Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
irbesartan hydrochloride
Krka, d.d., Novo mesto
C09CA04
irbesartan
Agents acting on the renin-angiotensin system
Hypertension
Treatment of essential hypertension.Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen.
Revision: 14
Authorised
2008-12-01
28 B. PACKAGE LEAFLET 29 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT IFIRMASTA 75 MG FILM-COATED TABLETS irbesartan READ ALL OF 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 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 signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Ifirmasta is and what it is used for 2. What you need to know before you take Ifirmasta 3. How to take Ifirmasta 4. Possible side effects 5. How to store Ifirmasta 6. Contents of the pack and other information 1. WHAT IFIRMASTA IS AND WHAT IT IS USED FOR Ifirmasta belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin- II is a substance produced in the body which binds to receptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Ifirmasta prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Ifirmasta slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes. Ifirmasta is used in adult patients - to treat high blood pressure (_essential hypertension_) - to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IFIRMASTA DO NOT TAKE IFIRMASTA - 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 also better to avoid Ifirmasta in early pregnancy – see pregnancy section), - if you have diabetes or impaired kidney function and you are treated Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Ifirmasta 75 mg film-coated tablets Ifirmasta 150 mg film-coated tablets Ifirmasta 300 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Ifirmasta 75 mg film-coated tablets_ Each film-coated tablet contains 75 mg irbesartan (as hydrochloride). _Ifirmasta 150 mg film-coated tablets_ Each film-coated tablet contains 150 mg irbesartan (as hydrochloride). _Ifirmasta 300 mg film-coated tablets_ Each film-coated tablet contains 300 mg irbesartan (as hydrochloride). Excipient with known effect _Ifirmasta 75 mg film-coated tablets_ Each film-coated tablet contains 4 mg castor oil. _Ifirmasta 150 mg film-coated tablets_ Each film-coated tablet contains 8 mg castor oil. _Ifirmasta 300 mg film-coated tablets_ Each film-coated tablet contains 16 mg castor oil. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. White, oval tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ifirmasta is indicated in adults for the treatment of essential hypertension. It is also indicated for the treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen (see sections 4.3, 4.4, 4.5 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The usual recommended initial and maintenance dose is 150 mg once daily, with or without food. Ifirmasta at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg. However, initiation of therapy with 75 mg could be considered, particularly in haemodialysed patients and in the elderly over 75 years. 3 In patients insufficiently controlled with 150 mg once daily, the dose of Ifirmasta can be increased to 300 mg, or other antihypertensive agents can be added (see sections 4.3, 4.4, 4.5 and 5.1). In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Ifirmasta (see section Przeczytaj cały dokument