Virgan 1.5 mg/g eye ointment
Poland
Table of Contents
PACKAGE LEAFLET: INFORMATION FOR THE USER
Warning! Keep the leaflet, information on the outer packaging in a foreign language!
Virgan 1.5 mg/g eye gel
Ganciclovirum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
- Keep this leaflet, so that you may read it again if necessary.
- 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 another person, even if their symptoms appear identical.
- If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
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 eye gel containing an antiviral agent called ganciclovir.
It is indicated for the treatment of certain superficial viral eye infections (cornea).
2. Important information before using Virgan
When not to use Virgan:
- if the patient is allergic to ganciclovir, aciclovir, 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 being treated with Virgan are advised to use contraceptive measures during treatment and for 6 months after its completion.
Warnings and precautions
Before starting to use Virgan, discuss this with your doctor.
- Do not swallow.
- Avoid touching the eyes and eyelids with the dropper tip.
- Contact lenses: Avoid contact between the medicine and 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:
first apply the other ophthalmic medicine,
wait 15 minutes,
then apply Virgan as the last one.
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
Pregnancy, breastfeeding and 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 have a child, she should consult her doctor before using this medicine. Only a doctor can modify the treatment.
Driving and using machines
After instillation, 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 discolour contact lenses. Contact lenses should be removed before applying this medicinal product and may be reinserted 15 minutes after administration.
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, after using this medicine, the patient experiences unusual eye reactions, eye pricking or eye pain, inform the doctor.
3. How to use Virgan
Dosage
This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a 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) requiring treatment.
Wash hands thoroughly before applying the product,
Gently pull down the lower eyelid and, while looking upward, gently squeeze the tube to instill the medicine into the affected eye,
Close the tube after use.
Duration of treatment:
Treatment usually does not exceed 21 days.
Use of a higher than recommended dose of Virgan
Continue treatment as directed by the doctor.
Seek immediate advice from a doctor or pharmacist.
Missed dose of Virgan
Do not use a double dose to make up for a missed 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 stinging or burning, eye irritation, blurred vision.
Common: may occur in less than 1 in 10 people
- corneal inflammation (punctate keratitis), conjunctival redness (conjunctival hyperaemia).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, please inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions of 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
By reporting adverse reactions, additional information on the safety of the medicine can be collected.
5. How to store Virgan
Keep this medicine out of the sight and reach of children.
No special storage instructions apply.
Do not use this medicine after the expiry date stated on the packaging. 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.
6. Contents of the packaging 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 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 more detailed information, please contact the responsible party or the 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:
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 numbers in Greece, the country of export: 1596/11-1-2006
12135/03-02-2014
Parallel Import Licence number: 123/21
This medicinal product is authorised in the European Economic Area countries under the following names:
Czech Republic, France, Germany, Greece, Hungary, Italy, Luxembourg, Poland, Spain ............ VIRGAN