PACKAGE LEAFLET: INFORMATION FOR THE USER

Virgan 1.5 mg/g, eye gel

Ganciclovir
Read all of this leaflet carefully before you start using this medicine.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful to them.
If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

What VIRGAN is and what it is used for
Before you use VIRGAN
How to use VIRGAN
Possible side effects
How to store VIRGAN
Further information

1. WHAT VIRGAN IS AND WHAT IT IS USED FOR

Virgan is an eye drop solution containing an antiviral agent called ganciclovir.
It is indicated for the treatment of certain superficial viral eye infections (cornea).

2. BEFORE USING VIRGAN

DO NOT use VIRGAN

If you are allergic (hypersensitive) to ganciclovir or to any of the other components of VIRGAN.
During pregnancy and breastfeeding, unless otherwise directed by your doctor.
In men and women of childbearing age who are not using contraceptive measures. In addition, male patients taking VIRGAN are advised to use local contraceptive precautions (such as condoms) during treatment and for up to three months afterwards.

Take special care with VIRGAN

Use of this product in children under 18 years of age is not recommended, as specific studies have not been conducted.
Do not swallow.
Keep out of the reach and sight of children.
Avoid contact between the eye or eyelid and the tip of the bottle.
Benzalkonium chloride may cause eye irritation.
Contact lens wearers: Avoid contact with soft contact lenses. Remove contact lenses before application and wait at least 15 minutes before reinserting them. VIRGAN contains benzalkonium chloride, which is known to discolor soft contact lenses.

Use with other medicines
If you are using any other eye medication, you must:
 apply the other ophthalmic drug first,
 wait 15 minutes,
 then apply VIRGAN last.
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines,
including those not requiring a prescription.
Pregnancy and breastfeeding
This medicine must not be used during pregnancy and breastfeeding, unless otherwise directed by your doctor. Contact your doctor immediately if you are planning a pregnancy or if you discover you are pregnant during treatment. Only your doctor can adjust your treatment.
Consult your doctor or pharmacist before taking any medicine.
Driving and using machines
You may experience transient blurred vision after ocular administration of the medicine. Wait until vision has returned to normal before driving or operating machinery.
List of excipients with known effects: Benzalkonium chloride (see section 2: Take special care with VIRGAN).

3. HOW TO USE VIRGAN

Dosage
Always use VIRGAN exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist.
The usual dose is one drop administered 3 to 5 times daily.
Children: The use of this ophthalmic gel in children under 18 years of age is not recommended.
Method of administration
This medicine is for ocular use only.

Wash your hands thoroughly before using the medicine,
Gently squeeze the tube to release one drop into the affected eye, looking upwards and gently pulling down the lower eyelid,
Close the tube after use.

Between administrations, the tube should be kept vertically upright with the tip pointing downwards, placed into the base provided with the package.
Duration of treatment
Treatment should generally not last longer than 21 days.
If you use more VIRGAN than you should
Follow the treatment as directed by your doctor.
Contact your doctor or pharmacist immediately.
If you forget to use VIRGAN
Do not use a double dose to make up for the missed dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, VIRGAN may cause adverse reactions, although not everyone experiences them.
Eye disorders:
Very common: may affect more than 1 in 10 people:

Transient burning and stinging sensation, eye irritation, blurred vision.

Common: may affect up to 1 in 10 people:

Inflammation of the cornea (superficial punctate keratitis), redness of the conjunctiva (conjunctival hyperemia).

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, please consult your
doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting adverse reactions, you can help provide further information on the safety of this medicine.

5. HOW TO STORE VIRGAN

Do not use VIRGAN after the expiry date stated on the tube. The expiry date refers to the last day of that month.
After opening, the container (tube) must not be kept for more than 4 weeks.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. OTHER INFORMATION

What VIRGAN contains

The active substance is ganciclovir. Each gram of solution contains 1.5 mg of ganciclovir.
The other ingredients are carbomer (carbopol 974P), sorbitol, sodium hydroxide, benzalkonium chloride and purified water.

Description of the appearance of VIRGAN and contents of the pack
This medicine is supplied in a tube containing 5 g of ophthalmic gel.
Marketing Authorization Holder
LABORATOIRES THEA
12, rue Louis Blériot
63017 CLERMONT-FERRAND CEDEX 2
FRANCE
Manufacturer
FARMILA-THEA FARMACEUTICI S.p.A.
Via Enrico Fermi, 50
SETTIMO MILANESE (MI)
ITALY
This medicinal product is authorized in the European Economic Area countries under the
following names:
France, Germany, Greece, Italy, Luxembourg, Poland, Czech Republic, Hungary……VIRGAN
This leaflet was last approved: [MM/YYYY]