Montelukast TecniGen 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Montelukast TecniGen 10 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• 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 only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

Pack contents and other information

1. What Montelukast TecniGen is and what it is 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 Montelukast TecniGen should be used

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

• Montelukast is used to treat patients whose asthma is not adequately controlled with their current medication and who require additional treatment.
• Montelukast also helps prevent airway narrowing triggered 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 Montelukast TecniGen 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, shortness of breath with wheezing, and chest tightness.

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. Symptoms of seasonal allergies typically include: nasal irritation, runny nose, itchy nose; sneezing; watery, swollen, red, and itchy eyes.

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

Inform your doctor of any allergies or medical conditions you currently have or have previously had.

Do not take Montelukast TecniGen if you

Are allergic to montelukast or to any of the other components 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, inform 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 keep your rescue inhaled medication available for asthma attacks.
• It is important 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 in arms or legs, worsening of pulmonary symptoms, and/or skin rash, they must consult their doctor.
• Do not take acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they cause your asthma to worsen.

Various neuropsychiatric events (for example, changes in behaviour and mood-related symptoms, 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 must contact your doctor.

Children and adolescents

Do not administer 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 how Montelukast works, or Montelukast may affect how other medicines you are taking work.

Before taking Montelukast TecniGen, inform your doctor if you 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 certain other infections)
• gemfibrozil (used for the treatment of high lipid levels in plasma).

Montelukast TecniGen with food and drinks

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 unknown whether montelukast passes into breast milk. If you are breastfeeding or planning 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 adverse effects (such as dizziness and somnolence), which have been reported very rarely with montelukast, may affect a patient's ability to drive or operate machinery.

Montelukast TecniGen 10 mg film-coated tablets contain lactose

If your doctor has informed you that you have an intolerance to certain 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 exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• You should take only one Montelukast TecniGen tablet once daily, as prescribed by your doctor.
• It should be taken even when you do not have symptoms or during an acute asthma attack.

For adults and adolescents aged 15 years and older:

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

If you are taking Montelukast TecniGen, make sure you do not take any other medication containing the same active substance, montelukast.

This medicine is for oral use.

You may take Montelukast TecniGen with or without food.

If you take more Montelukast TecniGen than you should

Seek immediate help from your doctor.

In most reported overdose cases, no adverse effects were observed. The most frequently reported symptoms in cases of overdose in adults and children were abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Montelukast TecniGen

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

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

If you stop taking Montelukast TecniGen

Montelukast TecniGen can only treat your asthma if you continue taking it.

It is important that you continue taking montelukast for the length of time prescribed by your doctor to keep your asthma under control.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

In clinical trials with montelukast 10 mg film-coated tablets, the adverse effects related to the administration of the medicine and reported most frequently (occurring in at least 1 in 100 patients and in fewer than 1 in 10 patients treated) were:

• abdominal pain
• headache

These adverse effects were generally mild and occurred more frequently in patients treated with montelukast than in those receiving placebo (a tablet containing no active medicine).

The frequency of the possible adverse 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 due to insufficient data.

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

• upper respiratory tract infection (Very common)
• increased tendency to bleeding (Rare)
• allergic reactions including skin rash, swelling of the face, lips, tongue, and/or throat, which may cause difficulty in breathing or swallowing (Uncommon)
• changes related to behaviour and mood [sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, anxious feeling, restlessness, excitement including aggressive behaviour or hostility, 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)
• nosebleeds (Uncommon), lung inflammation (Very rare)
• diarrhoea, nausea, vomiting (Common); dry mouth, indigestion (Uncommon)
• hepatitis (inflammation of the liver) (Very rare)
• bruising, itching, urticaria (Uncommon); painful red lumps under the skin, usually appearing 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 in arms and legs, worsening of pulmonary symptoms and/or skin rash (Churg-Strauss syndrome) have been reported. You should inform your doctor immediately if you experience one or more of these symptoms. (See section 2).

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 TecniGen

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The first two digits indicate the month; the last four digits indicate the year. The expiry date refers to the last day of the specified month.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the Punto Sigre collection point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Montelukast TecniGen

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

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

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

Appearance of the product and contents of the pack

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

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

Only some 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 the most recent revision of this leaflet: May 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/