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GANCICLOVIR 0.15% W/W EYE GEL

Active substance(s): GANCICLOVIR / GANCICLOVIR

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Ref: 1669/170816/1/F

®

Virgan 0.15% w/w Eye Gel
(ganciclovir)
Patient Information 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.
Your medicine is called Virgan 0.15% w/w Eye Gel but will be referred to as
Virgan Eye Gel throughout the rest of 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

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:
1. you should wait for at least 15 minutes between using the two
treatments,
2. 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 for advice
immediately, before taking this medicine.
This medicine should not be used during pregnancy and breast-feeding,
unless your doctor tells you to.

1

What Virgan Eye Gel is and what it is used for
Men and women of childbearing age should use a method of birth control.

Virgan Eye Gel contains ganciclovir as the active ingredient. Ganciclovir is
one of a group of active substances called anti-virals, used to treat infections
caused by viruses.
This eye gel is used to treat an infection in the eye called acute herpetic
keratitis in adults aged 18 years and over.

2

What you need to know before you use Virgan Eye
Gel

DO NOT USE Virgan Eye Gel
If you are allergic (hypersensitive) to:
* ganciclovir or any of the other ingredients of this medicine (listed in section
6),
* acyclovir, another antiviral drug.
If you are pregnant or breast-feeding, unless your doctor tells you to.
In men and women of childbearing age unless you use a method of birth
control. Men using Virgan Eye Gel should use a local method of
contraception (such as a condom) for three months after the end of
treatment.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Virgan Eye Gel.
* Virgan Eye Gel contains benzalkonium chloride which may cause eye
irritation.
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.

*
*

Men using Virgan Eye Gel should use a local method of contraception (such
as a condom) for three months after the end of treatment.
Driving and using machines
If you notice any visual disturbances (for instance, blurred vision), or if you
notice any other problems with your eye sight after using this eye gel, you
should not drive or operate machinery until you are satisfied that you can
see clearly.
Virgan Eye Gel contains benzalkonium chloride
See section 2: What you need to know before you use Virgan Eye Gel –
Warnings and precautions.

3

How to use Virgan Eye Gel

Always use this medicine exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure.
The recommended dose is
Adults and elderly: The usual dose is one drop of gel in each infected eye,
five times per day until healed, then three times per day for 7 days.
Use in children: Virgan Eye Gel should not be used in children, unless your
doctor tells you to.
The treatment should not usually exceed 21 days.

Ref: 1669/170816/1/B

®

Virgan 0.15% w/w Eye Gel
(ganciclovir)
Patient Information Leaflet (continued)
This medicine is intended to be administered into the eye (ocular use).
DO NOT INJECT. DO NOT SWALLOW.
1. Wash your hands thoroughly before using the product.
2. Do not touch your eye with the tip of the dropper.
3. While looking upwards and pulling the lower eyelid down, gently squeeze
the tube to release one drop into the eye.
4. Press the inner corner of your eye with your fingertip for 1-2 minutes. This
will prevent the drops from draining away too quickly.
5. Repeat for the other eye if necessary.
6. Close the tube after use.

5

How to store Virgan Eye Gel

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 25°C.
Do not use Virgan Eye Gel 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.
If your medicine becomes discoloured or shows any other signs of
deterioration consult your pharmacist who will tell you what to do.
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.

Between applications, the tube should be placed vertically with the tip
pointing downwards in the base provided with the pack.
6
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).
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.
Website: www.mhra.gov.uk/yellowcard By reporting side effects you can help
provide more information on the safety of this medicine.

Contents of the pack and other information

What Virgan Eye Gel contains:
Each gram of gel contains 1.5mg of ganciclovir.
The other ingredients are: carbomer (974P), sorbitol, sodium hydroxide,
benzalkonium chloride and purified water.
What Virgan Eye Gel looks like and contents of the pack
Virgan is a transparent eye gel in a tube with a detachable base cap.
Each tube contains 5g of the eye gel.
Manufacturer and Licence Holder
Manufactured by FARMILA – THEA Farmaceutici S.p.A Via Enrico Fermi,
50-20019 Settimo Milanese (MI), Italy and is procured from within the EU
and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1669

Virgan 0.15% w/w Eye Gel

Virgan is a registered trademark of Laboratoires Thea.
Revision date: 17/08/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: 1669/170816/2/F

Ganciclovir 0.15% w/w Eye Gel
Patient Information 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.
Your medicine is called Ganciclovir 0.15% w/w Eye Gel but will be referred
to as Ganciclovir Eye Gel throughout the rest of this leaflet.
What is in this leaflet:
1 What Ganciclovir Eye Gel is and what it is used for
2

What you need to know before you use Ganciclovir Eye Gel

3

How to use Ganciclovir Eye Gel

4

Possible side effects

5

How to store Ganciclovir Eye Gel

6

Contents of the pack and other information

1

What Ganciclovir Eye Gel is and what it is used for

Ganciclovir Eye Gel contains ganciclovir as the active ingredient. Ganciclovir
is one of a group of active substances called anti-virals, used to treat
infections caused by viruses.
This eye gel is used to treat an infection in the eye called acute herpetic
keratitis in adults aged 18 years and over.

2

What you need to know before you use Ganciclovir
Eye Gel

DO NOT USE Ganciclovir Eye Gel
If you are allergic (hypersensitive) to:
* ganciclovir or any of the other ingredients of this medicine (listed in section
6),
* acyclovir, another antiviral drug.
If you are pregnant or breast-feeding, unless your doctor tells you to.
In men and women of childbearing age unless you use a method of birth
control. Men using Ganciclovir Eye Gel should use a local method of
contraception (such as a condom) for three months after the end of
treatment.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Ganciclovir Eye Gel.
* Ganciclovir Eye Gel contains benzalkonium chloride which may cause eye
irritation.
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 Ganciclovir 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:
1. you should wait for at least 15 minutes between using the two
treatments,
2. Ganciclovir 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 for advice
immediately, before taking this medicine.
This medicine should not be used during pregnancy and breast-feeding,
unless your doctor tells you to.
Men and women of childbearing age should use a method of birth control.
Men using Ganciclovir Eye Gel should use a local method of contraception
(such as a condom) for three months after the end of treatment.
Driving and using machines
If you notice any visual disturbances (for instance, blurred vision), or if you
notice any other problems with your eye sight after using this eye gel, you
should not drive or operate machinery until you are satisfied that you can
see clearly.
Ganciclovir Eye Gel contains benzalkonium chloride
See section 2: What you need to know before you use Ganciclovir Eye Gel –
Warnings and precautions.

3

How to use Ganciclovir Eye Gel

Always use this medicine exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure.
The recommended dose is
Adults and elderly: The usual dose is one drop of gel in each infected eye,
five times per day until healed, then three times per day for 7 days.
Use in children: Ganciclovir Eye Gel should not be used in children, unless
your doctor tells you to.
The treatment should not usually exceed 21 days.

Ref: 1669/170816/2/B

Ganciclovir 0.15% w/w Eye Gel
Patient Information Leaflet (continued)
This medicine is intended to be administered into the eye (ocular use).
DO NOT INJECT. DO NOT SWALLOW.
1. Wash your hands thoroughly before using the product.
2. Do not touch your eye with the tip of the dropper.
3. While looking upwards and pulling the lower eyelid down, gently squeeze
the tube to release one drop into the eye.
4. Press the inner corner of your eye with your fingertip for 1-2 minutes. This
will prevent the drops from draining away too quickly.
5. Repeat for the other eye if necessary.
6. Close the tube after use.

5

How to store Ganciclovir Eye Gel

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 25°C.
Do not use Ganciclovir Eye Gel 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.
If your medicine becomes discoloured or shows any other signs of
deterioration consult your pharmacist who will tell you what to do.
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.

Between applications, the tube should be placed vertically with the tip
pointing downwards in the base provided with the pack.
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 Ganciclovir 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).
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.
Website: www.mhra.gov.uk/yellowcard By reporting side effects you can help
provide more information on the safety of this medicine.

6

Contents of the pack and other information

What Ganciclovir Eye Gel contains:
Each gram of gel contains 1.5mg of ganciclovir.
The other ingredients are: carbomer (974P), sorbitol, sodium hydroxide,
benzalkonium chloride and purified water.
What Ganciclovir Eye Gel looks like and contents of the pack
Ganciclovir is a transparent eye gel in a tube with a detachable base cap.
Each tube contains 5g of the eye gel.
Manufacturer and Licence Holder
Manufactured by FARMILA – THEA Farmaceutici S.p.A Via Enrico Fermi,
50-20019 Settimo Milanese (MI), Italy and is procured from within the EU
and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1669

Ganciclovir 0.15% w/w Eye Gel

Revision date: 17/08/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Expand Transcript

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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