NOTICE RECTO 135x210

PLAN n* 2.GD.02.DRA.0350.R01

Rozex® 0.75 % w/w Cream

metronidazole

CREAM

PACKAGE LEAFLET: INFORMATION FOR THE USER Rozex 0.75% w/w Cream

Metronidazole

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 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 Cream contains cetostearyl alcohol

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

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

6. Contents of the pack and other information

What Rozex contains

•    The active substance is metronidazole. Each gram of Rozex contains 7.5mg of metronidazole.

•    The other ingredients are emulsifying wax (cetostearyl alcohol and polysorbate-60), benzyl alcohol, isopropyl palmitate, glycerol, sorbitol solution 70% non-crystallising, lactic acid, sodium hydroxide (for pH adjustment) and purified water.

What Rozex looks like and contents of the pack

•    Rozex is a white to beige cream.It is available in a 30 g, 40 g or 50 g tube, only on prescription from your doctor. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Galderma (UK) Limited,

Meridien House, 69-71 Clarendon Road, Watford, Herts.,

WD17 1DS, UK (PL 10590/0028)

Manufacturer: Laboratoires Galderma, Z.I. - Montdesir, 74540,

Alby-sur-Cheran, France.

This leaflet was last revised in 08/2013.