Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
Phenoxymethylpenicillin potassium
Athlone Laboratories Ltd
J01CE; J01CE02
Phenoxymethylpenicillin potassium
125 mg/5ml
Powder for oral solution
Product subject to prescription which may not be renewed (A)
Beta-lactamase sensitive penicillins; phenoxymethylpenicillin
Marketed
1988-04-11
1 CCF21-008 RFI3 - 0015 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT KOPEN SUGAR FREE 125MG/5ML AND 250MG/5ML POWDER FOR ORAL SOLUTION PHENOXYMETHYLPENICILLIN 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, please 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 of the side effects, talk to your doctor or pharmacist, this includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Kopen Sugar Free Powder for Oral Solution is and what it is used for 2. What you need to know before you take Kopen Sugar Free Powder for Oral Solution 3. How to take Kopen Sugar Free Powder for Oral Solution 4. Possible side effects 5. How to store Kopen Sugar Free Powder for Oral Solution 6. Contents of the pack and other information 1. WHAT KOPEN SUGAR FREE POWDER FOR ORAL SOLUTION IS AND WHAT IT IS USED FOR The name of your medicine is Kopen Sugar Free Powder for Oral Solution. It is available as a pale yellow powder for reconstitution. The powder for reconstitution is prepared by the pharmacist before dispensing by adding water to the powder to give 100ml of oral solution. The reconstituted oral solution appears as a yellow solution with an orange odour and flavour. Phenoxymethylpenicillin, the active ingredient, is an antibiotic, which belongs to a group of medicines called penicillins, which are used to kill bacteria that cause infections in your body. Your medicine is used to: treat bacterial infections of the ear, throat, respiratory tract, skin and soft tissues prevent infections such as: infection occurring in patients without a spleen or in patients with sickle cell disease (a blood disorder) rheumatic fever. 2. WHAT YOU NEED TO KNOW BEFORE YOU TA Pročitajte cijeli dokument
Health Products Regulatory Authority 15 February 2022 CRN00CF1X Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Kopen Sugar Free 125mg/5ml Powder for Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml of Oral Solution contains 125mg of Phenoxymethylpenicillin as Phenoxymethylpenicillin Potassium. Excipients with known effect Sorbitol The 125mg/5ml solution contains 792.93 mg of sorbitol in each 5 ml dose. Sodium Benzoate (E211) Each 5ml of Oral Solution contains 16mg of Sodium benzoate (E 211). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for Oral Solution. A pale yellow granular powder 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For use in treatment of infections caused by susceptible staphylococci, pneumococci, gonococci, and haemolytic streptococci. Phenoxymethylpenicillin is also indicated for • Prophylaxis of pneumococcal infection (e.g. in asplenia and in patients with sickle cell disease). • Prophylaxis of rheumatic fever. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults: 250mg to 500mg every six hours depending on the severity of the condition. The elderly: as for adults Renal Impairment: Reduced dosage if renal function is markedly impaired. Prophylactic use: • Pneumococcal infection (e.g. asplenia) Adults: 500mg every 12 hours Children 6 - 12 years: 250mg every 12 hours Children <5 years: 125mg every 12 hours • Rheumatic fever 250 mg twice daily is recommended for long-term prophylaxis of rheumatic fever. Health Products Regulatory Authority 15 February 2022 CRN00CF1X Page 2 of 7 Children INFANTS (UP TO 1 YEAR): 62.5 mg every six hours. The total daily dose is 250mg in divided doses. Children 1 – 5 years: 125mg 6 hourly Children 6 – 12 years: 250mg 6 hourly Method of Administration For instructions on reconstitution on the medicinal product before administration, see section 6.6. For oral administratio Pročitajte cijeli dokument