Leaflet: information for the user

Diclofenaco Abamed 1 mg/ml eye drops in a single-dose container

diclofenac sodium

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

- Keep this leaflet, as you may need to read it again.

- If you have any questions, consult your doctor, pharmacist or nurse.

- This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1. What isDiclofenaco Abamedand what is it used for

2.What you need to know beforestarting to useDiclofenaco Abamed

3. How to useDiclofenaco Abamed

4. Possible side effects

5. Storage ofDiclofenaco Abamed

6.Contents of the container and additional information

This medication belongs to the group of topical ophthalmic medications. It contains diclofenac sodium as the active ingredient, which is a non-steroidal anti-inflammatory (NSAID).

Diclofenaco Abamed is used for:

• Postoperative treatment of inflammation of the anterior segment of the eye.
• Pre and postoperative treatment of miosis (pupil constriction) inhibition in cataract surgery.
• Symptomatic treatment of chronic non-infectious conjunctivitis.
• Treatment of ocular inflammation, eye pain, and photophobia after refractive surgery (performed to correct myopia, astigmatism, and hyperopia).

Do not useDiclofenaco Abamed

• if you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to useDiclofenaco Abamed.

Be especially careful withDiclofenaco Abamed:

• In case of infection or when there is a risk of one, your doctor may prescribeDiclofenaco Abamedconcurrently with another appropriate treatment (for example, antibiotics).
• Nonsteroidal anti-inflammatory drugs (NSAIDs) may mask an acute infectious process.

Other medications and Diclofenaco Abamed

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

No interactions with other medications have been described to date in ocular application.

Pregnancy, breastfeeding, 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.

Diclofenaco Abamed should not be used in the last 3 months of pregnancy. Do not use Diclofenaco Abamed during the first 6 months of pregnancy, 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 (e.g., tablets) of Diclofenaco Abamed may cause adverse reactions to the fetus. It is unknown if this same risk applies to Diclofenaco Abamed when used for the eyes.

Driving and operating machinery

It is advisable to avoid applying the eye drops before driving vehicles or operating machinery.

Diclofenaco Abamed contains boric acid

Do not administer to children under 2 years of age, as this medication contains boron and may affect fertility in the future.

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..

Your doctor will indicate the duration of your treatment with Diclofenaco Abamed.Do not discontinue treatment before the indicated time.

The recommended dose for the following cases is as follows:

• Before surgery: 1 drop of the eye drop solution 3 to 5 times during the 3 hours before the operation, applied at regular intervals of time, which means a maximum of 5 drops.

• After surgery: 3 drops of the eye drop solution applied at regular intervals of time, starting immediately after the operation. Then, during the required period of 1 to 2 drops of the eye drop solution 3 to 5 times a day, which means a maximum daily dose of 10 drops.

• Other indications: 1 to 2 drops of the eye drop solution 3 to 4 times a day, according to the severity of the case, which means a maximum daily dose of 8 drops.

If you estimate that the action of Diclofenaco Abamed is too strong or too weak, inform your doctor or pharmacist.

Instructions for the correct use of Diclofenaco Abamed

1. Separate a single-use container by pulling it downwards.
2. Gently tap the base of the single-use container with the tip of your finger to allow the eye drop solution to flow towards the opening.
3. Turn the cap gently to open the container.
4. Apply the eye drop solution to the eye by pressing the base of the container repeatedly to facilitate the flow of the liquid, which may be hindered by air bubbles.

If you use more Diclofenaco Abamed than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone: 91 562 04 20.

If you forgot to use Diclofenaco Abamed

Do not apply a double dose to compensate for the missed doses.

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

Like all medications,this medicationmay cause adverse effects, although not everyone will experience them.

Occasionally, as occurs with other eye drops in the same therapeutic class, a mild or moderate transient stinging sensation may occur shortly after application of the eye drop. Rarely, hypersensitivity reactions with pruritus (itching), erythema (redness), and photosensitivity (sensitivity to light) may occur. Additionally, with an unknown frequency, a burning sensation in the eye may occur.

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 prospectus. You may also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

No special storage conditions are required.

This medication does not contain preservatives. After opening and after use, the single-dose packaging should be discarded, even if only partially used.

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

Medications should not be thrown down the drain or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Diclofenaco Abamed:

• The active ingredient is diclofenac sodium.
• The other components are polyoxethylene ricin oil, boric acid (E-284), tromethamine, and purified water.

Appearance of the product and contents of the packaging

Diclofenaco Abamedis presented in the form of a single-dose eye drop solution in single-dose packaging. Carton box with 30 single-dose packaging units that are presented in blocks of 5 plastic units, packaged in a bag.

Holder of the marketing authorization

Qualix Pharma, S.L.

c/ Botánica, 137-139

08908 L’Hospitalet de Llobregat (Barcelona)

Spain

Responsible for manufacturing

Qualix Pharma, S.L.

c/ Botánica, 137-139

08908 L’Hospitalet de Llobregat (Barcelona)

Spain

Date of the last review of this leaflet:August 2024.

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