ROZEX

Posology For topical administration only. The average period of treatment is three to four months. The recommended duration of treatment should not be exceeded. However, if a clear benefit has been demonstrated, continued therapy for a further three to four months period may be considered by the prescribing physician depending on the severity of the condition.

In clinical studies, topical metronidazole therapy for rosacea has been continued for up to 2 years. In the absence of a clear clinical improvement, therapy should be stopped.

Older people:

The dosage recommended in the elderly is the same as that recommended in adults.

Paediatric population:

Not recommended. Safety and efficacy have not been established. Method of administration Rozex Gel should be applied in a thin layer to the affected areas of the skin twice daily, morning and evening. Areas to be treated should be washed with a mild cleanser before application.

Patients may use non-comedogenic and non-astringent cosmetics after application of Rozex Gel.

Because of the minimal absorption of metronidazole and consequently its insignificant plasma concentration after topical administration, the adverse experiences reported with the oral form of the drug have not been reported with Rozex Gel.

Adverse reactions reported with Rozex Gel have been only local and mild. System Organ Frequency Adverse drug reaction Class Common ( ≥ 1/100, < 1/10) Dry skin, erythema, pruritus, skin discomfort (burning, pain of skin/stinging), skin irritation, worsening of rosacea.

Skin and subcutaneous tissue disorders Unknown frequency Contact dermatitis, swelling face, skin exfoliation Nervous system disorders Uncommon (≥ 1/ 1,000, < 1/100) Hypothesia, paraesthesia, dysgeusia (metallic taste) Gastrointestinal disorders Uncommon (≥ 1/ 1,000, < 1/100) Nausea Watery eyes have been reported if applied too closely to this area.

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. uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store.

Contact with mucous membranes should be avoided. Rozex Gel has been reported to cause lacrimation of the eyes, therefore, contact with the eyes should be avoided. If a reaction suggesting local irritation occurs patients should be directed to use the medication less frequently or discontinue use temporarily and to seek medical advice if necessary.

Metronidazole is a nitroimidazole and should be used with care in patients with evidence of, or history of, blood dyscrasia. g. solarium, sun-lamp) or strong sunlight (including sun-bathing) should be avoided during use of 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. Unnecessary and prolonged use of this medication should be avoided.

Evidence suggests that metronidazole is carcinogenic in certain animal species. 3). This product contains methyl hydroxybenzoate (E218) and propyl hydroxybenzoate (E216) which may cause allergic reactions (possibly delayed). This product contains 30mg propylene glycol (E1520) in each gram which is equivalent to 3% w/w and may cause skin irritation.

1. Metronidazole must not be used in patients with Cockayne syndrome. Cases of severe hepatotoxicity/acute hepatic failure, including cases with a fatal outcome with very rapid onset after treatment initiation in patients with Cockayne syndrome have been reported with products containing metronidazole for systemic use.