ZIDOVAL VAG GEL40G 7.5MG/G+5AP

ZIDOVAL 7,5 MG/G GEL VAGINATION

active ingredients

Metronidazole 0.75% p/p, 7.5 mg/g Excipients with known effects: Metil parahydroxybenzoate (E218) 0,8 mg/g Propil parahydroxybenzoate (E216) 0.2 mg/g propylene glycol (E1520) 30,0 mg/g. For the full list of excipients, see paragraph 6.1.

Excellent

Carbomer (Carbopol) 974P, hedetate disode, methyl parahydroxybenzoate, propile parahydroxybenzoate, propylene glycol, sodium hydroxide, purified water.

Therapeutic indications

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

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1 or to other nitroimidazoles or parabens.

Population

Posology Vaginal administration. Adults An application of Zidoval vaginal gel (5 g) in vagina once a day, before going to bed, for 5 consecutive days. Older patients Bacterial vaginosis is not frequent in older patients and therefore no clinical evaluation has been made in patients belonging to this age group.Pediatric population In 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 administration Drill the sealed end of the tube and screw the open end of the applicator well. Press the tube by filling the applicator with the 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.

Conservation

Store at a temperature not exceeding 25°C.

Warnings

The use during the menstrual period is not recommended. During the therapy with Zidoval vaginal gel a candid note or previously undiagnosed can manifest a warning of symptoms and require therapy with a specific agent. If irritation occurs, the patient should be advised to use the metronidazole less frequently or to stop the treatment temporarily and to consult a doctor if necessary. Metronidazole is a nitroimidazole and should be used with caution in patients with anamnesi of hematic disorders. As with all vaginal infections, they are to avoid sexual intercourse during the infection and during treatment with Zidoval vaginal gel. The non-necessary and prolonged use of this medicine must be avoided. The evidence suggests that metronidazole is carcinogenic in some animal species. To date, there is no evidence of a carcinogenic effect in man (see paragraph 5.3 “Preclinical Safety Data”). Zidoval contains methyl parahydroxybenzoate and propyl parahydroxybenzoate that can cause allergic reactions (can be delayed). Zidoval also contains propylene glycol that can cause skin irritation.

Interactions

The oral metronidazole has a reaction similar to that of the disulfiram when associated with alcohol. During the concurrent use of metronidazole and disulfiram acute psychotic reactions and states of confusion were manifested. The possibility of similar reactions, at low serum concentrations reached with the use of Zidoval vaginal gel, is unlikely, but cannot be excluded. It has been shown that oral metronidazole increases the plasma concentrations of warfarin and other cumin anticoagulants resulting in an extension of protrombine time. The effect of the topical metronidazole on the protrombine time is not known. It has also been shown that it increases the concentrations of lithium, cyclosporin and 5-fluorouracil. Given the low plasma concentrations reached after vaginal administration, such effects are not expected, but cannot be completely excluded. Metronidazole can interfere with the determination of certain hematochemical values, such as aspartate aminotransferase (AST, SGOT), alanine aminotransferase (ALT, SGPT), lactic deidrogenase (LDH), triglycerides and exokinase glucose. You can observe values close to zero.

Effects

The side effects of the drug are listed below by organ/system, class and frequency according to the following definitions: - very common (≥ 1/10), - common (≥ 1/100, Infections and infestations Municipalities Vaginal candidosis. Disorders of metabolism and nutrition Municipalities Reduced appetite. Psychiatric disorders Not common Depression, sleep disorders. Nervous System pathologies Municipalities Cephalea, dizziness. Not common Parestesia, hypoesthesia, disgeusia (metal sapore). Gastrointestinal diseases Municipalities Abdominal gastrointestinal/cramp disorders, vomiting, alteration of taste and language sensitivity. Not common Nausea, Diarrea, stipsi, meteorism/aerophagia, dry mouth. Pathologies of skin and subcutaneous tissue Municipalities Skin dryness, erythema, itching, skin discomfort (burner, skin pain / skin stinging pain), skin irritation Notable Orticaria Connective tissue skeletal muscle system pathologies Not common Cramps. Kidney and urinary pathologies Not common Urine discoloration, symptoms of urinary tract infection. Pathologies of reproductive and mammary system Municipalities Prurito/irritation/burner/ loss of vaginal sensitivity, pelvic disorders, vaginal losses. Not common Edema vulvare, disorders/irregularities, vaginal bleeding/loss. General and administrative pathologies Not common Fatigue, irritability. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sosp ect-reaction-adversa.

Overdosing

There are no cases of overdose in man with Zidoval vaginal gel and there is no specific treatment. The metronidazole is promptly removed from the plasma with hemodialysis.

Pregnancy

Data concerning the treatment of a large number of patients (different hundreds) during pregnancy showed the absence of side effects of metronidazole at the expense of the fetus and the newborn; however specific studies have not been carried out with Zidoval vaginal gel on pregnant women. Therefore, caution is required in prescription to pregnant women.

Breastfeeding

The relationship between the plasma concentrations of Zidoval vaginal gel and those of oral metronidazole is about 0.02. The metronidazole is excreted in breast milk at concentrations similar to those of plasma and the ratio of plasma concentrations of metronidazole in the breast-feededed child compared to the mother is about 0.15. Prescribe Zidoval vaginal gel to nursing women.

Source: Farmadati