ROZEX*DERMAL CREAM 50G 0.75%

Rozex 0.75% Cream
Metronidazole

What it is and what it is used for
Rozex 0.75% cream contains the active ingredient metronidazole, which belongs to a group of medicines called topical chemotherapeutics, used to treat certain skin infections.
This medicine is indicated for the local treatment of rosacea, a skin condition that manifests with skin irritation (erythema), papules (small skin bumps), and pustules (small skin swellings with pus) in the central part of the face.

What you need to know before taking the medicine
Do not use Rozex 0.75% cream:
- if you are allergic to metronidazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Rozex 0.75% cream.
Talk to your doctor if you experience a reaction due to local irritation during the application of the medicine, as it may be necessary to reduce the number of daily applications or stop the treatment.
Inform your doctor if you suffer from blood disorders (blood dyscrasia).

Avoid contact with eyes and mucous membranes (eyelids, lips, mouth, ears, and the inside of the nose).
During therapy with metronidazole, avoid exposure to UV rays (sunlight, solariums, and sun lamps).
Avoid unnecessary and prolonged use of this medicine.

Children
This medicine is not recommended for use in children as safety and efficacy have not been established for this age group.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported:
Common (may affect up to 1 in 10 people):
- dry skin;
- skin redness (erythema);
- itching;
- skin discomfort (burning, pain, stinging pain);
- skin irritation;
- worsening of rosacea.

Uncommon (may affect up to 1 in 100 people):
- decreased sensitivity (hypoesthesia);
- altered sensation (paresthesia);
- altered taste, metallic taste (dysgeusia);
- nausea.

Not known (frequency cannot be estimated from the available data):
- contact dermatitis;
- peeling of the superficial layers of the skin (skin exfoliation);
- facial swelling (tumefaction).

Reporting of side effects
If you get 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.