Package Leaflet: Information for the User

Irbesartán Aurovitas 300mg tablets EFG

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

1. What isIrbesartán Aurovitasand what it is used for

2. What you need to know before starting to takeIrbesartán Aurovitas

3. How to takeIrbesartán Aurovitas

4. Possible side effects

5. Storage of Irbesartán Aurovitas

6. Contents of the pack and additional information

Irbesartán belongs to a group of medications 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 delays the deterioration of 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 altered renal function.

Do not take Irbesartán Aurovitas:

• if you areallergicto irbesartán or any of the other components of this medication (listed in section 6),
• if you aremore than 3 months pregnant. (In any case, it is better to avoid taking irbesartán also at the beginning of your pregnancy – see Pregnancy section),
• if you have diabetes or kidney failure and are being treated with a medication to lower blood pressure that contains aliskirén.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Irbesartán Aurovitas andif any of the following aspects affect you:

• if you haveexcessive vomiting or diarrhea,
• if you havekidney problems,
• if you haveheart problems,
• if you are taking irbesartán fordiabetic nephropathy. In this case, your doctor may perform regular blood tests, especially to measure potassium levels in case of impaired renal function,
• if you presentlow blood sugar levels(symptoms that may include sweating, weakness, hunger, dizziness, tremor, headache, flushing, or paleness, numbness, having a rapid and strong heartbeat), especially if you are being treated for diabetes,
• ifyou are to be operated(surgical intervention) orif you are to be administered anesthetics,
• if you are taking any of the following medications used to treat high blood pressure (hypertension):

- an angiotensin-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 blood electrolyte levels (such as potassium), at regular intervals.

See also the information under the heading “Do not take Irbesartán Aurovitas”.

If you are pregnant, think you may be pregnant, or plan to become pregnant, inform your doctor. Irbesartán is not recommended for use at the beginning of pregnancy (first 3 months), and in any case, it should not be administered from the third month of pregnancy, as it may cause serious harm to your baby (see Pregnancy section).

Children and adolescents

This medication should not be used in children and adolescents as its safety and efficacy have not been fully established.

Taking Irbesartán Aurovitas with other medications

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

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

If you are taking an ACEI or aliskirén (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,
• potassium-sparing salt substitutes,
• potassium-saving medications (such as certain diuretics),
• litium-containing medications,
• repaglinide (a medication 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 irbesartán may be reduced.

Taking Irbesartán Aurovitas with food, drinks, and alcohol

Irbesartán can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication. Your doctor will usually advise you to stop taking irbesartán before becoming pregnant or as soon as you become pregnant and recommend taking another antihypertensive medication instead. Irbesartán is not recommended for use at the beginning of pregnancy and should not be administered from the third month of pregnancy as it may cause serious harm to your baby when administered from that time.

Breastfeeding

If you are planning to start or are breastfeeding, consult your doctor or pharmacist before using this medication, as it is not recommended to administer irbesartán to women during this period. Your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially for newborns or premature babies.

Driving and operating machines

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

Irbesartán Aurovitas contains sodium

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

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 Form

Irbesartán is administered orally. The tablets should be swallowed with a sufficient amount of liquid (for example, a glass of water). Irbesartán can be taken with or without food. You should try to take your daily dose at the same time every day. It is essential to 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 Alteration

In patients with high blood pressure and type 2 diabetes, the recommended maintenance dose for the treatment of associated renal alteration is 300 mg once a day (one tablet a day).

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

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

If You Take More Irbesartán Aurovitas Than You Should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Use in Children and Adolescents

Irbesartán should not be administered to children under 18 years old. If a child swallows a tablet, contact your doctor immediately.

If You Forget to Take Irbesartán Aurovitas

If you accidentally forget to take a dose, simply take your regular dose when it is due next. Do not take a double dose to compensate for the missed doses.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them. Some of these side effects can be serious and may require medical attention.

Like with similar medicines, in rare cases, skin allergic reactions (skin rash, urticaria) have been reported in patients treated with irbesartan, as well as localized inflammation 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 the side effects mentioned below is defined following 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.

The side 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 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 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 (hemoglobin).

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

Tachycardia, skin redness, cough, diarrhea, indigestion/heartburn, sexual dysfunction (sexual function alterations), and chest pain.

Since the marketing of irbesartan, some side effects have been reported. The side effects observed with unknown frequency are: feeling of spinning, headache, taste alteration, ringing in the ears, muscle cramps, muscle and joint pain, decrease in the number of red blood cells (anemia – symptoms may include fatigue, headaches, difficulty breathing during exercise, dizziness, and paleness), decrease in the number of platelets, abnormal liver function, increase in potassium levels in the blood, kidney function impairment, and inflammation of small blood vessels, mainly in the skin area (condition known as leukocytoclastic vasculitis), severe allergic reactions (anaphylactic shock), and low blood sugar levels. Also, there have been reported cases of jaundice (yellowing of the skin and/or white of the eyes).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, 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 of Pharmacovigilance of Medicines for Human Use:https://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 box 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 trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition ofIrbesartan Aurovitas

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

Appearance of the product and contents of the package

Tablet.

Irbesartan Aurovitas300mg tablets EFG:

Uncoated white to off-white tablets, biconvex, oval-shaped, marked with “H30” on one face of the tablet and smooth on the other face.

Irbesartan Aurovitas is available in blister packs.

Package sizes:

Blister packs: 14, 28, and 56 tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91 630 86 45

Fax: 91 630 26 64

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicine is authorized in the member states of the European Economic Area with the following names:

Republic of Czechia:Irbesartan Aurovitas300 mg tablets

Poland:Irbesartan Aurovitas

Portugal:Irbesartan Aurovitas

Spain:Irbesartán Aurovitas300 mgtablets EFG

Last review date of this leaflet:September 2021

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