Label: information for the user

VIRGAN 1.5mg/g Ophthalmic Gel

Ganciclovir

Read the entire label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
  If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What is Virgan and for what it is used

2. What you need to know before starting to use Virgan

3. How to use Virgan

4. Possible adverse effects

5. Storage of Virgan

6. Contents of the package and additional information

VIRGAN is an eye gel that contains an antiviral agent called ganciclovir.

VIRGAN is indicated for the treatment of some superficial viral infections of the eye (cornea).

Do not use Virgan

• If you are allergic to ganciclovir, aciclovir, or any of the other components of this medication.
• During pregnancy or breastfeeding, unless your doctor advises you to do so.
• In men and women of childbearing age who do not use a method of birth control.

In addition, men undergoing treatment with Virgan are recommended to use contraceptive methods (condoms) during treatment and three months after completing treatment. As for women receiving treatment with Virgan, it is recommended to use contraceptive methods during treatment and for up to 6 months after completing 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 tip of the dropper.
• Users of contact lenses: Avoid contact with contact lenses. (see also Virgan contains benzalkonium chloride),

Children

• In the absence of specific studies, it is not recommended for use in individuals under 18 years of age.

Use of Virgan with other medications

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

1. Apply the other ophthalmic medication.
2. Wait 15 minutes.
3. Apply Virgan afterwards.

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Pregnancy, breastfeeding, and fertility

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

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication..Your doctor is the only one who can adjust your treatment.

Driving and operating machinery

Temporary visual disturbances may occur after application.

Wait until your vision returns to normal before driving or operating machinery.

Virgan contains benzalkonium chloride

This medication contains 2.625 micrograms of benzalkonium chloride in each drop of gel, equivalent to 0.075 mg/g.

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

Benzalkonium chloride may also cause eye irritation, especially in dry eyes or other corneal diseases (transparent layer at the front of the eye). Consult your doctor if you experience unusual sensations, stinging, or pain in the eye after using this medication.

Dosage

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist.If in doubt, consult your doctor or pharmacist again.

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

Use in children

This eye gel is not recommended for use in individuals under 18 years of age.

Method of administration

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

1. Wash your hands before each application.

2. Gently squeeze the tube to allow the drop to fall into the affected eye, looking upwards and gently pulling the lower eyelid downwards.

3. Close the tube.

Treatment duration

Generally, treatment should not exceed 21 days.

If you use more Virgan than you should

Continue treatment as directed by your doctor and consult your doctor or pharmacist. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, visit a medical center, or call the Toxicological Information Service at 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Virgan

Do not use a double dose to compensate for the missed dose.

Ask your doctor or pharmacist if you have any other questions about the use of this medication.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Eye Disorders:

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

- Transient sensation of burning or itching, eye irritation, blurred vision.

Common: may affect up to 1 in 10 people:

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at your local SIGRE collection point.Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment..

Composition ofVirgan

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

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

Appearance of the product and contents of the packaging

Virgan is an ophthalmic gel that is presented in a tube containing5 g.

Holder of the marketing authorization and responsible for manufacturing

Holder

Laboratoires Théa

12, rue Louis Blériot

63017 Clermont-Ferrand

France

Responsible for manufacturing

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, 2nd floor

08008 Barcelona

This medicine is authorized in the member states of the European Economic Areawith the following names:

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

Date of the last review of this leaflet:10/2022

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)