Maa: Israel
Kieli: englanti
Lähde: Ministry of Health
POTASSIUM CHLORIDE
A.L. MEDI-MARKET LTD.
A12BA01
CAPSULES PROLONGED RELEASE
POTASSIUM CHLORIDE 600 MG
PER OS
Required
G.L. PHARMA GMBH, AUSTRIA
POTASSIUM CHLORIDE
Treatment and prevention of hypokalemia
2022-08-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 This medicine is dispensed with a doctor’s prescription only Micro Kalium Prolonged release capsules 600 mg Active ingredient: Each capsule contains: Potassium chloride 600 mg For inactive ingredients, please refer to section 6- -“Additional Information”. Read the leaflet carefully in its entirety before using the medicine. This leaflet contains concise information about the medicine. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar. Micro Kalium is not intended for children and adolescents under the age of 18. 1. What the medicine is intended for? For the treatment or prevention of low levels of potassium in the blood (hypokalemia). Additional intake of potassium can be necessary in patients who either do not get enough potassium through usual diet, or who have lost too much potassium due to a disease or treatment with certain medicines. The intake of too much potassium can lead to health problems as well. Therefore, it is important to take this medicine exactly according to your doctor's instructions. Micro Kalium capsules contain potassium chloride. It has a slow-release system that releases your medicine evenly throughout the day. Therapeutic group Potassium supplement 2. Before using the medicine Do not use this medicine if: • you are sensitive (allergic) to the active ingredient (potassium) or to any of the other ingredients this medicine contains (please refer to section 6-“Additional Information”). • you are hypersensitive to the administration of potassium, e.g. if you suffer from a disease called Adynamia episodica hereditaria (a congenital disease with suddenly appearing attacks of flaccid paralysis as well as increased potassium blood levels during such an attack) or Eulenburg disease (a congenital disease with muscular Lue koko asiakirja
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Micro Kalium prolonged-release capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 capsule contains 600 mg of potassium chloride corresponding to 8 mmol (315 mg) of potassium ions. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release capsule, hard Maroon opaque hard capsules 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Treatment and prevention of hypokalaemia. 4.2 Posology and method of administration Posology _ _ _Potassium deficiency prevention: _ The recommended dose is 16-24 mmol (2-3 capsules) daily. _Existing potassium deficiency treatment: _ The recommended dose is 16-32 mmol (2-4 capsules) 2-3 times daily. Overall: 32-96 mmol (4-12 capsules) daily. The dose should be adapted to serum potassium levels. _ _ _Children and adolescents _ The safety and effectiveness of Micro-Kalium have not been established for children and adolescents. Method of administration Oral use. The capsules should not be chewed and should be taken during or after meals with plenty of fluid. The capsules should also not be sucked. 4.3 Contraindications - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. - Hypersensitivity to a potassium dose, e.g. for adynamia episodica hereditaria and paramyotonia congenita. - All types of hyperkalaemia as a further potassium intake can lead to arrhythmias and even cardiac arrest. - Hyperkalaemia can also lead to complications in the following diseases: marked renal failure, diseases with considerable cell destruction (e.g. trauma, burns, severe haemolysis, rhabdomyolysis, dissolution of tumour tissue), untreated Addison's disease, hyporeninemic hypoaldosteronism and decompensated metabolic acidosis and acute dehydration states. - Marked renal failure even if there is no evident hyperkalaemia present. - Concomittant use of potassium-sparing diuretics (spironolactone, triamterene, amiloride). - As with all potassium preparations, this medicinal p Lue koko asiakirja