ZIDOVAL 7.5 MG/G VAGINAL GEL
Zidoval vaginal gel is indicated for the treatment of bacterial vaginosis.
Dosage and method of use
Dosage Administration via vaginal route.AdultsOne application of Zidoval vaginal gel (5 g) into the vagina once a day, before going to bed, for 5 consecutive days.Elderly patientsBacterial vaginosis is not frequent in elderly patients and consequently a clinical evaluation has not been made in patients belonging to this age group.Pediatric populationIn girls and adolescents under 18 years of age the use of the product is not recommended as safety and effectiveness have not been established.Method of administrationPierce the sealed end of the tube and screw the open end of the applicator tightly. 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.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to other nitroimidazoles or parabens.
Undesirable drug effects are listed below by system organ/system, class and frequency according to the following definitions: - very common (≥ 1/10), - common (≥ 1/100,
|Infections and infestations
|Metabolism and nutrition disorders
|Depression, sleep disorders.
|Nervous System Pathologies
|Paresthesia, hypoesthesia, dysgeusia (metallic taste).
|Gastrointestinal disorders/abdominal cramps, vomiting, altered sense of taste and sensitivity of the tongue.
|Nausea, Diarrhea, constipation, meteorism/aerophagia, dry mouth.
|Pathologies of the skin and subcutaneous tissue
|Dry skin, erythema, pruritus, skin discomfort (burning, skin pain/stinging skin), skin irritation
|Pathologies of the musculoskeletal connective tissue system
|Renal and urinary disorders
|Discoloration of urine, symptoms of urinary tract infection.
|Reproductive and breast system pathologies
|Itching/irritation/burning/loss of vaginal sensation, pelvic discomfort, vaginal discharge.
|Vulvar edema, menstrual disorders/irregularities, vaginal discharge/bleeding.
|General pathologies and those relating to the administration site
Reporting of suspected adverse reactionsReporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product. 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-reazione-avversa.
Use during the menstrual period is not recommended. During therapy with Zidoval vaginal gel, known or previously undiagnosed candidiasis may result in worsening of symptoms and require therapy with a specific agent. If irritation occurs, the patient should be advised to use metronidazole less frequently or to discontinue treatment temporarily and to consult a doctor 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 the 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 may cause skin irritation.
Pregnancy and breastfeeding
PregnancyData relating to the treatment of a large number of patients (several hundreds) during pregnancy have demonstrated the absence of side effects of metronidazole on the fetus and newborn; however, no specific studies have been carried out with Zidoval vaginal gel on pregnant women. Therefore, caution should be exercised when prescribing to pregnant women.BreastfeedingThe ratio between the plasma concentrations of Zidoval vaginal gel and 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 breast-fed infant to that of the mother is approximately 0.15. Caution should be used when prescribing Zidoval vaginal gel to breastfeeding women.
Expiration and conservation
Store at a temperature not exceeding 25°C.
Interactions with other drugs
Oral metronidazole exhibits a reaction similar to that of disulfiram when combined with alcohol. Acute psychotic reactions and confusion have occurred during concomitant use of metronidazole and disulfiram. The possibility of similar 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 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 concentrations of lithium, cyclosporine, and 5-fluorouracil. Given the low plasma concentrations reached after vaginal administration, similar effects are not expected, but cannot be completely excluded. Metronidazole may interfere with the determination of some blood chemistry values, such as aspartate aminotransferase (AST, SGOT), alanine aminotransferase (ALT, SGPT), lactate dehydrogenase (LDH), triglycerides and glucose hexokinase. Values close to zero can be observed.
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.
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.
Carbomer (Carbopol) 974P, disodium edetate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, propylene glycol, sodium hydroxide, purified water.