ACYCLOVIR

Package leaflet: Information for the patient

ACY 30mg/g ophthalmic ointment

Aciclovir
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What ACY is and what it is used for
2. What you need to know before using ACY
3. How to use ACY
4. Possible side effects
5. How to store ACY
6. Contents of the pack and other information

1. What ACY is and what it is used for

This medicinal product is used for the treatment of inflammation of the cornea (the transparent membrane covering the eye), known as keratitis, caused by the Herpes Simplex virus.

2. What you need to know before using ACY

Do not use ACY
Do not use ACY if you are allergic to aciclovir, valaciclovir, or to any of the other ingredients of this
medicinal product (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using ACY.
This medicinal product is for ocular use only.
A mild, transient burning sensation may occur after application.
Do not wear contact lenses during treatment with aciclovir ophthalmic ointment.
Other medicines and ACY
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
No clinically significant interactions have been identified.
Pregnancy
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicinal product.
You must not use ACY ophthalmic ointment without first consulting your doctor, who will evaluate the benefit to you and the potential risk to your baby associated with using ACY ophthalmic ointment during pregnancy.
There has been no reported increase in birth defects among children born to mothers who used aciclovir in various formulations during pregnancy.
Breastfeeding
If you are breastfeeding or intend to breastfeed, speak with your doctor before using ACY ophthalmic ointment.
The dose received by an infant following maternal use of aciclovir ophthalmic ointment is expected to be negligible.
Driving and using machines
Blurred vision may occur after using ACY ophthalmic ointment. Do not drive or operate machinery if your vision is not clear.

3. How to use ACY

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Adults - Children - Elderly

Apply the ointment (approximately 1 cm) into the lower conjunctival sac five times a day, at intervals of about four hours.

Continue treatment for at least three days after healing.

If you use more ACY than you should

If you use more ACY than you should, contact your doctor or pharmacist for advice.
ACY ophthalmic ointment is for ocular use only. In case of accidental ingestion, contact your doctor or pharmacist.
No adverse effects are expected if the entire contents of a tube containing 135 mg of aciclovir (ophthalmic ointment) were ingested.

If you forget to use ACY

• If you forget to use ACY, apply it as soon as possible when you remember. However, if it is almost time for the next dose, skip the missed dose.
• Do not use a double dose to make up for the forgotten dose.

If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects may occur with ACY:

Very common side effects (may affect more than 1 in 10 people):

• eye irritation or foreign body sensation in the eye (superficial punctate keratopathy) which resolves spontaneously and does not require discontinuation of therapy

Common side effects (may affect up to 1 in 10 people):

• mild, transient eye burning after application of ACY
• eye swelling and discharge (conjunctivitis)

Rare side effects (may affect up to 1 in 1,000 people):

• inflammation of the eyelids (blepharitis)

Very rare side effects (may affect up to 1 in 10,000 people):

• allergic reactions (hypersensitivity) including swelling of the lips, face, neck and throat (angioedema) and skin reaction (urticaria).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ACY

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month. The shelf life applies to the product in its original, unopened packaging and properly stored.
Do not use the product more than thirty days after first opening.
Store below 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ACY contains

• The active substance is aciclovir. Each gram of ointment contains 30 mg of aciclovir.
• The other component is: white vaseline.

Description of the appearance of ACY and contents of the package
ACY is an ophthalmic ointment contained in an aluminum tube of 4.5 grams.
Marketing Authorization Holder
Farmigea S.p.A. - Via G. B. Oliva 6/8 - 56121, Pisa
Manufacturer
Farmigea S.p.A. - Via G.B. Oliva 8 - 56121, Pisa
Exclusive distributor for sale
Elleva Pharma - Via S. Francesco 5/7 - 80034 Marigliano, Naples