Zidoval Gel Vaginale 0,75% Metronidazolo 40g + 5 Applicatori

Metronidazole-based gel.

Therapeutic indications

Zidoval Gel is used in the treatment of bacterial vaginosis.

Dosage and Posology

The drug is taken according to the following doses and methods: an application of Zidoval vaginal gel (5 g) in the vagina once a day, before going to bed, for 5 consecutive days. Instructions for use: Pierce 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 its full length into the vagina. Push the plunger to release the gel. Discard the applicator according to the instructions provided.

Bacterial vaginosis is not common in elderly patients and consequently no clinical evaluation has been made in patients in this age group. In 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.

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.

Contraindications

• Hypersensitivity to metronidazole, other nitroimidazoles, parabens or any other component of the gel.

Side effects

- Infections and infestations

• Common (> 1/100, <1/10): Vaginal candidiasis

- Metabolism and nutrition disorders

• Common (> 1/100, <1/10) Decreased appetite

- Psychiatric Disorders

• Uncommon (> 1/1000, <1/100) Depression, sleep disturbances

- Nervous System Pathologies

• Common (> 1/100, <1/10) Headache, dizziness
• Uncommon (> 1/1000, <1/100) Abnormal sensations in limbs, metallic taste

- Gastrointestinal disorders

• Common (> 1/100, <1/10) Gastrointestinal upset, abdominal cramps, nausea and / or vomiting, altered sense of taste and perception of flavors, decreased appetite
• Uncommon (> 1/1000, <1/100) Diarrhea, constipation, bloating / aerophagia, flatulence, dry mouth

- Skin and subcutaneous tissue disorders

• Uncommon (> 1/1000, <1/100) Pruritus

- Musculoskeletal system disorders of connective tissue

• Uncommon (> 1/1000, <1/100) Cramps

- Renal and urinary disorders

• Uncommon (> 1/1000, <1/100) Urine discoloration, symptoms of urinary tract infection

- Reproductive and mammary system disorders

• Common (> 1/100, <1/10) Vaginal candidiasis, vaginal itching / irritation / burning / numbness, pelvic discomfort, vaginal discharge
• Uncommon (> 1/1000, <1/100) Vulvar edema, menstrual disturbances / irregularities, vaginal discharge / bleeding

- General and administration site disorders

• Uncommon (> 1/1000, <1/100) Fatigue, irritability

Pregnancy and breastfeeding

Data 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.

The 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.

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. 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.

Expiration and retention

Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored. Store at a temperature not exceeding 25 ° C.

Warning : do not use the medicine after the expiry date indicated on the package.

Composition

Zidoval Gel contains:

Active principle

Metronidazole 0.75% w / w, 7.5 mg / g

Excipients

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