METROSA 0.75% GEL

Active substance: METRONIDAZOLE

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Mock-up Metrosa 0.75% Gel (UK), 09_14-1 • 148 x 270 mm • Key •

03210200-0413

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

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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 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.

26.09.14 10:50

Mock-up Metrosa 0.75% Gel (UK), 09_14-1 • 148 x 270 mm • Key •

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:
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

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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
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
Sudbrackstraße 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 gél
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 09/2014

26.09.14 10:50

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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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