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ROSICED 7.5 MG/G CREAM

Active substance: METRONIDAZOLE

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- Common side effects include Local reactions “eczema like”, worsening of rosacea, dry skin,
inflammation, redness, itchiness, skin eruption, skin discomfort (burning and stinging) and pain.
- Uncommon side effects include hypothesia (reduced sense of touch or sensation) and
paraesthesia (skin sensation of tingling, pricking, or numbness).
- In rare cases, swelling of the face and neck, sudden itching, fainting and breathlessness
can occur. Rare side effects also include metallic taste and nausea.
If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE ROSICED 7.5 mg/g Cream
Keep out of the reach and sight of children.

Do not use ROSICED 7.5 mg/g Cream after the expiry date which is stated on the tube
and carton after Exp. 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 once ROSICED 7.5 mg/g Cream has been opened
The cream can be used for up to 8 weeks after opening.
Do not use ROSICED 7.5 mg/g Cream if you notice that the tube is damaged.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

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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 ingredients are:
glyceryl monolaurate, glyceryl monomyristate, propylene glycol, citric acid anhydrous,
sodium hydroxide, carbomers, purified water.
What ROSICED 7.5 mg/g Cream looks like and contents of the pack
ROSICED 7.5 mg/g Cream is available in synthetic (polyethylene) tubes containing 25 g,
30 g, 40 g and 50 g.
Not all pack sizes may be marketed in all countries.
Marketing authorisation holder
Pierre Fabre Dermatologie, 45 place Abel Gance, 92100 Boulogne, France
Manufacturer:
Bioglan AB - PO Box 50310 - S-202 13 Malmö - Sweden
For any information on this product contact: Pierre Fabre Ltd. Phone: 01962 874400
Other formats: To listen to or request a copy of this leaflet in Braille, large print or
audio call: 0800 198 5000
Be ready to give the following information: ROSICED 7.5mg/g Cream. PL 20693/0007
This is a service provided by the Royal National Institute of the Blind.
This leaflet was last approved in: 08.2011.

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For adult use
Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.

What ROSICED 7.5 mg/g Cream is and what it is used for
Before you use ROSICED 7.5 mg/g Cream
How to use ROSICED 7.5 mg/g Cream
Possible side effects
How to store ROSICED 7.5 mg/g Cream
Further information

1. WHAT ROSICED 7.5 mg/g Cream IS AND WHAT IT IS USED FOR
ROSICED 7.5 mg/g Cream is used to treat inflammation caused by rosacea.
Inflammatory rosacea is a skin condition that causes redness, papules (pink bumps) and
pustules (pus-filled spots) on the face.

2. BEFORE YOU USE ROSICED 7.5 mg/g Cream
Do not use ROSICED 7.5 mg/g Cream
- if you are allergic (hypersensitive) to metronidazole or any of the other ingredients of
ROSICED 7.5 mg/g Cream. All ingredients used in ROSICED 7.5 mg/g Cream are listed in
section 6 of this leaflet. If you are not sure whether you are allergic, please ask your
doctor or pharmacist.
- if you are in the first 3 months of pregnancy.
If you have any of the following:
- severe liver damage (e.g. cirrhosis of the liver),
- problems affecting blood formation (e.g. anaemia),
- diseases affecting the brain, bone marrow or nerves,
please tell your doctor. In such cases, treatment with ROSICED 7.5 mg/g Cream must
be carefully considered.

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Take special care with ROSICED 7.5 mg/g Cream:
- when using it near the eyes or mucous membranes. Such contact should be avoided. If
contact occurs, the cream should be washed away carefully with water.
- If irritation does occur, ROSICED 7.5 mg/g Cream should be used less frequently or
should be stopped and you should seek medical advice if necessary.
- When exposing your skin to sunlight or ultraviolet (UV) light. Avoid UV exposure
(sunbathing, solarium, sunlamp).
- You should not exceed the recommended duration of therapy. If required, the therapy
could be repeated, however the interval of 6 weeks in between should be considered.
- ROSICED 7.5 mg/g Cream should not be applied to children.
- Avoid unnecessary or prolonged use of this medication.
- If you have, or have ever had, a blood condition (dyscrasia). A dyscrasia may manifest
among other symptoms as a blood clotting disorder.
- Evidence suggests that metronidazole is carcinogenic in certain animal species. There is
no evidence to date of a carcinogenic effect in human.
Using ROSICED 7.5 mg/g Cream with other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
To date, there are no known interactions with other drugs applied to the skin.
Interaction with systemic medication (oral intake, intravenous…) is unlikely because absorption
of metronidazole following cutaneous application of ROSICED 7.5 mg/g Cream is low.
Nevertheless, disulfiram-like reactions (reaction which may include nausea, vomiting, flushing of the skin, accelerated heart rate, and shortness of breath) occurred in small number
of patients taking metronidazole and alcohol concomitantly.
Oral metronidazole has been reported to potentiate the effect of warfarin and other coumarin anticoagulants, resulting in a prolongation of prothrombin time (used to determine
the clotting tendency of blood). The effect of topical metronidazole on prothrombin time
is unknown.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
ROSICED 7.5 mg/g Cream should not be used in the first three months of pregnancy.
To be on the safe side, if you are not sure whether you are pregnant, you should
undergo a pregnancy test.
ROSICED 7.5 mg/g Cream should only be used in the last six months of pregnancy
if other treatments have proved ineffective.
Breast-feeding
Metronidazole (the active substance of ROSICED 7.5 mg/g Cream) passes into breast
milk.
During the breast-feeding period, you should either stop breast-feeding or refrain from
using ROSICED 7.5 mg/g Cream.

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Children and adolescents
There is no adequate clinical data on 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
Driving and using machines
ROSICED 7.5 mg/g Cream has no effect on the ability to drive vehicles.
Important information about some of the ingredients of ROSICED 7.5 mg/g Cream
ROSICED 7.5 mg/g Cream contains propylene glycol, which can cause skin irritations.

3. HOW TO USE ROSICED 7.5 mg/g Cream
Always use ROSICED 7.5 mg/g Cream exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.
Always wash and dry your face gently before each application.
Non-comedogenic cosmetics (that do not clog pores and cause blackheads) and nonastringent cosmetics (that do not draw together or constrict skin and wound tissue e.g.
styptic pen) may be used following application of the cream. If you are unsure, ask your
doctor or pharmacist which cosmetics you can use.
How much and how often you should apply ROSICED 7.5 mg/g Cream
Dosage and method of administration
Unless otherwise prescribed by your doctor, the usual dose is as follows:
Apply the cream as a thin film twice daily to the affected areas of the face and gently
rub it in.
Please consult your doctor or pharmacist if you have the impression that the action of
ROSICED 7.5 mg/g Cream is too strong or too weak.
How long you should use ROSICED 7.5 mg/g Cream
You should normally use ROSICED 7.5 mg/g Cream for a period of 6 to 12 weeks.
If necessary, treatment can be continued after an interval of 6 weeks. If no clinical
improvement is achieved, treatment should be discontinued.
If you use more ROSICED 7.5 mg/g Cream than you should:
Overdosage is extremely 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 take a double dose to make up for a forgotten dose. Simply carry on using
ROSICED 7.5 mg/g Cream at the dosage schedule prescribed by your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, ROSICED 7.5 mg/g Cream can cause side effects, although not everybody
gets them.
The evaluation of side effects is based on the following frequencies:
very common: more than 1 in 10 cases treated
common: fewer than 1 in 10, but more than 1 in 100 cases treated
uncommon: fewer than 1 in 100, but more than 1 in 1,000 cases treated
rare: fewer than 1 in 1,000, but more than 1 in 10,000 cases treated
very rare: fewer than 1 in 10,000 cases treated, including isolated reports

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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