ROSICED*CREAM 30G 0.75%

ROSICED 7.5 mg/g Cream
Metronidazole

What it is and what it is used for
ROSICED 7.5 mg/g Cream belongs to the therapeutic class of antibiotics and chemotherapeutics for dermatological use.

ROSICED 7.5 mg/g Cream contains the active ingredient metronidazole.

ROSICED 7.5 mg/g Cream is used to treat inflammation caused by rosacea in adults. Rosacea inflammation is a skin condition that causes redness, papules (pink bumps), and pustules (pus-filled bumps) on the face.

Consult your doctor if you do not feel better or if you feel worse.

What you need to know before taking the medicine
Do not use ROSICED 7.5 mg/g Cream:
- if you are allergic to metronidazole or any of the other ingredients of this medicine (listed in section 6). If you are unsure if you are allergic, talk to your doctor or pharmacist;
- if you are in the first 3 months of pregnancy.

Warnings and precautions
Talk to your doctor or pharmacist before using ROSICED 7.5 mg/g Cream:
- when applying it near the eyes or mucous membranes, contact must be avoided. In case of contact, remove the cream by washing thoroughly with water.
If irritation occurs, you should use ROSICED Cream 7.5 mg/g less frequently or discontinue its use and seek medical advice, if necessary.
- When exposed to sunlight or ultraviolet (UV) light. Avoid exposure to UV light (sunbathing, solariums, sun lamps).
- Avoid unnecessary or prolonged use of this medicine.
- If you have or have had a blood disorder (dyscrasia). Dyscrasia may manifest among other symptoms, such as a blood clotting disorder. - If you have any of these conditions, treatment with ROSICED 7.5 mg/g Cream should be carefully considered:
• severe liver damage (e.g., liver cirrhosis);
• problems affecting the formation of blood cell components (e.g., anemia);
• diseases affecting the brain, bone marrow, or nerves.
- Evidence suggests that metronidazole is carcinogenic in some animal species. To date, there is no evidence of a carcinogenic effect in humans.

Children
There are no adequate clinical studies on the efficacy and safety of ROSICED 7.5 mg/g Cream in children; therefore, ROSICED 7.5 mg/g Cream cannot be applied to children.

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

The following side effects may occur:
Common: may affect up to 1 in 10 people:
- Worsening of rosacea, dry skin, inflammation, redness, itching, rash, skin discomfort (burning sensation, pain, and stinging sensation), and pain.

Uncommon: may affect up to 1 in 100 people:
- Hypoesthesia (reduced sense of touch or sensation), paraesthesia (tingling, prickling, or numbness sensation), altered taste (metallic taste), and nausea.

Rare: may affect up to 1 in 1000 people:
- Swelling of the face and neck, sudden itching, fainting, and shortness of breath.

Not known: frequency cannot be estimated from the available data
Contact dermatitis (local eczema-like reactions), skin exfoliation, and facial swelling.

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.