DICLOFENAC-LEPORI 1 mg/ml EYE DROPS SOLUTION

2. What you need to know before starting to use Diclofenac-lepori eye drops in solution

Do not use Diclofenac-lepori eye drops in solution

• If you are allergic to the active ingredient or to any of the other components of this medicine (listed in section 6).
• If you have asthma attacks, hives, or acute rhinitis when given acetylsalicylic acid or other drugs with similar activity, inhibiting prostaglandin synthesis.
• 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 medicine, or to other non-steroidal anti-inflammatory drugs (NSAIDs), as there is a possibility of cross-sensitivity to these drugs.

Warnings and precautions

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

• In case of infection or when there is a risk of infection, your doctor may prescribe Diclofenac-lepori eye drops in solution together with another suitable treatment (e.g., antibiotics). Non-steroidal anti-inflammatory drugs (NSAIDs) can mask an acute infectious process.
• If you have any problems stopping bleeding or are taking any medication that may prolong bleeding time, inform your doctor before using Diclofenac-lepori eye drops in solution (see section "Other medicines and Diclofenac-lepori eye drops in solution").
• 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 medicine.

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

If you are using soft contact lenses, it is advisable to instill the eye drops in the container only when they are not being worn (see section "Diclofenac-lepori eye drops in solution contain benzalkonium chloride").

Children

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

Using Diclofenac-lepori eye drops in solution with other medicines

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

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

Before using other eye medicines, wait at least 5 minutes between applications.

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 medicine.

Diclofenac-lepori eye drops should not be used if you are in the last 3 months of pregnancy. You should not use Diclofenac-lepori eye drops 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 may cause adverse reactions in the fetus. It is not known if this same risk applies to Diclofenac-lepori eye drops 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 possible risks.

Driving and using machines

After instilling Diclofenac-lepori eye drops in solution, you may experience temporary blurred vision. If this is the case, do not drive or use machines until this effect has disappeared.

Diclofenac-lepori eye drops in solution contain benzalkonium chloride and boron

This medicine contains 10 mg of benzalkonium chloride in every 100 ml.

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

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (the transparent layer on the front of the eye). Consult your doctor if you feel any unusual sensation, itching, or pain in the eye after using this medicine.

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

3. How to use Diclofenac-lepori eye drops in solution

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

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 in solution is too strong or too weak, tell 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 in solution is not indicated in children.

Administration instructions

With your head tilted back, pull down the lower eyelid and instill the drop into the conjunctival sac (the space between the eye and the eyelid) while looking up. Close your eyes gently and keep them closed for 5 minutes. This will result in greater activity and reduce the risk of adverse reactions. Before using other eye medicines, wait at least 5 minutes.

As this is a sterile medicine, it is recommended to follow these instructions:

• Each patient will use their own container.
• The application of the eye drops should be done with the utmost cleanliness, avoiding any contact with the dropper as much as possible.
• After each application, close the container well.
• After finishing the treatment, the medicine should be discarded, even if it has not been fully consumed.

Your doctor will indicate the duration of your treatment with Diclofenac-lepori 1 mg/ml eye drops in solution. Do not stop treatment before the indicated time.

If you use more Diclofenac-lepori eye drops in solution 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 in solution

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 doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

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

Very common

Eye disorders: eye pain

Common

Eye disorders: eye irritation

Uncommon

Eye disorders: itching in the eye, redness of the eye, blurred vision, corneal changes

Rare

Immune system disorders: hypersensitivity

Eye 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

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

Respiratory, thoracic, and mediastinal disorders: cough

Skin and subcutaneous tissue disorders: hives, 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 leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: https://www.notificaram.es.

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

5. Storage of Diclofenac-lepori eye drops in solution

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

Do not store above 30°C. Close the container well after each application.

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

Do not use this medicine after the expiration date stated on the container after EXP. The expiration date is the last day of the month indicated.

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

6. Package contents and additional information

Composition of Diclofenac-lepori eye drops in solution

• The active ingredient is diclofenac sodium. One ml of eye drops contains 1 mg of this active ingredient.
• The other ingredients are L-lysine monohydrate, boric acid (E-284), sodium borate (borax) (E-285), sodium chloride, polyoxyethylene ricinoleate, benzalkonium chloride, sodium edetate, water for injectable preparations.

Appearance of the product and package contents

Diclofenac-lepori 1 mg/ml eye drops in solution are presented in cartons containing a dropper bottle of polyethylene and a polypropylene cap, with 5 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

TUBILUX PHARMA S.P.A. Via Costarica, 20/22. 00040 Pomezia (Rome, Italy)

Date of the last revision of this leaflet: August 2024

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