Irbesartan Tecnigen 300 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Irbesartan TecniGen 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, pharmacist, or nurse.
• This medicine has been prescribed for you only; do not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if the side effects are not listed in this leaflet. See section 4.

Leaflet Contents:

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

1. What Irbesartán TecniGen is and what it is 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, thereby relaxing blood vessels and reducing blood pressure. Irbesartan also helps slow down the worsening of kidney function in patients with high blood pressure and type 2 diabetes.

Irbesartán TecniGen is used to treat high blood pressure (hypertension) and to provide kidney protection in hypertensive patients with type 2 diabetes who have clinical evidence of impaired kidney function.

2. What you need to know before taking Irbesartán TecniGen

Do not take Irbesartán TecniGen

• If you are allergic to the active substance or to any of the other components 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 failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting Irbesartán TecniGen. You must inform your doctor if any of the following apply to you:

• If you have severe vomiting or diarrhoea.

• If you have kidney problems.

• If you have heart problems.

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

• If you are going to have surgery or will be given anaesthetics.

• 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), particularly 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 Irbesartán TecniGen”.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhoea after taking irbesartan. Your doctor will decide whether to continue treatment. Do not stop taking irbesartan as monotherapy without medical advice.

If you are pregnant, suspect you may be pregnant, or plan to become pregnant, you must inform your doctor. The use of Irbesartán TecniGen is not recommended during the first trimester of pregnancy (first 3 months), and it must not be used during the last 6 months of pregnancy as it may cause serious harm to your baby; see the pregnancy and breastfeeding section.

Use of Irbesartán TecniGen with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take 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 angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also the information under the headings “Do not take Irbesartán TecniGen” and “Warnings and precautions”).

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

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

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

Taking Irbesartán TecniGen with food, drinks, and alcohol:

Irbesartán TecniGen can be taken with or without food. Tablets should be swallowed with water.

Pregnancy, breastfeeding, and fertility:

You must inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Generally, your doctor will advise you to take another medicine instead of Irbesartán TecniGen during the first trimester of pregnancy (first 3 months), and in no case should it be used during the last 6 months of pregnancy because it may cause serious harm to your baby.

Usually, before you become pregnant, your doctor will switch Irbesartán TecniGen to another suitable antihypertensive medicine. In any case, Irbesartán TecniGen must not be taken during the second or third trimester of pregnancy or during breastfeeding.

Generally, your doctor will advise you to stop treatment with Irbesartán TecniGen as soon as you know you are pregnant. If you become pregnant while taking Irbesartán TecniGen, inform your doctor and seek medical advice immediately.

Driving and using machines

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

It is unlikely that Irbesartán 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, you should consult your doctor before performing such activities.

Irbesartán TecniGen contains lactose

If your doctor has informed you that you have an intolerance to certain sugars (e.g. lactose), consult him before taking this medicine.

3. How to take Irbesartán TecniGen

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

Method of administration:

Irbesartán TecniGen is administered orally. The tablets should be swallowed with a sufficient amount of liquid (for example, a glass of water). Irbesartán TecniGen may 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 taking this medicine until your doctor advises you otherwise.

Patients with high blood pressure

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

Patients with high blood pressure and type 2 diabetes with kidney impairment

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

Your doctor may recommend a lower dose, especially at the beginning of treatment, in certain patients, such as hemodialysis patients or those over 75 years of age.

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

If you take more Irbesartán TecniGen than you should

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

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

Children must not take Irbesartán TecniGen

Irbesartán TecniGen 300 mg tablets must not be given to children under 18 years of age. If a child swallows several tablets, contact your doctor immediately.

If you forget to take Irbesartán TecniGen

If you accidentally miss a dose, simply take your next dose at the usual time. Do not take a double dose to make up for forgotten doses. If you have any other questions about the use of this product, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.

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

As with similar medicines, rare cases of skin allergic reactions (rash, urticaria), as well as localized swelling of the face, lips and/or tongue, have been reported in patients treated with irbesartan. If you think you may be experiencing a reaction of this type or develop shortness of breath, stop taking Irbesartán ecniGen immediately and go to a medical facility.

The adverse effects listed below are grouped according to their frequency as follows:

Very common: affects at least 1 in 10 people.
Common: affects at least 1 in 100 people.
Uncommon: affects at least 1 in 1,000 people.

Adverse effects reported in clinical trials conducted in patients treated with Irbesartán TecniGen were:

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

Common: dizziness, nausea/vomiting, fatigue. Blood tests may show elevated levels of an enzyme that measures muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney impairment: 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: palpitations, skin redness, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (impairment of sexual function), and chest pain.

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

intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Since the update of irbesartan, some adverse effects have been reported, but their frequency is unknown. These observed adverse effects include: headache, taste disturbances, tinnitus (ringing in the ears), muscle cramps, muscle and joint pain, abnormal liver function, increased blood potassium levels, kidney function impairment, inflammation of small blood vessels, mainly in the skin area (a condition known as leukocytoclastic vasculitis), and reduced platelet count.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines. Website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Irbesartan TecniGen

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and packaging should be returned to the SIGRE Point at your pharmacy. If you are unsure, please ask your pharmacist where to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the container and additional 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 components are: Core: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hypromellose, anhydrous colloidal silica, magnesium stearate. Coating: lactose monohydrate, titanium dioxide, hypromellose, and macrogol 3350.

Appearance of the medicine and contents of the container

Film-coated, oblong, white tablets.

Presented 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 the most recent review of this leaflet: February 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/