DICLOFENAC ABAMED 1 mg/ml EYE DROPS IN SOLUTION IN SINGLE-DOSE CONTAINERS

Introduction

Package Leaflet: Information for the User

Diclofenac Abamed 1 mg/ml Eye Drops Solution in Single-Dose Container

diclofenac sodium

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What Diclofenac Abamed is and what it is used for
2. What you need to know before starting to use Diclofenac Abamed
3. How to use Diclofenac Abamed
4. Possible side effects
5. Storage of Diclofenac Abamed
6. Contents of the packaging and additional information

1. What Diclofenac Abamed is and what it is used for

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 drug (NSAID).

Diclofenac Abamed is used for:

• Postoperative treatment of inflammation of the anterior segment of the eye.
• Treatment to inhibit miosis (pupil constriction) before and after 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 hypermetropia).

2. What you need to know before starting to use Diclofenac Abamed

Do not useDiclofenacAbamed

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Diclofenac Abamed.

Be particularly careful with Diclofenac Abamed when:

• In case of infection or when there is a risk of infection, your doctor may prescribe Diclofenac Abamed in combination with other appropriate treatment (e.g., antibiotics).
• Non-steroidal anti-inflammatory drugs (NSAIDs) may mask an acute infectious process.

Other medications and Diclofenac Abamed

Tell your doctor or pharmacist if you are using, have recently used, or may need 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

Diclofenac Abamed should not be used if you are in the last 3 months of pregnancy. You should not use Diclofenac 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 Diclofenac Abamed may cause adverse reactions in the fetus. It is unknown whether this same risk applies to Diclofenac Abamed when used for the eyes.

Driving and using machines

It is advisable to avoid applying the eye drops before driving or using machines.

Diclofenac Abamed contains boric acid

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

3. How to use Diclofenac Abamed

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

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

The recommended dose for the following cases is as follows:

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

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

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

If you think the effect of Diclofenac Abamed is too strong or too weak, tell your doctor or pharmacist.

Instructions for the correct use of Diclofenac Abamed

1. Separate a single-dose container by making a downward movement, pulling it.
2. Gently tap the base of the single-dose container with the tip of your finger so that the eye drops flow towards the opening.
3. Turn the cap gently to open the container.
4. Apply the eye drops in 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 Diclofenac Abamed than you should

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

If you forget to use Diclofenac Abamed

Do not apply a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Occasionally, as with other eye drops in the same therapeutic class, a mild or moderate transient stinging sensation may occur immediately after applying the eye drops. Rarely, hypersensitivity reactions with itching, redness, and photosensitivity may occur. Additionally, with an unknown frequency, a burning sensation in the eye may occur.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Diclofenac Abamed

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 container should be discarded, even if it has only been partially used.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the packaging and additional information

Composition of Diclofenac Abamed:

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

Appearance of the product and contents of the packaging

Diclofenac Abamed is presented as eye drops in solution in single-dose containers. Carton box with 30 single-dose containers, presented in blocks of 5 plastic units, packaged in a bag.

Marketing authorization holder

Qualix Pharma, S.L.

c/ Botánica, 137-139

08908 L’Hospitalet de Llobregat (Barcelona)

Spain

Manufacturer

Qualix Pharma, S.L.

c/ Botánica, 137-139

08908 L’Hospitalet de Llobregat (Barcelona)

Spain

Date of the last revision of this package leaflet:August 2024.

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