UK/0820/001/IB/018 UK Metrosa 0.75% Gel

Package leaflet: Information for the user

Metrosa® 0.75% Gel

Metronidazole

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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Metrosa 0.75% Gel is and what it is used for

2.    Before you use Metrosa 0.75% Gel

3.    How to use Metrosa 0.75% Gel

4.    Possible side effects

5.    How to store Metrosa 0.75% Gel

6.    Further information

1.    What Metrosa 0.75% Gel is and what it is used for

Metrosa 0.75% Gel is an antiinflammatory gel to be applied on the skin.

Metrosa 0.75% Gel is used for the treatment of rosacea (redness in the face, sometimes together with additional pustules) when the condition suddenly gets worse, and the inflammation becomes troublesome.

1 g Metrosa 0.75% Gel contains 7.5 mg Metronidazole as active substance. Metronidazole acts against some of the fungi and other organisms that can affect the skin, and also, in patients suffering from rosacea, it can relieve the condition by acting against the inflammation which happens when the condition becomes troublesome.

2.    Before you use Metrosa 0.75% Gel

Do not use Metrosa 0.75% Gel

if you are hypersensitive (allergic) to Metronidazole, propylene glycol or any of the other ingredients listed below (see 6. Further Information; What Metrosa 0.75% Gel contains). Take special care with Metrosa 0.75% Gel Do not let the gel come into contact with the eyes and mucous membranes. If eye-contact should occur, wash the gel carefully out of the eyes with warm water.

If irritation does occur you should use Metrosa 0.75% Gel less frequently or stop temporarily. If necessary seek medical advice, please.

Do not go out into strong sunlight (sunbathing), or use UV lamps (solarium, sunlamps) while you are using this product. Avoid prolonged and unnecessary use of this medicine. You shouldn't exceed the recommended duration of therapy. If required, the therapy could be recommended again and be repeated. However you should consider that an interval of 6 weeks in between has to be kept.

Use Metrosa 0.75% Gel with care if you suffer or suffered in the past from blood disorders (blood dyscrasia).

Use in children and adolescents Metrosa 0.75% Gel should not be used in children and adolescents.

Using other medicines

Interaction with systemic medication is unlikely

because absorption (ability to get through the

skin into the body) of metronidazole following

cutaneous application of Metrosa 0.75% Gel is

low.

Nevertheless, it should be mentioned that reactions called disulfi ram-like reactions have been reported in a small number of patients taking metronidazole and alcohol concomitantly. These reactions can include nausea, vomiting, flushing of the skin, an accelerated heart rate and shortness of breath. Using Metrosa 0.75% Gel could interfere with drugs used to thin the blood (anticoagulants) such as warfarin and coumarin. Contact your doctor for advice if you are taking medicines to thin your blood, or if you suffer for any other blood disorders.

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

Using Metrosa 0.75% Gel with food and drink

Food and meals can be consumed with only one exception: It is best not to take alcohol while using the gel, as there is a very small possibility of a reaction that might make you feel sick or nauseous.

Pregnancy and breast-feeding Metrosa 0.75% Gel should be used in pregnancy only if it is clearly needed and recommended by your doctor. Please ask for medical advice.

You should ask your doctor for advice if you are breast-feeding whether to discontinue nursing or the drug.

Driving and using machines

You are allowed to drive and use machines since there are no effects known on the ability to drive.

Important information about some of the ingredients of Metrosa 0.75% Gel

Propylene glycol may cause skin irritation. Should this occur, stop using the medicine and consult your doctor.

3.    How to use Metrosa 0.75% Gel

Metrosa 0.75% Gel gel is for cutaneous use only.

Unless your doctor has told you differently, apply a 2 - 3 cm line of gel to the affected areas and rub it gently into the skin. Use the gel twice each day, for up to four weeks.

Always use Metrosa 0.75% Gel exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

If you use more Metrosa 0.75% Gel than you should

If you apply too much of the gel, simply wipe off the excess with a clean tissue or remove by washing with warm water. The gel is for use on the skin only. If you, or anyone else, should accidentally swallow a quantity of the gel, tell your doctor at once, or go to the nearest hospital casualty department.

If you forget to use Metrosa 0.75% Gel If you forget to use the gel, then use it as soon as you remember, unless the next application is due within about two or three hours, in which case omit the forgotten dose.

If you stop using Metrosa 0.75% Gel If you stop using the gel, contact your doctor or pharmacist.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.    Possible side effects

Like all medicines, Metrosa 0.75% Gel can cause side effects, although not everybody gets them.

The evaluation of side effects is based on the following frequencies:

Significant side effects, signs to look out for and what to do if you are affected:

If you are affected by any of the side effects listed below, stop using Metrosa 0.75% Gel and consult your doctor as quickly as possible. Common:

Skin and subcutaneous tissue disorders Contact dermatitis (skin reaction resulting from exposure to allergens), dry skin, erythema (abnormal redness and inflammation of the skin), pruritus (itching), rash (inflammation of the skin with reddening), skin discomfort (burning and stinging), skin irritation, worsening of rosacea (chronic skin condition involving inflammation of the cheeks, nose, chin, forehead or eyelids).

General disorders Pain.

Uncommon:

Nervous System disorders

Hypoaesthesia (decreased sensation to normal

or painful skin stimulation), paraesthesia (an

abnormal or inappropriate sensation in an organ).

Other possible side effects Rare:

Gastrointestinal disorders Metallic taste, nausea

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5.    How to store Metrosa 0.75% Gel

Keep out of the reach and sight of children.

Do not use Metrosa 0.75% Gel after the expiry date which is stated on the tube. The expiry date refers to the last day of that month.

Do not refrigerate or freeze the gel.

Use within 3 months of first opening.

6.    Further information

What Metrosa 0.75% Gel contains

-    The active substance is Metronidazole

1 g of gel contains 7.5 mg Metronidazole

-    The other ingredients are phenoxyethanol (Ph. Eur.), propylene glycol, hypromellose (E 464) and purified water.

What Metrosa 0.75% Gel looks

like and contents of the pack

It is made available as a collapsible aluminium

tube containing 25 g, 30 g, 40 g or 50 g of the

gel (not all pack sizes will be market at time).

Marketing Authorisation

Holder and Manufacturer

Dr. August Wolff GmbH & Co. KG Arzneimittel

SudbrackstraBe 56, 33611 Bielefeld, GERMANY

Phone: +49 521 8808-05

Fax:    +49 521 8808-334

E-Mail: info@wolff-arzneimittel.de

For any information about this medicine,

please contact the local representative of the

Marketing Authorisation Holder:

m & a pharmachem ltd

Allenby Laboratories, Wigan Road,

Westhoughton, Bolton BL5 2AL

Telephone 01942 816184

This medicinal product is authorised

in the Member States of the EEA

under the following names:

Estonia...........................Metrosa 7,5 mg/g geel

Germany.......................MetroGalen 7,5 mg/g Gel

Hungary........................Metrosa 7,5 mg/g    gel

Latvia .............................Metrosa 7,5 mg/g    gels

Lithuania.......................Metrosa 7,5 mg/g    gelis

Austria, Belgium ........Nidazea 7,5 mg/g    Gel

The Netherlands........Metrosa 7,5 mg/g, gel

United Kingdom........Metrosa 0.75% Gel

This leaflet was last revised in 10/2014

DRWOLFF