The active substance is: Ganciclovir 1.5 mg.
Excipients/Inactive Ingredients: The other ingredients are: carbomer (carbopol 974P), sorbitol, sodium hydroxide, benzalkonium chloride and purified water.
Pharmacotherapeutic class: anti-infectives - antivirals. ATC code: S01AD09.
VIRGAN is an eye gel containing an antiviral agent called ganciclovir.
It is indicated in the treatment of certain superficial and viral eye infections (cornea).
Dosage: Always use this medicine exactly as advised by the doctor or pharmacist. Advise the patient to check with the doctor or pharmacist if not sure.
The recommended dose is 1 drop 3 to 5 times daily.
Use in children: The use of this eye gel in children before 18 years is not recommended.
Method of administration: This medicine is intended to be administered into the affected eye (ocular use).
1. Wash hands thoroughly before using the product.
2. Gently squeeze the tube to release a drop into the affected eye, while looking upwards and pulling the lower eyelid down.
3. Close the tube after use.
Duration of treatment: The treatment should not usually exceed 21 days.
If the patient forgets to use VIRGAN 1.5 mg/g, eye gel: A double dose should not be taken to make up for a forgotten dose.
For any further questions on the use of this product, advise the patient to ask the doctor or pharmacist.
Continue the treatment as instructed by the doctor if the patient uses more VIRGAN 1.5 mg/g, eye gel than the patient should.
Advise the patient to immediately contact the doctor or the pharmacist.
VIRGAN 1.5 mg/g, eye gel should not be used: if the patient is allergic to ganciclovir, aciclovir or any of the other ingredients of this medicine (listed in Description).
During pregnancy and breast-feeding, unless instructed otherwise by the doctor.
In men and women of childbearing age not using a method of birth control.
Moreover, men treated by VIRGAN are advised to use a local method of contraception (such as a condom) during treatment and for three months after the end of the treatment.
Advise the patient to talk to the doctor or pharmacist before using VIRGAN.
VIRGAN 1.5 mg/g, eye gel should not be swallowed.
Touching the eye or eyelids with the tip of the dropper should be avoided.
Contact lenses wearing: Avoid contact with soft contact lenses (see VIRGAN 1.5 mg/g, eye gel contains benzalkonium chloride as follows).
VIRGAN 1.5 mg/g, eye gel contains benzalkonium chloride: This medicine contains 2.625 micrograms benzalkonium chloride in each drop of gel which is equivalent to 0.075 mg/g.
Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. The patient should remove contact lenses before using this medicine and put them back 15 minutes afterwards.
Benzalkonium chloride may also cause eye irritation, especially if the patient has dry eyes or disorders of the cornea (the clear layer at the front of the eye). If the patient feels abnormal eye sensation, stinging or pain in the eye after using this medicine, advise the patient to talk to a doctor.
Driving and using machines: The patient may experience temporary visual disturbances after ocular administration of the product. The patient should wait until normal vision returns before driving a vehicle or using any machine.
Use in Children: In the absence of any specific study, use in children aged under 18 years is not recommended.
Pregnancy, breast-feeding and fertility: This medicine should not be used during pregnancy and breast-feeding, except where instructed otherwise by the doctor. See also Contraindications.
If the patient is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a baby, advise the patient to ask the doctor or pharmacist for advice before taking this medicine. The doctor is the only one able to adjust the treatment.
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 sensations, 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 hyperaemia).
Reporting of side effects: If the patient gets any side effects, talk to the doctor or pharmacist. This includes any possible side effects not listed. The patient can also report side effects directly via the national reporting system.
By reporting side effects, more information on the safety of this medicine can be provided.
If the patient is using any other medicine to be applied in the eye, he/she should: 1. Apply the other ophthalmic medicine.
2. Wait for 15 minutes.
3. Apply VIRGAN last.
Advise the patient to inform the doctor or pharmacist if the patient is using, has recently used or might use any other medicines.
Do not throw away any medicine via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer used. These measures will help protect the environment.
After opening, the tube should not be kept for more than 4 weeks.
Do not store above 30°C.
S01AD09 - ganciclovir ; Belongs to the class of antiinfectives, antivirals. Used in the treatment of eye infections.
Virgan eye gel 1.5 mg/g
5 g x 1's
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