Virgan 1.5 mg/g gel for eyes
Poland
Table of Contents
Package leaflet: Information for the user
Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language.
Virgan 1.5 mg/g ophthalmic gel
Ganciclovir
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
- Keep this leaflet for future reference.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm someone else, even if their symptoms are similar.
- If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.
Table of contents of the leaflet
- What Virgan is and what it is used for
- Important information 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. It is indicated for the treatment of certain superficial viral eye infections (corneal infections).
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 doctor.
- in men and women of childbearing age who are not using a contraceptive method. In addition, men being treated with Virgan are advised to use a local contraceptive method (e.g. condom) during treatment and for three months after its completion. Women treated with Virgan are advised to use contraception 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:
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first apply the other eye medicine,
wait 15 minutes,
then apply Virgan as the last one.
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
Pregnancy, breastfeeding and effects on fertility
This medicine should not be used during pregnancy and breastfeeding, unless otherwise advised by a doctor.
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 a doctor before using this medicine. Only a doctor can modify the treatment.
Driving and operating machinery
Blurred vision may occur temporarily after instillation of the medicine. Wait until vision returns to normal before driving or operating mechanical devices.
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 medicinal product 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, eye pricking, 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 as directed by a physician or pharmacist. If in doubt,
consult a physician 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 (in the eye or eyes requiring treatment).
Before application, hands should be thoroughly washed.
Look upwards, gently pull down the lower eyelid and lightly squeeze the tube to instill the gel
into the affected eye.
After use, close the tube tightly.
Duration of treatment
Treatment usually does not exceed 21 days.
If you use more Virgan than you should
Continue treatment as advised by your physician.
If you have used more than the recommended dose, consult a physician or pharmacist immediately.
If you forget to use Virgan
Do not apply a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your physician or pharmacist.
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4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everybody 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 the leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department for Monitoring Adverse Reactions of Medicinal Products 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 helps to provide more information on the safety of the 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 stated on the container. The expiry date refers to the last day of the stated month.
No special storage conditions apply.
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. Such measures 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 pH), benzalkonium chloride, and purified water.
What Virgan looks like and contents of the pack
The medicine is available in a tube containing 5 grams of gel.
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For further information, please contact the marketing authorisation holder or parallel importer.
Marketing authorisation 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 in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorisation number in Greece, the country of export: 12135/03-02-2014
1596/11-01-2006
Parallel import authorisation number: 351/19
This medicinal product is authorised for sale in the European Economic Area countries under the following names:
Czech Republic, France, Germany, Greece, Hungary, Italy, Luxembourg, Poland, Spain............VIRGAN
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