Visunac

Package leaflet: Information for the user

VISUNAC 1 mg/ml eye drops, solution

sodium diclofenac
Read this entire 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What VISUNAC is and what it is used for

VISUNAC contains a substance called diclofenac which acts against inflammation.
It belongs to a group of medicines known as "Ophthalmological, Non-Steroidal Anti-Inflammatory Drugs".
VISUNAC is used to treat inflammatory conditions, possibly painful and not caused by infection, affecting the front part of the eye, particularly following cataract surgery (a condition involving progressive loss of transparency of a part of the eye called the lens).

2. What you need to know before using VISUNAC

Do not use VISUNAC:

• if you are allergic to diclofenac or to any of the other ingredients of this medicine (listed in section 6);
• if you have previously experienced reactions such as bronchospasm with shortness of breath (asthmatic attacks), itchy skin rash (urticaria), or acute rhinitis after taking aspirin (acetylsalicylic acid) or other anti-inflammatory medicines known as non-steroidal anti-inflammatory drugs (NSAIDs);
• if it is for a child under 14 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using VISUNAC.
If you have an increased risk of damage to a part of the eye called the cornea (corneal ulcers or thinning), for example due to the use of other anti-inflammatory medicines containing substances called "steroid hormones" or due to immune system disorders such as rheumatoid arthritis, the use of VISUNAC has been associated, in rare cases, with the development of corneal damage (corneal ulcers or thinning) which may require specific treatment prescribed by your doctor.
These effects have occurred in patients who have used VISUNAC for a very long time.
If you are at risk of infection, your doctor will prescribe appropriate therapy (e.g. antibiotics) to be used alongside VISUNAC.
Topical anti-inflammatory medicines (NSAIDs) such as VISUNAC eye drops should be used with caution when administered together with locally applied steroid anti-inflammatory medicines (see "Other medicines and VISUNAC").
The concomitant use of another eye medicine with VISUNAC may cause the active ingredient of VISUNAC to be displaced from the eye. To prevent this, wait at least 5 minutes between applying each eye drop.
Closing the tear duct that drains from the eye to the nose or closing the eyelid for three minutes after applying the eye drops may reduce the amount of medicine absorbed into the body (systemic absorption), thereby reducing side effects and increasing the medicine's effect in the eye.

VISUNAC multidose bottle eye drops contain benzalkonium chloride
The multidose bottle contains benzalkonium chloride as a preservative, 0.1 mg per 1 ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause a change in their color. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or corneal disorders (the transparent outer layer of the eye). If you experience unusual eye sensations, such as burning or pain after using this medicine, consult your doctor.

Children and adolescents
Experience in children and adolescents under 14 years of age is limited; therefore, VISUNAC is not recommended for use in pediatric patients.

Other medicines and VISUNAC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effects of VISUNAC may be influenced by, or may influence, the following medicines:

• non-steroidal anti-inflammatory drugs (NSAIDs), such as diclofenac,
• locally applied steroid anti-inflammatory medicines.

Using these medicines together with VISUNAC may increase the risk of complications in patients who already have significant corneal inflammation.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Administration of this medicine during pregnancy and breastfeeding is not recommended.
If you are pregnant or breastfeeding, your doctor will prescribe VISUNAC only if clearly needed, after carefully evaluating the benefits and potential risks of treatment.

Driving and using machines
Generally, VISUNAC eye drops do not affect the ability to drive or operate machinery.
However, if you experience side effects such as partial or complete vision loss (appearance of dark spots interfering with vision, scotomata), do not drive or operate machinery.

3. How to use VISUNAC

Use this medicine exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

The usual dose is one drop of Visunac eye drops into the affected eye four times a day, or as prescribed by your doctor.

Children and adolescents:
There is insufficient data on efficacy and safety in children and adolescents under 14 years of age (see section "Do not use VISUNAC").

If you use more VISUNAC than you should
In case of accidental ingestion or overdose of VISUNAC, contact your doctor immediately or go to the nearest hospital.

If you forget to use VISUNAC
Do not use a double dose to make up for the missed dose.

If you stop using VISUNAC
If you have any doubts about using this medicine, consult your doctor or pharmacist.

Instructions for use

Multidose bottle of 5 ml

1. Remove the cap.
2. Remove the cap from the bottle.
3. If you wear contact lenses, remove them before applying the eye drops and reinsert them after 15 minutes (see section "VISUNAC contains benzalkonium chloride").
4. Invert the bottle and apply the drops by gently pressing; avoid letting the tip of the container touch the eye or any other surface.
5. Close the bottle carefully after use.

Single-dose container of 0.5 ml

1. Make sure the single-dose unit is intact.
2. Detach the single-dose unit from the strip.
3. Open by twisting the tab until the container opens.
4. Invert the container and apply the drops with gentle pressure on the body of the container.
5. Dispose of the single-dose container and any remaining medicine after administration.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Below are listed the side effects of diclofenac administered into the eyes.
Common (may affect up to 1 in 10 people):

• Transient burning sensation and/or partial or complete loss of vision (appearance of dark spots interfering with vision, scotomata) immediately after application of the eye drops.

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

• Blurred vision immediately after application of the eye drops
• Inflammation of the cornea (punctate keratitis) and corneal disorders, usually after frequent applications
• Thinning and lesions (ulcers) of the cornea (see section “Warnings and precautions”)
• Difficulty in breathing (dyspnea) and worsening of asthma
• Eye redness (conjunctival hyperemia), inflammation of the membrane of the eye called “conjunctiva” due to allergy (allergic conjunctivitis), red spots on the eyelids (eyelid erythema), eye allergy, swelling (edema) and itching of the eyelids, skin eruptions (urticaria, rash, eczema, erythema), itching, redness, eye pain, light sensitivity (photosensitivity), cough and cold symptoms (rhinitis).

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.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store VISUNAC

Do not store above 25°C.
Keep this medicine out of the sight and reach of children.
Keep the multidose bottle tightly closed.
Store the multidose bottle and the single-dose containers away from sources of heat and in the
original packaging to protect the medicine from light.
Observe these storage conditions both before and after first opening the multidose bottle and the
pouch containing the single-dose containers.
After first opening the multidose bottle, the medicine can be used for 30 days; after this period, any
remaining medicine must be discarded.
After first opening the pouch containing the single-dose containers, the medicine can be used for 28
days; after this period, any remaining medicine must be discarded.
The single-dose container does not contain preservatives and must therefore be used immediately
after opening; any medicine remaining in the container must be discarded immediately after use.
Do not use this medicine after the expiry date stated on the carton after "Exp.". The expiry date refers
to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What VISUNAC contains

• Multi-dose bottle VISUNAC 1 mg/ml eye drops, solution - 5 ml bottle The active substance is: sodium diclofenac. 100 ml of eye drops contain 100 mg of sodium diclofenac. The other components are: benzalkonium chloride; disodium edetate; arginine; boric acid; borax; povidone; macrogol glycerol ricinoleate; water for injections.
• Single-dose containers VISUNAC 1 mg/ml eye drops, solution - 0.5 ml single-dose containers The active substance is: sodium diclofenac. 100 ml of eye drops contain 100 mg of sodium diclofenac. The other components are: disodium edetate; arginine; boric acid; borax; povidone; macrogol glycerol ricinoleate; water for injections.

Description of the appearance of VISUNAC and the contents of the pack
VISUNAC is an eye drop solution.
Pack contents are:

• Multi-dose bottle: Pack containing one 5 ml dropper bottle.
• Single-dose containers: Pack containing 30 single-dose containers of 0.5 ml each, arranged in strips of 5 containers per pouch. The pack contains 6 pouches.

Marketing Authorization Holder
VISUfarma S.p.A.
Via Alberto Cadlolo 21
00136 Rome
Manufacturer
Farmigea S.p.A. – Via GB Oliva 8 – 56121 Pisa