ROZEX 0.75% GEL

Active substance: METRONIDAZOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

ROZEX® 0.75% GEL
(metronidazole)
Your medicine is available using the name Rozex 0.75% Gel but
will be referred to as Rozex throughout this leaflet.

Read all of this leaflet carefully before you
start using this medicine.

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. Do not pass it on
to others. It may harm them, even if their symptoms are the
same as yours.
If any of the side effects get serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Rozex is and what it is used for
Before you use Rozex
How to use Rozex
Possible side effects
How to store Rozex
Further information

1. What Rozex is and what it is used for
Your doctor has prescribed Rozex 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.

Before you use Rozex

Do not use Rozex

If you are allergic (hypersensitive) to metronidazole or any
of the other ingredients of Rozex (see section 6 for other
ingredients). An allergic reaction may include a rash or
itching.

Take special care with Rozex

Do not get Rozex 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 (e.g. solariums, sunlamps) while you are using this product.
Avoid prolonged and unnecessary use of this medicine.

Using 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.

Please tell your doctor or pharmacist if you are using or have
recently used any other medicines, including medicines obtained
without a prescription.

Using Rozex with food and drink

Metronidazole taken by mouth can react with alcohol. This
reaction is unlikely with Rozex because it is only applied on the
skin. However, you are advised not to drink alcohol while you are
using Rozex.

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.

Ask your doctor or pharmacist for advice before taking any
medicine.

Important information about some of the
ingredients of Rozex

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

3. How to use Rozex
Always use Rozex exactly as your doctor has told you. You should
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.

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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 product, ask
your doctor or pharmacist.

4. Possible side effects
Like all medicines, Rozex can cause side effects, although not
everybody gets them.

Common side effects (occur in less than 1 in 10
patients)
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 side effects (occur in less than 1 in 100
patients)

Numbness (hypothesia) and tingling (paraesthesia) in the
fingers or toes
Metallic taste (dysgeusia)
Feeling sick (nausea)

Unknown frequency of occurrence (cannot be
estimated from the available data)
Contact dermatitis

If skin irritation should occur either use Rozex a little less often or
even stop using it until the irritation settles down. Seek medical
advice from your doctor or pharmacist if necessary.
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

5. How to store Rozex
Do not store above 25°C.
Do not freeze and keep away from direct heat.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not use Rozex after the ‘Expiry date’ shown on the tube
and carton label. The expiry date refers to the last day of
that month.
If your medicine appears discoloured, or shows any other
signs of deterioration, take it back to your pharmacist who
will advise you.
If your doctor decides to stop the treatment, return any
leftover tablets to the pharmacist. Only keep them if your
doctor tells you to.
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.

6. Further information
What Rozex contains

Rozex contains the active ingredient metronidazole 0.75% w/w.
It also contains the inactive ingredients: carbopol 980, disodium
edetate, methyl hydroxybenzoate (E218), propyl hydroxybenzoate
(E216), propylene glycol, sodium hydroxide, and purified water.

What Rozex looks like and contents of the pack
Rozex is a clear gel which is available in a 30g tube, only on
prescription from your doctor.

Manufacturer

Manufactured by: Laboratoires Galderma Z.I., 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.
PL No: 08929/0195

POM

Leaflet revision and issue date (Ref): 06.02.13
Rozex® is a registered trademark of Galderma S.A.

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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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