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Active substance(s): METRONIDAZOLE

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Package leaflet: Information for the user
Rozex 0.75% w/w Cutaneous Emulsion
Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.
- 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 only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
- If you get any of the side effects talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Rozex is and what it is used for
2. What you need to know before you use Rozex
3. How to use Rozex
4. Possible side effects
5. How to store Rozex
6. Contents of the pack and other information
1. What Rozex is and what it is used for
• Your doctor has prescribed this emulsion 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. What you need to know before you use Rozex
Do not use Rozex
• If you are allergic to metronidazole or any of the other ingredients of this medicine (listed in
section 6). An allergic reaction may include a rash or itching.
Warnings and precautions
Talk to your doctor or pharmacist before using Rozex
• Do not get the emulsion 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 and anyone under 18 years of age
• 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.
Other medicines and Rozex
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
• Using this medicinecould 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.

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.
. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before using this medicine.
Rozex Emulsion contains stearyl alcohol and potassium sorbate
- which may cause local skin reactions (e.g. contact dermatitis).
3. How to use Rozex
Always use this medicine exactly as your doctor has told you. 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 emulsion to the affected areas - be careful not to get it in your
• Rub the emulsion well in.
• Always replace the cap and wash your hands after use.
• Your emulsion 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
If you use more Rozex than you should
• 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 emulsion works best if you use it regularly as directed, don’t worry if you
forget to use your emulsion at the right time.
When you do remember, start using it again in the same way as before.
Do not use a double dose to make up for a forgotten dose.
If you stop using Rozex
Rosacea may respond slowly to antibiotics. It is important that you continue using this
medicine until your doctor tells you to stop.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common: may affect up to 1 in 10 people:
 skin reactions such as burning and stinging pain sensation
 redness and dryness
 irritation and itching of the skin
 worsening of rosacea
Uncommon: may affect up to 1 in 100 people
 nausea

metal taste in the mouth
tingling or numbness of arms or legs

Not known: frequency cannot be estimated from the available data
 contact dermatitis
 swelling of the face
 peeling skin (exfoliation)
Avoid contact with the eyes, mouth, angles of the nose and other mucous surfaces such as
the lining of your nose. If accidental contact should occur, rinse thoroughly with warm water.
If skin irritation should occur either use the lotion a little less often or even stop using it until
the irritation settles down. Seek medical advice from your doctor or pharmacist if necessary.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via Yellow Card
Scheme Website: By reporting side effects you can help
provide more information on the safety of this medicine.
5. How to store Rozex
• Keep this medicineout of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the tube and carton. The
expiry date refers to the last day of that month.
• Discard the tube 60 days after first opening.
• Do not store above 25°C Store in the original package.
• Do not refrigerate.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to throw awaymedicines you no longer use. These measures will help protect the
6. Contents of the pack and other information
What Rozex contains
• The active substance is metronidazole. Rozex contains 0.75% w/w of metronidazole.
• The other ingredients are carbomer 941, benzyl alcohol (E1519), glycerol, macrogol 400,
steareth-21, glyceryl stearate/PEG-100 stearate, stearyl alcohol, light liquid paraffin,
cyclomethicone, potassium sorbate (E202), lactic acid, sodium hydroxide and purified water.
What Rozex looks like and contents of the pack
• Rozex is a white to off-white emulsion. It is available in a 15g, 30 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 10590/0036)
Manufacturer: Laboratoires Galderma, Z.I. - Montdésir, 74540, Alby-sur-Chéran, France.
This leaflet was last revised in 0/2015.

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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.