Consumer Medicine Information

ROZEX^® GEL

Metronidazole 0.75%

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.

Side effects

• 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 for advice on 0800 POISON or 0800 764 766 if in New Zealand or on 13 11 26 if in Australia.

Ingredients

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

Storage

Store below 25 degrees and keep out of reach of children.

Product Description

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.

Sponsor

Supplier

Galderma Australia
9 Rodborough Road
Frenchs Forest 
NSW 2086.

New Zealand Distributor

Pacific Pharmaceuticals
76 Leonard Road
Mt Wellington
Auckland 6

Date of information

ROZEX GEL CMI 18/10/04

Australian registration number : AUST R 15211