Ülke: İsrail
Dil: İngilizce
Kaynak: Ministry of Health
AMOXICILLIN TRIHYDRATE
TEVA ISRAEL LTD
J01CA04
CAPSULES
AMOXICILLIN TRIHYDRATE 500 MG
PER OS
Required
TEVA CANADA LIMITED
AMOXICILLIN
AMOXICILLIN
Infections caused by amoxycillin - susceptible organisms. Prevention of bacteremia in patients at risk of developing bacterial endocarditis.
2024-01-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor’s prescription only MOXYPEN ® FORTE 500 MG CAPSULES COMPOSITION: Each capsule contains: Amoxicillin (as trihydrate) 500 mg For information on the inactive and allergenic ingredients, see section 2 – “Important information about some of the ingredients of the medicine” and section 6 – “Further Information”. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for the treatment of your ailment. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. 1. WHAT IS THIS MEDICINE INTENDED FOR? The medicine is intended for the treatment of infections caused by bacteria susceptible to amoxicillin. In addition, it is intended for the prevention of bacterial infections in patients who are at risk for developing bacterial endocarditis. THERAPEUTIC GROUP Antibiotic of the penicillins group. There are infections caused by viruses, such as the common cold. Moxypen Forte 500 mg Capsules does not affect viruses. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: • You are sensitive (allergic) to the active ingredient or to any of the additional ingredients contained in the medicine. • You are sensitive to the packaging components of the medicine. • You are sensitive to other medicines from the penicillin or cephalosporin group or to similar antibiotics such as amoxicillin, ampicillin, cephalexin and others. • You are suffering from mononucleosis (either suspected or confirmed). SPECIAL WARNINGS REGARDING USE OF THE MEDICINE BEFORE TREATMENT WITH MOXYPEN FORTE 500 MG CAPSULES, TELL THE DOCTOR IF: • You have suffered in the past from an allergic reaction to beta-lactam antibiotics (such as ampicillin, piperacillin). See section 4 – “S Belgenin tamamını okuyun
Moxypen forte 500mg capsules & 250mg powder for suspension SPC, NA& OKD 08/2023 1 SUMMARY OF PRODUCT CHARACTERISTICS NAME OF THE MEDICINAL PRODUCT Moxypen Forte 500 mg Capsules Each capsule contains: Amoxicillin (as Trihydrate) 500 mg Moxypen Forte 250 mg Powder for Suspension Each teaspoonful (5 ml) of suspension contains: Amoxicillin (as Trihydrate) 250 mg 1. THERAPEUTIC INDICATIONS Infections caused by amoxicillin ‐ susceptible organisms. Prevention of bacteremia in patients at risk of developing bacterial endocarditis. THERAPEUTIC CLASSIFICATION Antibiotic 2 CONTRAINDICATIONS Moxypen Forte is contraindicated in: patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. • patients with a history of a previous hypersensitivity reaction to any of the penicillins or cephalosporins. • in cases where infectious mononucleosis is either suspected or confirmed. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Box Hypersensitivity: Serious and occasionally fatal hypersensitivity (anaphylactic) and severe cutaneous adverse reactions (SCAR) have been reported in patients receiving therapy with beta‐lactams, including amoxicillin. (See _7_ WARNINGS AND PRECAUTIONS, Hypersensitivity and 7 WARNINGS AND PRECAUTIONS, Skin). Moxypen forte 500mg capsules & 250mg powder for suspension SPC, NA& OKD 08/2023 2 4 DOSAGE AND ADMINISTRATION With the exception of gonorrhea, treatment with Moxypen should be continued for a minimum of 48‐72 hours beyond the time at which the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. In the treatment of group A β‐hemolytic streptococcal infections, therapy with this drug should be continued for at least 10 days to help prevent the occurrence of acute rheumatic fever or glomerulonephritis. Upper Respiratory Tract and Chest Infections _Adults and Children over 10 Years of Age: _ The recommended dosage is 250‐500 mg 3 times daily, every 8 hours. _Infants and Children Belgenin tamamını okuyun