Skip to Content

ROZEX 0.75% W/W GEL

Active substance(s): METRONIDAZOLE

PDF options:  View Fullscreen   Download PDF

PDF Transcript

Rozex® 0.75% w/w Gel

Ref: 1233/270715/1/F

(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
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

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 and propyl
parahydroxybenzoate which may cause allergic
reactions (possibly delayed),
- propylene glycol which can cause skin irritation.

• 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.

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 (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.

3

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.
If you use more Rozex 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
• 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.
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

6

Contents of the pack and other
informtaion

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 Montdésir, F74540 Alby
sur Chéran 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: 27/07/15

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

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.

Ref:1233/270715/1/B

Metronidazole 0.75% w/w Gel

Ref: 1233/270715/2/F

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
1 What Metronidazole is and what it is used
for
2 What you need to know before you use
Metronidazole
3 How to use Metronidazole
4 Possible side effects
5 How to store Metronidazole
6 Contents of the pack and other information

1

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 and propyl
parahydroxybenzoate which may cause allergic
reactions (possibly delayed),
- propylene glycol which can cause skin irritation.

What Metronidazole is and what it is
used for
3

• 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.

2

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.

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.
If you use more Metronidazole 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 Metronidazole
• 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.
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

6

Contents of the pack and other
information

What Metronidazole 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 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 Montdésir, F74540 Alby
sur Chéran 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: 27/07/15

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

How to store Metronidazole

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.

Ref: 1233/270715/2/B

+ Expand Transcript

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.

Hide