Prospecto: information for the user

DICLOABAK 1 mg/ml, eye drops in solution

diclofenaco de sodio

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
  If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect.See section 4.

1. What isDICLOABAKand for what it is used

2. What you need to know before starting to useDICLOABAK

3. How to useDICLOABAK

4. Possible adverse effects

5. Storage ofDICLOABAK

6. Contents of the package and additional information

This medication 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 and anterior segment eye surgery.
• treatment of eye pain in photorefractive keratectomy (corrective surgery for myopia) during the first 24 hours after surgery.

No use Dicloabak:

-if you are allergic (hypersensitive) to sodium diclofenac or to any of the other components of this medication (including those listed in section 6),

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

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to use DICLOABAK.

• Dicloabak, like other NSAIDs, in rare cases may 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 medication, especially asthma attack or sudden sweating on the face and neck, discontinue treatment and immediately contact your doctor or emergency services.
• Before using this medication, inform your doctor if you have asthma associated with chronic rhinitis, chronic sinusitis, and/or nasal polyps.
• Acute ocular infection may be masked by the topical use of anti-inflammatory medications. NSAIDs do not have antimicrobial properties. In case of ocular infection, use with one or more antimicrobial medications should be done carefully.
• The use of topical NSAIDs and topical steroids (e.g. dexamethasone) at the same time may increase the risk of healing problems.
• NSAIDs may delay corneal healing.
• If you have a bleeding tendency or are following an anticoagulant treatment (blood-thinning medications).
• In case of high doses and prolonged use, the use of topical NSAIDs may cause keratitis.
• Patients who have undergone repeated eye surgery in a short period of time, diabetes, ocular surface disease (e.g. dry eye syndrome), rheumatoid arthritis, may be at higher risk of adverse effects on the cornea.
• It is not recommended to use contact lenses after cataract surgery. Your doctor will advise you when you can use contact lenses again.

Use of Dicloabak with other medications

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

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Pregnancy, lactation, and fertility

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

Pregnancy

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

Oral formulations of diclofenac (e.g. tablets) may cause adverse reactions to the fetus. It is unknown if this same risk applies to Dicloabak when used for the eyes.

Lactation

DICLOABAK can be used during breastfeeding.

Fertility

Like all nonsteroidal anti-inflammatory drugs (NSAIDs), this medication may affect fertility in women and make it difficult to conceive. This effect is reversed when treatment is discontinued. Consult your doctor if you are planning to become pregnant or have difficulty conceiving.

Driving and operating machinery

You may experience brief visual disturbances after administration of Dicloabak.

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

DICLOABAK containsricinoleate of macrogolglycerol

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Posology

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

Inhibition 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 1 drop up to 5 times during the 3 hours before surgery;
• Postoperative: administer 1 drop 3 times immediately after surgery and then 1 drop of 3 to 5 times a day, for a maximum of 4 weeks.

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

• Preoperative: administer 2 drops during the hour before surgery;
• Postoperative: administer 2 drops during the hour after surgery and then 4 drops during the following 24 postoperative hours.

Do not exceed the recommended dose.

Use in children:

No specific studies have been conducted.

Administration form

This medication 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 thoroughly before using the product.
2. Avoid touching the eye or eyelids with the tip of the dropper.
3. Instill one drop in the affected eye looking upwards and pulling the eyelid downwards.
4. Close the bottle after each use.
5. After instillation, press a finger on the point between the nose and eye and close the eyelids for 2 minutes. This will help prevent DICLOABAK from spreading to the rest of the body.

If you forgot to use DICLOABAK

Do not use a double dose to compensate for the missed dose.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medications, this medication may have adverse effects, although not everyone will experience them.

The following adverse effects have been reported:

Rare (may affect up to 1 in 100 patients))

Burning sensation in the eye after instillation,

Visual disturbances after instillation

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

Hypersensitivity reactions, itching, and redness.

Phototoxicity (allergic reaction after sun exposure).

Punctate keratitis (corneal lesions), corneal ulceration, corneal thinning.

Dyspnea (difficulty breathing).

Worsening of asthma.

Unknown frequency: (cannot be estimated from available data)

Rhinitis (nasal congestion and irritation)

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

Cough

Urticaria (itching), erythema, contact dermatitis.

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

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the box and on the packaging. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25º C.

The packaging must be disposed of eight weeks after the first opening.

Medicines should not be thrown away through drains or in the trash. Deposit the packaging and medicines that you do not need at the SIGRE collection point of the pharmacy.Ask your pharmacist if you are unsure how to dispose of the packaging and medicines that you do not need. In this way, you will help protect the environment.

Composition of DICLOABAK

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

Appearance of the product and content of the container

Dicloabak is a slightly yellowish liquid, presented in containers with 10 ml of eye drops.

Holder of the Marketing Authorization

Laboratoires Théa

12, rue Louis Blériot

63017 Clermont-Ferrand Cedex 2

France

Responsible for manufacturing

ExCELVISION

27,Rue de la Lombardière

ZI la Lombardière

07100 Annonay

France

Local representative

LABORATORIOS THEA S.A.

C/ Enric Granados, nº 86-88, 2nd floor

08008 Barcelona

This medicine is authorized in the member states of the European Economic Areawith the following names:

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

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

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

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

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

Last review date of this leaflet: January 2025

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.es/.