IRBESARTAN AUROVITAS 75 mg TABLETS

Introduction

Package Leaflet: Information for the User

Irbesartan Aurovitas75mg film-coated tablets

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 or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Irbesartan belongs to a group of medicines called angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body that causes blood vessels to narrow, leading to an increase in blood pressure.

Irbesartan prevents angiotensin-II from binding to its receptors, relaxing blood vessels and lowering blood pressure. Irbesartan delays the progression of kidney disease in patients with high blood pressure and type 2 diabetes.

Irbesartan Aurovitas is used in adult patients:

• to treat high blood pressure (essential hypertension),

to protect the kidneys in patients with high blood pressure, type 2 diabetes, and evidence of kidney disease.

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

Do not take Irbesartan Aurovitas:

• if you are allergicto irbesartan or any of the other ingredients of this medicine (listed in section 6),
• if you are pregnant more than 3 months. (In any case, it is better to avoid taking irbesartan also at the start of your pregnancy – see section Pregnancy),
• if you have diabetes or kidney insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Irbesartan Aurovitas and if any of the following apply to you:

• if you have excessive vomiting or diarrhea,
• if you have kidney problems,
• if you have heart problems,
• if you are taking irbesartan 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 have low blood sugar levels(symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing, or pallor, numbness, having a rapid and strong heartbeat), especially if you are being treated for diabetes,
• 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), 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 Irbesartan Aurovitas”.

If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Irbesartan is not recommended during the first trimester of pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby (see section Pregnancy).

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

Children and adolescents

This medicine must not be used in children and adolescents as the safety and efficacy have not been fully established.

Taking Irbesartan Aurovitas with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Your doctor may need to modify 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 Aurovitas” and “Warnings and precautions”).

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

• potassium supplements,
• potassium-sparing diuretics (e.g., certain water pills),
• lithium-containing medicines,
• repaglinide (a medicine used to lower blood sugar levels).

If you are taking certain types of painkillers, known as non-steroidal anti-inflammatory medicines, the effect of irbesartan may be reduced.

Taking Irbesartan Aurovitas with food, drinks, and alcohol

Irbesartan can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will normally advise you to stop taking irbesartan before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine to treat your high blood pressure. Irbesartan is not recommended during the first trimester of pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby.

Breastfeeding

If you are about to start or are already breastfeeding, consult your doctor or pharmacist before using this medicine, as irbesartan is not recommended for use during breastfeeding. Your doctor may decide to give you a different treatment that is more suitable if you want to breastfeed, especially if you are breastfeeding a newborn or premature baby.

Driving and using machines

Irbesartan is unlikely to 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 driving or using machines.

Irbesartan Aurovitas contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet; this is essentially “sodium-free”.

3. How to take Irbesartan Aurovitas

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 is taken by mouth. The tablets should be swallowed with a sufficient amount of liquid (e.g., a glass of water). Irbesartan 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.

Patients with high blood pressure

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

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

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

Your doctor may advise a lower dose, especially when starting 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 Aurovitas than you should

If you have taken more than the prescribed dose, contact your doctor or pharmacist immediately or go to the emergency department at your nearest hospital. Take this leaflet and any remaining tablets with you.

Use in children and adolescents

Irbesartan should not be given to children under 18 years of age. If a child swallows any tablets, contact your doctor immediately.

If you forget to take Irbesartan Aurovitas

If you accidentally miss a dose, just take your normal dose when it is due. Do not take a double dose to make up for a forgotten dose.

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. Some of these side effects may be serious and may require medical attention.

As with similar medicines, in rare cases, patients treated with irbesartan have reported allergic skin reactions (rash, urticaria), as well as localized swelling in the face, lips, and/or tongue. If you experience any of these symptoms or have difficulty breathing, stop taking Irbesartan Aurovitas and contact your doctor immediately.

The frequency of side effects is defined as follows:

• 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.

Side effects reported in clinical trials in patients treated with irbesartan were:

Very common (may affect more than 1 in 10 people):

If you have high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increase in potassium levels.

Common (may affect up to 1 in 10 people):

Dizziness, nausea/vomiting, fatigue, and 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 disease, dizziness, especially when standing up from a lying or sitting position, low blood pressure, especially when standing up from a lying or sitting position, muscle or joint pain, and decreased levels of a protein present in red blood cells (hemoglobin).

Uncommon (may affect up to 1 in 100 people):

Fast heartbeat, flushing, cough, diarrhea, indigestion/heartburn, sexual dysfunction (sexual function disorders), and chest pain.

Since the marketing of irbesartan, some side effects have been reported. The side effects with frequency not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, muscle and joint pain, decreased number of red blood cells (anemia – symptoms may include tiredness, headaches, difficulty breathing when exercising, dizziness, and paleness), reduced number of platelets, abnormal liver function, increased 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), severe allergic reactions (anaphylactic shock), and low blood sugar levels. There have also been rare cases of jaundice (yellowing of the skin and/or whites of the eyes).

Rare (may affect up to 1 in 1,000 people):

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Irbesartan Aurovitas

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 other information

Composition ofIrbesartan Aurovitas

• The active substance is irbesartan. Each tablet contains 75 mg of irbesartan.
• The other ingredients are: microcrystalline cellulose, calcium hydrogen phosphate dihydrate, sodium carboxymethyl starch (type A) (derived from potato starch), hypromellose (5cp), polysorbate 80, talc, anhydrous colloidal silica, sodium stearyl fumarate.

Appearance and packaging

Tablet.

Irbesartan Aurovitas 75 mg film-coated tablets:

White to off-white, biconvex, oval-shaped tablets, marked with “H 28” on one face of the tablet and smooth on the other face.

Irbesartan Aurovitas is available in blister packs.

Pack sizes:

Blister packs: 14, 28, and 56 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicine is authorised in the Member States of the European Economic Area under the following names:

Poland: Irbesartan Aurovitas

Portugal: Irbesartan Aurovitas

Spain: Irbesartán Aurovitas 75 mg film-coated tablets

Date of last revision of this leaflet:August 2025

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