Country: Израел
Језик: Енглески
Извор: Ministry of Health
RIFAXIMINE
MEGAPHARM LTD
A07AA11
FILM COATED TABLETS
RIFAXIMINE 200 MG
PER OS
Required
ALFASIGMA S.P.A., ITALY
RIFAXIMIN
RIFAXIMIN
• Casual treatment of diseases of grown-ups and youngsters from 12 years up, caused by bacteria in the gastrointestinal tract, sensitive to Rifaximin:• hepatic encephalopathy • traveller’s diarrhea, caused by not-invasive enteropathogeneous bacteria.• Non-complicated diverticular diseases.
2018-03-31
1 _ _ PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a physician’s prescription only LORMYX 200 MG FILM-COATED TABLETS _ _ ACTIVE INGREDIENT: Each film-coated tablet contains: Rifaximin (polymorphic form α) 200 mg FOR A LIST OF INACTIVE AND ALLERGENIC INGREDIENTS, SEE SECTION 6 - “ADDITIONAL INFORMATION”. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, consult your physician 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. _ _ 1. WHAT IS THIS MEDICINE INTENDED FOR? LORMYX 200 MG is used for treating infections of the gastrointestinal tract caused by bacteria sensitive to the medicine: • Traveller's diarrhoea - TD • Brain damage due to chronic liver disease allowing toxic substances to reach the brain as a result of inability of the liver to remove them from the bloodstream (hepatic encephalopathy) • Non-complicated diverticular diseases (eversion of the intestinal wall) THERAPEUTIC GROUP:_ _An antibiotic used for treating gastrointestinal infections._ _ _ _ LORMYX 200 MG is a broad spectrum antibiotic belonging to the rifamycin group. The active ingredient, rifaximin (polymorphic form α), affects bacterial metabolism by inhibiting a bacterial enzyme called RNA-polymerase. LORMYX 200 MG acts mainly in the gastrointestinal tract. _ _ 2. BEFORE USING THE MEDICINE DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to the active ingredient, rifaximin (polymorphic form α), other derivatives of the rifamycin group or to any of the additional ingredients that the medicine contains (please see Section 6 "Additional information"). • If you are suffering from partial or complete intestinal blockage (ileus). SPECIAL WARNINGS REGARDING USE OF THE MEDICINE BEFORE TAKING LORMYX 200 MG, Прочитајте комплетан документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 ._ _ NAME OF THE MEDICINAL PRODUCT Lormyx 200 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 film-coated tablet contains: 200 mg Rifaximin (polymorphic form α) For the full list of excipients, see section 6.1. 3. FHARMACEUTICAL FORM Film-coated tablet Visual nature: pink, bi-convex film-coated tablet with a diameter of 10 mm 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS: > Causal treatment of illnesses in adults and youths from the age of 12 years up caused by bacteria in the gastro-intestinal tract, sensitive to Rifaximin: - Non-complicated diverticular diseases - Hepatic encephalopathy - Travellers' Diarrhoea caused by non-invasive enteropathogenic bacteria 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ADULTS AND YOUNG PEOPLE FROM THE AGE OF 12: _ ➢ _Travellers' Diarrhoea_: 2 - 3 times a day 1 - 2 Film-coated tablets Lormyx (corresponding to 400 – 1200 mg Rifaximin (polymorphic form α)) ➢ Non-complicated diverticular diseases, _Hepatic encephalopathy: _2 - 3 times per day 2 film- coated tablets Lormyx (corresponding to 800 - 1200 mg Rifaximin (polymorphic form α)) per treatment cycle. _CHILDREN _ The safety and effectiveness of Rifaximin (polymorphic form α) for children under the age of 12 has not been examined. Currently available data is described in Section 5.1. However, no recommendation can be made regarding the dosage. Method of administration The film-coated tablets have to be taken with sufficient liquid and must not be chewed. Taking the tablets does not depend on meals. Duration of treatment _Travellers' Diarrhoea_: _ _ If not otherwise specified by the doctor, the duration of the treatment for Travellers' Diarrhoea must not exceed 3 days. _Non-complicated diverticular diseases_, _Hepatic encephalopathy: _ The duration of a treatment cycle should not exceed 7 - 10 days. For acute treatment, a single treatment cycle is sufficient. As maintenance treatment, one cycle per month is carried out. Patients with liver and/or kid Прочитајте комплетан документ