Patient leaflet - METRONIDAZOLE 0.75% W/W GEL, ROZEX 0.75% W/W GEL
(metronidazole)
Patient Information 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.
Your medicine is called Rozex 0.75% w/w Gel and will be referred to as Rozex throughout this leaflet.
What is in this leaflet
Q What Rozex is and what it is used for
Q What you need to know before you use Rozex
Q How to use Rozex
Q Possible side effects
Q How to store Rozex
A Contents of the pack and other information
Q
What Rozex 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 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.
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 (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 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.
Other medicines and Rozex
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
- Using Rozex 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 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 parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed),
-
– 30mg propylene glycol in each gram this is equivalent to 3% w/w, it may cause skin irritation.
Q
How to use Rozex
Always use this medicine exactly as your doctor had 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 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 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
Rosacea may respond slowly to antibiotics. It is important that you continue using Rozex until your doctor tells you to stop.
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 the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
Q
How to store Rozex
Expiry Date
Do not use this medicine after the expiry date shown on the carton or tube. If your doctor tells you to stop taking this medicine, return any unused medicine to your pharmacist for safe disposal.
Only keep this medicine, if your doctor tells you to. If your medicine becomes discoloured or shows any other signs of deterioration, consult your pharmacist who will tell you what to do.
Storing your medicine
- Do not store above 25°C.
- Do not freeze.
- Store away from heat.
- KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
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.
Important
Remember this medicine is for you. Only a doctor can prescribe it. Never give your medicine to other people. It may harm them, even if their symptoms are the same as yours. This leaflet does not tell you everything about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist. He/she will have additional information about this medicine and will be able to advise you.
What Rozex contains
The gel contains 0.75% w/w of metronidazole. Metronidazole also contains the following inactive ingredients: disodium edetate, carbomer 940, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), propylene glycol, sodium hydroxide and purified water.
What Rozex looks like and contents of the pack
Rozex is a clear, colourless gel in an aluminium tube with a screw cap incorporated with a piercing device.Rozex is available in a 30g tube
Manufacturer and Licence Holder
The medicine is manufactured by Laboratoires Galderma, Zone Industrielle Montdesir, F74540 Alby sur Cheran and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
Rozex is a registered trademark of Galderma S.A.
POM PL 15184/1233
Leaflet revision date: 20/01/22
Blind or partially sighted? Is this leaflet hard to see or read? Phone Lexon (UK) Limited, Tel: 01527 505414 to obtain the leaflet in a format suitable for you
Patient Information 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.
Your medicine is called Metronidazole 0.75% w/w Gel and will be referred to as Metronidazole throughout this leaflet.
What is in this leaflet
A What Metronidazole is and what it is used for
What you need to know before you use Metronidazole
Q How to use Metronidazole
Q Possible side effects
Q How to store Metronidazole
Q Contents of the pack and other information
Q
What Metronidazole 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.
- Metronidazole 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.
What you need to know before you use Metronidazole
Do not use Metronidazole
- 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 Metronidazole.
- 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 Metronidazole 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.
Other medicines and Metronidazole
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
- Using Metronidazole 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.
Metronidazole with alcohol
Metronidazole taken by mouth can react with alcohol. This reaction is unlikely with Metronidazole because it is only applied on the skin. However, you are advised not to drink alcohol while you are using Metronidazole.
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.
Metronidazole contains:
-
– methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).
-
– 30mg propylene glycol in each gram which is equivalent to 3% w/w, it may cause skin irritation.
Q
How to use Metronidazole
Always use this medicine exactly as your doctor had 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 Metronidazole 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 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 Metronidazole
Rosacea may respond slowly to antibiotics. It is important that you continue using Metronidazole until your doctor tells you to stop.
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 the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
Expiry Date
Do not use this medicine after the expiry date shown on the carton or tube. If your doctor tells you to stop taking this medicine, return any unused medicine to your pharmacist for safe disposal.
Only keep this medicine, if your doctor tells you to. If your medicine becomes discoloured or shows any other signs of deterioration, consult your pharmacist who will tell you what to do.
Storing your medicine
- Do not store above 25°C.
- Do not freeze
- Store away from heat
- KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
What Metronidazole looks like and contents of the pack
Metronidazole is a clear, colourless gel in an aluminium tube with a screw cap incorporated with a piercing device.
Metronidazole is available in a 30g tube
Manufacturer and Licence Holder
The medicine is manufactured by Laboratoires Galderma, Zone Industrielle Montdesir, F74540 Alby sur Cheran and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
POM PL 15184/1233
Leaflet revision date: 20/01/22
Blind or partially sighted? Is this leaflet hard to see or read? Phone Lexon (UK) Limited, Tel: 01527 505414 to obtain the leaflet in a format suitable for you
Ref: 1233/200122/2/B