irbesartan
Aprovel, Irbesartan Zentiva (previously Irbesartan Winthrop), Karvea · ATC code C09CA04
Brand names: Aprovel, Irbesartan Zentiva, Karvea, Irbepress, Irbesartan Hexal, Irbesartan Sandoz, Antrovel, Arbesta, Hirbes, Irbecor, Irda, Irprestan, Onesart, Rebevea, Rotazar …
- Key facts
- Active substance
- irbesartan
- ATC code
- C09CA04
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Aprovel 75 mg tablets. · Aprovel 150 mg tablets. · Aprovel 300 mg tablets. · Aprovel 75 mg film-coated tablets. · Aprovel 150 mg film-coated tablets. · Aprovel 300 mg film-coated tablets. · Irbesartan Zentiva 75 mg film-coated tablets. · Irbesartan Zentiva 150 mg film-coated tablets.
- Marketing authorisation holder
- Sanofi Winthrop Industrie, Zentiva k.s.
- Information as of
- 2026-10-27
Key facts
Irbesartan (Aprovel) is an angiotensin II receptor antagonist. It is used in adults to treat essential hypertension and renal disease in hypertensive patients with type 2 diabetes.
What it is used for
- Essential hypertension in adults
- Renal disease in adult patients with hypertension and type 2 diabetes, as part of an antihypertensive regimen
Dosing
- Usual initial and maintenance dose: 150 mg once daily, with or without food
- If insufficiently controlled: increase to 300 mg or add other antihypertensives (e.g. hydrochlorothiazide)
- Hypertensive type 2 diabetic patients: start at 150 mg and titrate to 300 mg as the preferred maintenance dose
- Consider a 75 mg starting dose in haemodialysis and in patients over 75 years
- No dose adjustment in renal impairment or mild to moderate hepatic impairment
- No posology recommendation for children and adolescents
Contraindications
- Hypersensitivity to the active substance or any of the excipients
- Second and third trimesters of pregnancy
- Combination with aliskiren in diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m²)
Important warnings
- Symptomatic hypotension in volume- or sodium-depleted patients, especially after the first dose
- Increased risk of severe hypotension and renal insufficiency with renal artery stenosis
- Monitor potassium and creatinine periodically in renal impairment
- Dual RAAS blockade increases risk of hypotension, hyperkalaemia and renal failure
Side effects
- Common: dizziness, orthostatic hypotension, nausea/vomiting, fatigue, musculoskeletal pain
- Hyperkalaemia very common in diabetic patients with renal disease
- Uncommon: tachycardia, cough, diarrhoea, jaundice, sexual dysfunction
- Angioedema and other hypersensitivity reactions (frequency not known)
Interactions
- Other antihypertensives and diuretics add to blood pressure lowering; prior high-dose diuretics raise hypotension risk
- ACE inhibitors, other ARBs or aliskiren: dual RAAS blockade with more adverse events
Pregnancy and breastfeeding
- Not recommended in the first trimester; contraindicated in the second and third trimesters
- Not recommended during breast-feeding
Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
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For patients
Package leaflet, verbatim
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- AprovelSanofi Winthrop Industrie · EMEA/H/C/000141
- Ifirmasta (previously Irbesartan Krka) · genericKrka, d.d., Novo mesto · EMEA/H/C/000962
- Irbesartan Teva · genericTeva B.V. · EMEA/H/C/001093
- Irbesartan Zentiva (previously Irbesartan Winthrop)Zentiva k.s. · EMEA/H/C/000785
- KarveaSanofi Winthrop Industrie · EMEA/H/C/000142
Source: European Medicines Agency (EMA), product information
Austria
- IrbepressG.L. Pharma Gmbh · 1 register entry
- Irbesartan HexalHexal Pharma Gmbh · 1 register entry
- Irbesartan SandozSandoz Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Germany
- IrbepressG.L. Pharma Gmbh · 1 register entry
- Irbesartan1 A Pharma Gmbh, Micro Labs Gmbh, Puren Pharma Gmbh & Co. Kg, Heumann Pharma Gmbh & Co. Generica Kg, Amarox Pharma Gmbh, Hennig Arzneimittel Gmbh & Co. Kg, Hexal Ag, Stadapharm Gmbh, Abz-Pharma Gmbh, Aliud Pharma Gmbh · 11 register entries
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Turkey
- AntrovelNOBEL SAĞLIK ÜRÜNLERİ LTD ŞTİ · 3 register entries
- ArbestaALİ RAİF İLAÇ SAN. A.Ş. · 4 register entries
- HirbesGENVEON İLAÇ SAN. VE TİC. A.Ş. · 6 register entries
- IrbecorİLKO İLAÇ SAN.VE TİC. A.Ş. · 2 register entries
- IrdaNOBEL İLAÇ SAN. VE TİC. A.Ş. · 5 register entries
- IrprestanACTAVİS İLAÇLARI A.Ş. · 2 register entries
- KarveaSANOFİ SAĞLIK ÜRÜNLERİ LTD. ŞTİ. · 5 register entries
- OnesartBİOFARMA İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
- RebeveaHUMANİS SAĞLIK A.Ş. · 6 register entries
- RotazarWORLD MEDICINE İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
- SanbartanSANDOZ İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 21 more European countries
- Belgium
- Irbesartan Eg, Irbesartan Sandoz, Irbesartan Viatris
- Bulgaria
- Ирбесан, Ирбесо, Ирпрестан
- Cyprus
- Converium, Irbesartan Vocate, Lucidel, Rycardon, Syntosartin
- Czechia
- Isame
- Denmark
- Irbesartan Accord, Irbesartan Jubilant, Irbesartan Medical Valley, Irbesartan Stada
- France
- Irbesartan Accord, Irbesartan Arrow, Irbesartan Bgr, Irbesartan Cristers, Irbesartan Eg, Irbesartan Evolugen, Irbesartan Sandoz, Irbesartan Viatris, Irbesartan Zydus
- Greece
- Besartan, Irbegen, Irbepress, Irbotens, Karvofil, Lucidel, Menago, Piesiton, Roverin
- Hungary
- Irabel, Irbesartan Sandoz, Irprestan
- Iceland
- Aprovel, Ifirmasta, Irbesartan Teva, Irbesartan Zentiva, Karvea
- Ireland
- Irbesartan Clonmel, Irbesartan Rowa
- Italy
- Abesart, Irbesartan Accord, Irbesartan Aurobindo, Irbesartan Doc Generici, Irbesartan Eg, Irbesartan Macleods Pharma, Irbesartan Mylan, Irbesartan Sandoz, Irbesartan Tecnigen, Irbetens, Rabesat, Retensir
- Liechtenstein
- Aprovel, Irbesartan Teva, Irbesartan Zentiva, Karvea
- Luxembourg
- Irbesartan Eg, Irbesartan Viatris
- Malta
- Irbesartan Aurobindo Pharma (Malta)
- Netherlands
- Artibesan, Irbesartan Accord, Irbesartan Amarox, Irbesartan Aurobindo, Irbesartan Jubilant, Irbesartan Sandoz, Irbesartan Stada, Irbesartan Sun, Irbesartan Viatris, Irbesartan Xiromed
- Norway
- Aprovel, Ifirmasta, Irbesartan Actavis, Irbesartan Sandoz, Irbesartan Teva, Irbesartan Viatris, Irbesartan Zentiva, Karvea
- Poland
- Irbesartan Aurovitas
- Portugal
- Irbesartan Alter, Irbesartan Aurovitas, Irbesartan Azevedos, Irbesartan Basi, Irbesartan Bluepharma, Irbesartan Ciclum, Irbesartan Farmoz, Irbesartan Generis, Irbesartan Ipca, Irbesartan Krka, Irbesartan Mylan, Irbesartan Omnicals Omnicals Pharma Unip., Irbesartan Pentafarma, Irbesartan Pharmakern, Irbesartan Ratiopharm, Irbesartan Sandoz, Irbesartan Stada, Irbesartan Tecnimede, Irbesartan Tetrafarma, Irbesartan Tolife, Irbesartan Vitória, Irbesartan Vocate
- Romania
- Irbesartan Terapia
- Spain
- Irbesartan Combix, Irbesartan Normon, Irbesartan Pensa, Irbesartan Tarbis, Irbesartan Viatris, Irbesartán Almus, Irbesartán Alter, Irbesartán Aurovitas, Irbesartán Cinfa, Irbesartán Davur, Irbesartán Kern Pharma, Irbesartán Liconsa, Irbesartán Sandoz, Irbesartán Stada, Irbesartán Sun, Irbesartán Tecnigen, Irbesartán Viatris
- Sweden
- Irbesartan Accord, Irbesartan Actavis, Irbesartan Sandoz, Irbesartan Stada
EMA – Article 57 product data (EU/EEA), 2026-10-28
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Sources
- European Medicines Agency. Aprovel – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/aprovel-epar-product-information_en.pdf
- European Medicines Agency. Irbesartan Zentiva (previously Irbesartan Winthrop) – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/irbesartan-zentiva-epar-product-information_en.pdf
- European Medicines Agency. Karvea – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/karvea-epar-product-information_en.pdf
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.