Country: Israel
Language: English
Source: Ministry of Health
TINIDAZOLE
UNIPHARM LTD, ISRAEL
P01AB02
TABLETS
TINIDAZOLE 500 MG
PER OS
Required
UNIPHARM LTD, ISRAEL
TINIDAZOLE
For the oral treatment of Trichomonas Vaginals infections of the genito urinary tract in both female and male. For the prevention of anerobic infections after gynocological operations and stomach operations.
2019-03-03
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS) – 1986 The medicine is dispensed with a doctor’s prescription only PROTOCIDE FILM-COATED TABLETS ACTIVE INGREDIENT: Each tablet contains: Tinidazole 500 mg For the list of inactive and allergenic ingredients in the preparation, see section 6: ”Further information“ and section 2: ”Before using the medicine“. 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 to treat you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar to yours. 1. WHAT IS THE MEDICINE INTENDED FOR? For treatment of infections in the genitals and in the urinary tracts in both women and men, caused by trichomonas vaginalis. For prevention of infections by anaerobic bacteria after gynecological and abdominal surgeries. THERAPEUTIC GROUP: Azole antibiotics. 119148010 12C21 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: • You are sensitive )allergic( to tinidazole, to similar medicines, or to any of the additional ingredients contained in the medicine )see section 6: ”Further information“(. An allergic reaction can cause itching, skin rash or breathing difficulties with wheezing. • You are in the first trimester of pregnancy )the first 13 weeks of pregnancy(, are trying to become pregnant or are breastfeeding. • You suffer from a central nervous system disease, including epilepsy. • You suffer, or have suffered in the past, from an impairment in the blood system )blood dyscrasia(. SPECIAL WARNINGS REGARDING USE OF THE MEDICINE: Inform the doctor or pharmacist if you develop abnormal neurological signs )such as: dizziness, vertigo, difficulty in controlling movements( during treatment with PROTOCIDE, as you may be asked to stop treatment with the medicine. IF YOU ARE TAKING, OR IF YOU HAVE RECE Read the complete document
1. NAME OF THE MEDICINAL PRODUCT PROTOCIDE 500mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each PROTOCIDE 500mg Tablet contains 500mg of Tinidazole. 3. PHARMACEUTICAL FORM Orange, round, film-coated biconvex tablet 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS FOR THE ORAL TREATMENT OF TRICHOMONAS VAGINALIS INFECTIONS OF THE GENITOURINARY TRACT IN BOTH FEMALE AND MALE. FOR THE PREVENTION OF ANAEROBIC INFECTIONS AFTER GYNECOLOGICAL OPERATIONS AND STOMACH OPERATIONS.4.2 POSOLOGY AND METHOD OF ADMINISTRATION It is recommended that PROTOCIDE be taken during or after a meal _PREVENTION OF POSTOPERATIVE INFECTIONS: _ ADULT Oral: A single oral dose of 2 g approximately 12 hours before surgery. CHILDREN LESS THAN 12 YEARS Data are not available to permit dosage recommendations for prophylaxis of anaerobic infections in children below the age of 12 years. UROGENITAL TRICHOMONIASIS: When infection with Trichomonas vaginalis is confirmed, simultaneous treatment of the consort is recommended. ADULT PREFERRED REGIMEN A single oral dose of 2 g. ADULT ALTERNATIVE REGIMEN One 150 mg tablet orally three times daily for 5 days, or one 150 mg tablet orally twice daily for 7 days. CHILDREN A single dose of 50 to 75 mg/kg of body weight. It may be necessary to repeat this dose once in some cases. _ _ _USE IN RENAL IMPAIRMENT _ Dosage adjustments in patients with impaired renal function are generally not necessary. However, because tinidazole is easily removed by haemodialysis, patients may require additional doses of tinidazole to compensate. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. As with other drugs of similar structure, tinidazole is contraindicated in patients having, or with a history of, blood dyscrasia, although no persistent haematological abnormalities have been noted in clinical or animal studies. Tinidazole should be avoided in patients with organic neurological disorders. Tinidazole, other 5-nitroimidazole derivatives or any of the c Read the complete document