Virgan 0.15% eye gel

United Kingdom - English - eMC (Electronic Medicines Compendium)

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Active ingredient:
Ganciclovir
Available from:
CST Pharma Ltd
ATC code:
S01AD09
INN (International Name):
Ganciclovir
Dosage:
1.5mg/1gram
Pharmaceutical form:
Eye gel
Administration route:
Ocular
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 11030300; GTIN: 5055946804811

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.

The name of your medicine is Virgan 0.15% w/w eye gel but will be

referred to as Virgan throughout this leaflet.

What is in this leaflet:

What Virgan is and what it is used for

What you need to know before you use Virgan

How to use Virgan

Possible side effects

How to store Virgan

Contents of the pack and other information

1. What Virgan is and what it is used for

Virgan 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

DO NOT USE Virgan

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 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.

Virgan contains benzalkonium chloride which may also cause eye

irritation, especially if you have dry eyes or disorders of the cornea

(the clear layer at the front of the eye).

If you feel anormal eye sensation, stinging or pain in the eye after using

this medicine, talk to your doctor.

Contact lenses

– Benzalkonium chloride may be absorbed by soft contact lenses and

may change the colour of the contact lenses.

– Remove contact lenses before using this medicine and put them back

15 minutes afterwards.

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

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 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 Virgan 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 contains benzalkonium chloride

See section 2: What you need to know before you use Virgan – Warnings

and precautions. This medicine contains 0.375 mg benzalkonium chloride

in each tube of 5 g.

3. How to use Virgan

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 should not be used in children, unless your doctor

tells you to.

The treatment should not usually exceed 21 days.

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

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:

Eye disorders:

Very common: may affect more than 1 in 10 people

- Burning or brief tingling sensations, eye irritation, blurred vision.

Package leaflet: Information for the patient

Virgan

®

0.15% w/w eye gel

(ganciclovir)

xxxxxxxxx

Common: may affect up to 1 in 10 people

Inflammation of the surface of the eye, (superficial punctate

keratitis, 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), redness of the conjunctiva (conjunctival

hyperaemia).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist.

This includes any possible side effects not listed on this leaflet.

You can also report side effects directly via the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the

Google Play or Apple App Store. By reporting side effects, you can help

provide more information on the safety of this medicine.

5. How to store Virgan

Keep this medicine out of the sight and reach of children.

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.

If this medicine becomes discoloured or shows any other signs of

deterioration, please contact your pharmacist who will advise you on

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.

6. Contents of the pack and other information

What Virgan contains

The active ingredient is ganciclovir 0.15 % w/w.

1 g gel contains 1.5 mg of ganciclovir.

The other ingredients are carbomer (carbopol 974P), sorbitol, sodium

hydroxide, benzalkonium chloride (see section 2: What you need to know

before you use Virgan) and purified water.

What Virgan looks like and contents of the pack

Your medicine is a colourless opalescent gel which is supplied in a tube.

Each tube contains 5 g of the eye gel.

Product Licence Holder and Manufacturer

Procured from within the EU by the Product Licence holder Orifarm A/S,

Energivej 15, 5260 Odense S, Denmark

Repacked by Orifarm Supply s.r.o., Palouky 1366, 253 01 Hostivice,

Czech Republic

Manufactured by Farmila-Thea Farmaceutici Spa, Via Enrico Fermi, 50,

Settimo Milanese (MI), Italy

Virgan 0.15% w/w eye gel

PL 46927/0056

Leaflet revision date: 13/03/2019

Blind or partially sighted?

Is this leaflet hard to see or read?

Call +45 63 95 27 00

to obtain the leaflet in a format

suitable for you.

POM

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