MONTELUKAST TECNIGEN 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Montelukast TecniGen 10 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

1. What is Montelukast TecniGen and what is it used for
2. What you need to know before you take Montelukast TecniGen
3. How to take Montelukast TecniGen
4. Possible side effects
5. Storage of Montelukast TecniGen

Package contents and further information

1. What is Montelukast TecniGen and what is it used for

What is Montelukast TecniGen

Montelukast TecniGen is a leukotriene receptor antagonist that blocks substances called leukotrienes.

How Montelukast TecniGen works

Leukotrienes cause narrowing and swelling of the airways in the lungs and can also cause allergy symptoms. By blocking leukotrienes, montelukast improves asthma symptoms, helps control asthma, and improves symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).

When to use Montelukast TecniGen

Your doctor has prescribed Montelukast TecniGen to treat asthma and prevent asthma symptoms during the day and night.

• Montelukast is used to treat patients who are not adequately controlled with their medication and need additional treatment.
• Montelukast also helps prevent narrowing of the airways caused by exercise.
• In asthmatic patients for whom montelukast is indicated for asthma, montelukast 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 TecniGen.

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.
• inflammation (swelling) of the inner layer of the airways.

The symptoms of asthma include: Cough, difficult breathing with wheezing and congestion in the chest.

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: irritation, nasal discharge, itching of the nose; sneezing; watery, swollen, red, and itchy eyes.

2. What you need to know before you take Montelukast TecniGen

Tell your doctor about any allergy or medical problem you have now or have had.

Do not take Montelukast TecniGen if you

are allergic to montelukast or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Montelukast TecniGen

• If your asthma or breathing worsens, tell your doctor immediately.
• Oral montelukast is not indicated for the treatment of 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 use all 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 acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.

Several neuropsychiatric events (such as changes in behavior and mood-related, depression, and suicidal tendencies) have been reported in patients of all ages treated with montelukast (see section 4). If you develop these symptoms while taking montelukast, you should contact your doctor.

Children and adolescents

Do not give this medicine to children under 15 years of age.

Other medicines and Montelukast TecniGen

Talk to your doctor or pharmacist if you are taking, have recently taken, or might take other medicines.

Some medicines may affect the way Montelukast TecniGen works, or Montelukast TecniGen may affect the way other medicines work.

Before taking Montelukast TecniGen, tell your doctor if you are taking the following medicines:

• phenobarbital (used to treat epilepsy)
• phenytoin (used to treat epilepsy)
• rifampicin (used to treat tuberculosis and some other infections)
• gemfibrozil (used to treat high lipid levels in the blood).

Montelukast TecniGen with food and drinks

Montelukast TecniGen 10 mg can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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

Breastfeeding

It is not known whether montelukast appears in breast milk. If you are breastfeeding or plan to breastfeed, you should consult your doctor before taking Montelukast TecniGen.

Driving and using machines

Montelukast TecniGen is not expected to affect your ability to drive a car or operate machinery. However, individual responses to the medicine may vary.

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

Montelukast TecniGen 10 mg film-coated tablets contain lactose

If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

Montelukast TecniGen 10 mg film-coated tablets contain sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Montelukast TecniGen

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

• You should only take one Montelukast TecniGen tablet 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.

For adults and adolescents 15 years of age and older:

The recommended dose is one 10 mg tablet daily in the evening.

If you are taking Montelukast TecniGen, make sure you do not take any other medicine that contains the same active ingredient, montelukast.

This medicine is for oral use.

You can take Montelukast TecniGen with or without food.

If you take more Montelukast TecniGen 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 reported in overdose in adults and children were abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Montelukast TecniGen

Try to take Montelukast TecniGen as prescribed. However, if you miss a dose, just resume your regular schedule of one tablet once a day.

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

If you stop taking Montelukast TecniGen

Montelukast TecniGen may only treat your asthma if you continue to take it.

It is essential that you continue taking montelukast for as long as your doctor prescribes it to keep your asthma under control.

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

4. Possible side effects

Like all medicines, this medicine 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 medicine and most frequently reported (occurring in at least 1 in 100 patients and 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 tablet that does not contain medicine).

The frequency of possible side effects, listed below, is defined using the following convention:

Very common (may affect more than 1 in 10 people)

Common (may affect up to 1 in 10 people)

Uncommon (may affect up to 1 in 100 people)

Rare (may affect up to 1 in 1,000 people)

Very rare (may affect up to 1 in 10,000 people)

Not known: frequency cannot be estimated from the available data.

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

• upper respiratory infection (Very common)
• increased risk of bleeding (Rare)
• allergic reactions including skin rash, swelling of the face, lips, tongue, and/or throat that can cause difficulty breathing or swallowing (Uncommon)
• mood-related changes [sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, feeling anxious, restlessness, excitement including aggressive or hostile behavior, depression (Uncommon) tremor, attention disorder, memory loss (Rare); hallucinations, disorientation, suicidal thoughts and actions, stuttering (Very rare)]
• dizziness, drowsiness, tingling/numbness, seizures (Uncommon)
• palpitations (Rare)
• nasal bleeding (Uncommon), lung inflammation (Very rare).
• diarrhea, nausea, vomiting (Common); dry mouth, indigestion (Uncommon)
• hepatitis (inflammation of the liver) (Very rare)
• bruising, itching, hives (Uncommon); red, painful bumps under the skin that most often appear on the shins (erythema nodosum) (Very rare)
• joint or muscle pain, muscle cramps (Uncommon)
• fever (Common); fatigue, malaise, swelling (Uncommon)

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. (See section 2).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects that are 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 medicine.

5. Storage of Montelukast TecniGen

Keep this medicine out of the sight and reach of children.

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

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Package contents and further information

Composition of Montelukast TecniGen

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

Core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hydroxypropylcellulose (E463), and magnesium stearate.

Coating: hypromellose, hydroxypropylcellulose (E463), titanium dioxide (E171), red iron oxide (E172), and yellow iron oxide (E172).

Appearance and packaging of the product

Montelukast TecniGen 10 mg film-coated tablets are round, pink, convex, and film-coated.

Montelukast TecniGen 10 mg film-coated tablets are available in blisters of 14, 28, and 56 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D.Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid) Spain

Manufacturer

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2; Abrunheira, 2710-089 Sintra, Portugal

or

Medinfar Manufacturing, S.A.

Parque Industrial Armando Martins Tavares

Rua Outeiro da Armada, 5, Condeixa-a-Nova

3150-194 Sebal

Portugal

Date of last revision of this leaflet: May 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/