VIRGAN 1.5 mg/g OPHTHALMIC GEL

Introduction

Package Leaflet: Information for the User

VIRGAN 1.5mg/g Ophthalmic 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 or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Virgan and what is it used for
2. What you need to know before you use Virgan
3. How to use Virgan
4. Possible side effects
5. Storage of Virgan
6. Contents of the pack and further information

1. What is VIRGAN and what is it used for

Virgan is an ophthalmic gel that contains an antiviral agent called ganciclovir.

Virgan is indicated for the treatment of certain superficial viral infections of the eye (cornea).

2. What you need to know before you use VIRGAN

Do not use Virgan

• if you are allergic to ganciclovir, aciclovir or any of the other ingredients of this medicine.
• during pregnancy or breastfeeding, unless your doctor advises you to.
• in men and women of childbearing age who do not use a method of birth control.

In addition, males being treated with Virgan are advised to use contraceptive methods (condoms) during treatment and for three months after the end of treatment. For women receiving treatment with Virgan, the use of contraceptive methods is recommended during treatment and up to 6 months after the end of treatment.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Virgan.

• Do not ingest.
• Avoid touching the eye and eyelid with the dropper tip.
• Contact lens wearers: Avoid contact with contact lenses. (See also Virgan contains benzalkonium chloride),

Children

• In the absence of specific studies, the use of this ophthalmic gel is not recommended in children under 18 years of age.

Using Virgan with other medicines

If you are using another topical ophthalmic medicine, you should:

1. apply the other ophthalmic medicine.
2. wait 15 minutes.
3. apply Virgan afterwards.

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Pregnancy, breastfeeding and fertility

The use of Virgan is not recommended during pregnancy and breastfeeding, unless your doctor advises you to. See also section 2: Do not use Virgan.

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Your doctor is the only one who can adjust your treatment.

Driving and using machines

Temporary visual disturbances may occur after application.

Wait until your vision is restored to normal before driving or using machinery.

Virgan contains benzalkonium chloride

This medicine contains 2.625 micrograms of benzalkonium chloride per drop of gel, which is equivalent to 0.075 mg/g.

Benzalkonium chloride can be absorbed by soft contact lenses, altering their color. Remove contact lenses before using this medicine and wait 15 minutes before putting them back.

Benzalkonium chloride can also cause eye irritation, especially in dry eyes or other corneal diseases (the transparent layer of the front of the eye). Consult your doctor if you feel any unusual sensation, itching or pain in the eye after using this medicine.

3. How to use VIRGAN

Dosage

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is one drop 3 to 5 times a day.

Use in children

The use of this ophthalmic gel is not recommended in children under 18 years of age.

Method of administration

Virgan should be administered only in the affected eye (via ophthalmic route):

1. Wash your hands before each application.
2. Gently squeeze the tube to drop the drop into the affected eye, while looking up and gently pulling the lower eyelid down.
3. Close the tube.

Duration of treatment

In general, treatment should not exceed 21 days.

If you use more Virgan than you should

Continue treatment as your doctor has indicated and consult your doctor or pharmacist. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, go to a medical center or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Virgan

Do not use a double dose to make up for forgotten doses.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Ocular disorders:

Very common: may affect more than 1 in 10 people:

• Transient burning or itching 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 side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 packaging after EXP. The expiry date is the last day of the month shown.

Do not use Virgan more than 4 weeks after first opening.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Virgan

• The active ingredient is ganciclovir. Each gram of ophthalmic gel contains 1.5 mg of ganciclovir.

• The other ingredients are: carbomer (carbopol 974), sorbitol, sodium hydroxide, benzalkonium chloride, and water for injectable preparations.

Appearance of the product and pack contents

Virgan is an ophthalmic gel presented in a tube containing 5 g.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Laboratoires Théa

12, rue Louis Blériot

63017 Clermont-Ferrand

France

Manufacturer

Farmila Thea Farmaceutici Spa

Via Enrico Fermi, 50

20019 Settimo Milanese (Milan)

Italy

Local representative

Laboratorios Thea, S.A.

C/ Enric Granados, nº 86-88, 2ª planta

08008 Barcelona

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Germany, Czech Republic, Spain, France, Greece, Hungary, Italy, Luxembourg, Poland: VIRGAN

Date of last revision of this leaflet:10/2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)