ZIDOVAL

Posology For vaginal administration. Adults One application of Metronidazole (5g) inserted into the vagina once daily, at bedtime, for 5 consecutive days. Elderly Bacterial vaginosis is not commonly seen in the elderly population and consequently clinical assessment in this age group has not been carried out.

Paediatric population Not recommended for use in children and adolescents under 18 years since safety and efficacy have not been established. Method of administration Pierce sealed end of tube and screw open end of applicator tightly onto tube of gel.

Squeeze tube, filling the applicator with gel. Remove applicator from tube and gently insert applicator into vagina as far as it will comfortably go. Push the plunger to release the gel. Dispose of applicator as instructed.

In controlled clinical trials involving 759 patients, the most commonly reported ADRs were urogenital (26%) and gastrointestinal (14%). The following 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, < 1/10) Uncommon (≥ 1/ 1,000, < 1/100) Rare (≥1/10,000, < 1/1,000) Very rare (<1/10,000), including isolated reports Infections and infestations Common: Vaginal candidiasis.

Metabolism and nutrition disorders Common:

Decreased appetite.

Psychiatric Disorders Uncommon:

Depression, difficulty sleeping.

Nervous system disorders Common:

Headache, dizziness.

Uncommon:

Paraesthesia, hypoesthesia, dysgeusia (metallic taste).

Gastrointestinal disorders Common:

GI discomfort/abdominal cramps, vomiting, unpleasant taste/unusual feeling on tongue.

Uncommon:

Diarrhoea, constipation, abdominal bloating/noises, nausea, dry mouth.

Skin and subcutaneous tissue disorders Common:

Dry skin, erythema, pruritus, skin discomfort (burning, pain of skin/stinging), skin irritation. Not known Urticaria.

Musculoskeletal and connective tissue disorders Uncommon:

Cramp.

Renal and urinary disorders Uncommon:

Use during menses is not recommended. Known or previously unrecognised candidiasis may present more prominent symptoms during therapy with metronidazole 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 metronidazole is not recommended.

Unnecessary and prolonged use of this medication should be avoided. Evidence suggests that metronidazole is carcinogenic in certain animal species. 3 preclinical safety data). Metronidazole contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).

Metronidazole also contains propylene glycol which may cause skin irritation.

1 or to other nitroimidazoles or parabens.