Țară: Israel
Limbă: engleză
Sursă: Ministry of Health
POTASSIUM CHLORIDE
TRUSTPHARM LTD, ISRAEL
A12BA01
CAPSULES PROLONGED RELEASE
POTASSIUM CHLORIDE 600 MG
PER OS
Required
DESMA GMBH , GERMANY
POTASSIUM CHLORIDE
Treatment and prevention of hypokalemia.
2022-08-28
Page 1 of 5 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only KALINOR-RETARD 600 MG PROLONGED-RELEASE HARD CAPSULES ACTIVE INGREDIENT Each capsule contains 600 mg potassium chloride Potassium content, 315 mg, corresponds to 8 mmol = 8 mval K + . Inactive ingredients and allergens: See section 2 "Important information about some of this medicine’s ingredients" and section 6 "Additional information". READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? For prophylaxis and treatment of low blood potassium levels (hypokalaemia). THERAPEUTIC GROUP: mineral/potassium for normalisation of potassium balance. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: − You are sensitive (allergic) to potassium chloride or to any of the other ingredients in this medicine (see section 6). − In case of diseases that are commonly linked to an increase in blood potassium level above the normal level (hyperkalaemia): − restricted excretory kidney function (reduced excretion capability of the kidneys) − dehydration (lack of body water as a result of disruption of the water-salt balance) − Addison’s disease (primary adrenal insufficiency, inadequate function of the adrenal gland cortex) − Adynamia episodica hereditaria (Gamstorp disease, a rare congenital disease with attacks of flaccid paralysis with elevated blood potassium concentration) − sickle cell anaemia (a disorder of haemoglobin formation) − metabolic imbalances in the acidic range, e.g. diabetic acidosis (hyperacidity of the blood in case of diabetes) − In case of an elevated blood potassium level due Citiți documentul complet
1. NAME OF THE MEDICINAL PRODUCT KALINOR-RETARD 600 MG 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Potassium chloride. 1 prolonged-release capsule, hard, contains: 600 mg potassium chloride, microencapsulated (potassium content 315 mg corresponds to 8 mmol = 8 mval K + ). Excipients with known effect: Sodium (less than 1 mmol) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release capsule, hard. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment and prevention of hypokalemia. 4.2 POSOLOGY, METHOD AND DURATION OF ADMINISTRATION Posology: Dosage is to be adapted to the individual conditions. The following guidelines apply: For prophylaxis of a potassium deficiency in general, 2–3 capsules Kalinor-retard 600 mg daily (corresponding to 16–24 mmol K + ). For treatment of a potassium deficiency, 4-12 capsules Kalinor- retard 600 mg daily (corresponding to 32-96 mmol K + ). A daily dose of more than 2 capsules should be divided into two or three individual doses of 2-4 tablets (16-32 mmol K + ). The dosage should be adapted to serum potassium levels of individual patient. If the cause of a potassium deficit cannot be determined, ongoing replacement is recommended. In other cases of potassium deficiency, days to weeks often suffice to balance the potassium deficit. Paediatric population There is no indication for use in children and adolescent for Kalinor-retard 600 mg. Method of administration: The capsules should be swallowed whole at mealtimes with plenty of fluid (at least the equivalent of a water glass full). The capsules can be opened if there are swallowing problems. The content (controlled-release micropellets) is taken in a liquid suspension or in semi-solid food. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or any of the excipients listed in section 6.1. The preparation should not be used in the case of diseases that are often linked to hyperkalaemia: - dehydration - restricted excretory kidney function - Addison's disease - Citiți documentul complet