Active substance: METRONIDAZOLE

View full screen / Print PDF » Download PDF ⇩



metronidazole Ph. Eur


Rozex 0.75% w/w Cream
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 Rozex is and what it is used for
2. Before you use Rozex
3. How to use Rozex
4. Possible side effects
5. How to store Rozex
6. Further information

1. What Rozex is and what it is used 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.
• Rozex contains the active substance metronidazole. 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.

2. Before you use Rozex
Do not use Rozex
• If you are allergic (hypersensitive) to metronidazole or any of the other ingredients of Rozex (see section 6 for other
ingredients). An allergic reaction may include a rash or itching.
Take special care with Rozex
• Do not get the cream in your eyes. If you do, rinse thoroughly with large amounts of warm water or eye wash.
• If you suffer from any blood disorders do not use Rozex unless your doctor says you can.
• This product should not be used in children.
• Do not go out into strong sunlight (including sun-bathing) and avoid exposure to ultra-violet light (eg solariums,
sun-lamps) while you are using this product.
• Avoid prolonged and unnecessary use of this medicine.
Using other medicines
• Using Rozex 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.
Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained
without a prescription.
Using Rozex Cream with food and drink
Metronidazole taken by mouth can react with alcohol. This reaction is unlikely with Rozex Cream because it is only applied
on the skin. However, you are advised not to drink alcohol while you are using Rozex Cream.
Pregnancy and breast-feeding
• If you are pregnant or breast-feeding, it may not be advisable to use this product, unless your doctor considers it essential.
Ask your doctor or pharmacist for advice before taking any medicine.

3. How to use Rozex
Always use Rozex exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

First wash and dry the affected areas of your skin.
Apply a thin layer of the cream to all 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 to keep your rosacea under control.

If you use more Rozex than you should or accidentally swallow the cream
• This product is for use on the skin only. Do not swallow it. If you accidentally do so, seek medical advice.
If you forget to use Rozex
• 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.
If you stop taking Rozex
Rosacea may respond slowly to antibiotics. It is important that you continue using Rozex until your doctor tells you to stop.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Rozex can cause side effects, although not everybody gets them
Common side effects (occur in less than 1 in 10 patients)
- dry skin
- redness of the skin (erythema)
- itching of the skin (pruritus)
- skin discomfort (burning, pain of skin / stinging)
- skin irritation
- worsening of rosacea
Uncommon side effects (occur in less than 1 in 100 patients)
- numbness (hypothesia) and tingling (paraesthesia) in the fingers or toes
- metallic taste (dysgeusia)
- feeling sick (nausea)
Unknown frequency of occurrence (cannot be estimated from the available data)
- contact dermatitis
If skin irritation should occur either use the cream a little less often or even stop using it until the irritation settles down.
Seek medical advice from your doctor or pharmacist if necessary.
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.

5. How to store Rozex
• Keep out of the reach and sight of children.
• Do not use Rozex after the expiry date which is stated on the tube and carton. The expiry date refers to the last day of that month.
• Store it at room temperature (below 25°C), in its original tube.
• Do not refrigerate.
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.

6. Further information
What Rozex contains
• Rozex contains 0.75% w/w of the active substance metronidazole.
• The other ingredients are emulsifying wax, benzyl alcohol, isopropyl palmitate, glycerol, sorbitol solution 70% noncrystallising, lactic acid, sodium hydroxide and purified water.
What Rozex looks like and contents of the pack
• Rozex is a white to beige cream.It is available in a 30 g, 40 g or 50 g tube, only on prescription from your doctor.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Galderma (UK) Limited,
Meridien House, 69-71 Clarendon Road, Watford, Herts.,
WD17 1DS, UK (PL 10590/0028)
Manufacturer: Laboratoires Galderma, Z.I. - Montdésir, 74540,
Alby-sur-Chéran, France.
This leaflet was last approved in 10/2011.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.