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Composition: 500 mg: Each film-coated tablet contains as active ingredient secnidazole 500 mg.

Indications And Usage: Urethritis and vaginitis caused by Trichomonas vaginalis • Intestinal amoebiasis • Hepatic amoebiasis • Giardiasis

Contraindications: Hypersensitivity to imidazole derivatives. • Pregnant and breastfeeding women (see Pregnancy and Lactation).

Dosage & Administration: Urethritis and vaginitis caused by Trichomonas vaginalis:Adults: 2 g in a single dose before meals. intestinal amoebiasis: Acute, symptomatic amoebiasis (histolytica form): Adults: 2 g in a single dose before meals. Asymptomatic amoebiasis (minuta and cystica forms): same daily dose for 3 days. Hepatic amoebiasis: Adults: 1.5 g per day in one or more doses before meals, for 5 days. Children above 6 years: 30 mg/kg/day in one or more doses before meals, for 5 days In the suppurative phase of hepatic amoebiasis: combine secnidazole treatment with removal of pus or lancing of abscesses Giardiasis: Children: 30 mg/kg/day in a single dose in a single day.

How Supplied: Fladazole® 500 mg : strips of 4 tablets in packs of 1 strip

Precautions: Alcoholic drinks should be avoided during secnidazole treatment. Do not administer to subjects with a history of blood dyscrasia. Drug and other interactions Contraindicated combination therapy Disulfiram: Delirious episodes, confusion. Alcohol: Hotness, redness, vomiting, tachycardia. Avoid alcoholic drinks and alcohol-containing medicine. Combinations subject to precautions + Oral anticoagulants (warfarin): Potentiation of the oral anticoagulant and increased risk of hemorrhage by lowering of its hepatic catabolism. More frequent determination of the prothrombin time and monitoring of the INR. Adjustment of the oral anticoagulant dose during secnidazole treatment and 8 days after its withdrawal.

Pregnancy & Lactation: Pregnancy No teratogenic effects is observed during animal experimentation. However, in view of the absence of data in humans, it is not recommended to take secnidazole during pregnancy Lactation Secnidazole is excreted in breast milk. Effects on the ability to drive vehicles and operate machinery Rare cases of dizziness have been reported with imidazole derivatives.

Adverse Effects: The following undesirable effects seen with imidazole derivatives may occur:Most frequently: digestive disorders, with abdominal pain, change in taste (metallic), glossitis, stornatitis.. Urticaria. Moderate leucopenia, reversible upon withdrawal of treatment.