Introduction

PATIENT INFORMATION LEAFLET

MONTI-LUKAST 10 mg FILM-COATED TABLETS

montelukast

Read this leaflet carefully before you start to take 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. Do not pass it on to others even if their symptoms are the same. It may harm them.

If you think you have suffered a side effect you can report it using the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

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

MONTELUKAST TARBIS 10 mg is a leukotriene receptor antagonist that blocks certain substances called leukotrienes. Leukotrienes produce narrowing and swelling of the airways in the lungs and can also cause allergy symptoms. By blocking leukotrienes, MONTELUKAST TARBIS 10 mg improves asthma symptoms, helps control asthma, and improves seasonal allergy symptoms (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 airway constriction caused by exercise.
In asthmatic patients for whom MONTELUKAST TARBIS 10 mg is indicated for asthma, it may also provide symptomatic relief of seasonal allergic rhinitis.

The dosage of MONTELUKAST TARBIS 10 mg will depend on your symptoms and the severity of your 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.
Airways that are sensitive and react to many things, such as cigarette smoke, pollen, or cold air, or exercise.
Inflammation of the inner lining of the airways.

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

What are seasonal allergies?

Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are an allergic response often caused by airborne pollen from trees, grass, and weeds. Typical symptoms of seasonal allergies may include: Stuffy nose, runny nose, sneezing; itchy, red, watery, and puffy eyes.

2. BEFORE TAKING MONTELUKAST TARBIS 10 mg

Inform your doctor about any allergy or medical condition you have now or have had.

Do not take MONTELUKAST TARBIS 10 mg if you

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

Be especially careful with MONTELUKAST TARBIS 10 mg

If your asthma or breathing worsens, inform your doctor immediately.
MONTELUKAST TARBIS 10 mg oral is not indicated for treating acute asthma attacks. If an attack occurs, follow the instructions given by your doctor. 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 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 respiratory symptoms, and/or skin rash, they should consult their doctor.
Do not take aspirin or anti-inflammatory medications (also known as nonsteroidal 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 (e.g., changes in behavior and mood-related) in adults, adolescents, and children (see section 4). If your child develops these symptoms while taking MONTELUKAST TARBIS 10 mg, 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 using.

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

Before taking MONTELUKAST TARBIS 10 mg, inform your doctor if you are 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 10 mg with food and beverages

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

Pregnancy and breastfeeding

Use during pregnancy

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

Use during breastfeeding

The safety of MONTELUKAST TARBIS 10 mg in breastfeeding women is unknown. If you are breastfeeding or intend to breastfeed, consult your doctor before taking MONTELUKAST TARBIS 10 mg.

Driving and operating machinery

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 adverse effects (such as dizziness and somnolence) that have been reported rarely with MONTELUKAST TARBIS 10 mg may affect the patient's ability to drive or operate machinery.

Important information about some components 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

Only take one MONTELUKAST TARBIS 10 mg tablet once a day, as prescribed by your doctor.
Take it even when you do not have symptoms or when you have an acute asthma attack.
Always take MONTELUKAST TARBIS 10 mg as instructed by your doctor. Consult your doctor or pharmacist if you have any doubts.
Take it orally.

For adults 15 years of age and older:

Take one 10 mg tablet daily at night. 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 adverse effects were reported. The symptoms that were most frequently reported in adults and children with overdose were abdominal pain, drowsiness, drowsiness, 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, simply resume your usual regimen of one tablet once a day.

Do not take a double dose to make up for the missed dose.

If you interrupt treatment with MONTELUKAST TARBIS 10 mg:

MONTELUKAST TARBIS 10 mg can only treat your asthma if you continue to take it. It is essential that you continue taking MONTELUKAST TARBIS 10 mg for the duration prescribed by your doctor. This will help control your asthma.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, MONTELUKAST TARBIS 10 mg can cause side effects, although not everyone will experience them.

In clinical trials conducted 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 less than 1 in 10 treated patients), were:

abdominal pain
headache

These side effects were generally mild and occurred more frequently in patients treated with montelukast than with placebo (a tablet that does not contain medication).

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

allergic reactions that include skin rash, swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing, itching, and urticaria
fatigue, restlessness, excitement including aggressive behavior, irritability, tremor, depression, and suicidal actions (in very rare cases), dizziness, somnolence, hallucinations, sleep disturbances, including nightmares and sleep problems, paresthesia, convulsions
uncomfort, 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 more frequently appear on the face (erythema nodosum), palpitations
swelling
stuttering(very rare - may affect up to 1 in 10,000 people).

In patients with asthma treated with montelukast, cases of a combination of symptoms such as flu-like illness, paresthesia 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 you have 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 experience are severe or if you notice any side effect not mentioned in this leaflet, report it to your doctor or pharmacist.

Reporting 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 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.

5. Conservation of MONTELUKAST TARBIS 10 mg

Keep out of reach and sight of children.

Do not use this medication after the date represented by the six numbers after CAD that appears on the blister. The first two numbers indicate the month; the last four numbers indicate the year. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light and moisture.

Medicines should not be thrown into the drains or trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of MONTELUKAST TARBIS 10 mg:

The active ingredient is montelukast.
The 10 mg tablet contains 10.4 mg of montelukast sodium corresponding to 10 mg of montelukast.
The other components are:

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

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

Appearance of the product and contents of the package

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

They are presented in packages of 28 tablets.

Holder of the marketing authorization

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 prospectus 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/