IRBESARTAN TECNIGEN 300 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Irbesartan TecniGen 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, pharmacist, or nurse.
• 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 pack:

1. What is Irbesartan TecniGen and what is it used for.
2. What you need to know before you take Irbesartan TecniGen.
3. How to take Irbesartan TecniGen.
4. Possible side effects.
5. Storage of Irbesartan TecniGen.
6. Contents of the pack and further information

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

Irbesartan belongs to a group of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in the body that binds to receptors, causing blood vessels to constrict. This results in an increase in blood pressure. Irbesartan prevents angiotensin II from binding to these receptors, relaxing blood vessels and reducing blood pressure. Irbesartan also slows the deterioration of kidney function in patients with high blood pressure and type 2 diabetes.

Irbesartan TecniGen is used to treat high blood pressure (hypertension) and to protect the kidneys in hypertensive patients with type 2 diabetes and evidence of clinical kidney function impairment.

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

Do not take Irbesartan TecniGen

• If you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• If you are in the second or third trimester of pregnancy (last 6 months of pregnancy).
• If you are breastfeeding.

• If you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine that contains aliskiren.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before taking Irbesartan TecniGen. You must inform your doctorin any of the following cases:

• If you have severe vomiting or diarrhea.
• If you have kidney problems.

• If you have heart problems.

• If you are taking Irbesartan TecniGen for diabetic kidney disease. In this case, your doctor may regularly perform blood tests, especially to measure potassium levels in case of impaired kidney function.

• If you are going to have surgery (surgical intervention) or if you are going to be given anesthetics.
• If you are taking any of the following medicines used to treat high blood pressure (hypertension):
• • An angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
  • Aliskiren.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take Irbesartan TecniGen”.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking irbesartan. Your doctor will decide whether to continue treatment. Do not stop taking irbesartan on your own.

If you are pregnant, think you may be pregnant, or are planning to become pregnant, inform your doctor. Irbesartan TecniGen is not recommended during the first trimester of pregnancy (first 3 months) and should not be used during the last 6 months of pregnancy, as it may cause serious harm to your baby (see section “Pregnancy and breastfeeding”).

Using Irbesartan TecniGen with other medicines

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Your doctor may need to adjust your dose and/or take other precautions:

If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Irbesartan TecniGen” and “Warnings and precautions”).

You may need to have blood tests if you are taking:

• Potassium supplements.
• Salt substitutes that contain potassium.
• Potassium-sparing medicines.
• Medicines that contain lithium.

If you are using a type of pain reliever known as non-steroidal anti-inflammatory drugs (NSAIDs), the effect of irbesartan may be altered.

Taking Irbesartan TecniGen with food, drinks, and alcohol:

Irbesartan TecniGen can be taken with or without food. The tablets should be swallowed with a sufficient amount of liquid (e.g., a glass of water).

Pregnancy, breastfeeding, and fertility:

Tell your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant. Your doctor will normally advise you to take a different medicine instead of Irbesartan TecniGen during the first trimester of pregnancy (first 3 months) and will not recommend its use during the last 6 months of pregnancy, as it may cause serious harm to your baby.

Normally, before you become pregnant, your doctor will switch you to a different blood pressure-lowering medicine. In any case, Irbesartan TecniGen should not be taken during the second or third trimester of pregnancy or during breastfeeding.

Usually, your doctor will advise you to stop treatment with Irbesartan TecniGen as soon as you know you are pregnant. If you become pregnant while taking Irbesartan TecniGen, inform your doctor immediately.

Driving and using machines

No studies have been performed on the effects on the ability to drive and use machines.

It is unlikely that Irbesartan TecniGen will affect your ability to drive or use machines. However, during treatment for high blood pressure, dizziness or fatigue may occasionally occur. If you experience these symptoms, consult your doctor before performing these activities.

Irbesartan TecniGen contains lactose

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

3. How to take Irbesartan TecniGen

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Method of administration:

Irbesartan TecniGen is taken orally. The tablets should be swallowed with a sufficient amount of liquid (e.g., a glass of water). Irbesartan TecniGen can be taken with or without food.

You should try to take your daily dose at the same time each day. It is important that you continue to take this medicine until your doctor tells you to stop.

Patient with high blood pressure

The usual dose is 150 mg once daily. Depending on the response to blood pressure, this dose may be increased to 300 mg once daily.

Patient with high blood pressure and type 2 diabetes with kidney damage

In patients with high blood pressure and type 2 diabetes, the recommended maintenance dose for the treatment of kidney damage is 300 mg once daily.

Your doctor may advise a lower dose, especially at the start of treatment, in certain patients, such as hemodialysis patientsor patients over 75 years of age.

The maximum blood pressure-lowering effect should be achieved within 4-6 weeks after starting treatment.

If you take more Irbesartan TecniGen than you should

If you accidentally take too many tablets, or if a child swallows some, contact your doctor immediately.

In case of overdose or accidental ingestion, go to the nearest hospital or contact the Toxicology Information Service, phone 915 620 420, indicating the medicine and the amount taken.

Children should not take Irbesartan TecniGen

Irbesartan TecniGen 300 mg film-coated tablets should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.

If you forget to take Irbesartan TecniGen

If you accidentally miss a dose, simply take your normal dose when it is due next. Do not take a double dose to make up for missed doses. If you have any further questions on 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.

However, some effects may be serious and may require medical attention.

As with similar medicines, in rare cases, the following allergic reactions have been reported in patients treated with irbesartan: skin rash (including urticaria), and localized swelling (in the face, lips, and/or tongue). If you think you may have an allergic reaction or experience difficulty breathing, stop taking Irbesartan TecniGen and go immediately to a medical center.

The following side effects are grouped by frequency:

Very common: at least 1 in 10 patients.

Common: at least 1 in 100 patients.

Uncommon: at least 1 in 1,000 patients.

The following side effects were reported in clinical trials in patients treated with Irbesartan TecniGen:

Very common:if you have high blood pressure and type 2 diabetes with kidney damage, blood tests may show high potassium levels.

Common:dizziness, nausea/vomiting, fatigue. Blood tests may show elevated levels of an enzyme that measures muscle and heart function (creatine kinase). In patients with high blood pressure and type 2 diabetes with kidney damage, dizziness (especially when standing up), low blood pressure (especially when standing up), muscle or joint pain, and decreased levels of a protein present in red blood cells (hemoglobin).

Uncommon:rapid heartbeat, skin flushing, cough, diarrhea, indigestion/heartburn, sexual dysfunction (sexual function disorders), and chest pain.

Rare (at least 1 in 10,000 patients):

Intestinal angioedema: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Since the update of irbesartan, some side effects have been reported, but their frequency is not known. These observed side effects include: headache, taste disturbance, ringing in the ears, muscle cramps, muscle and joint pain, abnormal liver function, high potassium levels in the blood, impaired kidney function, and inflammation of small blood vessels, mainly in the skin area (a condition known as leucocytoclastic vasculitis), and a decrease in the number of platelets.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Irbesartan TecniGen

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Irbesartan TecniGen 300 mg film-coated tablets EFG:

The active substance is irbesartan. Each tablet contains 300 mg of irbesartan.

The other ingredients are: Core:lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hypromellose, anhydrous colloidal silica, magnesium stearate. Coating:lactose monohydrate, titanium dioxide, hypromellose, and macrogol 3350.

Appearance and packaging of the product

White, oblong, film-coated tablets.

It is available in blister packs containing 28 tablets.

Marketing authorization holder

TECNIMEDE ESPAÑA INDUSTRIA FARMACEUTICA, S.A.

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

28108 Alcobendas, Spain

Manufacturer

Atlantic Pharma – Produções Farmacêuticas SA

Rua da Tapada Grande, 2, Abrunheira, 2710 – 089 Sintra

Portugal

Date of last revision of this leaflet:February 2025

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