Country: United Kingdom
Bahasa: Inggeris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Indapamide
Krka UK Ltd
C03BA11
Indapamide
1.5mg
Modified-release tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02020100; GTIN: 5391512450588
PACKAGE LEAFLET: INFORMATION FOR THE USER RAWEL XL PROLONGED-RELEASE TABLETS 1.5 MG INDAPAMIDE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Rawel XL is and what it is used for 2. Before you take Rawel XL 3. How to take Rawel XL 4. Possible side effects 5. How to store Rawel XL 6. Further information 1. WHAT RAWEL XL IS AND WHAT IT IS USED FOR Rawel XL is a drug that reduces blood pressure by promoting the excretion of urine and by dilating blood vessels. Rawel XL is used to treat increased blood pressure. 2. BEFORE YOU TAKE RAWEL XL DO NOT TAKE RAWEL XL • If you are allergic (hypersensitive) to indapamide or any of the other ingredients of Rawel XL or to other drugs of the same type (called sulphonamides). • If you have severe impairment of kidney function. • If you have severe impairment of liver function. • If you have a low level of potassium in your blood. TAKE SPECIAL CARE WITH RAWEL XL • If you have impairment of liver function. • If you have disorders of blood electrolyte levels or body water depletion. • If you have diabetes. • If you have gout. • If you have impairment of kidney function. • If you have a skin reaction when exposed to sunlight. • If you are an athlete. Rawel XL can interfere with results of doping tests. • You should monitor your blood pressure and heart rate regularly during treatment. • If you are an elderly person, your doctor will check your kidney function before the start of therapy. • If you are a child or an adolescent, this medicine is not recommended for you. Your doctor will give you a detailed Baca dokumen lengkap
OBJECT 1 RAWEL XL PROLONGED-RELEASE TABLETS 1.5 MG Summary of Product Characteristics Updated 20-May-2016 | Consilient Health Ltd 1. Name of the medicinal product Rawel XL prolonged-release tablets 1.5 mg 2. Qualitative and quantitative composition Each prolonged-release tablet contains 1.5 mg indapamide. Also contains lactose monohydrate 97.58 mg. For a full list of excipients, see 6.1. 3. Pharmaceutical form Prolonged-release tablet White, round, slightly biconvex. 4. Clinical particulars 4.1 Therapeutic indications Essential hypertension. 4.2 Posology and method of administration Indapamide is administered orally. One tablet should be taken once a day, preferably in the morning. It should 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). In the elderly, this plasma creatinine must be adjusted in relation to age, weight and gender. Elderly patients can be treated with Rawel XL when renal function is normal or only minimally impaired. Rawel XL is not recommended for use in children and adolescents due to lack of data on safety and efficacy. Renal failure (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. Patients with hepatic impairment (see sections 4.3 and 4.4): In severe hepatic impairment, treatment is contraindicated. 4.3 Contraindications Indapamide is contraindicated in: • Hypersensitivity to indapamide, to other sulfonamides or to any of the excipients • Severe renal failure • Hepatic encephalopathy or severe impairment of liver function • Hypokalaemia 4.4 Special warnings and precautions for use _WARNING_ In patients with impaired liver function, thiazide-related diuretics may cause hepatic encephalopathy particularly in case of electrolyte imbalance. Administration of the diuretic must Baca dokumen lengkap