Metronidazole Same 1% 30g gel

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

INDICATIONS

METRONIDAZOLE SAME is indicated for topical application in the treatment of inflammatory papules, pustules and erythema of rosacea.

CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the excipients. Contraindicated during pregnancy and breastfeeding (see p.4.6).

WARNINGS AND PRECAUTIONS FOR USE

However, due to the minimal absorption of Metronidazole applied locally and, consequently, the negligible plasma concentrations, the side effects reported following oral administration of the drug were not recorded following topical application. Avoid contact with eyes and mucous membranes; Metronidazole applied to the face has been reported to cause tearing. In case of contact with eyes, the gel must be carefully removed with water. The patient should be informed that if irritation occurs, he or she should use Metronidazole Same less frequently or temporarily suspend therapy and inform the doctor. Avoid exposure to ultraviolet light (sun, UV lamps, tanning equipment) during therapy with Metronidazole Same. Since the drug is a nitroimidazole derivative it must be used with caution in patients presenting with blood dyscrasias or with anamnestic data relating to them. The product must be used according to the instructions provided by the treating doctor. Do not exceed the recommended doses. The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena. There are no adequate clinical data on the efficacy and safety of Metronidazole Same in children, therefore Metronidazole Same should not be used in children. Do not ingest. Keep out of reach of children. This medicine contains methyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed).

INTERACTIONS

In consideration of the low blood levels resulting from the topical application of Metronidazole, interactions with other drugs are unlikely. However, it must be remembered that disulfiram-like reactions have been reported in a small number of patients taking metronidazole and alcohol at the same time and in the case of treatment of patients undergoing anticoagulant therapy at the same time, it must be kept in mind that Metronidazole, following oral administration, determines an enhancement of the anticoagulant effects of coumarins and warfarin which manifests itself by inducing a prolongation of the prothrombin time. The effect of topical metronidazole on prothrombin time is not known.

SIDE EFFECTS

Following the use of topical Metronidazole, the following side effects have been reported: Skin and subcutaneous tissue disorders: contact dermatitis, dry skin, erythema, itching, rash, skin discomfort (burning and stinging sensation), skin irritation, transient redness and worsening of rosacea. Eye disorders: tearing. None of these side effects occurred in more than 2% of treated patients. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse