ROSICED Cream Ref.[6988] Active ingredients: Methronidazole

Avoid contact with the eyes or any mucocutaneous application. If contact occurs, the cream should be washed out carefully with water.

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

UV exposure (sunbathing, solarium, sunlamp) should be avoided during the therapy with Rosiced cream.

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.

There is no adequate clinical data on efficacy and safety of Rosiced cream in children; therefore Rosiced cream should not be applied to children

ROSICED 7.5 mg/g Cream should be used with caution in patients with evidence or history of blood dyscrasia.

Unnecessary or 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.

ROSICED 7.5 mg/g Cream contains propylene glycol which may cause skin irritation.

Interactions with other topically applied medicinal products are not known.

Interaction with systemic medication is unlikely because absorption of metronidazole following cutaneous application of Rosiced cream is low.

Nevertheless, it should be mentioned that disulfiram-like reactions has 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.

The safety of the use of metronidazole during pregnancy is not sufficiently proven.

Contradictory reports are available especially regarding early pregnancy. Some studies have yielded indications of an increased rate of malformations. The risk of possible sequelae, including a carcinogenic risk, is not yet clarified.

In case of unrestricted use of nitroimidazoles by the mother, the foetus and/or neonate is exposed to a carcinogenic or genotoxic risk. So far, there is no proven evidence of a damage to embryo or foetus. In animal experimental studies, metronidazole did not exhibit any teratogenic properties (see. 5.3)

ROSICED 7.5 mg/g Cream is contraindicated during the first third of pregnancy. During the middle and the last third of pregnancy ROSICED 7.5 mg/g Cream should only be administered if other treatments have been unsuccessful.

Metronidazole passes into maternal milk. After oral administration, up to 100% of the plasma value can be reached. Following topical application of ROSICED 7.5 mg/g Cream the plasma levels are lower than after oral administration of metronidazole. Nevertheless, during lactation breast-feeding should either be interrupted or the treatment with ROSICED 7.5 mg/g Cream should be discontinued.

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

Immune system disorders

Rare: anaphylaxis

Skin and subcutaneous tissue disorders

Common: contact dermatitis, dry skin, erythema, pruritus, rash, skin discomfort (burning and stinging), skin irritation, worsening of rosacea

Rare: angio-edema

Nervous system disorder

Uncommon: hypothesia, paraesthesia

General disorders and administration site conditions:

Common: pain

Gastrointestinal disorders

Rare: metallic taste, nausea

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, website: www.mhra.gov.uk/yellowcard.

Not applicable.