ZYOMET

Posology The average period of treatment varies according countries. It is usually of 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 upon 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. Elderly The dosage does not need to be adjusted for elderly patients Paediatric population Metronidazole is not recommended for use in children due to a lack of data on safety and efficacy.

Method of administration Metronidazole 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 metronidazole.

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 to, < 1/10) Uncommon (≥1/ 1,000 to,< 1/100) Rare (≥1/10,000 to,< 1/1,000) Very rare (<1/10,000), Not known (cannot be estimated from the available data) Nervous system disorders: Uncommon: hypothesia, paraesthesia, dysgeusia (metallic taste) Eye disorders: Not known: watery eyes if applied too closely to this area.

Gastrointestinal disorders:

Uncommon: nausea Skin and subcutaneous tissue disorders: Common: dry skin, erythema, pruritus, skin discomfort (burning, pain of skin/stinging), skin irritation, worsening of rosacea. Not known: contact dermatitis 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/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

Metronidazole Gel has been reported to cause lacrimation of the eyes, contact with eyes and mucous membranes should be avoided. If eye contact does occur the gel should be washed out carefully with water. If irritation does occur the patient should be advised to use metronidazole 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. 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) Avoid drinking alcohol while using Metronidazole Gel. Excipients This medicine contains 30 mg propylene glycol in each gram. Propylene glycol may cause skin irritation.

This medicine contains 10 mg benzyl alcohol in each gram. Benzyl alcohol may cause allergic reactions. Benzyl alcohol may also cause mild local irritation.

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