Virgan 1,5 mg/g zhel do ohu

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

Ganciclovir

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. 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:

• during pregnancy and breastfeeding, unless the doctor recommends otherwise.
• in men and women of childbearing age who are not using a method of birth control. Additionally, men treated with Virgan are advised to use a local contraceptive method (e.g., a condom) during treatment and for three months after its completion. Women treated with Virgan are advised to use contraceptive measures during treatment and for six months after its completion.

Warnings and precautions

Before starting to use 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 of Virgan in children under 18 years of age is not recommended.

Virgan and other medicines

If the patient is using any other eye drops, they should:
first use the other eye medicine,
wait 15 minutes,
use Virgan as the last one.
Tell the doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines they plan to take.

Pregnancy, breastfeeding, and fertility

The medicine should not be used during pregnancy and breastfeeding, unless the doctor recommends otherwise.
See also section 2: When not to use Virgan. If the patient is pregnant, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine. The doctor is the only person who can modify the 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 per 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 can 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 the patient experiences any unusual reactions from the eye, stinging, or eye pain after using this medicine, they should tell their doctor.

3. How to use Virgan

Dosage
This medicine should always be used exactly as recommended by the doctor or pharmacist. If in doubt, consult the doctor or pharmacist.
The recommended dose of the medicine 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 intended for use in the eye (eye) that needs treatment (administration to 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,
close the tube after use.
Duration of treatment:
Treatment usually does not exceed 21 days.

Using more Virgan than recommended

Continue treatment as recommended by the doctor.
Consult a doctor or pharmacist immediately.

Missing a dose of Virgan

Do not use a double dose to make up for a missed dose.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Eye disorders:

Very common: may occur more often than in 1 in 10 people

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

Common: may occur less often than in 1 in 10 people

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

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring 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
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Virgan

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

6. Contents of the pack 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 (Carbopol 974P), sorbitol, sodium hydroxide (to adjust the pH), benzalkonium chloride, and purified water.

What Virgan looks like and contents of the pack

Virgan is available in a tube containing 5 grams of gel.
For more detailed information, consult the marketing authorization holder or the parallel importer.

Marketing authorization holder in Greece, the country of export:

Laboratoires THÉA, 12, rue Louis Blériot, 63017 Clermont-Ferrand Cedex 2, France

Manufacturer:

Farmila-Thea Farmaceutici Spa, Via Enrico Fermi, 50, 20019 Settimo Milanese (MI), Italy

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Greek marketing authorization number, country of export: 12135/03-02-2014
1596/11-01-2006

Parallel import authorization number: 351/19

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 approval of the leaflet: 17.09.2024

[Information about the trademark]
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