ROSICED 7.5 mg/g Cream
Active substance: metronidazole
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. 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
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.
BEFORE YOU USE ROSICED 7.5mg/g Cream
Do not use ROSICED 7.5mg/g Cream
- if you are allergic (hypersensitive) to metronidazole or any of the other ingredients of ROSICED 7.5mg/g Cream . All ingredients used in ROSICED 7.5mg/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 7.5mg/g Cream must be carefully considered.
Take special care with ROSICED 7.5mg/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.
- when exposing your skin to sunlight or ultraviolet (UV) light (e.g. sun beds or solarium visits). Avoid strong sunlight or UV light as metronidazole is not stable under UV light and it may lose its effectiveness, or its effectiveness may be altered.
- if you have, or have ever had, a blood condition (dyscrasia). A dyscrasia may manifest among other symptoms as a blood clotting disorder.
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.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
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.
Breast-feeding
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
ROSICED 7.5mg/g Cream is not recommended for use in children.
As rosacea does not affect children, no trials have been performed on children with regard to safety and tolerability.
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.
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 weeks. If necessary, treatment can be extended. 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 by removed by washing with warm water.
If you forget to use ROSICED 7.5mg/g Cream:
Do not increase the 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.
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
Common side effects include dry skin, inflammation and a burning sensation on the skin.
In rare cases, swelling of the face and neck, sudden itching, fainting and breathlessness can occur.
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.
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.
Storage conditions
Do not store above 25ºC.
Storage once ROSICED 7.5mg/g Cream has been opened
The cream can be used for up to 28 days 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.
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
Manufacturer
This leaflet was last approved in:
26/02/2008
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