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VIRGAN EYE GEL

Active substance(s): GANCICLOVIR

PDF Transcript

Package leaflet: Information for the patient

Virgan 0.15 % w/w
Eye Gel
Ganciclovir
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.
What is in this leaflet:
1. What Virgan Eye Gel is and what it is used
for
2. What you need to know before you use
Virgan Eye Gel
3. How to use Virgan Eye Gel
4. Possible side effects
5. How to store Virgan Eye Gel
6. Contents of the pack and other information

Contact lenses
- Avoid contact with soft contact lenses.
- Remove contact lenses prior to application
and wait at least 15 minutes before
reinsertion.
- Benzalkonium chloride is known to
discolour soft contact lenses.
Children
Do not give this medicine to children under
the age of 18 years as there is not enough
information to know if it is safe in children.
Other medicines and Virgan Eye Gel
Tell your doctor or pharmacist if you are using,
have recently used or might use any other
medicines.
- If you are using any additional eye
treatments:
 you should wait for at least 15 minutes
between using the two treatments,
 Virgan Eye Gel should always be the last
treatment put into the eye.
- Talk to your doctor before using this eye
gel if you are taking any other medicines,
especially any of the following:
- antigout drugs such as probenecid,
- anti-infectives such as trimethoprim/
sulpha, dapsone, pentamidine,
amphotericin B, imipenem/cilastatin or
zidovudine,
- anticancer therapy such as vincristine,
vinblastine, adriamycin or flucytosine.

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
Virgan Eye Gel contains ganciclovir as the
active ingredient. Ganciclovir is one of a group for advice immediately, before taking this
of active substances called anti-virals, used to medicine.
treat infections caused by viruses.
This medicine should not be used during
pregnancy and breast-feeding, unless your
This eye gel is used to treat an infection in
the eye called acute herpetic keratitis in adults doctor tells you to.
aged 18 years and over.
Men and women of childbearing age should
use a method of birth control.
2. What you need to know before you use
Men using Virgan Eye Gel should use a local
Virgan Eye Gel
method of contraception (such as a condom)
DO NOT USE Virgan Eye Gel
for three months after the end of treatment.
If you are allergic (hypersensitive) to:
Driving and using machines
- ganciclovir or any of the other ingredients of
If you notice any visual disturbances (for
this medicine (listed in section 6),
instance, blurred vision), or if you notice any
- acyclovir, another antiviral drug.
other problems with your eye sight after using
If you are pregnant or breast-feeding, unless
this eye gel, you should not drive or operate
your doctor tells you to.
machinery until you are satisfied that you can
In men and women of childbearing age
see clearly.
unless you use a method of birth control.
Virgan Eye Gel contains benzalkonium
Men using Virgan Eye Gel should use a local
method of contraception (such as a condom) chloride
See section 2: What you need to know before
for three months after the end of treatment.
you use Virgan Eye Gel – Warnings and
Warnings and precautions
precautions.
Talk to your doctor, pharmacist or nurse
before using Virgan Eye Gel.
- Virgan Eye Gel contains benzalkonium
chloride which may cause eye irritation.
1. What Virgan Eye Gel is and what it is
used for

Reporting of side effects
If you get any side effects, talk to your doctor,
Always use this medicine exactly as your
doctor has told you. Check with your doctor or pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
pharmacist if you are not sure.
You can also report side effects directly via the
The recommended dose is
Yellow Card Scheme.
Adults and elderly: The usual dose is one
Website: www.mhra.gov.uk/yellowcard
drop of gel in each infected eye, five times
By reporting side effects you can help provide
per day until healed, then three times per day more information on the safety of this
for 7 days.
medicine.
Use in children: Virgan Eye Gel should not be 5. How to store Virgan Eye Gel
used in children, unless your doctor tells you - Keep this medicine out of the sight and
to.
reach of children.
3. How to use Virgan Eye Gel

This medicine is intended to be administered
into the eye (ocular use).
DO NOT INJECT. DO NOT SWALLOW.
 Wash your hands thoroughly before using
the product.
 Do not touch your eye with the tip of the
dropper.
 While looking upwards and pulling the
lower eyelid down, gently squeeze the tube
to release one drop into the eye.
 Press the inner corner of your eye with your
fingertip for 1-2 minutes. This will prevent
the drops from draining away too quickly.
 Repeat for the other eye if necessary.
 Close the tube after use.
Follow the instructions carefully. If there is
anything you do not understand, ask your
doctor or pharmacist.
Your doctor may advise you to use this
medicine in a different way. Always follow
your doctor’s directions. Your pharmacist can
also help if you are not sure.
If you forget to use Virgan Eye Gel
Do not take a double dose to make up for a
forgotten dose.
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
them.
The possible side effects are:
- Very common (may affect more than
1 in 10 people) - burning or brief tingling
sensations,
- Common (may affect up to 1 in 10 people)
- inflammation of the surface of the eye
(such as burning or irritation, feeling like
there is something in your eye, tears in
the eye, sensitive to light and sometimes a
small decrease in vision).

- Do not use this medicine after the expiry
date which is stated on the tube and the
carton after EXP. The expiry date refers to
the last day of that month.
- Use within 28 days of first opening.
- 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
information
What Virgan Eye Gel contains
The active ingredient is ganciclovir
0.15 % w/w.
Each gram of gel contains 1.5 milligrams
ganciclovir.
The other ingredients are benzalkonium
chloride (see section 2: What you need
to know before you use Virgan Eye Gel),
carbomer 974P, sorbitol, sodium hydroxide
and purified water.
What Virgan Eye Gel looks like and
contents of the pack
Your medicine is a transparent eye gel which
is supplied in a tube. Each tube contains 5 g
of the eye gel.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Laboratoires THEA
12, Rue Louis Blériot
63017 Clermont-Ferrand Cedex 2
FRANCE.
Manufacturer:
FARMILA - THEA FARMACEUTICI SpA
Via Enrico Fermi, 50
SETTIMO MILANESE (MI)
ITALY.
The leaflet was last revised in 02/2016.
If you would like any more information,
or would like the leaflet in a different
format, please contact Medical Information
at THEA Pharmaceuticals Ltd, telephone
number 0870 192 3283.

N550G5ASP/0216

The treatment should not usually exceed
21 days.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.