ROZEX® CREAM

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(Metronidazole Ph.Eur 0.75% w/w)

 What you should know about Rozex Cream

Please read this leaflet carefully before you start using Rozex Cream. Don’t throw it away, you might want to read it again. If you follow the advice in this leaflet you will give your medicine a chance to work. If you have any questions about using Rozex Cream, or there is anything you do not understand, please ask your doctor.

 

What is in Rozex Cream?

  •         Rozex Cream contains the active ingredient metronidazole Ph.Eur 0.75% w/w.
  •         It also contains the inactive ingredients emulsifying wax, benzyl alcohol, isopropyl palmitate, glycerol, sorbitol solution 70% non-     crystallising, lactic acid, sodium hydroxide and purified water.
  •         It is available in a 30g or 40g tube, only on prescription from your doctor.
  •         Metronidazole belongs to a group of medicines called antiprotozoal and antibacterial agents and has been shown to help to control infection and inflammation in certain skin problems, such as rosacea.

 

 

Marketing Authorisation Holder:

Galderma (UK) Limited

Meridien House

69-71 Clarendon Road

Watford

Herts

WD17 1DS

UK

            Manufacturer:

Laboratoires Galderma

Z.I. – Montdésir

74540

Alby-sur-Chéran

France

 

 

 

What is Rozex Cream for?

  •          Your doctor has prescribed this cream for your skin condition, rosacea.
  •          It helps to treat the pimples, pustules (spots) and redness found with this condition.

 

Before using Rozex Cream for the first time…..

  •         Do not use this product if you have been told that you are allergic to metronidazole or any of the other ingredients in the product. Please check by reading the list of ingredients above.
  •         If you are pregnant or breast feeding, it may not be advisable to use this product, unless your doctor considers it essential.
  •         This product should not be used in children.
  •         Do not get the cream in your eyes. If you do, rinse thoroughly with large amounts of warm water or eye wash.
  •         Using Rozex Cream could interfere with drugs used to reduce blood clotting (anticoagulants) such as warfarin and dicoumarin. Contact your doctor for advice if you are taking medicines to reduce blood clotting, or if you suffer from any other blood disorders.
  •          Do not go out into strong sunlight, or use UV lamps while you are using this product.
  •          Avoid prolonged and unnecessary use of this medicine
  •          If you are not sure about using Rozex Cream, ask your doctor.

 

 

How to use your Rozex Cream

  •           First wash and dry the affected areas of your skin.
  •           Apply a pea-sized amount of cream to the affected areas – be careful not to get it in your eyes.
  •           Rub the cream well in.
  •           Always replace the cap and wash your hands after use.
  •           Your cream should be used in this way twice a day, (morning and evening), or as advised by your doctor.
  •           Your doctor will decide how long you need to use Rozex Cream to keep your rosacea under control.
  •           This product is for use on the skin only. Do not swallow it. If you accidentally do so, seek medical advice.
  •           Although this cream works best if you use it regularly as directed, don’t worry if you forget to use your cream at the right time. When you do remember, start using it again in the same way as before.

 

While you are using Rozex Cream

Like many medicines, this medicine may occasionally cause some unwanted side effects:

  •        If used too closely to the eyes, it has been known to cause watering of the eyes. If this should happen or you accidentally get some of the cream in your eyes, immediately bathe them thoroughly with an eye-wash or clean water.
  •        This product can also cause some temporary redness, slight dryness or mild burning of the skin. If this should happen, you must either use the cream a little less often, or even stop using it until the irritation settles down or until your doctor tells you to start using this cream again.
  •        Other side effects reported include worsening of rosacea, nausea, a metallic taste and tingling or numbness of the extremities such as hands and feet.
  •         If you should have any side effects other than these, tell your doctor immediately.

 

How to store your Rozex Cream

  •         Do not use the cream after the ‘Use Before’ date shown on the tube and carton.
  •         Store it at room temperature (below 25°C), in its original tube.
  •         Do not keep it in the fridge.
  •         Keep out of the reach and sight of children.
  •         When your doctor tells you that you can stop using this medicine, we suggest that you take any product you have not used back to your pharmacist who will dispose of it safely.

 

REMEMBER:

Your doctor prescribed this product for you. Never give it to other people to use, even if they appear to have, or tell you that they have rosacea.

 

For more information, please contact the

 

Acne Support Group

P O Box 230

Hayes

Middx

UB4 9HW

Marketing Authorisation Nos.: PL 10590/0028 (UK).

® Registered Trade Mark