Regulatory Information
INTEGA PTE LTD
INTEGA PTE LTD
Therapeutic
Prescription Only
Formulation Information
SUPPOSITORY
**Posology and method of administration** _**Posology**_ Do not use without consulting a physician. If it is not advised otherwise by a physician; One ovule should be inserted at night and in the morning for 7 days. In recurrent cases, application of one ovule in the morning and one ovule at night for 14 days is recommended. It is not recommended that the administration of NEO-PENOTRAN® in the menstrual period because of the impaired efficacy of the product or facing some difficulties during administration. _**Method of administration**_ Only for intravaginal use. NEO-PENOTRAN® should be applied in lying position, high into the vagina. Not to be swallowed or applied by other routes. Additional information on special populations: _**Renal/Liver failure:**_ In renal failure, the half-life of metronidazole is not changed. In serious liver function failures, metronidazole clearance may be impaired. Metronidazole may increase encephalopathy symptoms due to increased plasma levels and therefore should be used carefully in hepatic encephalopathy patients. _**Paediatric population:**_ Not recommended for children. _**Geriatric population:**_ Same dose as for adults is administered in elderly over 65 years.
VAGINAL
Medical Information
**Therapeutic indications** It is used in the treatment of candidal vulvovaginitis due to Candida albicans, in bacterial vaginosis due to anaerobic bacteria and Gardnerella vaginalis, in trichomonal vaginitis due to Trichomonas vaginalis and in mixed vaginal infections.
**Contraindications** NEO-PENOTRAN® should not be used; - In patients known to be hypersensitive to the active ingredients or their derivatives, - In patients using alcohol during the treatment or at least 3 days after the treatment, - In patients using disulfiram during the treatment or within 2 weeks, - During the first trimester of pregnancy, - In pregnant women who have trichomonal vaginitis in the first trimester, - In cases of porphyria, epilepsy, and serious liver function disorders.
G01AF01
metronidazole
Manufacturer Information
INTEGA PTE. LTD.
Exeltis IIac San. Ve Tic. A.S.
Active Ingredients
Documents
Package Inserts
07b. Neo-Penotran Pessary PI Proposed Clean.pdf
Approved: November 12, 2020