ROSICED <7.5 mg/g Cream

Зміст інструкції

1. ROSICED 7,5 mg/g Crema
   1. WHAT IS ROSICED 7.5 mg/g Cream AND WHAT IS IT 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

ROSICED 7,5 mg/g Crema

metronidazolo

Read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What ROSICED 7,5 mg/g Crema is and what it is used for
• 2. What you need to know before using ROSICED 7,5 mg/g Crema
• 3. How to use ROSICED 7,5 mg/g Crema
• 4. Possible side effects
• 5. How to store ROSICED 7,5 mg/g Crema
• 6. Contents of the pack and other information

1. WHAT IS ROSICED 7.5 mg/g Cream AND WHAT IS IT 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 ingredient metronidazole.
ROSICED 7.5 mg/g Cream is used to treat inflammation caused by rosacea in adults.
Rosacea-related inflammation is a skin condition that causes redness, papules (pinkish bumps) and pustules (pus-filled elevations) on the face.
See your doctor if you do not feel better or if you feel worse.

2. WHAT YOU NEED TO 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 any of the other ingredients of this medicine (listed in section 6). If you are not sure 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 7.5mg/g Cream

• When applying it near the eyes or mucous membranes, you must avoid contact. If contact occurs, 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) radiation. 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, such as a blood clotting disorder.
• If you have any of these conditions, treatment with ROSICED 7.5 mg/g Cream must be carefully considered: or severe liver damage (e.g. cirrhosis), or problems affecting the formation of blood cells (e.g. anemia), 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 7.5mg/g Cream in
children; therefore ROSICED 7.5mg/g Cream cannot be applied to children

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

• An interaction with systemic medicines (taken orally or intravenously) is unlikely, as absorption of metronidazole is low after application to the skin of ROSICED 7.5mg/g Cream.
• However, disulfiram-like reactions (reactions including nausea, vomiting, skin flushing, rapid heartbeat and shortness of breath) have occurred in a small number of patients taking metronidazole and alcohol at the same time.
• It has been reported that oral metronidazole potentiates 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 not known.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant or are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
ROSICED 7.5 mg/g Cream is contraindicated during the first 3 months of pregnancy. To be
safe, if you are not sure if you are pregnant, have a pregnancy test. ROSICED 7.5 mg/g
Cream may only be used during the last 6 months of pregnancy, if other therapies have proven
ineffective.

Breastfeeding
Metronidazole (the active ingredient of ROSICED 7.5 mg/g Cream) passes into breast milk. During the
breastfeeding period you must stop breastfeeding or refrain from using ROSICED 7.5 mg/g
Cream.

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

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

3. HOW TO USE ROSICED 7,5 mg/g Cream

Always use this medicine exactly as your doctor or pharmacist has told you.
If you have any doubts, ask your doctor or pharmacist.
The recommended dose is as follows:
Apply the cream as a thin layer twice a dayto the affected areas of the face and
massage gently.

How to apply ROSICED 7,5 mg/g Cream:

• Before each application of the cream, always wash and gently dry your face.
• After applying the cream, you can use non-comedogenic (that do not clog pores and cause comedones) and non-astringent (that do not tighten or contract the skin and tissues with wounds, such as a styptic pencil) cosmetics. If you have any doubts, ask your doctor or pharmacist which cosmetics you can use.

For 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, the
treatment can be continued. In clinical studies, topical therapy with metronidazole for
rosacea has lasted for 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
Overdosage is very unlikely. If necessary, the product should be removed 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 forgotten dose. Simply return to using ROSICED
7,5 mg/g Cream as indicated by your doctor or pharmacist.
If you have any doubts about using this medicine, talk to your doctor or pharmacist.

4. 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 prickling sensation) 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 feeling of itching, fainting and shortness of breath.

Not known:frequency cannot be estimated based on available data
Contact dermatitis (local reactions “similar to eczema”), skin peeling and swelling of the
face.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects 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 which is stated on the tube and the packaging. The
expiry date refers to the last day of that month.

Storage conditions
Do not store at a temperature 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 in 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 PACK AND OTHER INFORMATION

What ROSICED 7,5 mg/g, Cream contains:

• The active ingredient is metronidazole. One gram of cream contains 7.5 mg of metronidazole.
• The other ingredients 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 (polyethylene) tubes containing 25g, 30g, 40g or 50g
of cream.
Not all pack sizes may be 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