IRBESARTAN SANDOZ 300 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Irbesartan Sandoz 300 mg film-coated tablets EFG

Read all of 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 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 symptoms are the same as yours.
• If you experience 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 Sandoz and what is it used for
2. What you need to know before you take Irbesartan Sandoz
3. How to take Irbesartan Sandoz
4. Possible side effects
5. Storage of Irbesartan Sandoz
6. Contents of the pack and other information

1. What is Irbesartan Sandoz and what is it 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 constricts blood vessels, leading to an increase in blood pressure. Irbesartan blocks the action of angiotensin-II, relaxing blood vessels and lowering blood pressure. Irbesartan also slows the progression of kidney disease in patients with high blood pressure and type 2 diabetes.

Irbesartan Sandoz 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 Sandoz

Do not takeIrbesartan Sandoz:

• if you are allergic to the active substance or 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 recommended to avoid taking this medicine during the first trimester of pregnancy - see section Pregnancy),
• if you have diabetes or kidney disease and are being treated with a blood pressure-lowering medicine that contains aliskiren.

Warnings and precautions

Talk to your doctor before starting to take irbesartan 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, rapid and strong heartbeats), 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), especially 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 Sandoz”.

If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. It is not recommended to use irbesartan during the first trimester of pregnancy and in no case should it be administered after the third month of pregnancy, as it may cause serious harm to your baby.

Talk to your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking irbesartan. Your doctor will decide whether to continue treatment. Do not stop taking irbesartan 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 Irbesartan Sandoz

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 angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also the information under the headings “Do not take Irbesartan Sandoz” and “Warnings and precautions”).

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

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

If you are using a type of pain reliever known as non-steroidal anti-inflammatory medicines, the effect of irbesartan may be reduced.

TakingIrbesartan Sandozwith food and drinks

Irbesartan Sandoz can be taken with or without food.

The tablets should be swallowed with a sufficient amount of liquid (e.g., a glass of water). Irbesartan Sandoz can be taken with or without food. You should try to take your daily dose at the same time every day. It is important that you continue to take this medicine until your doctor tells you to stop.

Pregnancy and breastfeeding

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 usually advise you to stop taking irbesartan before you become pregnant or as soon as you find out you are pregnant and will recommend that you take another blood pressure-lowering medicine instead. It is not recommended to use irbesartan during the first trimester of pregnancy and in no case should it be administered after the third month of pregnancy, as it may cause serious harm to your baby.

Breastfeeding

Tell your doctor if you are about to start or are already breastfeeding, as it is not recommended to take irbesartan during this period. Your doctor may decide to give you a treatment that is more suitable if you want to breastfeed, especially for newborns or premature babies.

Driving and using machines

No studies have been performed on the effects of this medicine on the ability to drive or use machines.

It is unlikely that irbesartan will 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, talk to your doctor before driving or using machines.

Irbesartan Sandoz contains lactose and hydrogenated castor oil

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

This medicine may cause stomach upset and diarrhea because it contains hydrogenated castor oil.

3. How to take Irbesartan Sandoz

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 Sandoz is taken orally. The tablets should be swallowed with a sufficient amount of liquid (e.g., a glass of water). Irbesartan Sandoz can be taken with or without food. You should try to take your daily dose at the same time every day. It is important that you continue to take this medicine until your doctor tells you to stop.

Patient with high blood pressure

The usual dose is 150 mg once daily. Depending on the response to blood pressure, this dose can be increased to 300 mg once daily.

Patient 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.

Your doctor may advise a lower dose, especially at the start of treatment, in certain patients, such as hemodialysis patientsor patients over 75 years.

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

Use in children and adolescents

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

If you take moreIrbesartan Sandozthan you should

If you accidentally take too many tablets, or if a child swallows several tablets, 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, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to takeIrbesartan Sandoz

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

As with similar medicines, in rare cases, the following side effects have been reported for patients treated with irbesartan: allergic skin reactions (rash, urticaria), as well as localized swelling in the face, lips, and/or tongue. If you think you may have a reaction of this type or experience shortness of breath, stop taking irbesartan and go immediately to a medical center.

The following side effects are grouped by frequency:

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.

The following side effects have been reported in clinical trials in patients treated with irbesartan:

• Very common(may affect more than 1 in 10 patients):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 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 disease, 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):rapid heartbeat, flushing, cough, diarrhea, indigestion/heartburn, sexual dysfunction (impotence), and chest pain.

• Rare (may affect up to 1 in 1,000 patients):intestinal angioedema; swelling in the intestine that presents with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Since the marketing of irbesartan, the following side effects have been reported with a frequency not known: feeling of spinning, headache, altered taste, ringing in the ears, muscle cramps, muscle and joint pain, decreased number of red blood cells (anemia - symptoms may include fatigue, headaches, difficulty breathing when exercising, dizziness, and pallor), reduced number of platelets, abnormal liver function, increased potassium levels in the blood, kidney failure, and inflammation of small blood vessels, mainly in the skin area (a condition known as leucocytoclastic vasculitis) and severe allergic reactions (anaphylactic shock) and low blood sugar levels.

Jaundice (yellowing of the skin and/or whites of the eyes) has also been reported in rare cases.

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 to the Spanish Medicines and Healthcare Products Agency (AEMPS) via the website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Irbesartan Sandoz

Keep this medicine out of the sight and reach of children.

No special storage conditions are required. Store in the original packaging to protect from light.

Do not use this medicine after the expiry date stated on the packaging after “EXP”. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. If you have any further questions, ask your pharmacist. By doing so, you will help protect the environment.

6. Contents of the pack and other information

If you want more information about your disease or treatment, you should consult your doctor or pharmacist.

Composition of Irbesartan Sandoz 300 mg film-coated tablets EFG

• The active substance is irbesartan. Each tablet contains 300 mg of irbesartan.
• The other ingredients are: povidone K90 (E1201), magnesium stearate, microcrystalline cellulose (E460), lactose monohydrate, sodium croscarmellose, colloidal anhydrous silica, hydrogenated castor oil, and maize starch.

Appearance and packaging of the product

Irbesartan Sandoz 300 mg tablets are white, oblong, biconvex, and scored. The tablet can be divided into equal doses.

Each pack contains 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Sandoz Farmacéutica S.A

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer:

Laboratorios Liconsa, S.A.

Avd. Miralcampo, nº 7

Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

Date of last revision of this leaflet: February 2025

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