ACIVISION Augensalbe 30 mg/g

The efficacy and safety of AciVision have only been reviewed summarily by Swissmedic.

The approval of AciVision is based on AciVision 30 mg/g eye ointment with information as of May 2020, which contains the same active ingredient and is approved in Germany.

What is AciVision and when is it used?

AciVision is a medicine for the treatment of viral infections (antiviral).

AciVision is used for:

Corneal inflammation of the eye caused by the herpes simplex virus.

On prescription of the doctor.

When should AciVision not be used?

AciVision should not be used if you are allergic to aciclovir, valacyclovir, or any of the other ingredients of this medicine listed in "What does AciVision contain? listed other ingredients of this medicine.

When should caution be exercised when using AciVision?

Please talk to your doctor or pharmacist before using AciVision.

Please note that there is a possibility of viral transmission, particularly in fresh lesions.

Systemic treatment should be considered in severely immunosuppressed patients (AIDS patients or bone marrow transplant recipients). These patients are advised to consult their doctor in case of any infection.

Wearing contact lenses should be avoided while using AciVision.

Interactions with other medications have not been reported to date, however, if additional treatment is being used with other eye drops/ointments, there should be at least a 15-minute interval between the application of the different medications. Eye ointments should be administered last.

Eye ointments may cause temporary visual impairment. Therefore, special caution is advised when driving a motor vehicle or operating machinery.

Inform your doctor or pharmacist if you

• suffer from any other medical conditions;
• have any allergies; or
• are taking other medicines (including those you have bought yourself!) or using them on your eyes.

Can AciVision be used during pregnancy or while breastfeeding?

If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Use during pregnancy should only be considered after careful consideration of the The expected benefits must be weighed against possible risks.

The limited data available in humans show that acyclovir passes into breast milk after systemic administration. However, the dose received by a breastfed infant following application of acyclovir ointment or eye ointment to the mother is negligible.

How to use AciVision

Always use this medicine exactly as your doctor has told you. Please ask your doctor or pharmacist if you are unsure.

The following information applies unless your doctor has prescribed AciVision differently. Please follow the instructions for use, otherwise AciVision will not work properly.

The recommended dose is 5 times daily, every 4 hours, applying a strip of ointment approximately 1 cm long into the lower conjunctival sac.

By pulling down the lower eyelid, the conjunctival sac is exposed, into which the strip of ointment is then applied. The ointment is distributed by closing the eyelids and moving the eyeball.

The treating physician will decide on the duration of use.

You should continue treatment for at least 3 days even after the corneal inflammation has healed.

If you forget to use AciVision

Do not use a double dose if you have forgotten the previous dose.

If you miss several doses, please inform your doctor so that he or she can take additional measures if necessary.

If you stop using AciVision

Please strictly follow the dosage recommendations of your doctor. Doctor.

If you are not receiving treatment due to If you want to stop taking this medicine because of side effects, please talk to your doctor so that he or she can prescribe you a different medication if necessary.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Do not change the prescribed dosage on your own initiative. If you think the medicine is too weak or too strong, talk to your doctor or pharmacist.

What side effects can AciVision have?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported with Aciclovir Eye Ointment during clinical trials or after market launch:

Very common (affects more than 1 in 10 people)

Superficial punctate corneal damage (superficial punctate keratopathy). These generally did not require premature cessation of treatment and healed without visible consequences.

Common (affects 1 to 10 in 100 patients)

Temporary mild stinging or burning in the eye, conjunctivitis.

Rare (affects 1 to 10 in 10,000 patients)

Blepharitis.

Very rare (affects less than 1 in 10,000 patients)

Sudden hypersensitivity reaction, including angioedema (pale swelling of the skin, especially in the facial area) and hives (itchy skin rash, urticaria).

If you experience any side effects, contact your doctor or pharmacist. This applies in particular to side effects not listed in this package leaflet.

What else should you bear in mind?

Shelf life

This medicine must not be used until the end of the expiry date which is stated on the container with "EXP" Use by the date indicated.

Use by date after opening

AciVision should not be used for longer than one month after first opening the tube.

Storage instructions

Do not store above 25°C.

Keep out of reach of children.

Further information

Never dispose of medicines via wastewater (e.g., not down the toilet or sink). Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

Your doctor or pharmacist will be able to provide you with further information. These people have the detailed product information.

What does AciVision contain?

Active ingredients

1 g of eye ointment contains 30 mg aciclovir (30 mg/g).

Excipients

White petrolatum.

Authorization number

68800 (Swissmedic).

Where can you get AciVision? Which packages are available?

Available in pharmacies with a doctor's prescription, which only entitles you to a single use.

Packs containing 4.5 g eye ointment are available [A].

Marketing Authorization Holder

OmniVision AG, 8212 Neuhausen.

This package insert was last reviewed by the foreign reference authority in May 2020. With safety-relevant additions from Swissmedic: September 2022.