Rosiced

PACKAGE LEAFLET: INFORMATION FOR THE USER

ROSICED 7.5 mg/g Cream

metronidazole
Please read this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you need more advice or information, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What ROSICED 7.5 mg/g Cream is and what it is used for
2. What you need to know before using ROSICED 7.5 mg/g Cream
3. How to use ROSICED 7.5 mg/g Cream
4. Possible side effects
5. How to store ROSICED 7.5 mg/g Cream
6. Contents of the pack and other information

1. WHAT ROSICED 7.5 mg/g CREAM IS AND WHAT IT IS USED FOR

ROSICED 7.5 mg/g Cream belongs to the therapeutic class of antibiotics and chemotherapeutic agents 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-related inflammation is a skin condition causing redness, papules (pinkish swellings), and pustules (pus-filled bumps) on the face.
Consult your doctor if you do not feel better or if you feel worse.

2. WHAT YOU SHOULD KNOW BEFORE USING ROSICED 7.5 mg/g CREAM

Do not use ROSICED 7.5 mg/g Cream:

• if you are allergic to metronidazole or to any of the other ingredients of this medicine (listed in section 6). If you are unsure whether you are allergic, consult 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 near the eyes or mucous membranes, avoid contact. In case of contact, remove the cream by thoroughly washing with water. If irritation occurs, use ROSICED 7.5 mg/g Cream less frequently or discontinue use and consult your doctor if necessary.
• When exposed to sunlight or ultraviolet (UV) light. Avoid exposure to UV radiation (sunbathing, solariums, sunlamps).
• Avoid unnecessary or prolonged use of this medicine.
• If you have or have had a blood disorder (dyscrasia). A dyscrasia may manifest, among other symptoms, as a disturbance in blood coagulation.
• If you have any of the following conditions, treatment with ROSICED 7.5 mg/g Cream should be carefully considered: severe liver damage (e.g. hepatic cirrhosis), conditions affecting the formation of blood cells (e.g. anaemia), or 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 should not be applied to children.

Other medicines and ROSICED 7.5 mg/g Cream
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

• Interaction with systemic medicines (administered orally or intravenously) is unlikely, as absorption of metronidazole after topical application of ROSICED 7.5 mg/g Cream is low.
• However, disulfiram-like reactions (including nausea, vomiting, skin flushing, rapid heartbeat, and shortness of breath) have occurred in a small number of patients taking metronidazole and alcohol simultaneously.
• Orally administered metronidazole has been reported to enhance the effect of warfarin and other coumarin anticoagulants, resulting in prolonged prothrombin time (used to determine blood clotting tendency). The effect of topical metronidazole on prothrombin time is unknown.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
ROSICED 7.5 mg/g Cream is contraindicated during the first 3 months of pregnancy. To be certain, if you are unsure whether you are pregnant, take a pregnancy test. ROSICED 7.5 mg/g Cream may only be used during the last 6 months of pregnancy, if other treatments have proven ineffective.

Breastfeeding
Metronidazole (the active substance in ROSICED 7.5 mg/g Cream) passes into breast milk. During treatment, you must either stop breastfeeding or avoid using ROSICED 7.5 mg/g Cream.

Driving and using machines
ROSICED 7.5 mg/g Cream has no effect on the ability to drive vehicles.

ROSICED 7.5 mg/g Cream contains:
400 mg of propylene glycol in 2 g (daily dose), which may cause skin irritation.

3. HOW TO USE ROSICED 7.5 mg/g Cream

Always use this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is as follows:
Apply the cream as a thin layer twice daily to the affected areas of the face and
gently massage it in.

How to apply ROSICED 7.5 mg/g Cream:

• Before each application, always wash and gently dry your face.
• After applying the cream, non-comedogenic (which do not block pores or cause comedones) and non-astringent cosmetics (which do not tighten or contract the skin and tissues, such as hemostatic pencils) may be used. If you have any doubts, ask your doctor or pharmacist which cosmetics you can use.

How long to use ROSICED 7.5 mg/g Cream
Normally, you should use Rosiced 7.5 mg/g Cream for a period of 3 to 4 months. If necessary,
treatment may be continued. In clinical studies, topical therapy with metronidazole for
rosacea lasted up to 2 years. If you do not experience clinical improvement, you should
discontinue treatment.

If you use more ROSICED 7.5 mg/g Cream than you should
Overdose is very unlikely. If necessary, remove the product by washing with warm water.

If you forget to use ROSICED 7.5 mg/g Cream
Do not use a double dose to make up for the missed dose. Simply resume using ROSICED
7.5 mg/g Cream as directed by your doctor or pharmacist.

If you have any questions about the use of this medicine, talk to your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions 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), paresthesia (tingling, prickling, or numbness sensation), taste disturbance (metallic taste), and nausea.

• Rare: may affect up to 1 in 1,000 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 exfoliation, and facial swelling.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ROSICED 7.5 mg/g Cream

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the tube and packaging.
The expiry date refers to the last day of that month.
Storage conditions
Do not store above 30°C.
Do not refrigerate or freeze.
Storage after opening
The cream can be used for up to 8 weeks after opening the tube.
Do not use this medicine if you notice that the tube is damaged.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What ROSICED 7.5 mg/g Cream contains:

• The active substance is metronidazole. One gram of cream contains 7.5 mg of metronidazole.
• The other components are: glyceryl monolaurate, glyceryl monomyristate, propylene glycol, anhydrous citric acid, sodium hydroxide, carbomers, purified water.

Description of the appearance of ROSICED 7.5 mg/g Cream and contents of the pack
ROSICED 7.5 mg/g Cream is available in synthetic tubes (polyethylene) containing 25 g, 30 g, 40 g or 50 g of cream.
It is possible that not all pack sizes are marketed in all countries.
Marketing Authorisation Holder:
LABORATOIRES BAILLEUL S.A.
14-16, AVENUE PASTEUR
L-2310 LUXEMBOURG
LUXEMBOURG
Manufacturer:
BIOGLAN AB
PO Box 50310
S 202 13 Malmö - Sweden