ROSICED 7.5 MG/G CREAM 30 G PE TUBE

Name
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 substance 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 raised areas) on the face.

Talk to 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 not sure if you are not allergic, talk to your doctor or pharmacist;
- if she is in the first 3 months of pregnancy.


Warnings and precautions
Talk to your doctor or pharmacist before using ROSICED 7.5mg/g Cream:
- when applying it near the eyes or mucous membranes, avoid contact. 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 stop using it and seek medical advice if necessary.
- When exposed to sunlight or ultraviolet (UV) light. Avoid UV exposure (tanning beds, solariums, sun lamps).
- Avoid unnecessary or prolonged use of this medicine.
- If you have or have had a blood disorder (dyscrasia). Dyscrasia may occur 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 that affect the formation of cellular components of the blood (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 7.5mg/g Cream in children; therefore ROSICED 7.5mg/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, stinging, and stinging sensations) and pain.

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

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

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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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.