Patient Leaflet Updated 09-Sep-2015 | Pierre Fabre Dermo-Cosmetique
ROSICED 7.5 mg/g cream
PACKAGE LEAFLET: INFORMATION FOR THE USER
ROSICED 7.5 mg/g Cream
Active substance: metronidazole
For adult use
Read all of this leaflet carefully before you start using this medicine.
In this leaflet:
1. What ROSICED 7.5mg/g Cream is and what it is used for
2. Before you use ROSICED 7.5mg/g Cream
3. How to use ROSICED 7.5mg/g Cream
4. Possible side effects
5. How to store ROSICED 7.5mg/g Cream
6. Further information
1. WHAT ROSICED 7.5mg/g Cream IS AND WHAT IT IS USED FOR
ROSICED 7.5mg/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 7.5mg/g Cream
Do not use ROSICED 7.5mg/g Cream
If you have any of the following:
please tell your doctor. In such cases, treatment with ROSICED 7.5mg/g Cream must be carefully considered.
Take special care with ROSICED 7.5mg/g Cream:
Using ROSICED 7.5mg/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 7.5mg/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.
ROSICED 7.5mg/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 7.5mg/g Cream should only be used in the last six months of pregnancy if other treatments have proved ineffective.
Metronidazole (the active substance of ROSICED 7.5mg/g Cream) passes into breast milk. During the breast-feeding period, you should either stop breast-feeding or refrain from using ROSICED 7.5mg/g Cream.
Children and adolescents
There is no adequate clinical data on efficacy and safety of ROSICED 7.5mg/g Cream in children; therefore ROSICED 7.5mg/g Cream should not be applied to children
Driving and using machines
ROSICED 7.5mg/g Cream has no effect on the ability to drive vehicles.
Important information about some of the ingredients of ROSICED 7.5mg/g Cream
ROSICED 7.5mg/g Cream contains propylene glycol, which can cause skin irritations.
3. HOW TO USE ROSICED 7.5mg/g Cream
Always use ROSICED 7.5mg/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 non-astringent 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 7.5mg/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 7.5mg/g Cream is too strong or too weak.
How long you should use ROSICED 7.5mg/g Cream
You should normally use ROSICED 7.5mg/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 7.5mg/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 7.5mg/g Cream:
Do not take a double dose to make up for a forgotten dose. Simply carry on using ROSICED 7.5mg/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 7.5mg/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
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 MHRA Yellow Card Scheme, website: www.mhra.go.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE ROSICED 7.5mg/g Cream
Keep out of the reach and sight of children.
Do not use ROSICED 7.5mg/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.
Do not store above 30°C.
Do not refrigerate or freeze.
Storage once ROSICED 7.5mg/g Cream has been opened
The cream can be used for up to 8 weeks after opening.
Do not use ROSICED 7.5mg/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
What ROSICED 7.5mg/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 7.5mg/g Cream looks like and contents of the pack
ROSICED 7.5mg/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:
For any information on this product contact: Pierre Fabre Ltd. Phone: 01962 874400
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 (RNIB).
This leaflet was last revised on 25/03/2015