Irbesartan Aurovitas 300 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Irbesartán Aurovitas 300 mg 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Irbesartán Aurovitas 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 leads to an increase in blood pressure.

Irbesartan blocks angiotensin-II from binding to these receptors, relaxing blood vessels and thereby lowering blood pressure. Irbesartan delays the decline in renal function in patients with high blood pressure and type 2 diabetes.

Irbesartán 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 clinical evidence of impaired kidney function.

2. What you need to know before taking Irbesartán Aurovitas

Do not take Irbesartán Aurovitas:

• if you are allergic to irbesartan or to any of the other ingredients of this medicine (listed in section 6),
• if you are more than 3 months pregnant. (In any case, it is better to avoid taking irbesartan also during the early months of pregnancy – see Pregnancy section),
• 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 or pharmacist before starting to take Irbesartán Aurovitas and if any of the following apply to you:

• if you have excessive vomiting or diarrhoea,

• 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 carry out regular blood tests, especially to measure potassium levels if kidney function is impaired,

• if you have low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, rapid and strong heartbeat),

• if you are scheduled for surgery or if you are to receive anaesthetics,

• if you are taking any of the following medicines used to treat high blood pressure (hypertension):

• an angiotensin-converting enzyme (ACE) inhibitor (for example 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 Aurovitas”.

If you are pregnant, think you might be pregnant, or are planning to become pregnant, you must inform your doctor. Use of irbesartan is not recommended during early pregnancy (first 3 months), and must not be initiated from the third month of pregnancy onwards, as it may cause serious harm to your baby (see Pregnancy section).

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

Children and adolescents

This medicine should not be used in children and adolescents, as safety and efficacy have not yet been established.

Taking Irbesartán Aurovitas with other medicines

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

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

If you are taking an angiotensin-converting enzyme (ACE) inhibitor or aliskiren (see also the information under the headings “Do not take Irbesartán Aurovitas” and “Warnings and precautions”).

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

• potassium supplements,
• salt substitutes containing potassium,
• potassium-sparing medicines (such as certain diuretics),
• medicines containing lithium,
• repaglinide (a medicine used to lower blood sugar levels).

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

Taking Irbesartán Aurovitas with food, drinks and alcohol

Irbesartan may be taken with or without food.

Pregnancy, breastfeeding and fertility

Pregnancy

If you are pregnant, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Generally, your doctor will advise you to stop taking irbesartan before becoming pregnant or as soon as pregnancy is detected, and will recommend an alternative antihypertensive medicine. Irbesartan is not recommended during early pregnancy and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby when used from that time.

Breastfeeding

If you are planning to breastfeed or are currently breastfeeding, consult your doctor or pharmacist before using this medicine, as irbesartan is not recommended for women during this period. Your doctor may decide to prescribe a treatment more suitable for breastfeeding, especially if the infant is a newborn or premature.

Driving and using machines

It is unlikely that irbesartan will affect your ability to drive or operate machinery. However, during treatment for hypertension, dizziness or fatigue may occasionally occur. If you experience these symptoms, consult your doctor before driving or operating machinery.

Irbesartán Aurovitas contains sodium

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

3. How to take Irbesartan Aurovitas

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

Method of administration

Irbesartan is administered orally. The tablets should be swallowed with a sufficient amount of liquid (e.g., a glass of water). Irbesartan 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, 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 (one tablet daily).

Your doctor may recommend a lower dose, especially at the beginning of treatment, in certain patients, such as those undergoing haemodialysis or those 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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

Use in children and adolescents

Irbesartan must 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, simply take your next dose at the usual time. Do not take a double dose to make up for missed doses.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. Some of these adverse effects may be serious and may require immediate medical attention.

As with other 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 experience any of these symptoms or have difficulty breathing, stop taking Irbesartán Aurovitas and contact your doctor immediately.

The frequency of the adverse effects listed below is defined according to 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.

Adverse effects reported in clinical trials conducted 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 impairment, blood tests may show increased levels of potassium.

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 enzyme). In patients with high blood pressure and type 2 diabetes with kidney impairment, 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 (haemoglobin).

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

Tachycardia, skin redness, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (disturbances in sexual function), and chest pain.

Since the marketing of irbesartan, some adverse effects have been reported. Adverse effects observed with unknown frequency include: sensation of spinning (vertigo), headache, taste disturbances, tinnitus (ringing in the ears), muscle cramps, muscle and joint pain, decreased number of red blood cells (anaemia – symptoms may include tiredness, headaches, shortness of breath on exertion, dizziness and paleness), reduced platelet count, 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), severe allergic reactions (anaphylactic shock), and low blood sugar levels. Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been observed.

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

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the carton 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. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Irbesartán Aurovitas

• The active substance is irbesartan. Each tablet contains 300 mg of irbesartan.
• The other components (excipients) are: microcrystalline cellulose, calcium hydrogen phosphate dihydrate, sodium carboxymethyl starch from potato (type A) (derived from potato starch), hypromellose (5 cp), polysorbate 80, talc, colloidal anhydrous silica, sodium stearyl fumarate.

Appearance of the product and contents of the pack

Tablet.

Irbesartán Aurovitas 300 mg tablets EFG:

White to off-white, biconvex, oval-shaped, uncoated tablets, marked with “H 30” on one side and smooth on the other.

Irbesartán Aurovitas is available in blister packs.

Pack sizes:

Blister packs: 14, 28, and 56 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 medicinal product is authorized in the European Economic Area member states under the following names:

Poland: Irbesartan Aurovitas

Portugal: Irbesartan Aurovitas

Spain: Irbesartán Aurovitas 300 mg tablets EFG

Date of the most recent review of this leaflet: August 2025

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