Irbesartan Sandoz

Package leaflet: Information for the user

Irbesartan Sandoz 75 mg film-coated tablets, 150 mg film-coated tablets, 300 mg film-coated tablets

Equivalent medicine
Please read 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 give it to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Irbesartan Sandoz and what is it used for?

Irbesartan Sandoz belongs to a group of medicines called angiotensin II receptor antagonists.
Angiotensin II is a substance produced by the body that binds to receptors in blood vessels, causing them to constrict.
This results in increased blood pressure. Irbesartan Sandoz prevents angiotensin II from binding to these receptors, causing blood vessels to relax and thereby lowering blood pressure. Irbesartan Sandoz slows the decline in kidney function in patients with high blood pressure and type 2 diabetes.
Irbesartan Sandoz tablets are used in adult patients:

• to treat high blood pressure ( essential hypertension )
• to protect the kidneys in patients with high blood pressure, type 2 diabetes mellitus, and evidence of kidney dysfunction shown by laboratory tests.

2. What you need to know before taking Irbesartan Sandoz

DO NOT take Irbesartan Sandoz:

• if you are allergic to irbesartan or any of the other ingredients of this medicine (listed in section 6);
• if you are more than 3 months pregnant. (It is advisable to avoid Irbesartan Sandoz even in early pregnancy; see section “Pregnancy”)
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions
Talk to your doctor or pharmacist before taking Irbesartan Sandoz:

• if you have excessive vomiting or diarrhoea
• if you have kidney problems
• if you have heart problems
• if you are taking Irbesartan Sandoz to treat diabetic kidney disease. In this case, your doctor may prescribe regular blood tests, especially to monitor potassium levels in case of poor kidney function
• if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, rapid or pounding heartbeat), especially if you are being treated for diabetes
• if you are due to undergo surgery or receive anaesthetics
• if you are taking any of the following medicines used to treat high blood pressure:
  • an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes

Your doctor may check your kidney function, blood pressure, and levels of electrolytes (such as potassium) in your blood at regular intervals.
See also the information under the section “Do not take Irbesartan Sandoz”.
Inform your doctor if you suspect (or are planning) a pregnancy. Use of Irbesartan Sandoz is not recommended during early pregnancy, and the medicine must not be taken if you are more than 3 months pregnant, as it may severely harm your baby (see section on pregnancy).
Contact your doctor if, after taking Irbesartan Sandoz, you experience abdominal pain, nausea, vomiting, or diarrhoea.
Your doctor will decide whether treatment should continue. Do not stop taking Irbesartan Sandoz on your own.

Children and adolescents
This medicine must not be used in children and adolescents, as its safety and efficacy have not yet 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 consider it necessary to adjust the dose and/or take other precautions if you are taking an
ACE inhibitor or aliskiren (see also the sections “Do not take Irbesartan Sandoz” and “Warnings and precautions”).
Blood tests may be required if you are taking:

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

The effectiveness of irbesartan may be reduced when taken with certain painkillers, known as non-steroidal anti-inflammatory drugs (NSAIDs).

Irbesartan Sandoz with food and drink
Irbesartan Sandoz can be taken with or without food.

Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Irbesartan Sandoz before starting pregnancy or as soon as you find out you are pregnant, and will recommend another medicine instead of Irbesartan Sandoz.
Irbesartan Sandoz is not recommended during early pregnancy, and must not be taken after the first 3 months of pregnancy, as it may cause serious harm to the baby if taken beyond the third month of pregnancy.
Breast-feeding
Inform your doctor if you are breast-feeding or planning to start breast-feeding. Irbesartan Sandoz is not recommended for breastfeeding mothers, and your doctor may choose another treatment if you wish to breast-feed, especially if your baby is a newborn or was born prematurely.

Driving and using machines
It is unlikely that Irbesartan Sandoz will affect your ability to drive or use machines. However, dizziness or fatigue may occasionally occur during treatment for high blood pressure. If you experience these symptoms, consult your doctor before driving or operating machinery.

Irbesartan Sandoz contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially ‘sodium-free’.

3. How to take Irbesartan Sandoz

Always take this medicine exactly as your doctor has instructed. If you are unsure, consult your doctor or pharmacist.

Method of administration
Irbesartan Sandoz is intended for oral use. The tablet should be swallowed with a sufficient amount of liquid (e.g. a glass of water). The break line is only intended to facilitate breaking the tablet for easier swallowing and does not allow for division into equal parts. Irbesartan Sandoz can be taken regardless of food intake. You should try to take your daily tablet at the same time each day. It is important that you continue taking Irbesartan Sandoz unless your doctor tells you otherwise.

• Patients with high blood pressure: The usual dose is 150 mg once daily (two tablets daily). The dose may subsequently be increased to 300 mg (four tablets daily) once daily, depending on your blood pressure response.
• Patients with high blood pressure, type 2 diabetes and kidney disease: In patients with high blood pressure and type 2 diabetes, the recommended maintenance dose is 300 mg (four tablets daily) once daily for the treatment of associated kidney disease.

Your doctor may decide to use lower doses, especially at the beginning of treatment, in particular patients such as those on haemodialysis, or in patients over 75 years of age.
The maximum blood pressure-lowering effect should be achieved within 4–6 weeks after starting treatment.

Use in children and adolescents
Irbesartan Sandoz must not be administered to children and adolescents under 18 years of age. If a child accidentally swallows any tablets, contact a doctor immediately.

If you take more Irbesartan Sandoz than you should
If you take too many tablets, contact your doctor immediately.

If you forget to take Irbesartan Sandoz
If you miss a dose by mistake, take the next dose as usual. Do not take a double dose to make up for a forgotten dose.

If you have any 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 everyone experiences them.
Some of these effects may be serious and may require medical attention.
As with similar medicines, rare cases of allergic skin reactions (rash, urticaria) and also 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 develop shortness of breath, stop taking Irbesartan Sandoz and contact your doctor immediately.

Very common (may affect more than 1 in 10 people):
if you have high blood pressure and type 2 diabetes associated with kidney disease, blood tests may show an increase in potassium levels.

Common (may affect up to 1 in 10 people):
dizziness, feeling unwell/nausea, fatigue, and blood tests may show increased 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, low blood pressure upon standing from a lying or sitting position, joint or muscle pain, and decreased levels of a protein in red blood cells (haemoglobin) have also been reported.

Uncommon (may affect up to 1 in 100 people):
increased heart rate, hot flushes, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.

Rare (may affect up to 1 in 1,000 people):
Intestinal angioedema: following the use of similar products, swelling in the intestine has been reported, presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

From post-marketing experience with irbesartan, additional adverse reactions have been reported. The frequency of these adverse reactions is unknown: dizziness, headache, taste disturbances, ringing in the ears (tinnitus), muscle cramps, joint and muscle pain, reduced platelet count, abnormal liver function, increased blood potassium levels, decreased red blood cell count (anaemia—symptoms may include tiredness, headache, shortness of breath during physical activity, dizziness and pale appearance), kidney function disorders, inflammation of small blood vessels mainly affecting the skin (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 reported.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Irbesartan Sandoz

Keep this medicine out of the sight and reach of children.
Do not use Irbesartan Sandoz after the expiry date stated on the carton, blister, and bottle, following
EXP. The expiry date refers to the last day of that month.
Do not store above 30°C.
Shelf life after first opening of the bottle: 3 months.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Irbesartan Sandoz contains

• The active substance is irbesartan. Each tablet contains 75 mg of irbesartan. Each tablet contains 150 mg of irbesartan. Each tablet contains 300 mg of irbesartan.
• The other components are:

Microcrystalline cellulose
Silicified microcrystalline cellulose
Monohydrate lactose
Sodium croscarmellose
Anhydrous colloidal silica
Hypromellose
Magnesium stearate
Hydroxypropylcellulose
Macrogol 6000
Titanium dioxide (E171)
Talc

Description of the appearance of Irbesartan Sandoz and contents of the pack
75 mg film-coated tablets:
White, oval, biconvex film-coated tablets with the imprint “75” on one side and a break line on the other.
150 mg film-coated tablets:
White, oval, biconvex film-coated tablets with the imprint “150” on one side and a break line on the other.
300 mg film-coated tablets:
White, oval, biconvex film-coated tablets with the imprint “300” on one side and a break line on the other.

The tablets are packaged in blisters made of OPA/Alu/PVC/Alu and PVC/PVDC/Alu, and placed in a carton box or packaged in an HDPE bottle with a PP screw cap.
Blister packs: 7, 10, 14, 20, 28, 30, 56, 60, 84, 90, 98, 100 film-coated tablets.
Unit dose blister packs: 56x1, 100x1 film-coated tablets.
Bottle: 100, 250 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy

Manufacturers
Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana, Slovenia
LEK S.A., ul. Domaniewska 50 C, 02-672 Warszawa, Poland
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
Lek Pharmaceuticals d.d., Trimlini 2D, 9220 Lendava, Slovenia
LEK S.A., Ul. Podlipie 16C, 95 010 Strykow, Poland

This medicinal product is authorized in the European Economic Area (EEA) Member States and the United Kingdom (Northern Ireland) under the following names:
Austria: Irbesartan Sandoz 75 mg filmtabletten
Irbesartan Sandoz 150 mg tabletten
Irbesartan Sandoz 300 mg tabletten

Belgium: Irbesartan Sandoz 75 mg filmomhulde tabletten
Irbesartan Sandoz 150 mg filmomhulde tabletten
Irbesartan Sandoz 300 mg filmomhulde tabletten

Denmark: Irbesartan Sandoz 150 mg
Irbesartan Sandoz 300 mg

France: Irbesartan Sandoz 75 mg comprime pelicule
Irbesartan Sandoz 150 mg comprime pelicule
Irbesartan Sandoz 300 mg comprime pelicule

Germany: Irbesartan 1 A Pharma 75 mg filmtabletten
Irbesartan 1 A Pharma 150 mg tabletten
Irbesartan 1 A Pharma 300 mg tabletten

United Kingdom: Irbesartan Sandoz 75 mg film-coated tablets
Irbesartan Sandoz 150 mg film-coated tablets
Irbesartan Sandoz 300 mg film-coated tablets

Greece: Irbesartan Sandoz 75 mg
Irbesartan Sandoz 150 mg
Irbesartan Sandoz 300 mg

Ireland: Irbesartan 75 mg film-coated tablets
Irbesartan 150 mg film-coated tablets
Irbesartan 300 mg film-coated tablets

Italy: Irbesartan Sandoz 75 mg compresse rivestite con film
Irbesartan Sandoz 150 mg compresse rivestite con film
Irbesartan Sandoz 300 mg compresse rivestite con film

Luxembourg: Irbesartan Sandoz 75 mg filmomhulde tabletten
Irbesartan Sandoz 150 mg filmomhulde tabletten
Irbesartan Sandoz 300 mg filmomhulde tabletten

Norway: Irbesartan Sandoz 150 mg filmdrasjerte tabletter
Irbesartan Sandoz 300 mg filmdrasjerte tabletter

Netherlands: Irbesartan Sandoz 75 mg filmomhulde tabletten
Irbesartan Sandoz 150 mg filmomhulde tabletten
Irbesartan Sandoz 300 mg filmomhulde tabletten

Portugal: Irbesartan Sandoz 75 mg
Irbesartan Sandoz 150 mg
Irbesartan Sandoz 300 mg

Slovakia: Irbesartan Sandoz 150 mg filmom obalené tablety
Irbesartan Sandoz 300 mg filmom obalené tablety

Romania: Irbesartan Sandoz 150 mg comprimate filmate
Irbesartan Sandoz 150 mg comprimate filmate

Spain: Irbesartan Sandoz Farmaceutica 75 mg comprimidos recubiertos con pelicula EFG
Irbesartan Sandoz Farmaceutica 150 mg comprimidos recubiertos con pelicula EFG
Irbesartan Sandoz Farmaceutica 300 mg comprimidos recubiertos con pelicula EFG

Sweden: Irbesartan Sandoz 75 mg filmdragerad tablett
Irbesartan Sandoz 150 mg filmdragerad tablett
Irbesartan Sandoz 300 mg filmdragerad tablett

Hungary: Irbesartan Sandoz 75 mg filmtabletta
Irbesartan Sandoz 150 mg filmtabletta
Irbesartan Sandoz 300 mg filmtabletta

This patient information leaflet was approved in 04/2026