Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Indapamide
KRKA, d.d., Novo mesto
C03BA; C03BA11
Indapamide
1.5 milligram(s)
Prolonged-release tablet
Product subject to prescription which may be renewed (B)
Sulfonamides, plain; indapamide
Marketed
2012-02-03
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ICORVIDA SR 1.5 MG PROLONGED-RELEASE TABLETS indapamide 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 Icorvida SR is and what it is used for 2. What you need to know before you take Icorvida SR 3. How to take Icorvida SR 4. Possible side effects 5. How to store Icorvida SR 6. Contents of the pack and other information 1. WHAT ICORVIDA SR IS AND WHAT IT IS USED FOR Icorvida SR is a drug that reduces blood pressure by promoting the excretion of urine and by dilating blood vessels. Icorvida SR is used to treat increased blood pressure. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ICORVIDA SR DO NOT TAKE ICORVIDA SR - if you are allergic to indapamide or any of the other ingredients of this medicine or to other drugs of the same type (called sulphonamides) (listed in section 6). - if you have severe impairment of kidney function. - if you have severe impairment of liver or suffer from a condition called hepatic encephalopathy (degenerative disease of the brain). - if you have low level of potassium in your blood. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Icorvida SR. - if you have impairment of liver function. - if you have diabetes. - if you have gout. - if you have impairment of kidney function. - if you have any heart rhythm problems. - if you need to have a test to check how well your parathyroid gland is working. If you experience a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascu Прочитать полный документ
Health Products Regulatory Authority 09 May 2023 CRN00DGDT Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Icorvida SR 1.5mg Prolonged-release Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 1.5 mg indapamide. Excipient with known effect Each prolonged-release tablet contains 97.58 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release tablet White, round, slightly biconvex film coated-tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Icorvida SR is indicated in essential hypertension in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY One tablet per 24 hours, preferably in the morning, to be swallowed whole with water and not chewed. At higher doses the antihypertensive effect of indapamide is not enhanced but the excretion of salt is increased (saluretic effect). Special populations _Elderly_ In the elderly, this plasma creatinine must be adjusted in relation to age, weight and gender. Elderly patients can be treated with Icorvida SR when renal function is normal or only minimally impaired. _Renal impairment (see sections 4.3 and 4.4):_ In severe renal failure (creatinine clearance below 30 ml/min), treatment is contraindicated. Thiazide and related diuretics are fully effective only when renal function is normal or only minimally impaired. _Hepatic impairment (see sections 4.3 and 4.4):_ In severe hepatic impairment, treatment is contraindicated. _Paediatric population_ The safety and efficacy of Icorvida SR in children and adolescents have not been established. No data are available. Method of administration Indapamide is administered orally. 4.3 CONTRAINDICATIONS Indapamide is contraindicated in: hypersensitivityto the active substance, to other sulfonamides or to any of the excipients listed in section 6.1; Health Products Regulatory Authority 09 May 2023 CRN00DGDT Page 2 of 8 severe renal failure; hepatic encephalopathy or severe impairment of l Прочитать полный документ