Skip to Content

ROZEX 0.75% W/W CREAM

Active substance(s): METRONIDAZOLE

View full screen / Print PDF » Download PDF ⇩
Transcript
S0386-30-PL-PIL-21.01.2015

PACKAGE LEAFLET: INFORMATION FOR THE
USER

Rozex® 0.75% w/w Cream
(Metronidazole)
The name of your medicine is Rozex® 0.75% w/w Cream but will
be referred to as Rozex throughout the remainder of 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 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
 Your doctor has prescribed this cream 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 (listed in section 6). 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 cream in your eyes. If you do, 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 reduce blood clotting
(anticoagulants) such as warfarin and dicoumarin.
Contact your doctor for advice if you are taking medicines to reduce
blood clotting, 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 Cream because it is only applied on the skin.
However, you are advised not to drink alcohol while you are using
Rozex Cream.

Pregnancy and breast-feeding
 If you are pregnant or breast-feeding, it may not be advisable to use

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.
 First wash and dry the affected areas of your skin.
 Apply a thin layer of the cream to all the affected areas - be careful
not to get it in your eyes.
 Rub the cream well in.
 Always replace the cap and wash your hands after use.
 Your cream 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 cream
 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 cream works best if you use it regularly as directed,

don’t worry if you forget to use your cream 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 cream 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
 Keep out of the sight and reach and of children.
 Do not use Rozex after the expiry date which is stated on the tube

and carton. The expiry date refers to the last day of that month.
 Do not store above 25ºC, in its original tube.
 Do not refrigerate.
 Medicines should not be disposed of via wastewater or household

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.

waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
 If your cream shows signs of deterioration or discolouration, you
should seek the advice of your pharmacist who will tell you what to
do.

Rozex Cream contains cetostearyl alcohol

6. CONTENTS OF THE PACK AND OTHER INFORMATION

Cetostearyl alcohol may cause local skin reactions (e.g. contact
dermatitis).

What Rozex contains
Rozex contains 0.75% w/w of the active substance Metronidazole.
The other ingredients are benzyl alcohol, isopropyl palmitate, glycerol,
sorbitol solution 70% (noncrystallising), emulsifying wax, lactic acid or
sodium hydroxide and purified water.

What Rozex looks like and contents of the pack
Rozex is a white cream.
It is available in a 30g tube.

Manufacturer
Laboratoires Galderma
Zone Industrielle-Montdesir, Alby-sur-Chéran
74540
France

Procured from within the EU and repackaged by: Amimed
Direct Ltd, Hendon London, NW9 6AQ.
Product Licence holder: Sam Pharma Ltd, Unit 20 Garrick
Industrial Estate, Irving Way, Hendon, London, NW9 6AQ.
POM

PL No: 33902/0386

Leaflet revision date: 21/01/2015
Rozex® is a registered trademark of Galderma SA.

S0386-30-PL-PIL-21.01.2015

Expand view ⇕

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