Diclofenac Lepori 1 mg/ml eye drops solution in single-dose container

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Diclofenaco-lepori 1 mg/ml eye drops solution in single-dose container

Sodium diclofenac

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

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

Contents of the leaflet:

1. What Diclofenaco-lepori eye drops in single-dose container is and what it is used for
2. What you need to know before using Diclofenaco-lepori eye drops in single-dose container
3. How to use Diclofenaco-lepori eye drops in single-dose container
4. Possible adverse effects
5. How to store Diclofenaco-lepori eye drops in single-dose container
6. Contents of the pack and other information

1. What Diclofenac-lepori eye drops single-dose container is and what it is used for

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

Diclofenac-lepori eye drops in single-dose container are used for:

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

2. What you need to know before using Diclofenaco-lepori eye drops in single-dose containers

Do not use Diclofenaco-lepori eye drops in single-dose containers

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

Warnings and precautions

Talk to your doctor or pharmacist before using Diclofenaco-lepori eye drops in single-dose containers

• If you have an infection or are at risk of one, your doctor may prescribe Diclofenaco-lepori eye drops in single-dose containers together with another appropriate treatment (e.g., antibiotics). Non-steroidal anti-inflammatory drugs (NSAIDs) may mask an acute infectious process.
• If you have problems with stopping bleeding or are taking any medication that may prolong bleeding time, inform your doctor before using Diclofenaco-lepori eye drops in single-dose containers (see section “Other medicines and Diclofenaco-lepori eye drops in single-dose containers”).
• If you are using anti-inflammatory eye drops such as diclofenac or corticosteroids, consult your doctor before using this medicine.

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

Children

Diclofenaco-lepori eye drops in single-dose containers are not indicated for use in children, as experience with use in this population is limited.

Using Diclofenaco-lepori eye drops in single-dose containers with other medicines

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

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

Wait at least 5 minutes between applications when using other ophthalmic medications.

Pregnancy and breastfeeding

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

Diclofenaco-lepori eye drops in single-dose containers must not be used during the last three months of pregnancy. You should not use Diclofenaco-lepori eye drops in single-dose containers during the first six months of pregnancy unless strictly necessary and recommended by your doctor. If treatment is required during this period, the lowest possible dose for the shortest possible duration should be used.

Oral formulations (e.g., tablets) of Diclofenaco-lepori eye drops in single-dose containers may cause adverse effects on the fetus. It is unknown whether the same risk applies to Diclofenaco-lepori eye drops in single-dose containers when used in the eyes.

Although no adverse effects have been reported following its use, its use during breastfeeding is not recommended unless the expected benefits outweigh the potential risks.

Driving and use of machines

After instillation of Diclofenaco-lepori eye drops in solution, transient blurred vision may occur. If this happens, do not drive or operate machinery until this effect has disappeared.

Diclofenaco-lepori single-dose eye drops contain boron

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

3. How to use Diclofenac-lepori eye drops in single-dose containers

Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine the duration of your treatment with Diclofenac-lepori 1 mg/ml eye drops in single-dose containers. Do not stop the treatment before advised.

The correct dosage for the conditions indicated below is as follows:

• Before surgery: 1 drop of the eye drops 3 to 5 times within the 3 hours prior to the operation, administered at regular time intervals, meaning a maximum of 5 drops.

• After surgery: 3 drops of the eye drops administered at regular time intervals, starting immediately after the operation. Afterwards, for the required period, 1 to 2 drops of the eye drops 3 to 5 times a day, meaning 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, meaning a maximum daily dose of 8 drops.

If you feel that the effect of Diclofenac-lepori eye drops in single-dose containers is too strong or too weak, inform your doctor or pharmacist.

Use in elderly patients

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

Use in children

The use of Diclofenac-lepori eye drops in solution in single-dose containers is not indicated in children.

Instructions for correct use of Diclofenac-lepori eye drops in single-dose containers

1. Separate a single-dose container by applying an up-and-down motion, pulling it apart.

(Illustration)

1. Gently tap the base of the single-dose container with your fingertip so that the eye drops move down toward the opening.

(Illustration)

1. Gently twist the cap to open the container.

(Illustration)

1. Apply the eye drops to the eye by repeatedly pressing the base of the container to facilitate the flow of liquid, which may be hindered by air bubbles.

(Illustration)

If you use more Diclofenac-lepori eye drops in single-dose containers than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20.

If you forget to use Diclofenac-lepori eye drops in single-dose containers

Do not apply a double dose to make up for missed doses. If you forget a dose, apply it as soon as possible, unless it is almost time for the next dose; then return to your regular dosing schedule. If you miss several doses, consult your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

Very common

Eye disorders: eye pain

Common

Eye disorders: eye irritation

Uncommon

Eye disorders: eye itching, eye redness, blurred vision, corneal disorder

Rare

Immune system disorders: hypersensitivity

Eye disorders: small spots on the surface of the eye (punctate keratitis), inflammation and ulceration of the cornea (ulcerative keratitis), corneal thinning, defect in the outermost layer of the cornea, corneal inflammation

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

Eye disorders: redness of the surface of the eye (conjunctival hyperemia), allergic conjunctivitis, eyelid redness (eyelid erythema), ocular allergy, eyelid inflammation, eyelid itching

Respiratory, thoracic and mediastinal disorders: cough

Skin and subcutaneous tissue disorders: urticaria, rash, eczema

Reporting of 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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es.

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

5. Storage of Diclofenac-lepori eye drops in single-dose containers

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

No special storage conditions are required.

After opening the aluminium pouch, the product should be used within 60 days.

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Diclofenac-lepori eye drops in single-dose containers:

The active substance is sodium diclofenac. One ml of eye drops contains 1 mg of this active substance.

• Each 0.3 ml container of eye drop solution contains 0.3 mg of sodium diclofenac.
• The other components are polyoxyl 35 castor oil, L-lysine monohydrate, boric acid (E-284), sodium borate (borax) (E-285), sodium chloride, disodium edetate, water for injections.

Appearance of the product and contents of the pack

Diclofenac-lepori 1 mg/ml eye drops solution in single-dose containers is supplied in cartons containing 3 polyethylene and aluminum sachets, each with two strips of 5 low-density polyethylene single-dose containers. Each container holds 0.3 ml of eye drop solution.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

ANGELINI PHARMA ESPAÑA, S.L.

c/ Antonio Machado, 78-80

3rd floor, module A-Edificio Australia

08840 Viladecans, Barcelona (Spain)

Manufacturer

Laboratoire UNITHER

1 Rue De L’Arquerie

50200 Coutances – France

Date of the most recent revision of this summary: August 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/