Rozex 0.75% 50g cream

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

Rozex 0.75% cream is indicated in the topical treatment of rosacea in its erythematous and papulopustular manifestations.

CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1.

WARNINGS AND PRECAUTIONS FOR USE

Avoid contact with eyes and mucous membranes. During therapy with metronidazole, avoid exposure to UV rays (exposure to sun rays, solariums and sun lamps). Metronidazole converts into an inactive metabolite as a result of UV exposure, therefore its effectiveness decreases significantly. No side effects of phototoxicity have been reported in clinical studies in relation to metronidazole. If a reaction due to local irritation should occur, it is advisable to reduce the number of daily applications of the drug or to suspend administration according to the doctor's opinion. Metronidazole is a nitroimidazole compound and should therefore be used with caution in patients with blood dyscrasia. Avoid unnecessary and prolonged use of this medicine. Metronidazole has been shown to be carcinogenic in some animal species. There are no data demonstrating its carcinogenic effect in humans. Important information about some excipients. Rozex 0.75% cream contains: cetylstearyl alcohol which may cause localized skin reactions (e.g. contact dermatitis). This medicinal product also contains 22 mg of benzyl alcohol (E1519) per gram, equivalent to 2.2% w/w, which may cause allergic reactions and mild local irritation.

INTERACTIONS

Considering the poor systemic absorption of Rozex 0.75% cream applied topically, negative interactions with other drugs are quantitatively irrelevant. Metronidazole administered orally can lead to an enhancement of the effects of anticoagulant drugs. An increase in prothrombin time has been observed after concomitant administration of oral metronidazole and an oral coumarin-type anticoagulant (Warfarin). The effect of topical metronidazole on prothrombin time is unknown. Furthermore, in a small number of patients taking oral metronidazole and alcohol at the same time, a reaction similar to that which occurs with Disulfiram occurred.

SIDE EFFECTS

Only mild local reactions occurred during topical use of Rozex 0.75% cream. The following spontaneous adverse reactions have been reported and these are ranked by frequency within system organ classes, according to 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) not known (frequency cannot be estimated from the available data) Pathology of the skin and subcutaneous tissue: Common: dry skin, erythema, pruritus, skin discomfort (burning, skin pain, stinging), skin irritation, worsening of rosacea. Not known: contact dermatitis, skin exfoliation, facial swelling. Nervous system disorders: Uncommon: hypoesthesia, paraesthesia, dysgeusia (metallic taste).Gastrointestinal disorders: Uncommon: nausea. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous 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 at www.agenziafarmaco.gov.it/it/responsabili.