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Package leaflet: Information for the user



cutaneous solution

erythromycin 40 mg and zinc acetate 12 mg per ml on constitution


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.
•  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.
•  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.  hat Zineryt is and what it is used for
2.  hat you need to know before you use
3. How to use Zineryt

4. Possible side effects

5. How to store Zineryt

6.  ontents of the pack and other
1.  hat 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.  hat you need to know before you
use Zineryt
Do not use Zineryt
•  you are allergic to erythromycin or zinc
or any of the other ingredients of this
medicine (listed in section 6).
•  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.
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.
Other medicines and Zineryt
Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines.
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.
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.
Driving and using machines
It is not likely that Zineryt affects your ability
to drive or use machines.
3. How to use Zineryt
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
Instructions for proper use
Wash the affected area first before using
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

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
If you use more Zineryt than you should
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.
If you forget to use Zineryt
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.
If you stop using Zineryt
If you stop using Zineryt, the original
symptoms may come back. Always contact
your doctor if you want to stop using Zineryt.
If you have any further questions on the use
of this medicine, ask your doctor, pharmacist
or nurse.
4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets
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:
Continued overleaf

By reporting side effects you can help
provide more information on the safety of
this medicine.
5. How to store Zineryt
Keep this medicine out of the sight and
reach of children.
Do not use this medicine after the “Use
before” date which has been put on the label
by your pharmacist.
Do not store above 25°C.
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

What Zineryt contains
The active substances are erythromycin
(40 mg/ml) and zinc acetate (12 mg/ml)
combined in a special way.
The other ingredients are di-isopropyl
sebacate and ethanol.
What Zineryt looks like and contents of
the pack
Zineryt is made available as a solution
for use on the skin (cutaneous use). The
packaging contains a bottle of powder,
a bottle of solvent and an applicator in a
plastic holder. The contents of the bottles
will be mixed together by your pharmacist
to form a solution. Your pharmacist will also
fit the special applicator top to the bottle
containing the mixed solution. The applicator
top is protected by a cap.
Zineryt is available in packs which, when
made up, will contain 30 ml or 90 ml of the


Marketing Authorisation Holder and
Marketing Authorisation Holder:
Astellas Pharma Ltd.,
2000 Hillswood Drive, Chertsey,
Surrey, KT16 0RS,
Astellas Pharma Europe B.V.
Sylviusweg 62
2333 BE Leiden
The Netherlands
This leaflet was last revised in March

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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.