Virgan 1.5 mg/g ophthalmic gel
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
VIRGAN 1.5 mg/g Ophthalmic Gel
ganciclovir
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again. If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Virgan is and what it is used for
- What you need to know before using Virgan
- How to use Virgan
- Possible side effects
- How to store Virgan
- Contents of the pack and other information
1. What VIRGAN is and what it is used for
Virgan is an ophthalmic gel containing 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 using 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 tells you to.
- in men and women of childbearing age who are not using a method of birth control.
In addition, male patients undergoing treatment with Virgan are advised to use contraceptive methods (e.g. condom) during treatment and for three months after stopping treatment. For women receiving treatment with Virgan, the use of contraceptive methods is recommended during treatment and for up to 6 months after stopping treatment.
Warnings and precautions
Talk to your doctor or pharmacist before starting to use Virgan.
- Do not swallow.
- 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, use in patients under 18 years of age is not recommended.
Using Virgan with other medicines
If you are using another topical ophthalmic medication, you should:
- apply the other eye medication first.
- wait 15 minutes.
- then apply Virgan.
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy, breastfeeding and fertility
The use of Virgan is not recommended during pregnancy and breastfeeding, unless your doctor tells 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 become pregnant, consult your doctor or pharmacist before using this medicine. Only your doctor can adjust your treatment appropriately.
Driving and use of machines
Transient visual disturbances may occur after application.
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, equivalent to 0.075 mg/g.
Benzalkonium chloride may be absorbed by soft contact lenses, altering their colour. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, particularly in dry eyes or other corneal diseases (the transparent layer at the front of the eye). Consult your doctor if you experience a foreign body sensation, stinging, or pain in the eye after using this medicine.
3. How to use VIRGAN
Dosage
Follow exactly the instructions given by your doctor or pharmacist for using this medicine. If in 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 individuals under 18 years of age.
Method of administration
Virgan must be administered only in the affected eye (ophthalmic route):
- Wash your hands before each application.
- Gently squeeze the tube so that one drop falls into the affected eye while looking upward and gently pulling down the lower eyelid.
- 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 directed by your doctor and consult your doctor or pharmacist. In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, go to a medical center, or call the Toxicology Information Service at telephone 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 further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everybody gets 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), redness of the conjunctiva (conjunctival hyperemia).
Reporting of 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 leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Do not use Virgan more than 4 weeks after first opening.
Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE Point at your usual pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Virgan
-
The active substance 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 injections.
Appearance of the product and contents of the container
Virgan is an ophthalmic gel supplied in a tube containing 5 g.
Marketing Authorization Holder and Manufacturer
Marketing Authorization 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, 2nd floor
08008 Barcelona
Spain
This medicinal product is authorized in the European Economic Area member states under the following names:
Germany, Czech Republic, Spain, France, Greece, Hungary, Italy, Luxembourg, Poland: VIRGAN
Date of the most recent revision of this leaflet: 10/2022
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)