METROSA 0.75% GEL

Active substance: METRONIDAZOLE

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Mock-up Metrosa 0.75% Gel (GB) • Ver. 5 • 04_2012

03210200-0511

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.
1g Metrosa 0.75% Gel contains 7.5mg 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 Metroni­
dazole, 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

PL Metrosa GB Ver5 0412.indd 1

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 disulfiram-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.

24.04.12 14:37

Mock-up Metrosa 0.75% Gel (GB) • Ver. 5 • 04_2012

3. How to Metrosa 0.75% Gel
Metrosa 0.75% Gel gel is for cutaneous use
only.
Unless your doctor has told you differently,
apply a 2-3cm 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:
Very common:

More than one patient in 10

Common:

1 to 10 patients in 100

Uncommon:

1 to 10 patients in 1,000

Rare:

1 to 10 patients in 10,000

Very rare:

Less than 1 patient in 10,000

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

PL Metrosa GB Ver5 0412.indd 2

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 store above 25° C. 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
1g of gel contains 7.5mg 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 25g, 30g, 40g or 50g of the gel
(not all pack sizes will be market at time).
Marketing Authorisation
Holder and Manufacturer
Dr. August Wolff GmbH & Co. KG Arzneimittel
Sudbrackstraße 56, D-33611 Bielefeld, Germany
Phone: +49 (0)521 8808-05
Fax: +49 (0)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, Wiglan 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............................... Metrosa 7,5 mg/g Gel
Hungary................................ Metrosa 7,5 mg/g gél
Latvia..................................... Metrosa 7,5 mg/g gels
Lithuania............................... Metrosa 7.5 mg/g gelis
Austria, Belgium,
The Netherlands:............... Nidazea 7.5 mg/g Gel
United Kingdom:............... Metrosa 0.75% Gel

This leaflet was last approved in 04/2012

24.04.12 14:37

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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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