Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Aciclovir Agepha 30 mg/g eye ointment
⚠ This medicine appears to have been discontinued
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 Aciclovir may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for?
Aciclovir Agepha eye ointment contains a medicine called aciclovir, which belongs to a group of medicines called antivirals. It is used to treat eye infections caused by the Herpes simplex virus. It works by killing or stopping the growth of viruses on the front of your eyeball (cornea) 2.
What you need to know before you take it
e Aciclovir Agepha 30 mg/g eye ointment?
Do not use Aciclovir Agepha 30 mg/g eye ointment, − If you are allergic to aciclovir or valaciclovir or any of the other ingredients of this medicine (listed in Section 6). Warnings and precautions Talk to your doctor or pharmacist before using Aciclovir Agepha 30 mg/g eye ointment
- Use Aciclovir Agepha 30 mg/g eye ointment only on eye
- You may immediately experience a mild stinging and burning sensation after the application.
- Immediate hypersensitivity reactions, including angioedema, swelling of the face etc. can occur. Contact a doctor immediately in case of such hypersensitivity reactions.
- If you experience allergic reactions such as itching of eyelid, swelling or redness of the eye, discontinue the treatment with Aciclovir Agepha 30 mg/g eye ointment and consult a doctor.
- Please contact your doctor immediately for advice,if any symptoms gets serious or reoccurs.
During the treatment with Aciclovir Agepha 30 mg/g eye ointment, contact lenses should not be worn. Children and adolescents Same as in adults. Other medicines and Aciclovir Agepha 30 mg/g eye ointment
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Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. When applied locally in the eye, no significant interactions were observed so far. There is however insufficient information on the use of Aciclovir Agepha eye ointment and simultaneous use with eye medicines containing corticosteroids. Your doctor will decide if this is appropriate for you. Pregnancy and breast-feeding If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Aciclovir Agepha eye ointment can be used during pregnancy or breast-feeding as when used at recommended doses no side effects are expected during pregnancy, for the foetus or new born child Driving and using machines Due to its nature, this medicine may cause temporary vision impairment. Therefore, special care should be taken when driving motor vehicles, when working without secure hold and when operating machinery. 3.
How to take it
Aciclovir Agepha 30 mg/g eye ointment
Instructions for Use For ocular use Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist, if you are note sure. Unless otherwise prescribed by a doctor, the recommended dose is: Place an 1 cm ribbon of ointment inside the lower conjunctival sac 5 times a day (every 4 hours). Suggested times are: 7:00, 11:00, 15:00, 19:00 and 23:00. Pull down the lower lid and place the ointment strand inside the conjunctival sac. Close your eye lids, and rotate your eye ball so that the ointment gets better distributed. It is essential that you apply Aciclovir Agepha 30 mg/g eye ointment during the day in regular intervals of 4 hours to ensure the success of treatment. After the inflammation of the cornea has healed up, the treatment should still be continued for at least 3 days. Use in children and adolescents Same as in adults.
If you use more Aciclovir Agepha than you should Talk to your doctor or pharmacist if you use too much Aciclovir Agepha. Aciclovir Agepha eye ointment is for use in the eye, if you swallow any talk to your doctor or pharmacist. If you forget to use Aciclovir Agepha 30 mg/g eye ointment If you forget to use Aciclovir Agepha, use it as soon as you remember. However, if it is nearly time for your next application, skip the missed application. Do not use a double dose to make up for a forgotten dose. If you stop using Aciclovir Agepha 30 mg/g eye ointment If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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Possible side effects
Like all medicines, Aciclovir Agepha eye ointment can cause side effects, although not everybody gets them. Immediately after application of the eye ointment, a transient mild stinging or burning may occur. If you notice swelling of the face, angioedema etc, stop using Aciclovir Agepha and see a doctor straight away. Allergic reactions very rare (may affect less than 1 in 10,000 people)) If you have an allergic reaction or acute hypersensitivity reactions, stop using Aciclovir Agepha and see a doctor straight away. The signs may include:
- rash, itching or hives on your skin
- swelling of your face, lips, tongue or other parts of your body
- shortness of breath, wheezing or trouble breathing
- unexplained fever (high temperature) and feeling faint, especially when standing up. Other side effects include: Very common (may affect more than 1 in 10 people): burning or irritation, photophobia/light sensitivity or feeling as if there is something in your eye (superficial punctuate keratopathy) This usually does not require cessation of the treatment and heals immediately Uncommon (may affect up to 1 in 100 people): transient mild stinging or burning occurring immediately following application swollen, runny eyes (Conjunctivitis) Rare (may affect up to 1 in 1,000 people): swollen, red, irritated, itchy eyelids (blepharitis)
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. 5.
How to store it
Aciclovir Agepha 30 mg/g eye ointment?
Store below 25 ° C. 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 label and carton. The expiry date refers to the last day of that month. Do not use for more than 4 weeks after first opening. 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 to protect the environment. 6.
Contents of the pack and other information
What Aciclovir Agepha 30 mg/g eye ointment contains:
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The active substance is Aciclovir. 1g ointment contains 30 mg Aciclovir. The other excipient is White soft paraffin
What Aciclovir Agepha 30 mg/g eye ointment looks like and contents of the pack 1 carton contains one Aluminium tube with polyethylene cap and polyethylene Cannula (tip) containing 4.5g of white to whitish-grey eye ointment. Marketing Authorisation Holder and Manufacturer AGEPHA Pharma s.r.o Diaľničná cesta 5 Senec 903 01 Slovakia
This leaflet was last revised in March 2019
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Frequently asked questions about Aciclovir Agepha 30 mg/g eye ointment
How do I take Aciclovir Agepha 30 mg/g eye ointment?
Aciclovir Agepha 30 mg/g eye ointment comes as ointment containing 30mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Aciclovir Agepha 30 mg/g eye ointment?
The active substance in Aciclovir Agepha 30 mg/g eye ointment is aciclovir.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Aciclovir Agepha 30 mg/g eye ointment, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Aciclovir Agepha 30 mg/g eye ointment without a prescription?
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.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: aciclovir
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Aciclovir Agepha 30 mg/g eye ointment is indicated for the treatment of herpes simplex keratitis.
4.2. Posology and method of administration
Adults:
Unless otherwise prescribed, a 1cm ribbon of ointment should be placed inside the lower conjunctival sac five times a day (at approximately 4 hourly intervals). The treatment should continue for at least 3 days after the healing is complete.
Paediatric population:
As for adults
Use in elderly people (≥ 65 years):
No adjustment in dosage is required.
Use in people with impaired renal and liver function:
No adjustment in dosage is required.
Method of administration:
Ocular use.
4.3. Contraindications
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
• Hypersensitivity to Valaciclovir.
4.4. Special warnings and precautions for use
For ocular use only. Not for injection or oral intake.
There is insufficient clinical data on the use of Aciclovir Agepha eye ointment for deep corneal defects and the combined use of Aciclovir Agepha eye ointment with topical corticosteroids.
In case of a bacterial coinfection, an additional antibiotic therapy must be carried out.
Patients should be informed that transient mild stinging immediately following application may occur.
Patients should avoid wearing contact lenses when using Aciclovir Agepha eye ointment.
4.5. Interaction with other medicinal products and other forms of interaction
No clinically significant interactions have been identified when applied topically.
4.6. Fertility, pregnancy and lactation
Fertility
No studies have been performed to investigate the effect of topically ophthalmic use of aciclovir on fertility.
There is no information on the effect of aciclovir on human female fertility.
In a study of 20 male patients with normal sperm count, oral aciclovir administered at doses of up to 1g per day for up to six months has been shown to have no clinically significant effect on sperm count, motility or morphology. With the recommended use of Aciclovir Agepha , the systemic exposure of aciclovir is expected to be negligible and no risk is anticipated.
Pregnancy
A post-marketing aciclovir pregnancy registry has documented pregnancy outcomes in women exposed to aciclovir. The registry findings have not shown an increase in the number of birth defects described amongst aciclovir exposed subjects compared with the general population, and any birth defects showed no uniqueness or consistent pattern to suggest a common cause.
Systemic administration of aciclovir in internationally accepted standard tests did not produce embryotoxic or teratogenic effects in rabbits, rats or mice.
With the recommended use of Aciclovir Agepha no effects during pregnancy are anticipated since systemic exposure of aciclovir is expected to be negligible. When necessary, Aciclovir Agepha eye ointment can be used during pregnancy.
Breast Feeding
Limited data show that the drug does pass into breast milk following systemic administration.
However, the dosage received by the nursing infant following maternal use of Aciclovir Agepha eye ointment would be insignificant. The use of Aciclovir Agepha eye ointment can be considered during breast feeding.
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
Aciclovir Agepha eye ointment can affect visual ability and therefore caution is advised when driving or using machines.
4.8. Undesirable effects
Immediately after the application of the ophthalmic ointment, a temporary slight pricking or burning may occur but this may not interfere with the treatment.
Serious side effects after the use of systemically applied aciclovir are rare and most of the symptoms are reversible.
Adverse reactions are listed below by MedDRA body system organ class and by frequency.
The frequency categories used are: very common: (≥1/10) common: (≥1/100 and <1/10) uncommon: (≥1/1000 and <1/100) rare: (≥1/10,000 and <1/1000) very rare: (<1/10,000)
Not known: frequency cannot be estimated from the available data.
Due to the nature of the side effects, it is not possible to clearly determine whether these reactions were caused by the disease or the administration of the drug. Postmarketing spontaneous reports served as the basis for assigning frequencies of side effects.
Immune system disorders:
Very rare:
Immediate hypersensitivity reactions, including angioedema (Quincke's oedema, pale swelling of the skin especially in the face) and urticaria (hives)
Eye disorders:
Very common:
Superficial punctate keratopathy. This did not necessitate an early termination of therapy and healed without sequelae.
Uncommon:
Transient mild stinging or burning occurring immediately following application, Conjunctivitis
Rare:
Blepharitis
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 at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
No case of overdose has been reported. Even if the entire content of a 4.5 g tube of Aciclovir Agepha eye ointment, containing 135 mg aciclovir, is swallowed, no undesirable effects would be expected.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- XOROX 30 mg/g prescriptionACICLOVIRUM · eye / ear / nose
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 →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- Viru-PosAciclovirum · eye / ear / nose
- XoroxAciclovirum · eye / ear / nose
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 about this leaflet
Ask anything about Aciclovir Agepha 30 mg/g eye ointment. 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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