Consumer Medicine Information

ROZEX^® CREAM

Metronidazole

What is in this leaflet

This leaflet answers some common questions about ROZEX CREAM. Please read this leaflet carefully before you start using the cream. 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.

Before you use ROZEX

When you must not use it

Do not use Rozex Cream

• if you have an allergy to metronidazole or any of the inactive ingredients in the cream.
• if you have or ever have had a blood disorder
• to treat your child's skin problem. Rozex Cream has not been studied for use in children.
• if you are pregnant. There are no well controlled studies of therapy with Rozex cream in pregnant women.

What ROZEX is used for and how it works.

ROZEX CREAM is used for the treatment of inflammatory papules and pustules 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 cream works however it may have antibacterial and anti-inflammatory action.

Preparations which are applied to the skin such as ROZEX CREAM can be used in combination with other oral medications prescribed by your doctor.

How to use ROZEX.

Things you must do

• Wash and dry your hands before applying the cream.
• Apply morning and evening to a dry, clean face.
• Squeeze a small quantity of Rozex onto your finger tips 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 cream 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 cream to sunlight or other sources of UV light.
• Unnecessary or prolonged use of Rozex cream should be avoided as the long term safety is unknown.

Things you can do

• Apply make up over Rozex cream.
• If you forget to apply Rozex cream use it again as directed, as soon as you remember.

Things to be careful of

ROZEX CREAM 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.

Unwanted 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 cream and see your doctor if the problem persists.

If you swallow it

Immediately telephone your doctor or Poisons Information Centre for advice on telephone 0800 POISON or 0800 764 766 if in New Zealand or on 13 11 26 if in Australia.

Ingredients

Each gram of ROZEX CREAM contains:

Active: metronidazole 7.5 mg/g. Preservative: benzyl alcohol 22.0 mg/g. Excipients: isopropyl palmitate, glycerol, sorbitol, emulsifying wax, lactic acid or sodium hydroxide and purified water.

Storage conditions

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

Availability

ROZEX is a smooth white cream in a plastic tube with a screw top. It is available in a 30g tube by prescription only.

Further information

If you have any questions about this product, contact your doctor or pharmacist.

Sponsor:

Galderma Australia Pty Ltd
9 Rodborough Road
Frenchs Forest 
NSW 2086.

Distributed in New Zealand by:

Pacific Pharmaceuticals Pty Ltd
76 Leonard Road
Mt Wellington
Auckland

Manufactured by:

Laboratoires Galderma
ZI - Montdésir
74540 Alby-sur-Chéran - France.

Date of information:

Patient information revised October 2004

Australian registration number: AUST R72393