VIRGAN 1.5 MG/G EYE OINTMENT

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet, information on the immediate packaging in a foreign language
Virgan 1.5 mg/g eye gel
Ganciclovirum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Virgan is and what it is used for
2. Important information before using Virgan
3. How to use Virgan
4. Possible side effects
5. How to store Virgan
6. Contents of the pack and other information

1. What Virgan is and what it is used for

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

2. Important information before using Virgan

When not to use Virgan

• if the patient is allergic to ganciclovir, acyclovir, or any of the other ingredients of this medicine (listed in section 6).
• during pregnancy and breastfeeding, unless otherwise advised by a physician.
• in men and women of childbearing potential who are not using contraception. Additionally, men undergoing treatment with Virgan should use a local contraceptive method (e.g. condom) during treatment and for three months after its completion. Women undergoing treatment with Virgan should use contraceptive measures during treatment and for 6 months after its completion.

Warnings and precautions
Before starting treatment with Virgan, discuss this with your doctor.

• Do not swallow.
• Avoid touching the eyes and eyelids with the dropper tip.
• Contact lenses: Avoid contact of the medicine with soft contact lenses (see also Virgan contains benzalkonium chloride).

Children and adolescents
Due to lack of detailed studies, use in children under 18 years of age is not recommended.

Virgan with other medicines
If the patient is using any other eye drops, they should:
① apply the other ophthalmic medicine first,
② wait 15 minutes,
③ then apply Virgan as the last medicine.
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.

Pregnancy, breastfeeding, and effects on fertility
This medicine should not be used during pregnancy and breastfeeding, unless otherwise advised by a physician.
See also section 2: When not to use Virgan.
If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine. Only a doctor can modify the treatment.

Driving and operating machinery
After instillation of the medicine, transient blurred vision may occur. Wait until vision returns to normal before driving or operating machinery.

Virgan contains benzalkonium chloride
This medicine contains 2.625 micrograms of benzalkonium chloride per drop of gel, equivalent to 0.075 mg/g.
Benzalkonium chloride may be absorbed by soft contact lenses and may change the color of contact lenses. Remove contact lenses before using this medicine and reinsert them after 15 minutes.
Benzalkonium chloride may also cause eye irritation, particularly in cases of dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If the patient experiences unusual eye reactions, stinging, or eye pain after using this medicine, inform the doctor.

3. How to use Virgan 1.5 mg/g eye gel

Dosage
This medicine should always be used according to the instructions given by the doctor or pharmacist. In case of doubts, consult your doctor or pharmacist.
The recommended dose is 1 drop, 3 to 5 times daily.

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

Method of administration
This medicine is intended for ocular use (instillation into the eye) in the affected eye(s).
① Wash your hands thoroughly before using the medicine.
② Look upwards, gently pull the lower eyelid downwards and lightly squeeze the tube to instill the medicine into the infected eye.
③ Close the tube after use.

Duration of treatment:
Treatment usually does not exceed 21 days.

Accidental overdose of Virgan
Continue treatment as prescribed by your doctor.
If you have used more than you should, contact your doctor or pharmacist immediately.

If you forget to use Virgan
Do not use a double dose to make up for a forgotten dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Eye disorders:
Very common: may occur in more than 1 in 10 people

• transient burning or stinging, eye irritation, blurred vision.

Common: may occur in less than 1 in 10 people

• keratitis (punctate keratitis), conjunctival hyperemia (conjunctival redness).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions allows more information on the safety of the medicine to be collected.

5. How to store Virgan

Keep this medicine out of the sight and reach of children.
No special storage instructions are required.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
After opening the tube, do not store the medicine for longer than 4 weeks.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Virgan contains

• The active substance is ganciclovir. 1 gram of gel contains 1.5 mg of ganciclovir.
• The other ingredients are: carbomer 974P, sorbitol, sodium hydroxide, benzalkonium chloride and water for injections.

What Virgan looks like and contents of the pack
The medicine is available in a tube containing 5 grams of gel.
For further information, contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Romania, the country of export:
Laboratoires THÉA
12, rue Louis Blériot
63017 Clermont-Ferrand Cedex 2
France
Manufacturer:
Farmila-Thea Farmaceutici S.p.A.
Via Enrico Fermi, 50
20019 Settimo Milanese (MI)
Italy
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorisation number in Romania, the country of export: 13277/2020/01
Parallel import authorisation number: 339/25
This medicine is authorised for sale in the following European Economic Area countries under the following names:
Czech Republic, France, Germany, Greece, Hungary, Italy, Luxembourg, Poland, Spain .............. Virgan