METROSA Gel Ref.[27651] Active ingredients: Methronidazole

Contact with eyes and mucous membranes should be avoided. If eye-contact should occur, wash out of the eyes carefully with warm water.

If irritation does occur the patient should be advised to use Metrosa 0.75% Gel less frequently or to stop temporarily and to seek medical advice if necessary.

The UV exposure (sunbathing, solarium, sunlamp) should be avoided during the therapy with metronidazole. Metronidazole transforms into inactive metabolite due to UV exposure, therefore its efficacy decreases significantly. Phototoxic side-effects haven’t been reported in clinical trials in relation to metronidazole.

Metronidazole is a nitro imidazole and should be used with caution in patients with an evidence of, or history of blood dyscrasia.

The recommended duration of therapy should not be exceeded. If required, the therapy could be repeated, however the interval of 6 weeks in between should be considered.

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 preclinical safety data).

Metrosa 0.75% Gel contains propylene glycol, which may cause skin irritation.

Paediatric population

There is no adequate clinical data on efficacy and safety of Metrosa 0.75% Gel in children; therefore Metrosa 0.75 % Gel should not be applied to children.

Interaction with systemic medication is unlikely because absorption of metronidazole following cutaneous application of Metrosa 0.75% Gel is low.

Nevertheless, it should be mentioned that disulfiram-like reactions have been reported in small number of patients taking metronidazole and alcohol concomitantly.

Oral Metronidazole has been reported to potentiate the effect of warfarin and other coumarin anticoagulants, resulting in a prolongation of prothrombin time. The effect of topical Metronidazole on prothrombin time is unknown.

There has been no experience to date with the use of topical metronidazole in pregnant patients. In case of oral administration, metronidazole crosses the placental barrier and enters foetal circulation rapidly. No foetotoxicity was observed after oral metronidazole in either rats or mice. However, because animal reproduction studies are not always predictive of human response and since oral metronidazole has been shown to be a carcinogen in some rodents, this drug should be used in pregnancy only if clearly needed.

After oral administration metronidazole is secreted in breast milk in concentrations similar to those found in plasma. Even though blood levels are significantly lower with cutaneous application of metronidazole than those achieved after oral metronidazole in nursing mothers, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Based upon the pharmacodynamic profile and clinical experience performance related to driving and using machines should not be affected.

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, <1/10), Uncommon (≥1/1,000, <1/100), Rare (≥1/10,000, <1/1,000), Very rare (<1/10,000), including isolated reports.

Skin and subcutaneous tissue disorders

Common: dry skin, erythema, pruritus, rash, skin discomfort (burning, pain of skin/ stinging), skin irritation, worsening of rosacea

Unknown frequency: contact dermatitis

Nervous System disorders

Uncommon: hypoaesthesia, paraesthesia, dysgeusia (metallic taste)

General disorders

Common: pain

Gastrointestinal disorders

Uncommon: nausea

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization 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 national reporting system listed in Appendix V.

Not applicable.