Name
metronidazole same 1% gel
metronidazole
What is it and what is it used for?
Metronidazole Same is a gel applied to the skin that contains the active ingredient metronidazole. Metronidazole is active against microbes and protozoa.
Metronidazole Same is indicated for the treatment of papules (red spots), inflammatory pustules (pus-filled red spots) and redness (erythema) caused by a skin condition called rosacea.
Talk to your doctor if you do not feel better or if you feel worse after 3 weeks of treatment.
What you need to know before taking the medicine
Do not use Metronidazole Same
• if you are allergic to metronidazole or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”).
Warnings and precautions
Talk to your doctor or pharmacist before using Metronidazole Same.
• Avoid contact of this medicine with eyes and mucous membranes. In case of contact with eyes, remove the gel carefully with water. Please note that metronidazole applied to the face has been reported to cause tearing.
• If you experience skin irritation, use this medicine less frequently or temporarily stop treatment and inform your doctor.
• Avoid exposure to ultraviolet light (sun, UV lamps, tanning equipment) during treatment with Metronidazole Same.
• Use this medicine with caution if you have or have had blood disorders (blood dyscrasias).
• Always follow your doctor's instructions. Do not exceed the recommended dose.
• The use, especially if prolonged, of products to be applied to the skin can give rise to sensitization phenomena (allergy to one or more components) (see paragraph 4 “Possible side effects”).
Children
Metronidazole Same should not be used in children as there are inadequate data on the efficacy and safety of this medicine.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following adverse reactions have been reported in no more than 2% of patients treated with metronidazole applications to the skin:
• Affecting the skin and underlying tissue: allergic reaction (contact dermatitis), dryness, marked redness (erythema), itching, eruption with numerous small spots (rash), discomfort (burning and stinging sensation), irritation, transient redness and worsening of rosacea
• Affecting the eye: tearing.
Following the instructions in the package leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.