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

Introduction

Package Leaflet: Information for the User

Diclofenac-Lepori 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 or pharmacist.
• 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 or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What Diclofenac-Lepori Eye Drops, Single-Dose Container is and what it is used for
2. What you need to know before starting to use Diclofenac-Lepori Eye Drops, Single-Dose Container
3. How to use Diclofenac-Lepori Eye Drops, Single-Dose Container
4. Possible side effects
5. Storage of Diclofenac-Lepori Eye Drops, Single-Dose Container
6. Package Contents and Additional Information

1. What Diclofenac-Lepori Eye Drops, Single-Dose Container 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-Lepori Eye Drops, Single-Dose Container is used for:

• Postoperative treatment of inflammation of the anterior segment of the eye.
• Treatment of inhibition of 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-Lepori Eye Drops, Single-Dose Container

Do not use Diclofenac-Lepori Eye Drops, Single-Dose Container

• if you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).
• if you have asthma attacks, hives, or acute rhinitis when given acetylsalicylic acid or other medications with similar activity, inhibiting prostaglandin synthetase.
• if you know you are sensitive to acetylsalicylic acid or to phenylacetic acid derivatives, which belong to the same chemical group as the active ingredient of this medication, or to other non-steroidal anti-inflammatory drugs (NSAIDs), as there is a possibility of cross-sensitivity to these medications.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Diclofenac-Lepori Eye Drops, Single-Dose Container

• In case of infection or when there is a risk of infection, your doctor may prescribe Diclofenac-Lepori Eye Drops, Single-Dose Container in combination with other appropriate treatment (e.g., antibiotics). Non-steroidal anti-inflammatory drugs (NSAIDs) may mask an acute infectious process.
• If you have any problems stopping bleeding or are taking any medication that may prolong bleeding, inform your doctor before using Diclofenac-Lepori Eye Drops, Single-Dose Container (see section "Other medications and Diclofenac-Lepori Eye Drops, Single-Dose Container").
• If you are using non-steroidal anti-inflammatory medications, such as diclofenac, or corticosteroids in the form of eye drops, consult your doctor before using this medication.

Do not exceed the recommended dose in the dosage instructions, as more frequent application than recommended may cause complications in the cornea.

Children

Diclofenac-Lepori Eye Drops, Single-Dose Container is not indicated for use in children, as experience with its use in them is limited.

Using Diclofenac-Lepori Eye Drops, Single-Dose Container with other medications

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

If you are taking non-steroidal anti-inflammatory medications, such as diclofenac, or corticosteroids, consult your doctor before using this medication, as there may be a risk of complications.

Before using other ophthalmic medications, wait at least 5 minutes between applications.

Pregnancy and Breastfeeding

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-Lepori Eye Drops, Single-Dose Container should not be used if you are in the last 3 months of pregnancy. You should not use Diclofenac-Lepori Eye Drops, Single-Dose Container during the first 6 months of pregnancy, unless it is strictly necessary and your doctor recommends it. 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-Lepori Eye Drops, Single-Dose Container may cause adverse reactions in the fetus. It is unknown whether this same risk applies to Diclofenac-Lepori Eye Drops, Single-Dose Container when used for the eyes.

Although no adverse effects have been described as a result of its application, its use is not recommended during breastfeeding, unless the expected benefits outweigh the potential risks.

Driving and Using Machines

After instillation of Diclofenac-Lepori Eye Drops, Solution, you may experience temporary blurred vision. If this occurs, do not drive or use machines until this effect has disappeared.

Diclofenac-Lepori Eye Drops, Single-Dose Container contains boron

Do not administer to children under 12 years of age, as this medication contains boron and may affect fertility in the future.

3. How to use Diclofenac-Lepori Eye Drops, Single-Dose Container

Follow your doctor's instructions for administering this medication exactly. If you are unsure, consult your doctor or pharmacist again.

Your doctor will indicate the duration of your treatment with Diclofenac-Lepori 1 mg/ml Eye Drops, Single-Dose Container. Do not stop treatment before the indicated time.

The correct 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-Lepori Eye Drops, Single-Dose Container is too strong or too weak, inform your doctor or pharmacist.

Use in Elderly Patients

There is no indication that the dose needs to be modified in elderly patients.

Use in Children

The use of Diclofenac-Lepori Eye Drops, Solution, Single-Dose Container is not indicated in children.

Instructions for the correct use of Diclofenac-Lepori Eye Drops, Single-Dose Container

1. Separate a single-dose container by performing a downward movement, pulling it.

(Illustration)

1. Gently tap the base of the single-dose container with the tip of your finger so that the eye drops flow towards the opening.

(Illustration)

1. Gently turn the cap to open the container.

(Illustration)

1. Apply the eye drops 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.

(Illustration)

If you use more Diclofenac-Lepori Eye Drops, Single-Dose Container 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-Lepori Eye Drops, Single-Dose Container

Do not apply a double dose to make up for forgotten doses. If you forget a dose, apply it as soon as you can, except if it is almost time for the next dose; then return to your regular administration schedule. If you forget several doses, consult your doctor.

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

4. Possible Side Effects

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

Talk to your doctor or pharmacist if you experience any of the following side effects:

Very Common

Ocular disorders: eye pain

Common

Ocular disorders: ocular irritation

Uncommon

Ocular disorders: itching in the eye, redness of the eye, blurred vision, corneal disorder

Rare

Immune system disorders: hypersensitivity

Ocular disorders: small marks on the surface of the eye (punctate keratitis), inflammation and ulceration of the cornea (ulcerative keratitis), thinning of the cornea, defect in the outer layer of the cornea, inflammation of the cornea.

Respiratory, thoracic, and mediastinal disorders: dyspnea (difficulty breathing), worsening of asthma.

Skin and subcutaneous tissue disorders: redness (erythema), itching

Frequency Not Known

Infections and infestations: rhinitis

Ocular disorders: redness of the conjunctiva (conjunctival hyperemia), allergic conjunctivitis, redness of the eyelids (eyelid erythema), ocular allergy, inflammation of the eyelids, itching of the eyelids

Respiratory, thoracic, and mediastinal disorders: cough

Skin and subcutaneous tissue disorders: urticaria, rash, eczema.

Reporting Side Effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Diclofenac-Lepori Eye Drops, Single-Dose Container

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

No special storage conditions are required.

After opening the aluminum pouch, the product must be used within 60 days.

This medication does not contain preservatives. After opening and after use, the single-dose container must be discarded, even if it has only been partially used.

Do not use this medication after the expiration date stated 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 any unused medications in the pharmacy's SIGRE collection point. If you have any questions, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Diclofenac-Lepori Eye Drops, Single-Dose Container:

The active ingredient is diclofenac sodium. One milliliter of eye drops contains 1 mg of this active ingredient.

• Each 0.3 ml container of eye drops in solution contains 0.3 mg of diclofenac sodium.
• The other components are ricinoleic acid polyoxyethylene, L-lysine monohydrate, boric acid (E-284), sodium borate (borax) (E-285), sodium chloride, disodium edetate, water for injectable preparations.

Appearance of the Product and Package Contents

Diclofenac-Lepori 1 mg/ml Eye Drops, Solution, Single-Dose Container is presented in cartons containing 3 polyethylene and aluminum pouches, with two strips of 5 single-dose containers of low-density polyethylene each. Each container contains 0.3 ml of eye drops in solution.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

ANGELINI PHARMA ESPAÑA, S.L.

c/ Antonio Machado, 78-80

3rd floor, module A-Australia Building

08840 Viladecans, Barcelona (Spain)

Manufacturer

Laboratoire UNITHER

1 Rue De L’Arquerie

50200 Coutances – France

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/