKAST TARBIS 10 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

MONTelukast TARBIS 10 mg

film-coated tablets EFG

montelukast

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

• Keep this leaflet, 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 only. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What MONTELUKAST TARBIS 10 mg is and what it is used for
2. Before taking MONTELUKAST TARBIS 10 mg
3. How to take MONTELUKAST TARBIS 10 mg
4. Possible side effects
5. Storage of MONTELUKAST TARBIS 10 mg
6. Further information

1. What MONTELUKAST TARBIS 10 mg is and what it is used for

MONTelukast TARBIS 10 mg is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of the airways in your lungs and can also cause allergy symptoms. By blocking leukotrienes, MONTELUKAST TARBIS 10 mg improves asthma symptoms, helps control asthma, and improves symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).

Your doctor has prescribed MONTELUKAST TARBIS 10 mg to treat asthma and prevent asthma symptoms during the day and night.

• MONTelukast TARBIS 10 mg is used for the treatment of patients who are not adequately controlled with their medication and need additional treatment.
• MONTelukast TARBIS 10 mg also helps prevent narrowing of the airways caused by exercise.
• In asthmatic patients in whom MONTELUKAST TARBIS 10 mg is indicated for asthma, it may also provide symptomatic relief of seasonal allergic rhinitis.

Depending on your symptoms and the severity of your asthma, your doctor will determine how you should use MONTELUKAST TARBIS 10 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 and react to many things, such as cigarette smoke, pollen, cold air, or exercise.
• swelling (inflammation) of the inner layer of the airways.

The symptoms of asthma include: coughing, wheezing, and chest congestion.

What are seasonal allergies?

Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are an allergic reaction often caused by airborne pollen from trees, grass, and weeds. The symptoms of seasonal allergies typically include: stuffy nose, runny nose, itchy nose, sneezing; watery, swollen, red, and itchy eyes.

2. Before taking MONTELUKAST TARBIS 10 mg

Tell your doctor about any allergies or medical problems you have now or have had.

Do not take MONTELUKAST TARBIS 10 mg if you

• are allergic (hypersensitive) to montelukast or any of the other ingredients of MONTELUKAST TARBIS 10 mg. (see 6. FURTHER INFORMATION).

Be careful with MONTELUKAST TARBIS 10 mg

• If your asthma or breathing worsens, tell your doctor immediately.
• MONTELUKAST TARBIS 10 mg oral is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions given by your doctor. Always carry your rescue inhaler for asthma attacks.
• It is essential that you or your child use all asthma medications prescribed by your doctor. MONTELUKAST TARBIS 10 mg should not replace other asthma medications prescribed by your doctor.
• 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.
• Do not take aspirin or anti-inflammatory medications (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 10 mg (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 10 mg, you should consult your child's doctor.

Use in children

This presentation is not suitable for children.

Use of other medications

Some medications may affect the functioning of MONTELUKAST TARBIS 10 mg, or MONTELUKAST TARBIS 10 mg may affect the functioning of other medications you are taking.

Tell your doctor or pharmacist if you are taking or have recently taken any other medications, including those obtained without a prescription.

Before taking MONTELUKAST TARBIS 10 mg, tell your doctor if you 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 10 mg with food and drinks

MONTelukast TARBIS 10 mg can be taken with or without food.

Pregnancy and breastfeeding

Use during pregnancy

Women who are pregnant or plan to become pregnant should consult their doctor before taking MONTELUKAST TARBIS 10 mg. Your doctor will assess whether you can take MONTELUKAST TARBIS 10 mg during this period.

Use during breastfeeding

It is not known whether MONTELUKAST TARBIS 10 mg appears in breast milk. If you are breastfeeding or plan to breastfeed, you should consult your doctor before taking MONTELUKAST TARBIS 10 mg.

Driving and using machines

MONTelukast TARBIS 10 mg 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 10 mg may affect the patient's ability to drive or operate machinery.

Important information about some of the ingredients of MONTELUKAST TARBIS 10 mg

The film-coated tablets of MONTELUKAST TARBIS 10 mg contain lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medication.

3. How to take MONTELUKAST TARBIS 10 mg

• You should only take one tablet of MONTELUKAST TARBIS 10 mg once a day, as prescribed by your doctor.
• It should be taken even when you do not have symptoms or when you have an acute asthma attack.
• Always take MONTELUKAST TARBIS 10 mg as your doctor has told you. Consult your doctor or pharmacist if you have any doubts.
• It should be taken orally.

For adults 15 years of age and older:

You should take one 10 mg tablet daily in the evening. MONTELUKAST TARBIS 10 mg can be taken with or without food.

If you are taking MONTELUKAST TARBIS 10 mg, make sure you do not take any other product that contains the same active ingredient, montelukast.

If you take more MONTELUKAST TARBIS 10 mg than you should

Seek help from your doctor immediately.

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 forget to take MONTELUKAST TARBIS 10 mg

Try to take MONTELUKAST TARBIS 10 mg as prescribed. However, if you forget a dose, just resume your regular schedule of one tablet a day.

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

If you stop taking MONTELUKAST TARBIS 10 mg

MONTelukast TARBIS 10 mg will only treat your asthma if you continue to take it. It is essential that you continue to take MONTELUKAST TARBIS 10 mg for as long as your doctor prescribes it. It will help control your 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 10 mg can cause side effects, although not everybody gets them.

In clinical trials with montelukast 10 mg film-coated 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:

• abdominal pain
• headache

These side effects were generally mild and occurred more frequently in patients treated with montelukast 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, and suicidal 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, hematoma, painful red 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, 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 experience any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: 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 10 mg

• Keep out of the reach and sight of children.

• Do not use this medication after the expiry date stated on the blister. The first two numbers indicate the month; the last four numbers indicate the year. The expiry date is the last day of the month indicated.

• 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 10 mg:

• The active ingredient is montelukast.
• The 10 mg tablet contains 10.4 mg of montelukast sodium, equivalent to 10 mg of montelukast.
• The other ingredients are:

Lactose monohydrate (85.81 mg), microcrystalline cellulose, hydroxypropylcellulose, sodium croscarmellose, and magnesium stearate.

Coating:polyvinyl alcohol, titanium dioxide (E 171), talc, soy lecithin, xanthan gum, and yellow and red iron oxide (E 172).

Appearance of the product and packaging contents

The 10 mg tablets are orange, round, biconvex, film-coated, and have the inscription "10" on one side.

It is presented 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/