Prospecto:information for the user

Diclofenaco-lepori 1 mg/ml eye drop solution

Diclofenaco sodium

Read this prospectus carefully before starting to use this medication,because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribedonlyto you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects,consult your doctor or pharmacist, evenifthey are not listed in this prospectus. See section 4.

1.What is Diclofenaco-lepori eye drop solution and for what it is used

2.What you need to know beforestartingto use Diclofenaco-lepori eye drop solution

3.How to use Diclofenaco-lepori eye drop solution

4.Possible adverse effects

5.Storage of Diclofenaco-lepori eye drop solution

6.Contents of the package and additional information

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 solution 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 miosis following 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).

Do not use Diclofenaco-lepori eye drops in solution

• 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 attacks, urticaria, or acute rhinitis when administered with acetylsalicylic acid or other medications with similar activity, inhibiting prostaglandin synthetase
• 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 medications

Warnings and precautions

Consult your doctor or pharmacist before starting to use Diclofenaco-lepori eye drops in solution

• In case of infection or when there is a risk of infection, your doctor may prescribe Diclofenaco-lepori eye drops in solution along with another appropriate treatment (e.g., antibiotics). Non-steroidal anti-inflammatory drugs (NSAIDs) may mask an acute infectious process
• If you have a problem stopping bleeding or are taking a medication that may prolong bleeding, inform your doctor before using Diclofenaco-lepori eye drops (see section “Other medications and Diclofenaco-lepori eye drops”)
• If you are using non-steroidal anti-inflammatory medications, such as diclofenac, or corticosteroids in eye drop form, consult your doctor before using this medication

Do not exceed the recommended dose in the posology, as frequent application of the recommended dose may cause complications in the cornea

When using soft contact lenses, it is advisable to instill the eye drops contained in the package only when the lenses are not in place (see section “Diclofenaco-lepori eye drops contain benzalkonium chloride”)

Children

Diclofenaco-lepori eye drops in solution are not indicated for use in children, as experience with their use is limited

Use of Diclofenaco-lepori eye drops with other medications

Inform your doctor or pharmacist if you are using or have used recently 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

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

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-lepori eye drops should not be used in the last 3 months of pregnancy. Do not use Diclofenaco-lepori eye drops during 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 possible dose for the shortest possible time

Oral formulations (e.g., tablets) of Diclofenaco-lepori eye drops may cause adverse reactions to the fetus. It is unknown whether this same risk applies to Diclofenaco-lepori eye drops when used for the eyes

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

Driving and operating machinery

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

Diclofenaco-lepori eye drops contain benzalkonium chloride and boron

This medication contains 10 mg of benzalkonium chloride in each 100 ml

Benzalkonium chloride can be absorbed by soft contact lenses and may alter the color of the lenses. Remove the contact lenses before using this medication and wait 15 minutes before reinserting them

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (transparent layer of the front part of the eye). Consult your doctor if you feel a strange sensation, burning, or pain in the eye after using this medication

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 as indicated by your doctor.In case of doubt, consult your doctor or pharmacist again.

The correct dose for the cases indicated below is as follows:

• Before surgery: 1 drop of the eye drop 3 to 5 times during the 3 hours prior to 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 solution is too strong or too weak, inform your doctor or pharmacist.

Use in elderly patients

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

Use in children

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

Administration instructions

With the head tilted back, separate the lower eyelid downward and instill the drop into the conjunctival sac (space between the eye and the eyelid) while looking up. Close the eyes gently and keep them closed for 5 minutes. In this way, a greater activity is obtained and the risk of adverse reactions is reduced. Before using other eye medications, wait at least 5 minutes.

As this is a sterile medication, it is recommended to follow the following instructions:

• Each patient will use their own container.
• The application of the eye drop should be carried out with the utmost cleanliness, avoiding contact with the dropper as much as possible.
• After each application, close the container well.
• After completing the treatment, the medication should be discarded, even if it has not been used in its entirety.

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

If you use more Diclofenaco-lepori eye drop solution 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 solution

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

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

Like all medications, this medication may 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, blurry 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 (keratitis ulcerosa), corneal thinning, defect in the outer layer of the cornea, corneal inflammation.

Respiratory, Thoracic, and Mediastinal Disorders: shortness of breath (dyspnea), worsening of asthma.

Skin and Subcutaneous Tissue Disorders: redness (erythema), itchiness

Unknown Frequency

Infections and Infestations:rhinitis

Eye Disorders:redness on the surface of the eye (hyperemia of the conjunctiva), 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 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 can also report them directly through the Spanish System for 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 medication.

Keepthis medicationout of the sight and reach of children.

Do not store at a temperature above30°C. Close the container tightly after each use.

After opening the container, the prepared eye drops for use and stored under normal environmental conditions can be used within a period not exceeding one month.

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

Medications should not be disposed of through drains or in the trash.Deposit the containers and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need.This will help protect the environment.

Composition of Diclofenaco-lepori eye drop solution

• The active ingredient is diclofenac sodium. One milliliter of the eye drop solution contains 1 mg of this active ingredient.
• The other components are L-lysine monohydrate, boric acid (E-284), sodium borate (bórax) (E-285), sodium chloride, 35 polyoxylated ricin oil, benzalkonium chloride, sodium edetate, and water for injection preparations.

Appearance of the product and contents of the packaging

Diclofenaco-lepori 1 mg/ml eye drop solution is presented in cases containing a polyethylene dropper bottle and a polypropylene stopper, with 5 ml of eye drop 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

TUBILUX PHARMA S.P.A. Via Costarica, 20/22.00040 Pomezia (Rome, Italy)

Last review date 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/