Pajjiż: Malta
Lingwa: Ingliż
Sors: Medicines Authority
POTASSIUM CHLORIDE
Novartis Pharmaceuticals UK Limited Frimley Business Park, Frimley Camberley, Surrey GU16 7SR, United Kingdom
A12BA01
POTASSIUM CHLORIDE 600 mg
TABLET
POTASSIUM CHLORIDE 600 mg
POM
MINERAL SUPPLEMENTS
Withdrawn
2005-12-22
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SLOW-K ® 600 MG TABLETS 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 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 side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1 What Slow-K ® is and what it is used for 2 What you need to know before you take Slow-K 3 How to take Slow-K 4 Possible side effects 5 How to store Slow-K 6 Contents of the pack and other information 1 WHAT SLOW-K IS AND WHAT IT IS USED FOR WHAT SLOW-K IS Slow-K is available as 600 mg sugar-coated sustained release tablets containing potassium chloride. WHAT SLOW-K IS USED FOR Slow-K is intended for oral potassium supplementation to correct or prevent lack of potassium in the blood. Potassium supplements may be needed by patients who do not take enough potassium in their regular diet or who have lost too much potassium because of illnesses like diarrhoea, renal or intestinal diseases, muscle paralysis, anaemia or certain metabolic diseases or treatment with certain medicines. Slow-K is indicated in those patients who cannot tolerate or refuse to take liquid or effervescent potassium chloride. HOW SLOW-K WORKS Slow-K is a sustained-release formulation containing potassium chloride (KCl). This formulation controls the release of KCl so that adequate amounts of KCl are available in your body throughout the day. Potassium is fundamentally involved in many body processes, such as fluid balance, acid-alkali balance, protein synthesis, nerve conduction, energy production, muscle contraction, synthesis of nucleic acids and control of heartbeat and kidney function. MONITORING DURING YOUR T Aqra d-dokument sħiħ
Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT SLOW-K ® 600 mg sugar-coated sustained release tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One sugar-coated tablet contains 600 mg potassium chloride as active substance equivalent to 8 mmol potassium ion (K + ). 3 PHARMACEUTICAL FORM Slow-K 600 mg sugar-coated tablets are a prolonged-release dosage form for oral administration. Tablets 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Slow-K is indicated for the correction and/or prevention of hypokalaemia in patients who cannot tolerate or refuse to take liquid or effervescent potassium chloride, or when there is a problem of compliance with these preparations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION GENERAL RULES The usual dietary intake of potassium by the average adult is 50 to 100 mmol per day. As a rule, potassium depletion sufficient to cause hypokalemia does not occur until at least 200 mmol of potassium has been lost from the total body store. Dosage must be adjusted to the individual needs of each patient and to the cause and degree of the manifest or potential hypokalaemic state. Where intermittent diuretic therapy is being used, it is advisable to give Slow-K on the intervening days between administration of the diuretic. The sugar-coated tablets must not be crushed, chewed, or sucked, but should be swallowed whole during meals with an adequate amount of fluid while the patient is sitting upright. If the dosage exceeds 20 mmol K + , it should be taken in divided doses, so that not more than 20 mmol is given in a single dose. GENERAL POPULATION Adults Depending on the patient’s individual needs, a daily dosage of 2 to 3 sugar-coated tablets (16 to 24 mmol K + ) should generally suffice to prevent hypokalaemia. When correcting hypokalemia, doses of 40 to 50 up to 100 mmol K + (corresponding to 5 to 6 up to 12 sugar-coated tablets) may be required, depending on the initial plasma K + concentration. Page 2 of 9 Treatment response should preferably be monitored by Aqra d-dokument sħiħ