Dicloabak

Package Leaflet: Information for the User

DICLOABAK, 1 mg/ml, eye drops, solution

Diclofenac sodium

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Dicloabak and what is it used for
• 2. Important information before using Dicloabak
• 3. How to use Dicloabak
• 4. Possible side effects
• 5. How to store Dicloabak
• 6. Contents of the package and other information

1. WHAT IS DICLOABAK AND WHAT IS IT USED FOR

The preparation contains a non-steroidal anti-inflammatory drug (NSAID) intended for administration to the eyes.
It is used during and after certain eye surgeries to:

• inhibit pupil constriction during cataract surgery,
• prevent the occurrence of inflammatory conditions associated with cataract surgery and the anterior segment of the eye,
• relieve pain in the eyeball in photorefractive keratectomy procedures (corrective corneal surgery for myopia) within the first 24 hours after the procedure.

2. IMPORTANT INFORMATION BEFORE USING DICLOABAK

When not to use Dicloabak

• if the patient is hypersensitive to diclofenac sodium or any of the other ingredients of this medicine (listed in section 6);
• if the patient has previously experienced an allergy, hives (itching rash), acute rhinitis (swelling and irritation inside the nose), or asthma caused by the use of these eye drops or similar medicines, such as aspirin and other NSAIDs.

Warnings and precautions

Before starting treatment with Dicloabak, discuss it with your doctor, pharmacist, or nurse.

• The medicine should be used with caution:
• Dicloabak, like other NSAIDs, may rarely cause allergic reactions, including anaphylactic reactions (severe allergic reaction causing breathing difficulties or dizziness), even without prior exposure to the medicine.
• In case of hypersensitivity reactions or symptoms of allergy to the medicine, especially asthma attacks or sudden swelling of the face and neck, treatment should be discontinued and medical attention should be sought immediately.
• Before using the medicine, inform your doctor if you have asthma combined with chronic rhinitis, chronic sinusitis, and/or nasal polyps.
• Local use of anti-inflammatory drugs may mask acute eye infections. Non-steroidal anti-inflammatory drugs do not have antibacterial effects. In case of eye infections, their use should be carefully considered with one or more antibacterial drugs.
• Concomitant use of topical NSAIDs and topical steroids (such as dexamethasone) may increase the risk of problems during treatment.
• NSAIDs may delay corneal healing.
• In case of a tendency to bleed or treatment with anticoagulant drugs (drugs that reduce blood clotting).
• Prolonged use of topical NSAIDs in high doses may cause corneal inflammation.
• Patients who have undergone another eye surgery in a short time, patients with diabetes, eye surface disease (e.g., dry eye syndrome), rheumatoid arthritis, may be at increased risk of adverse reactions related to the cornea.
• It is not recommended to wear contact lenses after cataract surgery. The attending doctor will advise the patient when it is possible to wear contact lenses again.
• In case of no improvement or worsening of symptoms, consult a doctor.

Dicloabak and other medicines

In case of using other eye drops during the same period as Dicloabak, wait 15 minutesbetween administrations.
Tell your doctor about all medicines you are currently taking or have recently taken, as well as those you plan to use, including those available without a prescription.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.

Pregnancy
Dicloabak should not be used from the beginning of the 6th month of pregnancy (from the 24th week of amenorrhea) until the end of pregnancy. During the first 5 months of pregnancy (up to the 24th week of amenorrhea), Dicloabak should not be used unless it is necessary and recommended by a doctor. If use is necessary, the smallest dose should be administered for the shortest time possible.
After oral administration of diclofenac (e.g., tablets), adverse reactions may occur in the unborn child. It is not known if the same risk applies to Dicloabak after administration to the eye.
Breastfeeding
Dicloabak can be used during breastfeeding.
Fertility
Like all non-steroidal anti-inflammatory drugs (NSAIDs), this medicine may affect fertility in women and make it more difficult to become pregnant. This effect disappears after treatment is discontinued. Inform your doctor if you are planning a pregnancy or having trouble getting pregnant.

Driving and using machines

For a short period after administration of the preparation, vision disturbances may occur. During this time, do not drive vehicles or operate hazardous machinery.

Dicloabak contains macrogolglycerol ricinoleate

Dicloabak contains macrogolglycerol ricinoleate, which may cause contact dermatitis (skin reactions).

3. HOW TO USE DICLOABAK

This medicine should always be used exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Dosage
Recommended doses for adults and the elderly are as follows:
Inhibition of pupil constriction during cataract surgery:

• Before surgery: 1 drop 5 times within 3 hours before surgery;

Cataract surgery and anterior segment surgery:

• Before surgery: 1 drop 5 times within 3 hours before surgery;
• After surgery: 1 drop 3 times immediately after surgery, and then 1 drop 3-5 times a day, usually for no more than 4 weeks.

Pain in the eyeball associated with photorefractive keratectomy (corrective corneal surgery for myopia):

• Before surgery: 2 drops within 1 hour before surgery;
• After surgery: 2 drops within 1 hour after surgery, and then 4 drops within 24 hours after surgery.

Do not exceed the recommended dose.

Use in children

No special studies have been conducted.
Method of administration
The medicine is intended for administration to the eye (eye drops).
The medicine should not be injected or taken orally.
The medicine should not be injected into the eyeball or around the eyeball.

Before using the medicine, wash your hands thoroughly.

Be careful not to touch the eye or eyelids with the dropper tip.

Looking up and gently pulling the lower eyelid down, put one drop into the affected eye.
After use, close the bottle.

After administration, press the corner of the eye near the nose with your finger and gently close the eyelids for 2 minutes. This will prevent Dicloabak from entering the entire body.

Missing a dose of Dicloabak

Do not use a double dose to make up for a missed dose.
In case of doubts about using the medicine, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Dicloabak can cause side effects, although not everybody gets them.
The following side effects have been reported:

Uncommon: may affect up to 1 in 100 people

• Burning sensation after administration
• Visual disturbances after administration

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

• Hypersensitivity reactions, itching, and redness
• Phototoxicity (allergic reaction after sun exposure)
• Punctate keratitis (changes in the cornea), corneal ulceration, decreased corneal thickness
• Dyspnea (breathing difficulties)
• Exacerbation of asthma

Unknown: frequency cannot be estimated from the available data

• Rhinitis (swelling and irritation inside the nose)
• Conjunctival hyperemia (redness of the eye), allergic conjunctivitis (inflammation of the eye surface), eyelid edema
• Cough
• Urticaria (itching), rash, contact dermatitis

Due to the presence of macrogolglycerol ricinoleate, there is a risk of contact dermatitis.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE DICLOABAK

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and carton. The expiry date refers to the last day of the month stated.
Store in a temperature below 25°C.
Shelf life after first opening the bottle: 8 weeks
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Dicloabak contains

• The active substance is diclofenac sodium at a concentration of 1 mg/ml.
• The other ingredients are: macrogolglycerol ricinoleate, trometamol, boric acid, water for injections.

What Dicloabak looks like and contents of the package

Dicloabak is a slightly yellow liquid supplied in bottles with a dropper containing 10 ml of eye drop solution.

Marketing authorization holder and manufacturer

Marketing authorization holder
Laboratoires THEA
12, rue Louis Blériot
63017 CLERMONT-FERRAND Cedex 2
France
Manufacturer
EXCELVISION
27, rue de la Lombardière
ZI la Lombardière
07100 Annonay
France

For more information, contact the representative of the marketing authorization holder:

Thea Polska Sp. z o.o.
ul. Cicha 7
00-353 Warsaw
Tel.: +48 22 642 87 77

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria, Norway ..................................................................................... VOLTAREN OPHTA ABAK
Belgium, Bulgaria, Czech Republic, Finland, Greece, Luxembourg, Netherlands, Poland, Portugal, Spain, Sweden .................................................... DICLOABAK
Denmark ......................................................................................................... VOLTABAK
France ...................................................................................................... VOLTARENOPHTABAK
Italy ............................................................................................................. VOLTAREN OFTA ABAK

Date of last revision of the package leaflet: 16-01-2025