Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
piperaquine tetraphosphate, Artenimol
Alfasigma S.p.A.
P01BF05
piperaquine tetraphosphate, artenimol
Antiprotozoals
Malaria
Eurartesim is indicated for the treatment of uncomplicated Plasmodium falciparum malaria in adults, children and infants 6 months and over and weighing 5 kg or more.Consideration should be given to official guidance on the appropriate use of antimalarial agents.
Revision: 13
Authorised
2011-10-27
43 B. PACKAGE LEAFLET 44 PACKAGE LEAFLET: INFORMATION FOR THE USER EURARTESIM 160 MG/20 MG FILM-COATED TABLETS Piperaquine tetraphosphate/artenimol READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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. WHAT IS IN THIS LEAFLET : 1. What Eurartesim is and what it is used for 2. What you need to know before you or your child takes Eurartesim 3. How to take Eurartesim 4. Possible side effects 5. How to store Eurartesim 6. Contents of the pack and other information 1. WHAT EURARTESIM IS AND WHAT IT IS USED FOR Eurartesim contains the active substances piperaquine tetraphosphate and artenimol. It is used to treat uncomplicated malaria when use of a medicine given by mouth is appropriate. Malaria is caused by infection with a parasite called _Plasmodium_ , spread by the bite of an infected mosquito.There are different types of _Plasmodium_ parasite. Eurartesim kills the _Plasmodium _ _falciparum_ parasite. The medicine can be taken by adults, adolescents, children and infants over 6 months old who weigh 5 kilograms or more. 2. WHAT YOU NEED TO KNOW BEFORE YOU OR YOUR CHILD TAKES EURARTESIM DO NOT TAKE EURARTESIM IF YOU OR YOUR CHILD: • is allergic to the active substances, piperaquine tetraphosphate or artenimol, or to any of the other ingredients of this medicine (listed in section 6); • has a severe type of malaria infection which has affected parts of the body such as the brain, lungs or kidneys; • has a heart condition, such as changes to the rhythm or rate of heart beat, or heart disease; • knows that any member of your Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Eurartesim 160 mg/20 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 160 mg piperaquine tetraphosphate (as the tetrahydrate; PQP) and 20 mg artenimol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). White oblong biconvex film-coated tablet (dimension 11.5x5.5mm / thickness 4.4mm) with a break-line and marked on one side with the letters “S” and “T”. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Eurartesim is indicated for the treatment of uncomplicated _Plasmodium falciparum _ malaria in adults, adolescents, children and infants 6 months and over and weighing 5 kg or more. Consideration should be given to official guidance on the appropriate use of antimalarial medicinal products, including information on the prevalence of resistance to artenimol/piperaquine in the geographical region where the infection was acquired (see section 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Eurartesim should be administered over three consecutive days for a total of three doses taken at the same time each day. 3 Dosing should be based on body weight as shown in the table below. BODY WEIGHT (KG) DAILY DOSE (MG) TABLET STRENGTH AND NUMBER OF TABLETS PER DOSE PQP Artenimol 5 to <7 80 10 ½ x 160 mg / 20 mg tablet 7 to <13 160 20 1 x 160 mg / 20 mg tablet 13 to <24 320 40 1 x 320 mg / 40 mg tablet 24 to <36 640 80 2 x 320 mg / 40 mg tablets 36 to <75 960 120 3 x 320 mg / 40 mg tablets > 75* 1,280 160 4 x 320 mg / 40 mg tablets * see section 5.1 If a patient vomits within 30 minutes of taking Eurartesim, the whole dose should be re-administered; if a patient vomits within 30-60 minutes, half the dose should be re-administered. Re-dosing with Eurartesim should not be attempted more than once. If the second dose is vomited, alternative antimalarial therapy should be instituted. If a d Lesen Sie das vollständige Dokument