ZIDOVAL * VAG GEL40G 7,5MG / G + 5AP

ZIDOVAL * VAG GEL40G 7,5MG / G + 5AP

Therapeutic indications

Zidoval vaginal gel is indicated for the treatment of bacterial vaginosis.

Dosage and method of use

Posology Administration by vaginal route.AdultsOne application of Zidoval vaginal gel (5 g) in the vagina once a day, before going to bed, for 5 consecutive days.Elderly patientsBacterial vaginosis is not common in elderly patients and consequently no clinical evaluation has been made in patients in this age group.Pediatric populationIn girls and adolescents under 18 years of age the use of the product is not recommended as the safety and efficacy have not been established.Method of administrationPierce the sealed end of the tube and screw the open end of the applicator tight. Squeeze the tube filling the applicator with gel. Remove the applicator from the tube and gently insert it into the vagina until it enters easily. Push the plunger to release the gel. Discard the applicator according to the instructions provided.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to other nitroimidazoles or parabens.

Side effects

Drug side effects are listed below by organ / system, class and frequency according to the following definitions: - very common (≥ 1/10), - common (≥ 1/100,

Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sosp etta-adverse-reaction.

Special warnings

Use during the menstrual period is not recommended. Known or previously undiagnosed candidiasis may manifest an accentuation of symptoms and require therapy with a specific agent during therapy with Zidoval vaginal gel. If irritation occurs, the patient should be advised to use metronidazole less frequently or to discontinue treatment temporarily and consult a physician if necessary. Metronidazole is a nitroimidazole and should be used with caution in patients with a history of blood dyscrasias. As with all vaginal infections, sexual intercourse should be avoided during infection and during treatment with Zidoval vaginal gel. Unnecessary and prolonged use of this medicine should be avoided. Evidence suggests that metronidazole is carcinogenic in some animal species. To date, there is no evidence of a carcinogenic effect in humans (see section 5.3 “Preclinical safety data”). Zidoval contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (may be delayed). Zidoval also contains propylene glycol which can cause skin irritation.

Pregnancy and breastfeeding

PregnancyData concerning the treatment of a large number of patients (several hundreds) during pregnancy have shown the absence of side effects of metronidazole affecting the fetus and the newborn; however, no specific studies have been performed with Zidoval vaginal gel in pregnant women. Therefore, caution should be exercised when prescribing to pregnant women.BreastfeedingThe ratio of plasma concentrations of vaginal Zidoval gel to those of oral metronidazole is approximately 0.02. Metronidazole is excreted in breast milk at concentrations similar to those in plasma and the ratio of plasma concentrations of metronidazole in the nursing infant to the mother is approximately 0.15. Caution should be exercised when prescribing Zidoval vaginal gel to breastfeeding women.

Expiration and retention

Store at a temperature not exceeding 25 ° C.

Interactions with other drugs

Oral metronidazole exhibits a similar reaction to that of disulfiram when combined with alcohol. Acute psychotic reactions and states of confusion have occurred during concomitant use of metronidazole and disulfiram. The possibility of such reactions, at the low serum concentrations achieved with the use of Zidoval vaginal gel, is unlikely, but cannot be excluded. Oral metronidazole has been shown to increase the plasma concentrations of warfarin and other coumarin anticoagulants resulting in a prolongation of prothrombin time. The effect of topical metronidazole on prothrombin time is unknown. It has also been shown to increase the concentrations of lithium, cyclosporine and 5-fluorouracil. Given the low plasma concentrations achieved after vaginal administration, similar effects are not expected, but cannot be completely excluded. Metronidazole can interfere with the determination of some blood chemistry values, such as aspartate aminotransferase (AST, SGOT), alanine aminotransferase (ALT, SGPT), lactic dehydrogenase (LDH), triglycerides and glucose hexokinase. Values close to zero can be observed.

Overdose

There are no reported cases of overdose in humans with Zidoval vaginal gel and there is no specific treatment. Metronidazole is readily removed from plasma by hemodialysis.

Active principles

Metronidazole 0.75% w / w, 7.5 mg / g Excipients with known effects: Methyl parahydroxybenzoate (E218) 0.8 mg / g Propyl parahydroxybenzoate (E216) 0.2 mg / g Propylene glycol (E1520) 30.0 mg / g. For the full list of excipients, see section 6.1.

Excipients

Carbomer (Carbopol) 974P, edetate disodium, methyl parahydroxybenzoate, propyl parahydroxybenzoate, propylene glycol, sodium hydroxide, purified water.