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ROZEX 0.75% W/W GEL

Active substance(s): METRONIDAZOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Rozex® 0.75% w/w Gel
(metronidazole)

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.
2.
3.
4.
5.
6.

What Rozex Gel is and what it is used for
What you need to know before you use Rozex Gel
How to use Rozex Gel
Possible side effects
How to store Rozex Gel
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.


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)

Rozex Gel contains:






Not known: frequency cannot be estimated from the
available data



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.

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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-Chéran, 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
POM

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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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.

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