Prospecto: information for the user

Irbesartán TecniGen film-coated tablets

Read this prospectus carefully before starting to take this medicine because it contains important information for you:

-Keep this prospectus, as you may need to read it again.

-If you have any doubts, consult your doctor, pharmacist or nurse.

-This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms, 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 prospectus. See section 4.

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

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

3. How to take Irbesartán TecniGen.

4. Possible adverse effects.

5. Storage of Irbesartán TecniGen.

6. Contents of the pack and additional information

Irbesartán 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. Irbesartán prevents the binding of angiotensin II to these receptors, relaxing blood vessels and reducing blood pressure. Irbesartán slows the deterioration of renal function in patients with high blood pressure and type 2 diabetes.

Irbesartán TecniGen is used for the treatment of high blood pressure (hypertension) and for the protection of the kidney in hypertensive patients with type 2 diabetes and clinical evidence of altered renal function.

Do not take Irbesartán TecniGen

• If you are allergic to the active ingredient or to any of the other components of this medication (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 insufficiency and are being treated with a blood pressure medication that contains aliskirén.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Irbesartán TecniGen.You must inform your doctorin any of the following cases:

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

• If you have heart problems.

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

• If you are to be operated on (surgical intervention) or if you are to receive anesthetics.
• if you are taking any of the following medications used to treat high blood pressure (hypertension):
• • a converting enzyme inhibitor (ACEI) (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes
  • aliskirén

Your doctor may monitor your renal function, blood pressure, and electrolyte levels in the blood (such as 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 diarrhea after taking irbesartán. Your doctor will decide whether to continue treatment. Do not stop taking irbesartán in monotherapy.

If you are pregnant, if you suspect you may be, or if you plan to become pregnant, you must inform your doctor. Irbesartán TecniGen is not recommended for use in the first 3 months of pregnancy and should not be used in the last 6 months of pregnancy because it may cause serious harm to your baby, see pregnancy or lactation section.

Use of Irbesartán TecniGen with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

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

If you are taking a converting enzyme inhibitor (ACEI) or aliskirén (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.

-potassium-sparing salt substitutes.

-potassium-sparing medications.

-lithium-containing medications.

If you are using a type of analgesic, known as nonsteroidal anti-inflammatory drugs (NSAIDs), the effect of irbesartán may be modified.

Taking Irbesartán TecniGen with food, drinks, and alcohol:

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

Pregnancy, lactation, and fertility:

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

Normally, before becoming pregnant, your doctor will replace Irbesartán TecniGen with another suitable antihypertensive medication. In any case, Irbesartán TecniGen should not be taken during the second or third trimester of pregnancy or during breastfeeding.

In general, 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 and see your doctor immediately.

Driving and operating machinery

No studies have been conducted on the effects on the ability to drive and use machinery.

It is unlikely that Irbesartán TecniGen will modify the ability to drive vehicles or use machinery. However, during hypertension treatment, occasional dizziness or fatigue may occur. If you experience these symptoms, you should consult your doctor before performing these activities.

Irbesartán TecniGen contains lactose

If your doctor has told you that you have intolerance to certain sugars (such as lactose), consult with them before taking this medication.

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

Administration Method:

Irbesartán TecniGen is administered orally. The tablets should be swallowed with a sufficient amount of liquid (for example, a glass of water). Irbesartán TecniGen can be taken with or without food.

You should try to take your daily dose at the same time every day. It is essential that you continue taking this medication until your doctor advises you otherwise.

Patients with High Blood Pressure

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

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 a day.

Your doctor may advise a lower dose, especially at the beginning of treatment, in certain patients, such ashemodialysispatients or thoseover 75 years old.

The 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 consult the Toxicology Information Service, phone 915 620 420, indicating the medication and the amount ingested.

Children Should Not Take Irbesartán TecniGen

Irbesartán TecniGen 300 mg tablets should not be administered to children under 18 years old. If a child swallows several tablets, contact your doctor immediately.

If You Forget to Take Irbesartán TecniGen

If you accidentally forget to take a dose, simply take your regular dose when it is due. Do not take a double dose to compensate for missed doses. If you have any other questions about the product, consult your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

Like with similar medicines, in rare cases, there have been reports of skin allergic reactions (skin rash, urticaria) as well as localized inflammation in the face, lips, and/or tongue in patients treated with irbesartan. If you think you may be having this type of reaction or experience shortness of breath,stop taking Irbesartan TecniGen and seek immediate medical attention.

The side effects listed below 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 side effects reported in clinical trials conducted in patients treated with Irbesartan TecniGen were:

Very common:if you have high blood pressure and type 2 diabetes with kidney impairment, blood tests may show an increase in 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 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:rapid heartbeat, skin redness, cough, diarrhea, indigestion/heartburn, sexual dysfunction (alteration of sexual function), and chest pain.

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

intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

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

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use. Website: 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 expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist where to dispose of unused medications. By doing so, you will help protect the environment.

Composition of Irbesartán TecniGen 300 mg film-coated tablets:

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

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

Appearance of the product and contents of the packaging

Oblong, film-coated tablets of white color.

Presented in a blister pack with 28 tablets.

Holder of the marketing authorization

TECNIMEDE ESPAÑA INDUSTRIA FARMACEUTICA, S.A.

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

28108 Alcobendas, Spain

Responsible for manufacturing:

Atlantic Pharma – Produções Farmacêuticas SA

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

Portugal

Date of the last review of this leaflet:February 2025

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