Virgan 1,5 mg/g zhel do ohu

Package Leaflet: Information for the User

Virgan 1.5 mg/g Eye Gel

Ganciclovir

Read All of This Leaflet Carefully Before Using This Medicine.

• You should 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Table of Contents of the Leaflet

• 1. What is Virgan and What is it 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 is Virgan and What is it Used For

VIRGAN is an eye gel containing the antiviral medicine ganciclovir.
It is used to treat certain superficial and viral eye infections (of the cornea).

2. Important Information Before Using Virgan

When Not to Use Virgan

• if you are allergic to ganciclovir, aciclovir, or any of the other ingredients of this medicine (listed in section 6).
• during pregnancy and breastfeeding, unless your doctor advises otherwise.
• in men and women of childbearing age who are not using a method of contraception. Additionally, men treated with Virgan are advised to use a local contraceptive method (e.g., condom) during treatment and for 3 months after its completion. Women treated with VIRGAN are advised to use contraceptive measures during treatment and up to 6 months after its completion.

Warnings and Precautions

Before starting treatment with Virgan, discuss it with your doctor.

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

Children and Adolescents

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

Virgan and Other Medicines

If you are using any other eye drops, you should:
 first use the other eye medicine,
 wait 15 minutes,
 use Virgan last.
Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and any you plan to take.

Pregnancy, Breastfeeding, and Fertility

The medicine should not be used during pregnancy and breastfeeding, unless your doctor advises otherwise.
See also section 2: When Not to Use Virgan.
If you are pregnant, think you may be pregnant, or plan to have a baby, ask your doctor for advice before using this medicine. Your doctor is the only person who can modify your treatment.

Driving and Using Machines

After administering the medicine, temporary blurred vision may occur. Wait until your vision returns to normal before driving or operating machinery.

Virgan Contains Benzalkonium Chloride

This medicine contains 2.625 micrograms of benzalkonium chloride in each drop of gel, which corresponds to 0.075 mg/g.
Benzalkonium chloride may be absorbed by soft contact lenses and may change the color of the contact lenses. Remove contact lenses before using this medicinal product and put them back 15 minutes later.
Benzalkonium chloride may also cause eye irritation, especially in the case of dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If you experience any unusual reactions from the eye, stinging, or eye pain after using this medicine, tell your doctor.

3. How to Use Virgan

Dosage
This medicine should always be used exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is 1 drop 3 to 5 times a day.

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 for use in the eye (or eyes) that needs treatment (administration into the eye).

Before using the product, wash your hands thoroughly,

Looking up, gently pull down the lower eyelid and squeeze the tube to drop the medicine into the infected eye,

After use, close the tube.
Duration of Treatment:
Treatment usually does not exceed 21 days.

Using More Than the Recommended Dose of Virgan

Continue treatment as advised by your doctor.
Seek immediate advice from your doctor or pharmacist.

Missing a Dose of 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 product, ask your doctor or pharmacist.

4. Possible Side Effects

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

Eye Disorders:

Very Common: may affect more than 1 in 10 people

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

Common: may affect up to 1 in 10 people

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

Reporting Side Effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Side effects can be reported to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
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 after EXP. The expiry date refers to the last day of that month.
After opening the tube, do not store for more 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. These measures will help protect the environment.

What Virgan Contains

• The active substance is ganciclovir. 1 gram of gel contains 1.5 mg of ganciclovir.
• The other ingredients are carbomer (Carbopol 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.

Marketing Authorization Holder and Manufacturer

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
20019 Settimo Milanese (MI)
Italy

For Further Information, Please Contact the Marketing Authorization Holder’s Representative:

Théa Polska Sp. z o.o.
ul. Cicha 7
00-353 Warsaw
phone: +48 22 642 87 77

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

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

Date of Last Revision of the Leaflet: 21-06-2023

Detailed Information on This Medicinal Product is Available on the Website www.urpl.gov.pl