Package Insert: Information for the Patient

Irbesartan Sandoz 75 mg Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Irbesartan Sandoz and how is it used

2. What you need to know before starting to take Irbesartan Sandoz

3. How to take Irbesartan Sandoz

4. Possible adverse effects

5. Storage of Irbesartan Sandoz

6. Contents of the package 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 angiotensin-II from binding 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 Sandozis 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 takeIrbesartán Sandoz:

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

Warnings and precautions

Consult your doctor before starting to take irbesartánand if 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 may include sweating, weakness, hunger, dizziness, tremors, headache, flushing or paleness, numbness, rapid and strong heartbeats), especially if you are being treated for diabetes,
• ifyou are to be operated(surgical intervention)or if you are to be administered anesthetics.
• if you are taking any of the following medicines 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 blood electrolyte levels (e.g., potassium), at regular intervals.

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

If you are pregnant, if you suspect you may be pregnantor if you plan to become pregnant, inform your doctor. Irbesartán is not recommended for use at the beginning of pregnancy (first 3 months) and should not be administered at all after the third month of pregnancy, as it may cause severe damage to your baby.

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 on your own.

Children and adolescents

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

Other medicines and Irbesartán Sandoz

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

Your doctor may need to adjust 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 Sandoz” and “Warnings and precautions”).

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

• potassium supplements,
• potassium-sparing salt substitutes,
• potassium-saving medicines (such as certain diuretics),
• litium-containing medicines,
• repaglinida (a medicine used to reduce blood sugar levels)..

If you are taking a type of pain reliever known as nonsteroidal anti-inflammatory drugs (NSAIDs), the effect of irbesartán may be reduced.

Irbesartán Sandoz with food and drinks

Irbesartán Sandoz can be taken with or without food.

The tablets should be swallowed with water.

Pregnancy and lactation

Pregnancy

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consultyour doctor or pharmacist before using this medicine.Generally, your doctor will advise you to stop taking irbesartán before becoming pregnant or as soon as you become pregnant and recommend taking another antihypertensive medicine instead. Irbesartán is not recommended for use at the beginning of pregnancy and should not be administered at all after the third month of pregnancy as it may cause severe damage to your baby when administered from that point onwards.

Lactation

Inform your doctor if you plan to start or are breastfeeding, as irbesartán is not recommended for use 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

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

It is unlikely that irbesartán will affect your ability to drive vehicles or use machines. However, during hypertension treatment, occasional dizziness or fatigue may occur. If you experience these symptoms, discuss them with your doctor before driving or using machines.

Irbesartán Sandoz contains lactose and hydrogenated ricin oil

This medicine contains Lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

This medicine may cause stomach discomfort and diarrhea due to the presence of hydrogenated ricin oil.

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

Administration Method:

Irbesartán Sandoz is administeredorally. The tablets should be swallowed with a sufficient amount of liquid (e.g., a glass of water). Irbesartán Sandoz 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 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.

Use in Children and Adolescents

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

If You Take MoreIrbesartán SandozThan You Should

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

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

If You Forget to TakeIrbesartán Sandoz

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 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.

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

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

The side effects mentioned below are grouped by frequency:

Very common:may affect more than1 in 10 patients.

Common:may affect up to 1 in 10 patients.

Uncommon:may affect up to1 in 100 patients.

Rare:may affect up to 1 in 1000 patients.

Side effects reported in clinical trials conducted in patients treated with irbesartán were:

• Very common(may affect more than 1 in 10 patients):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 patients):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), low blood pressure (especially when standing up), muscle or joint pain, and decreased levels of a protein present in red blood cells (hemoglobin).

• Uncommon(may affect up to 1 in 100 patients):palpitations, skin flushing, cough, diarrhea, indigestion/heartburn, sexual dysfunction (alteration of sexual function), and chest pain.

• Rare (may affect up to 1 in 1000 patients):intestinal angioedema; intestinal swelling that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Since the marketing of irbesartán, some side effects have been reported. The side effects reported with unknown frequency are: dizziness, headache, altered taste, tinnitus, muscle cramps, muscle and joint pain,decreased red blood cell count (anemia - symptoms may include fatigue, headaches, difficulty breathing during exercise, dizziness, and paleness),reduced platelet count, abnormal liver function, increased potassium levels in the blood, kidney function impairment, and inflammation of small blood vessels, mainly in the skin area (condition known as leukocytoclastic vasculitis)and severe allergic reactions (anaphylactic shock) and low blood sugar levels.

Also, cases of jaundice (yellowing of the skin and/or white of the eyes) have been observed in rare cases.

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 theSpanish System for 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.

No special storage conditions are required.Store in theoriginal packagingto protect it from light.

Do not use this medication after the expiration date that appears on the packaging after “CAD/EXP”. The expiration date is the last day of the month indicated.

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

Composition of Irbesartán Sandoz 75 mg tablets EFG

Appearance of the product and contents of the packaging

Irbesartan Sandoz 75 mg tablets are white, cylindrical, and biconvex.

Each package contains 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Sandoz Farmacéutica S.A

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing:

Laboratorios Liconsa, S.A.

Avd. Miralcampo, nº 7

Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

Last review date 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/