DICLOABAK 1 mg/ml EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the User

DICLOABAK 1 mg/ml, Eye Drops Solution

diclofenac sodium

Read this package leaflet carefully before you start using this medicine, because it contains important information for you.

• 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, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is DICLOABAK and what is it used for

This medicine contains a non-steroidal anti-inflammatory (NSAID) for use in the eye.

It is used during certain eye surgeries and as a continuation of surgery for:

• prevention of miosis (reduction of pupil size) during cataract surgery.
• prevention of inflammation in cataract surgery and anterior segment surgery of the eye.
• treatment of eye pain in photorefractive keratectomy (corrective surgery for myopia) during the first 24 hours after surgery.

2. What you need to know before you start using DICLOABAK

Do not use Dicloabak:

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• if you have a history of allergy, urticaria (rash with itching), acute rhinitis (swelling and irritation inside the nose), or asthma due to the use of this eye drop or a similar medicine, such as another NSAID or aspirin.

Warnings and Precautions

Talk to your doctor, pharmacist, or nurse before you start using DICLOABAK.

• You must use this medicine with caution:

• Dicloabak, like other NSAIDs, can rarely induce allergic reactions, including anaphylactic reactions (severe allergic reaction that causes difficulty breathing or dizziness), even without prior exposure to the drug.
• In case of hypersensitivity reactions or signs of allergy to this medicine, especially asthma attacks or sudden sweating on the face and neck, discontinue treatment and contact your doctor or emergency services immediately.
• Before using this medicine, inform your doctor if you have chronic rhinitis, chronic sinusitis, and/or nasal polyps associated with asthma.
• An acute eye infection can be masked by the topical use of anti-inflammatory medicines. NSAIDs do not have antimicrobial properties. In case of eye infection, their use with one or more anti-infective medicines should be done carefully.
• The simultaneous use of topical NSAIDs and topical steroids (such as dexamethasone) may increase the potential problem of healing.
• NSAIDs can delay corneal healing.
• If you have a tendency to bleed or are undergoing anticoagulant treatment (blood-thinning medicines).
• In case of high doses and prolonged use, the use of topical NSAIDs can produce keratitis.
• Patients who have undergone repeated eye surgery in a short period, diabetes, ocular surface disease (e.g., dry eye syndrome), rheumatoid arthritis, may be at higher risk of adverse effects on the cornea.
• The use of contact lenses is not recommended after cataract surgery. Your doctor will advise you when you can use contact lenses again.

• If your symptoms worsen or do not improve, you should visit a doctor.

Using Dicloabak with other medicines

If you are using another type of eye drops at the same time as Dicloabak, please wait 15 minutesbetween treatments.

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine.

Pregnancy, Breastfeeding, and Fertility

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

Pregnancy

Dicloabak should not be used from the beginning of the 6th month (24 weeks of amenorrhea) until the end of pregnancy. You should not use Dicloabak during the first 5 months of pregnancy (up to 24 weeks of amenorrhea), unless it is strictly necessary and your doctor recommends it. If you need treatment during this period, you should take the minimum possible dose for the shortest possible time.

Oral formulations (e.g., tablets) of diclofenac may cause adverse reactions to the fetus. It is not known if this same risk applies to Dicloabak when used for the eyes.

Breastfeeding

DICLOABAK can be used during breastfeeding.

Fertility

Like all non-steroidal anti-inflammatory medicines (NSAIDs), this medicine may affect fertility in women and make it difficult to conceive. This effect is reversible when treatment is stopped. Consult your doctor if you are planning to become pregnant or have problems conceiving.

Driving and Using Machines

You may experience brief visual disturbances after administering Dicloabak.

Wait until your vision returns to normal before driving a vehicle or using any hazardous machinery.

DICLOABAK contains ricinoleate of macrogolglycerol

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

3. How to use DICLOABAK

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Dosage

The recommended dose in adults and elderly patients is as follows:

Prevention of miosis during cataract surgery

• Preoperative: apply one drop up to five times during the three hours before surgery.

Cataract and anterior segment eye surgeries:

• Preoperative: administer one drop up to five times during the three hours before surgery;
• Postoperative: administer one drop three times immediately after surgery and then one drop three to five times a day, for a maximum of four weeks.

Treatment of eye pain in photorefractive keratectomy (corrective surgery for myopia)

• Preoperative: administer two drops during the hour before surgery;
• Postoperative: administer two drops during the hour after surgery and then four drops during the following 24 hours postoperative.

Do not exceed the recommended dose.

Use in Children:

No specific studies have been conducted.

Method of Administration

This medicine is intended for use in the eye (ophthalmic use).

Do not inject, do not ingest.

Eye drops should not be administered by peri- or intraocular injection.

1. Wash your hands carefully before using the product.
2. Avoid touching the eye or eyelids with the dropper tip.
3. Instill one drop into the affected eye, looking up and pulling the lower eyelid down.
4. Close the bottle after each use.
5. After instillation, press with a finger on the point between the nose and the eye and close the eyelids for 2 minutes. This will help prevent DICLOABAK from spreading to the rest of the body.

If you forget to use DICLOABAK

Do not use a double dose to make up for the forgotten dose.

If you have any further questions on the use of this product, ask 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:

Uncommon (may affect up to 1 in 100 patients)

Burning sensation in the eye after instillation,

Visual disturbances after instillation

Rare (may affect up to 1 in 1,000 patients)

Hypersensitivity reactions, itching, and redness.

Photosensitivity reaction (allergic reaction after sun exposure).

Punctate keratitis (lesions on the cornea), corneal ulcers, corneal thinning.

Dyspnea (difficulty breathing).

Worsening of asthma.

Frequency not known: (cannot be estimated from the available data)

Rhinitis (swelling and irritation inside the nose)

Conjunctival hyperemia (redness in the eyes), allergic conjunctivitis (inflammation of the eye surface), eyelid edema (swelling of the eyelids).

Cough

Urticaria (itching), erythema, contact eczema.

Due to the presence of ricinoleate of macrogolglycerol, risk of contact eczema.

If you think any of the side effects you are experiencing are serious, or if you notice any side effects not listed in this package leaflet, please tell your doctor or pharmacist.

Reporting of Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of DICLOABAK

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 bottle. The expiry date is the last day of the month stated.

Do not store above 25°C.

The bottle should be discarded 8 weeks after the first opening.

Medicines should not be disposed of via wastewater or household waste. Return the bottle and any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition of DICLOABAK

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

Appearance and Pack Contents

Dicloabak is a slightly yellowish liquid, presented in bottles containing 10 ml of eye drops.

Marketing Authorisation Holder

Laboratoires Théa

12, rue Louis Blériot

63017 Clermont-Ferrand Cedex 2

France

Manufacturer

ExCELVISION

27, Rue de la Lombardière

ZI la Lombardière

07100 Annonay

France

Local Representative

LABORATORIOS THEA S.A.

C/ Enric Granados, nº 86-88, 2ª planta

08008 Barcelona

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

Austria, Norway: ……………………………………………….VOLTAREN OPHTHA ABAK

Belgium, Bulgaria, Finland, Spain, Greece, Netherlands, Luxembourg, Poland, Portugal, Czech Republic, Slovakia, Sweden: ………………………………DICLOABAK.

Denmark: ……………………………………………………………………VOLTABAK

France:………………………………………………………… VOLTARENOPHTABAK

Italy: …………………………………………………………….VOLTAREN OFTABAK

Date of the last revision of this package leaflet: January 2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/.