NOTICE RECTO VERSO 147 x 208

PLAN n°09.DRA.2251 .R00.2

Metrogel® 0.75% w/w Gel

metronidazole

GEL

Package leaflet: Information for the user Metrogel 0.75% w/w Gel

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 Metrogel is and what it is used for

2.    What you need to know before you use Metrogel

3.    How to use Metrogel

4.    Possible side effects

5.    How to store Metrogel

6.    Contents of the pack and other information

1.    What Metrogel 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.

•    Metrogel 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 Metrogel

Do not use Metrogel

•    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 Metrogel.

•    Do not get the gel 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 Metrogel 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 Metrogel

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

•    Using Metrogel 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.

Metrogel with alcohol

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

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.

Metrogel contains

-    propylene glycol which may cause skin irritation

-    hydroxybenzoic acid esters which may cause allergic reactions (possibly delayed)

3.    How to use Metrogel

Always use this medicine exactly as your doctor has 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 gel to all the affected areas - be careful 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 Metrogel to keep your rosacea under control.

If you use more Metrogel 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 Metrogel

•    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 Metrogel

Rosacea may respond slowly to antibiotics. It is important that you continue using Metrogel 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.    How to store Metrogel

•    Keep this medicine out of the sight and reach of children.

•    Do not use this medicine after the expiry date which is stated on the tube and carton. The expiry date refers to the last day of that month.

•    Store between 15°C- 25°C. Store in the original tube.

•    Do not refrigerate.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.    Contents of the pack and other information

What Metrogel contains

The active substance is metronidazole. Each gram of Metrogel contains 7.5mg of metronidazole. The other ingredients are phosphoric acid, hydroxybenzoic acid esters, bronopol, hydroxyethyl cellulose, propylene glycol and purified water.

What Metrogel looks like and contents of the pack

•    Metrogel is a clear gel.

•    Metrogel is available in 25 g and 40 g tubes. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Galderma (UK) Ltd. Meridien House,

69-71 Clarendon Road, Watford, Herts. WD17 1DS, UK. (PL 10590/0035)

Manufacturer: Bioglan AB, PO Box 50310, S-202 13 Malmo, Sweden.

This leaflet was last revised in 12/2014.