Leaflet: information for the user

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

Diclofenac sodium

Read 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do 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 or pharmacist, even if they are not listed in this leaflet. See section 4.

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

Diclofenaco-lepori eye drop single-dose is used for:

• Postoperative treatment of inflammation of the anterior segment of the eye.
• Postoperative treatment of inhibition of miosis (pupil constriction) and treatment of postoperative cataracts.
• 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 use Diclofenaco-lepori eye drops in single-dose packaging

• if you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).
• if you suffer from asthma, urticaria, or acute rhinitis when administered with acetylsalicylic acid or other drugs with similar activity, prostaglandin synthetase inhibitors.
• 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 of this medication, or to other non-steroidal anti-inflammatory drugs (NSAIDs), as there is a possibility of cross-sensitivity with these drugs.

Warnings and precautions

Consult your doctor or pharmacist before starting to useDiclofenaco-lepori eye drops in single-dose packaging

• In case of infection or when there is a risk of this, your doctor may prescribe Diclofenaco-lepori eye drops in single-dose packaging together with another appropriate treatment (e.g., antibiotics). Non-steroidal anti-inflammatory drugs (NSAIDs) may mask an acute infectious process.
• If you have any difficulty stopping bleeding or are taking a medication that may prolong bleeding, inform your doctor before using Diclofenaco-lepori eye drops in single-dose packaging (see section “Other medications and Diclofenaco-lepori eye drops”).
• If you are using non-steroidal anti-inflammatory drugs, 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 posology, as frequent application of the recommended dosemay cause complications in the cornea.

Children

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

Use of Diclofenaco-lepori eye drops in single-dose packaging with other medications

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

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

Wait at least 5 minutes between one application and another before using other eye medications.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consultyour doctor or pharmacist before using this medication.

Diclofenaco-lepori eye drops in single-dose packagingshould not be used in the last 3 months of pregnancy. Do not useDiclofenaco-lepori eye drops in single-dose packagingduring the first 6 months of pregnancy, unless 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.

The oral formulations (e.g., tablets) ofDiclofenaco-lepori eye drops in single-dose packagingmay cause adverse reactions to the fetus. It is unknown whether this same risk applies toDiclofenaco-lepori eye drops in single-dose packagingwhen used in the eyes.

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

Driving and operating machines

After instillation of Diclofenaco-lepori eye drops in solution, you may experience transient blurred vision. If this is the case, do not drive or operate machines until this effect has disappeared.

Diclofenaco-lepori eye drops single-dose packaging contains boron

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

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

Your doctor will indicate the duration of your treatment with Diclofenaco-lepori 1 mg/ml eye drop in single-dose container. Do not discontinue treatment before indicated.

The correct dose for the following indications is as follows:

• Before surgery: 1 drop of the eye drop 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 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 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 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-lepori eye drop in single-dose container is too strong or too weak, inform your doctor or pharmacist.

Use in elderly patients

No indication is required to modify the dose in elderly patients.

Use in children

The use of Diclofenaco-lepori eye drop in solution in single-dose container is not indicated in children.

Instructions for the correct use of Diclofenaco-lepori eye drop in single-dose container

1. Separate a single-dose container by pulling it from top to bottom.

(Illustration)

2. Gently tap the base of the single-dose container with the tip of your finger to allow the eye drop to flow down to the opening.

(Illustration)

3. Turn the cap gently to open the container.

(Illustration)

4. Apply the eye drop 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 Diclofenaco-lepori eye drop in single-dose container 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-lepori eye drop in single-dose container

Do not apply a double dose to compensate for the missed doses.If you forget a dose, apply it as soon as possible, except if it is almost time for the next one; then return to the usual administration schedule. If you forget several doses, consult your doctor.

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

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

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

Very Common

Eye Disorders: eye pain

Common

Eye Disorders: eye irritation

Uncommon

Eye Disorders: itchy eye, red eye, blurred vision, corneal alteration

Rare

Immune System Disorders: hypersensitivity

Eye Disorders: small marks on the surface of the eye (keratitis punctata), 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), itchiness

Frequency Not Known

Infections and Infestations:rhinitis

Eye Disorders:conjunctival hyperemia, allergic conjunctivitis, redness of the eyelids(erythema of the eyelid), ocular allergy, inflammation of the eyelids, itchiness of the eyelid

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 that does not appear in this leaflet. You can also report them directly through the Spanish System for the 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 medicine.

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

No special storage conditions are required.

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

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

Do not use this medication after 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 away through drains or in the trash. Deposit the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Diclofenaco-lepori eye drop in single-dose packaging:

The active ingredient is diclofenac sodium. One ml of eye drop contains 1 mg of this active ingredient.

-Each package of 0.3 ml eye drop in solution contains 0.3 mg of diclofenac sodium.

-The other components are ricin oil 35 polyoxethyleneated, L-lysine monohydrate, boric acid (E-284), sodium borate (bórax) (E-285), sodium chloride, disodium edetate, water for injection preparations.

Appearance of the product and contents of the packaging

Diclofenaco-lepori 1 mg/ml eye drop in solution in single-dose packaging is presented in boxes containing 3 polyethylene and aluminum pouches, with two strips of 5 single-dose polyethylene low-density packaging each. Each package contains 0.3 ml of eye drop in solution.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

ANGELINI PHARMA ESPAÑA, S.L.

c/ Antonio Machado, 78-80

3rd floor, module A-Edificio Australia

08840 Viladecans, Barcelona (Spain)

Responsible for manufacturing

Laboratoire UNITHER

1 Rue De L’Arquerie

50200 Coutances – France

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/