Package Insert: Information for the User

Montelukast TecniGen 10 mg Film-Coated Tablets

Read this package insert carefully before starting to take the medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms of illness as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

Contents of the package and additional information

What is Montelukast TecniGen

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

How Montelukast TecniGen works

Leukotrienes produce bronchospasm and inflammation of the airways in the lungs and can also cause allergy symptoms.By blocking leukotrienes, montelukast improves asthma symptoms, helps control asthma, and improves seasonal allergy symptoms (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.

The dosage of Montelukast TecniGen will depend on your symptoms and the severity of your asthma, which your doctor will determine.

What is asthma?

Asthma is a chronic disease.

Asthma includes:

• Difficulty breathing due to bronchospasm. This bronchospasm worsens and improves in response to various conditions.
• Respiratory airways that are sensitive and react to many things, such as cigarette smoke, pollen, or cold air, or exercise.
• Inflammation (inflammation) of the inner layer of the respiratory airways.

Asthma symptoms include: Coughing, 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 response often caused by airborne pollen from trees, grass, and weeds. Typical symptoms of seasonal allergies may include: Irritation, nasal discharge, nasal itching; sneezing; watery, itchy, red, and puffy eyes.

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

Do not take Montelukast TecniGen if you

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

Warnings and precautions

Speak with your doctor or pharmacist before taking Montelukast TecniGen

Several neuropsychiatric events (e.g., changes in behavior and mood, 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, contact your doctor.

Children and adolescents

Do not administer this medication to children under 15 years of age.

Other medications and Montelukast TecniGen

Speak with your doctor or pharmacist if you are taking, have taken recently, or may take other medications.

Some medications may affect the functioning of Montelukast, or Montelukast may affect the functioning of other medications you are using.

Before taking Montelukast TecniGen, inform your doctor if you are taking the following medications:

• phenobarbital (used for epilepsy treatment)
• phenytoin (used for epilepsy treatment)
• rifampicin (used for tuberculosis and some other infections treatment)
• gemfibrozil (used for high lipid levels in plasma treatment)

Montelukast TecniGen with food and beverages

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

Pregnancy and breastfeeding

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

Pregnancy

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

Breastfeeding

The presence of montelukast in breast milk is unknown. If you are breastfeeding or plan to breastfeed, consult your doctor before taking Montelukast TecniGen.

Driving and operating machinery

Montelukast TecniGen 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 very rarely with montelukast may affect the patient's ability to drive or operate machinery.

Montelukast TecniGen 10 mg coated tablets contain lactose

If your doctor has indicated that you have an intolerance to certain sugars, consult your doctor before taking this medication.

Montelukast TecniGen 10 mg coated tablets contain sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult again with your doctor or pharmacist.

• You should only take one Montelukast TecniGen tablet once a day, as prescribed by your doctor.
• You should take it 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 at night.

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

This medication 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 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.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 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 forget a dose, limit yourself to resuming the usual regimen of one tablet once a day.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Montelukast TecniGen:

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

It is essential that you continue taking montelukast for the time your doctor prescribes to maintain control of your asthma.

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

Like all medicines, this medicine 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 drug and reported most frequently (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 a medicine).

The frequency of possible side effects, indicated 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: the frequency cannot be estimated as no data are available.

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

• upper respiratory tract infection (Very common)
• increased risk of bleeding (Rare)
• allergic reactions that include skin rash, swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing (Uncommon)
• behavioral and mood changes [sleep disturbances, including nightmares, sleep problems, somnambulism, irritability, anxiety, restlessness, excitement including aggressive or hostile behavior, depression (Uncommon) tremors, attention disorder, memory loss(Rare); hallucinations, disorientation, suicidal thoughts and actions, stuttering (Very rare)]
• dizziness, somnolence, paresthesia, convulsions (Uncommon)
• palpitations (Rare)
• nasal bleeding (Uncommon), lung inflammation(Very rare).
• diarrhea, nausea, vomiting (Common); dry mouth, indigestion (Uncommon)
• hepatitis (liver inflammation) (Very rare)
• hematomas, pruritus, urticaria (Uncommon); red painful bumps under the skin that more frequently appear on the acne (erythema nodosum) (Very rare)
• musculoskeletal pain or cramps (Uncommon)
• fever (Common); fatigue, malaise, swelling (Uncommon)

In patients with asthma treated with montelukast, rare cases of a combination of symptoms such as flu-like illness, tingling 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. (See section 2).

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 System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. 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.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the Pharmacy Take-Back Point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need.This will help protect the environment.

Composition of Montelukast TecniGen

• The active ingredient is montelukast. Each tablet contains montelukast sodium, which corresponds 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), red iron oxide (E172) and yellow iron oxide (E172).

Appearance of the product and content of the packaging

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

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

Only some package sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3rd floor. Building América. Arroyo de la Vega Industrial Estate,

28108 Alcobendas (Madrid) Spain

Responsible for manufacturing

Atlantic Pharma – Produções Farmacêuticas, S.A.

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

or

Medinfar Manufacturing, S.A.

Armando Martins Tavares Industrial Park

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

3150-194 Sebal

Portugal

Last review date of this leaflet: May 2024

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/