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ZINERYT TOPICAL SOLUTION

Active substance(s): ERYTHROMYCIN / ZINC ACETATE / ZINC ACETATE DIHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

ZINERYT® TOPICAL SOLUTION /
ERYTHROMYCIN 40MG/ML AND ZINC
ACETATE 12MG/ML TOPICAL SOLUTION
(erythromycin and zinc acetate)
Your medicine is available using one of the above names, but will
be referred to as Zineryt throughout this leaflet.

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,
pharmacist or nurse.
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, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. See section 4.

What is in this leaflet
1.
2.
3.
4.
5.
6.

What Zineryt is and what it is used for
What you need to know before you use Zineryt
How to use Zineryt
Possible side effects
How to store Zineryt
Contents of the pack and other information

1. What Zineryt is and what it is used for
The active substance of Zineryt belongs to the group of antibiotics
for treatment of acne vulgaris, often referred to as pimples or
spots.
These medicines are used to reduce the growth of bacteria which
cause acne.

2. What you need to know before you use
Zineryt
Do not use Zineryt



if you are allergic to erythromycin or zinc or any of the other
ingredients of this medicine (listed in section 6).
if you are allergic to antibiotics of the macrolide group. Your
doctor or pharmacist will be able to tell you if that is the
case.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Zineryt.

Other medicines and Zineryt

If you use more Zineryt than you should

Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.

If you have applied too much Zineryt, blot it off with some tissue.
Swallowing the entire contents of a single pack of Zineryt would
mainly lead to symptoms associated with alcohol intake. You
should contact your doctor or pharmacist if you or somebody else
accidentally swallows this medicine.

Pregnancy, breast-feeding and fertility
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 using this medicine.

If you forget to use Zineryt

You may use Zineryt if you are pregnant.
You may breast-feed during treatment with Zineryt but do not use
this medicine on the area of your chest.

Try not to forget to use Zineryt, as missing an application will slow
down the healing process. If you have missed an application, use
Zineryt when you remember, but leave about three hours before
you use it again.

Driving and using machines

If you stop using Zineryt

It is not likely that Zineryt affects your ability to drive or use
machines.

If you stop using Zineryt, the original symptoms may come back.
Always contact your doctor if you want to stop using Zineryt.

3. How to use Zineryt

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

This medicine is for cutaneous use.
Always use this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.

4. Possible side effects

Instructions for proper use
Wash the affected area first before using Zineryt.
If you want to apply make-up, use the medicine first and let it dry.
Zineryt comes to you in a special bottle with a special applicator
pad protected by a cap which you should remove just before use
and replace firmly after each use. The pad makes it easy to apply
the solution to the whole of the affected area of the skin to be
treated.
To use Zineryt unscrew the protective cap, hold the bottle upside
down, place the pad against the skin, and spread the solution over
the whole of the affected area (including the surrounding skin).
The flow of solution can be increased by pressing the pad a little
more firmly against the skin.
If you use the applicator properly, just the right quantity should be
applied. But if you do put too much on, blot it off with some tissue,
and make sure it does not run into the eyes, nose or mouth. If it
does, wash well with plenty of water (see also
‘Warnings and precautions’ under section 2. What you need to
know before you use Zineryt).

Frequency of administration
Usually, Zineryt should be applied all over the affected area and
the surrounding skin twice a day.

Duration of treatment
Successful treatment of acne may take several weeks or even
months. The normal treatment time is 10 to 12 weeks.
Consult your doctor if you still have acne at the end of the
prescribed course of treatment.

Cross resistance may occur with other antibiotics of the macrolide
group and also with lincomycin and clindamycin. Contact with the
eyes or the mucous membranes of the nose and mouth should be
avoided. However, if this occurs, then rinse the affected area
immediately with cold or lukewarm water for several minutes.
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Like all medicines, this medicine can cause side effects, although
not everybody gets them.
Zineryt may very rarely cause allergic reactions. Symptoms may
include rash, itching, swelling of the mouth, face and lips or tongue
and difficulty breathing.
Please contact your doctor immediately if you experience any of
these side effects.
Zineryt may cause the following rare side effects (may affect up to
1 in 1,000 people):

Temporary stinging or slight redness of the skin.
If you get a very painful rash or burning feeling after using Zineryt
which does not go away in a few hours, or gets worse each time
you use it, stop using it and tell your doctor as soon as possible.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the
Yellow Card Scheme at: 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 Zineryt










Keep out of the sight and reach of children.
Do not use after the Expiry date (Exp), which is printed on
the carton and bottle label.
Do not store above 25°C. Store in the original package.
Do not use this medicine after the “Use before” date which
has been put on the label by your pharmacist. This date is 8
weeks from the date of preparation.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.
If you have any solution left over at the end of treatment,
take it back to your pharmacist for safe disposal.
If your medicine appears to be discoloured or shows any
other signs of deterioration, please return to your pharmacist
who will advise you further.

6. Contents of the pack and other
information
What Zineryt contains
Zineryt contains: Erythromycin-zinc complex containing the
equivalent of 40 mg/ml erythromycin and 12 mg/ml zinc acetate
(as the complex) on constitution. The application also contains
di-isopropyl sebacate and ethanol.

What Zineryt looks like and contents of the pack
This medicine is made available as a dry, white powder and clear,
colourless solvent for cutaneous solution. The powder and solvent
are provided in separate bottles and will be mixed together by
your pharmacist to form a solution. Your pharmacist will then fit a
special applicator top to the bottle containing the mixed solution.
Zineryt is available in packs which, when made up, will contain
30ml of the solution.

Manufacturer
Your medicine is manufactured by: Astellas Pharma Europe B.V.,
Hogemaat, 2 NL-7942 JG Meppel, Holland.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Doncaster Pharmaceuticals Group Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
PLPI No: 04423/0371

POM

Leaflet revision and issue date (Ref): 02.07.15
Zineryt® is a registered trademark of Astellas Pharma Europe B.V.

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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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