País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
Bendroflumethiazide; Potassium chloride
Leo Laboratories Limited
C03AB; C03AB01
Bendroflumethiazide; Potassium chloride
2.5/573 milligram(s)
Modified-release tablet
Product subject to prescription which may be renewed (B)
Thiazides and potassium in combination; bendroflumethiazide and potassium
Marketed
1978-04-01
1 PACKAGE LEAFLET: INFORMATION FOR THE USER CENTYL ® K 2.5 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, Centyl ® K modified-release tablets will be called Centyl K. WHAT IS IN THIS LEAFLET 1. What Centyl ® K is and what it is used for 2. What you need to know before you take Centyl ® K 3. How to take Centyl ® K 4. Possible side effects 5. How to store Centyl ® K 6. Contents of the pack and other information 1. WHAT CENTYL ® K IS AND WHAT IT IS USED FOR 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. 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 Centyl K is a supplement to replace some of the potassium you may lose. Centyl K is used to treat: • Oedema which occurs as a result of heart, kidney or liver problems. Oedema means that there is too much water in your body. Oedema can cause symptoms such as swollen ankles or trouble breathing. • 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 CENTYL ® K DO NOT TAKE CENTYL K If y Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Centyl K 2.5 mg/573 mg modified-release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2.5mg of bendroflumethiazide and 573mg of potassium chloride. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Modified-release tablet Green, film-coated, oval shaped tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Centyl K is indicated as a diuretic: • In the management of oedema such as that which arises from cardiac, renal or hepatic origin. • In the management of hypertension alone or in combination with other antihypertensives. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Hypertension:_ 1-2 tablets once daily. _Oedema:_ Initial dosage 1-4 tablets once daily. Maintain with 1-2 tablets daily. Method of administration For oral administration. Centyl K should be taken in the morning to avoid nocturia. The tablets should be taken with or after meals with at least a full glass of water or other 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. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Leia o documento completo