Diclocular

Patient Information Leaflet

Diclocular 0.1% eye drops, solution

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

Contents of this leaflet:

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

1. What Diclocular is and what it is used for

Diclocular is indicated for inflammatory conditions, possibly painful and non-infectious, affecting the anterior segment of the eye, particularly following cataract surgery.

2. What you need to know before using Diclocular

Do not use Diclocular

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6). In particular, do not use this eye drop if, after taking aspirin or other anti-inflammatory medicines of the same type (so-called non-steroidal drugs), you have experienced asthma attacks, hives, or acute rhinitis.

Warnings and precautions
Talk to your doctor or pharmacist before using Diclocular:

• if you have an increased risk of damage to a part of the eye called the cornea;
• if you are using other medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), acetylsalicylic acid, or phenylacetic acid derivatives;
• if you are using other anti-inflammatory medicines containing "corticosteroid hormones" (see section "Other medicines and Diclocular");
• if you have undergone repeated and/or complicated eye surgeries within a short period of time;
• if you have a tendency to bleed or are being treated with other medicines that may prolong bleeding time;
• if you have an eye infection. Infections may be masked by the use of topical non-steroidal anti-inflammatory agents, including Diclocular. If you have an infection or are at risk of one, your doctor will prescribe appropriate treatment (e.g. antibiotics), which should be started at the same time as Diclocular.

You should use this medicine with caution.
This medicine may cause:

• allergic reactions, including anaphylactic reactions (serious allergic reactions causing breathing difficulties and dizziness), even without prior exposure. Cross-sensitivity with acetylsalicylic acid, phenylacetic acid derivatives, and other non-steroidal anti-inflammatory drugs (NSAIDs) is possible;
• development of corneal diseases: keratitis, epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration, or corneal perforation. These effects, which may threaten vision, have occurred in patients who have undergone repeated and complicated eye surgeries within a short period of time, those with pre-existing ocular surface disease (e.g. dry eye syndrome), corneal denervation, corneal epithelial defects, diabetes mellitus, or rheumatoid arthritis, who may be at higher risk of corneal adverse events. Prolonged use of topical NSAIDs such as Diclocular may increase the risk and severity of corneal side effects. Patients showing signs of corneal epithelial disruption must immediately stop using Diclocular and should be closely monitored to assess corneal health.

Children and adolescents
This medicine must not be used in children and adolescents.
Other medicines and Diclocular
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Concomitant use of diclofenac and anti-inflammatory medicines known as topical steroids in patients with significant pre-existing corneal inflammation may increase the risk of developing corneal complications.
Concomitant use of diclofenac and anti-inflammatory medicines known as topical steroids may cause potential problems with healing.

Diclocular with food, drinks and alcohol
No interactions are known.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before using this medicine.
Pregnancy
Diclocular must not be used during the last three months of pregnancy. Do not use Diclocular during the first six months of pregnancy unless strictly necessary and under medical advice. If treatment is required during this period, the lowest dose for the shortest possible duration should be used.
Oral forms (e.g. tablets) of diclofenac may cause adverse effects in the newborn. It is not known whether the same risk applies when diclofenac is used in the eye.
Breastfeeding
Use of this medicine during breastfeeding is not recommended, although no side effects are known.

Driving and using machines
Diclocular does not impair the ability to drive or operate machinery.
However, patients experiencing side effects such as blurred vision should refrain from driving or operating machinery (see section 4).

Diclocular (multi-dose bottle eye drops) contains benzalkonium chloride
This medicine contains 2.57 micrograms of benzalkonium chloride per drop, equivalent to 0.1 mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause a change in their colour. Remove your contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, particularly if you have dry eye or corneal disorders (the transparent outer layer of the eye). If you experience unusual sensations in the eye, such as burning or pain, after using this medicine, speak with your doctor.

3. How to use Diclocular

Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is the one specified in the prescription you will receive.
To prevent the active substance from being washed out of the eye when another ophthalmic treatment is used, a minimum interval of 5 minutes should be left between the application of each medicine.

Method of administration
Single-dose eye drops

1. Detach the individual single-dose container by applying a downward motion and pulling it towards you.

2. Gently tap the single-dose container with the fingertip so that the eye drop solution moves to the bottom of the container.

3. Gently twist the cap to open the single-dose container.

4. Instill the eye drops into the eye by repeatedly squeezing the base of the single-dose container to help the liquid flow out, even if air bubbles are present.

Use in children and adolescents
Not applicable.

If you use more Diclocular than you should
In case of overdose, which may present as the undesirable effects described in section 4, stop treatment.

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

If you stop using Diclocular
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported with Diclocular:
Rare ( may affect up to 1 in 1,000 people ):

• eye itching;
• eye redness (hyperaemia);
• sensitivity of the eye to light (photosensitivity);
• inflammation of the white part of the eye with possible formation of small grey spots (punctate keratitis);
• hypersensitivity at the site of instillation.

Not known ( frequency cannot be estimated from the available data ):

• sensation of eye burning;
• corneal disorders (e.g. corneal oedema), usually after frequent instillations;
• blurred vision immediately after eye drop instillation;
• thinning and lesions (ulcers) of the cornea (see section “Warnings and precautions”);
• inflammation of the membrane of the eye called “conjunctiva” due to allergy (allergic conjunctivitis), red spots on the eyelids (eyelid erythema), eye allergy, swelling (oedema), itching of the eyelids, skin rashes (urticaria, rash, eczema, erythema), itching, redness, eye pain;
• cough and cold (rhinitis), difficulty in breathing (dyspnoea) and worsening of asthma. Cases of damage to the stomach and intestinal wall have been reported.

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 https://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 Diclocular

Store below 30°C.
Multi-dose eye drop bottle
The ready-to-use eye drops, stored under normal environmental conditions, can be used for up to 30 days after opening the package. The bottle must be closed immediately after each single application.
Single-dose eye drops
The single-dose container does not contain a preservative: therefore, it must be discarded after use, even if only partially used. After opening the aluminium pouch, the product must be used within 30 days.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the bottle after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine 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 Diclocular contains

• The active substance is sodium diclofenac.
• The other components are listed below. Multi-dose eye drop bottle: L-lysine monohydrate, boric acid, sodium borate, sodium chloride, glycerol polyethylene glycol ricinoleate, benzalkonium chloride, sodium edetate, water for injections. Single-dose eye drop container: Glycerol polyethylene glycol ricinoleate, L-lysine monohydrate, boric acid, sodium borate, sodium chloride, sodium edetate, water for injections.

Description of the appearance of Diclocular and contents of the pack
Diclocular multi-dose: 5 ml white polyethylene bottle with dropper and screw cap.
Diclocular single-dose: 30 single-dose containers of 0.3 ml each, made of transparent polyethylene.

Marketing Authorization Holder
OmniVision Italia S.r.l.
Via Montefeltro, 6
20156 Milan, Italy

Manufacturers
Multi-dose eye drops
TUBILUX PHARMA S.p.A. – Via Costarica, 20/22 – 00071 Pomezia (Rome), Italy
Single-dose eye drops
Laboratoire UNITHER - 1 rue de l’Arquerie - 50200 Coutances, France