Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Ganciclovir may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
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Virgan Eye Gel contains ganciclovir as the active ingredient. Ganciclovir is one of a group of active substances called anti-virals, used to treat infections caused by viruses. This eye gel is used to treat an infection in the eye called acute herpetic keratitis in adults aged 18 years and over. 2.
e Virgan Eye Gel
DO NOT USE Virgan Eye Gel If you are allergic (hypersensitive) to: ganciclovir or any of the other ingredients of this medicine (listed in Section 6). acyclovir, another anti-viral drug If you are pregnant or breast-feeding, unless your doctor tells you to. In men and women of childbearing age unless you use a method of birth control. Men using Virgan Eye Gel should use a local method of contraception (such as a condom) during treatment and for three months after the end of the treatment. Women using Virgan Eye Gel should use contraceptives during treatment and for up to six months after the end of the treatment. Warnings and precautions Talk to your doctor, pharmacist or nurse before using Virgan Eye Gel. Virgan Eye Gel contains benzalkonium chloride which may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor. Contact lenses Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses.. Remove contact lenses before using this medicine and put them back 15 minutes afterwards.. Children Do not give this medicine to children under the age of 18 years as there is not enough information to know if it is safe in children.
Other medicines and Virgan eye Gel Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. If you are using any additional eye treatments: you should wait for at least 15 minutes between using the two treatments, Virgan Eye Gel should always be the last treatment put into the eye. Talk to your doctor before using this eye gel if you are taking any other medicines, especially any of the following:
Virgan Eye Gel
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is Adults and the elderly: The usual dose is one drop of gel in each infected eye, five times per day until healed, then three times per day for 7 days. Use in children: Virgan Eye Gel should not be used in children, unless your doctor tells you to. The treatment should not usually exceed 21 days. This medicine is intended to be administered into the eye (ocular use). DO NOT INJECT. DO NOT SWALLOW. 1. Wash your hands thoroughly before using the product, 2. Do not touch your eye with the tip of the dropper. 3. While looking upwards and pulling the lower eyelid down, gently squeeze the tube to release one drop into the eye. 4. Press the inner corner of your eye with your fingertip for 1-2 minutes. This will prevent the drops from draining away too quickly.
5. Repeat for the other eye if necessary. 6. Close the tube after use. Follow the instructions carefully. If there is anything you do not understand, ask your doctor or pharmacist. Your doctor may advise you to use this medicine in a different way. Always follow your doctor's directions. Your pharmacist can also help if you are not sure. If you forget to use Virgan Eye Gel Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4.
Like all medicines, this medicine can cause side effects, although not everybody gets them. The possible side effects are: Eye disorders: Very common: may affect more than 1 in 10 people
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Virgan Eye Gel –
6.
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the tube and the carton after EXP. The expiry date refers to the last day of that month. Use within 28 days of first opening. This medicine does not require any special storage conditions. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Virgan Eye Gel contains The active ingredient is ganciclovir 0.15% w/w. Each gram of gel contains 1.5 milligrams ganciclovir. The other ingredients are benzalkonium chloride (see section 2: What you need to know before you use Virgan Eye Gel), carbomer 974P, sorbitol, sodium hydroxide, and water for injections. What Virgan Eye Gel looks like and contents of the pack Your medicine is a transparent eye gel which is supplied in a tube. Each tube contains 5g of the eye gel. Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Laboratoires THEA 12, rue Louis Blériot 63017 Clermont-Ferrand Cedex 2 FRANCE Manufacturer: FARMILA – THEA FARMACEUTICI SpA Via Enrico Fermi, 50 SETTIMO MILANESE (MI) ITALY This leaflet was last revised in 12/2023. If you would like any more information, or would like the leaflet in a different format, please contact Medical Information at THEA Pharmaceuticals Ltd, telephone number 0345 521 1290.
Virgan 0.15% w/w eye gel comes as gel. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Virgan 0.15% w/w eye gel is ganciclovir.
This leaflet reproduces the patient information leaflet approved for Virgan 0.15% w/w eye gel, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Treatment of acute herpetic keratitis (dendritic and geographic ulcers).
Instil one drop of gel in the inferior conjunctival sac of the eye to be treated, 5 times a day until complete corneal re-epithelialisation. Then 3 instillations a day for 7 days after healing. The treatment does not usually exceed 21 days.
Use in the elderly:
The dosage in the elderly is the same as in adults (see above). There is no need to adjust the dosage in the elderly as in clinical trials patients up to the age of 85 years have been treated and no specific health concerns were observed.
Use in children:
Use of the medicinal product in children under 18 years is not recommended since no specific studies have been conducted.
Method of administration
Ocular instillation.
Hypersensitivity to ganciclovir or acyclovir or to any of the excipients listed in section 6.1.
This medicinal product is not indicated in the treatment of cytomegalovirus (CMV) retina infections.
Efficacy in other viral types of keratoconjunctivitis has not been demonstrated.
No specific clinical studies were performed in immunodepressed subjects.
This medicine contains 0.375 mg benzalkonium chloride in each tube of 5 g.
Benzalkonium chloride may also cause eye irritation, especially in dry eyes or disorders of the cornea. Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. Remove contact lenses prior to application and wait at least 15 min before reinsertion.
If more than one topical ophthalmic drug is being used, the drugs should be administered at least fifteen minutes apart. VIRGAN should be instilled last.
Although the quantities of ganciclovir passing into the general circulation after ophthalmic use are small, the risk of drug interactions cannot be ruled out. Interactions with ganciclovir administered systemically have been observed:
Binding of ganciclovir to plasma proteins is only about 1-2% and drug interactions involving binding site displacement are not anticipated.
It is possible that drugs which inhibit replication of rapidly dividing cell populations such as bone marrow, spermatogonia and germinal layers of skin and gastrointestinal mucosa might have combined additive toxic effects when used concomitantly with, before or after ganciclovir. Because of the possibility of additive toxicity with co-administration of drugs such as dapsone, pentamidine, flucystosine, vincristine, vinblastine, adriamycin, amphotericin B, trimethoprim/sulpha combinations or other nucleoside analogues, combination with ganciclovir therapy should be used only if the potential benefits outweigh the risks.
Since both zidovudine and ganciclovir can result in neutropenia, it is recommended that these two drugs should not be given concomitantly during induction treatment with ganciclovir. Maintenance ganciclovir treatment plus zidovudine at the recommended dose resulted in severe neutropenia in most patients studied to date.
Generalised seizures have been reported in patients taking ganciclovir and imipenem-cilastatin concomitantly.
It is also possible that probenecid, as well as other drugs which inhibit renal tubular secretion or resorption, may reduce renal clearance of ganciclovir and could increase the plasma half-life of ganciclovir.
There is insufficient experience regarding administration during pregnancy or lactation for evaluating the safety of VIRGAN during these periods.
Teratogenicity and effect on fertility have been observed in animal studies with orally or intravenous administered ganciclovir. Furthermore ganciclovir had shown potential genotoxicity with low safety margin (see section 5.3).
Consequently, administration during pregnancy or lactation is therefore not recommended, except in the absence of an alternative treatment. For women of childbearing age, contraceptives measures should be used during treatment and for up to six months thereafter.
Due to the genotoxic effect in animal studies, men taking VIRGAN are advised to use local contraceptive measure (for example condoms) during treatment and for up to three months thereafter.
Patients should refrain from driving a vehicle or operating machines on the occurrence of any visual disturbance or other visual symptomatology.
The following adverse reactions were reported during four clinical trials with VIRGAN 0.15% w/w eye gel (three phase IIB trials and one Phase III trial)
Adverse events are categorised by frequency as follows: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1,000 to <1/100), rare (≥ 1/10,000 to <1/1,000) and very rare (<1/10,000). Not known (cannot be estimated from the available data).
Eye disorders
- Very common: Transient burning or stinging sensations, eye irritation, blurred vision.
- Common: Superficial punctate keratitis, conjunctival hyperaemia.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
There is practically no risk of adverse events due to accidental oral ingestion since a tube of 5g contains 7.5mg ganciclovir compared to the daily adult i.v. dose of 500-1000mg.
In the unlikely event of overdose, dialysis and hydration may be of benefit in reducing drug plasma levels.
Toxic manifestations seen in animals given very high single intravenous doses of ganciclovir (500mg/kg) included emesis, hypersalivation, anorexia, bloody diarrhoea, inactivity, cytopenia, abnormal liver function tests and BUN, testicular atrophy and death.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
Medicines sold in Poland with the same active substance: W Polsce znany jako
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about Virgan 0.15% w/w eye gel. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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