Rozex 0.75%W/W Gel
Rozex® 0.75% w/w Gel
(metronidazole)
PACKAGE LEAFLET: INFORMATION FOR THE USER
Your medicine is available using the name Rozex 0.75% w/w Gel, but will be referred to as Rozex Gel throughout this leaflet.
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 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 Gel is and what it is used for
2. What you need to know before you use Rozex Gel
3. How to use Rozex Gel
4. Possible side effects
5. How to store Rozex Gel
6. Contents of the pack and other information
1. What Rozex Gel is and what it is used for
■ Your doctor has prescribed this gel for your skin condition, rosacea.
■ It helps to treat the pimples, pustules (spots) and redness found with this condition.
■ Rozex Gel 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 Gel
Do not use Rozex Gel
■ If you are allergic to metronidazole or any of the other ingredients of this medicine (see section 6 for other ingredients). 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 gel in your eyes. If you do so, rinse thoroughly with large amounts of warm water or eye wash.
■ If you suffer from any blood disorders do not use Rozex Gel unless your doctor says you can.
■ This product should not be used in children.
■ Do not go out into strong sunlight, (including sunbathing) and avoid exposure to ultra-violet light (e.g. solariums, sun-lamps) while you are using this product.
■ Avoid prolonged and unnecessary use of this medicine.
Other medicines and Rozex Gel
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
■ Using Rozex Gel could interfere with drugs used to thin the blood (anticoagulants) such as warfarin and dicoumarin. Contact your doctor for advice if you are taking medicines to thin your blood, or if you suffer from any other blood disorders.
Rozex Gel with alcohol
Metronidazole taken by mouth can react with alcohol. This reaction is unlikely with Rozex Gel because it is only applied on the skin. However, you are advised not to drink alcohol while you are using Rozex Gel.
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 taking this medicine.
Rozex Gel contains:
■ methyl hydroxybenzoate and propyl hydroxybenzoate which may cause allergic reactions (possibly delayed),
■ propylene glycol which can cause skin irritation.
3. How to use Rozex Gel
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Adults and the elderly
■ First wash and dry the affected areas of your skin.
■ Apply a thin layer of the gel to all the affected areas - be careful also not to get it in your eyes.
■ Rub the gel in well.
■ Always replace the cap and wash your hands after use.
■ Your gel 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 Gel to keep your rosacea under control.
If you use more Rozex Gel than you should or accidentally swallow the gel
■ 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 Gel
■ Although this gel works best if you use it regularly as directed, don't worry if you forget to use your gel at the right time. When you do remember, start using it again in the same way as before.
If you stop taking Rozex Gel
Rosacea may respond slowly to antibiotics. It is important that you continue using Rozex Gel 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
■ 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: may affect up to 1 in 100 people
■ numbness (hypothesia) and tingling (paraesthesia) in the fingers or toes
■ metallic taste (dysgeusia)
■ feeling sick (nausea)
Not known: frequency cannot be estimated from the available data
■ contact dermatitis
■ swelling of the face
■ peeling skin (exfoliation)
If skin irritation should occur either use the gel 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 www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Rozex Gel
■ Do not store above 25°C and do not refrigerate, store away from heat.
■ Keep out of the sight and reach of children.
■ Do not use this medicine after the expiry date shown on the label. The expiry date refers to the last day of that month.
■ If your doctor decides to stop your treatment, return any left over medication to the pharmacist (chemist). Only keep it if your doctor tells you to.
■ If your medicine appears discoloured, or shows any other signs of deterioration, take it back to your pharmacist (chemist) who will advise you.
■ 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.
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 protect the environment.
6. Contents of the pack and other information
What Rozex Gel contains
■ Rozex Gel contains the active ingredient metronidazole 0.75% w/w.
■ It also contains the inactive ingredients: carbopol 940, disodium edetate, methyl hydroxybenzoate, propyl hydroxybenzoate, propylene glycol, sodium hydroxide, and purified water.
What Rozex Gel looks like and contents of the pack
■ Rozex Gel is available in an aluminium tube with a piercing device incorporated into the cap containing clear, colourless gel, only on prescription from your doctor.
■ Rozex Gel is available in a 30g tube.
Manufacturer
The product is manufactured by: Laboratoires Galderma S.A. 74540, Alby-Sur-Cheran, France.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd, Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd,
Kirk Sandall, Doncaster, DN3 1QR
iPOMl PL No: 08929/0412
Rozex® is a registered trademark of Galderma S.A.
Leaflet revision and issue date (Ref): 15.03.16
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