Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
Bendroflumethiazide; Potassium chloride
KARO PHARMA AB
C03AB; C03AB01
Bendroflumethiazide; Potassium chloride
1.25/573 milligram(s)
Modified-release tablet
Thiazides and potassium in combination; bendroflumethiazide and potassium
Marketed
1997-11-14
PACKAGE LEAFLET: INFORMATION FOR THE USER LOW CENTYL ® K 1.25 MG/573 MG MODIFIED-RELEASE TABLETS bendroflumethiazide/potassium chloride 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. - In this leaflet, Low Centyl ® K modified-release tablets will be called Low Centyl K. WHAT IS IN THIS LEAFLET 1. What Low Centyl® K is and what it is used for 2. What you need to know before you take Low Centyl® K 3. How to take Low Centyl® K 4. Possible side effects 5. How to store Low Centyl® K 6. Contents of the pack and other information 1. WHAT LOW CENTYL ® K IS AND WHAT IT IS USED FOR Low Centyl K contains two different types of active substances. One is called bendroflumethiazide, it is a diuretic (water tablet). The other active substance is called potassium chloride. It is a potassium supplement. The two medicines work at the same time in different ways. Low Centyl K works by removing any excess water from your body. It will make you go to the toilet more. This means you will also lose potassium from your body. The potassium chloride in Low Centyl K is a supplement to replace some of the potassium you may lose. Low Centyl K is used: To treat high blood pressure (hypertension). Your doctor may also decide to give you other blood pressure lowering medicines as well as this medicine. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOW CENTYL ® K DO NOT TAKE LOW CENTYL K: • If you are allergic (hypersensitive) to bendroflumethiazide or potassium chloride, or any of the other ingredients of this medicine (listed in section 6). • If yo Прочитайте повний документ
Health Products Regulatory Authority 27 October 2023 CRN00DQ8T Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Low Centyl K 1.25 mg/573 mg modified-release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1.25mg of bendroflumethiazide and 573mg of potassium chloride. For the full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Modified-release tablet. Light yellow, film-coated, oval shaped tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Low Centyl K is indicated in the management of hypertension alone or in combination with other antihypertensives. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults:_ Hypertension: 1 tablet daily. Method of administration For oral administration. The tablets should be taken with or after meals with at least a full glass of water or fluid. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Addison’s disease. Severe renal impairment or anuria (see section 4.4) Severe hepatic impairment (see section 4.4) Established arthritis urica. Severe dehydration electrolyte imbalance including hypercalcaemia, hyponatraemia, hyperchloraemia, hyperkalaemia or any situation which might lead to hyperkalaemia. Ulcer or obstruction of the gastrointestinal tract. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Hypersensitivity Bendroflumethiazide is a sulphonamide, which should be considered by prescribers in relation to hypersensitivity. Renal Impairment, Hepatic impairment and Urinary tract obstruction Thiazide diuretics should be used with caution in patients with mild or moderate renal or hepatic impairment and in patients with potential obstruction of the urinary tract (see section 4.3). Potassium levels With long-term treatment, potassium blood levels should be monitored and consideration should be given to fluid and electrolyte status especially in elderly patients. Depending on the results, potassium containing food or ext Прочитайте повний документ