ZIDOVAL Vaginal gel Ref.[50031] Active ingredients: Methronidazole

Use during menses is not recommended.

Known or previously unrecognised candidiasis may present more prominent symptoms during therapy with Zidoval vaginal gel and may require treatment with a candicidal agent.

If irritation does occur the patient should be advised to use metronidazole less frequently or to stop temporarily and to seek medical advice if necessary.

Metronidazole is a nitroimidazole and should be used with care in patients with evidence of a history of blood dyscrasias.

As with all vaginal infections, sexual intercourse during the infection and during treatment with Zidoval vaginal gel is not recommended.

Unnecessary and prolonged use of this medication should be avoided. Evidence suggests that metronidazole is carcinogenic in certain animal species. There is no evidence to date of a carcinogenic effect in human (see section 5.3 preclinical safety data).

Zidoval contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).

Zidoval also contains propylene glycol which may cause skin irritation.

Oral metronidazole has been associated with a disulfiram-like reaction in combination with alcohol. Acute psychotic reactions and confusion have occurred during concomitant use of disulfiram with oral metronidazole. At the low serum concentrations which result from the use of Zidoval vaginal gel, the possibility of similar reactions is unlikely although 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 plasma concentrations of lithium, cyclosporin and 5-fluorouracil. Similar effects after vaginal administration of metronidazole are not expected due to the low plasma concentrations but cannot be completely ruled out.

Metronidazole may interfere with certain types of determination of serum chemistry values, such as aspartate aminotransferase (AST, SGOT), alanine aminotransferase (ALT, SGPT), lactic dehydrogenase (LDH), triglycerides and hexokinase glucose. Values of zero may be observed.

Pregnancy

Data on a large number (several hundred) of exposed pregnancies indicate no adverse effects of metronidazole on the foetus/newborn child. There have been no formal studies with Zidoval vaginal gel in pregnant women. Caution should, therefore, be exercised when prescribing to pregnant women.

Breastfeeding

The ratio of serum concentrations of Zidoval vaginal gel/oral metronidazole is approximately 0.02. Metronidazole is excreted in milk at concentrations similar to those in maternal serum and the ratio of serum concentrations of metronidazole in the breastfed infant/mother is approximately 0.15. Caution should be exercised when prescribing to lactating women.

Zidoval has no influence on the ability to drive and use machines.

In controlled clinical trials involving 759 patients, the most commonly reported ADRs were urogenital (26%) and gastrointestinal (14%).

The following spontaneous adverse experiences have been reported, and within each system organ class, are ranked by frequency, using the following convention: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

None known.