Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about ROZEX GEL. Please read this leaflet carefully before you start using the GEL. It does not contain all the information available on this medicine. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of using ROZEX against the benefits it might have for you. If you have concerns about using this medicine ask your doctor or pharmacist.
Keep this leaflet with your tube. You may wish to read it again later.
What ROZEX is used for
ROZEX GEL is used for the treatment of rosacea.
Skin affected by rosacea has one or more of the following features: a redness that looks like a blush; pimples; small knobbly lumps on the nose and / or thin red lines due to enlarged blood vessels.
The active ingredient in ROZEX is metronidazole which belongs to the class of medicines known as antiprotozoals and antibacterials.
It is not clear how ROZEX GEL works however it may have antibacterial and anti-inflammatory action.
Preparations which are applied to the skin such as ROZEX GEL can be used in combination with other oral medications prescribed by your doctor.
Before you use ROZEX
When you must not use it
Do not use ROZEX GEL
if you have an allergy to metronidazole or any other ingredient of the gel.
if you have or ever have had a blood disorder.
to treat your child's skin problem. ROZEX GEL has not been studied for use in children.
if you are pregnant. There are no well-controlled studies of therapy with ROZEX GEL in pregnant women.
How to use ROZEX
Things you must do
Wash and dry your hands before applying the gel.
Apply morning and evening to a dry, clean face.
Squeeze a small quantity of ROZEX GEL onto your fingertips and rub a thin film onto the affected areas.
Use a sunscreen when exposure to the sun cannot be avoided.
ROZEX is only for use on the skin.
Continue to use even though there may not be an immediate effect. Medicines can take several weeks to show an effect.
While you are using ROZEX
Things you must not do
Do not use cosmetic products that contain alcohol or are abrasive.
Do not use medicated soaps.
These may have an extra drying or irritant effect.
It is not known if ROZEX GEL can increase the likelihood of skin cancers developing in people who have excessive exposure to sunlight. Therefore you should avoid or minimise exposure of areas treated with ROZEX GEL to sunlight or other sources of UV light.
Unnecessary or prolonged use of ROZEX GEL should be avoided as the long-term safety is unknown.
Things you can do
Apply make up over ROZEX GEL.
If you forget to apply ROZEX GEL use it again as directed, as soon as you remember.
Things to be careful of
ROZEX GEL should not come into contact with the eyes or mucous membranes. If accidental contact occurs, rinse thoroughly with water and pat dry.
Avoid conditions known to make rosacea worse such as hot, spicy foods, alcohol, extremes of temperature and excessive exposure to sunlight.
Avoid contact with the eyes. Contact will cause irritation.
Use ROZEX less frequently if your face becomes hot, red, itchy or swollen.
Stop using ROZEX GEL and see your doctor if the problem persists.
In case of accidental swallowing Immediately telephone your doctor or Poisons Information Centre on 13 11 26 for advice if in Australia.
Each gram of ROZEX GEL contains:
Active: metronidazole 7.5 mg/g. Preservatives: methyl hydroxybenzoate 0.8 mg/g, propyl hydroxybenzoate 0.2 mg/g.
Inactives: disodium edetate, carbomer, propylene glycol, sodium hydroxide to adjust pH and purified water q.s. to 1.0g.
After using ROZEX
Store below 25 degrees and keep out of reach of children.
ROZEX is a homogeneous gel in an aluminium tube with a screw cap. It is available in a 15g, 30g and 50g tube by prescription only.
Where to go for further information.
If you have any questions about this product, contact your doctor or pharmacist.
9 Rodborough Road
Frenchs Forest NSW 2086
New Zealand Distributor
76 Leonard Road
Mt Wellington, Auckland 6.
Australian Registration Number: AUST R 15211