VOLTAREN 1 mg/ml EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the User

Voltarén 1 mg/ml Eye Drops Solution

Diclofenac Sodium

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

• Keep this package leaflet, you may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Voltarén Eye Drops and what is it used for
2. What you need to know before you use Voltarén Eye Drops
3. How to use Voltarén Eye Drops
4. Possible side effects
5. Storage of Voltarén Eye Drops
6. Contents of the pack and further information

1. What is Voltarén Eye Drops and what is it used for

Voltarén Eye Drops contains the active substance diclofenac sodium, a non-steroidal anti-inflammatory agent (NSAID), with anti-inflammatory and pain-relieving (analgesic) properties.

The mechanism of action of the group of non-steroidal anti-inflammatory agents is based on the inhibition of the biosynthesis of prostaglandins, which play an essential role in the appearance of inflammation and pain.

Voltarén Eye Drops is indicated for:

Post-operative treatment of inflammation of the anterior segment of the eye, as well as inhibition of intraoperative pupil contraction (miosis) in cataract surgery.

Treatment of eye pain and light intolerance (photophobia) after surgery for the correction of myopia, hypermetropia, and astigmatism.

2. What you need to know before you use Voltarén Eye Drops

Do not use Voltarén Eye Drops:

• if you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6).
• if you have asthma attacks, urticaria, or acute rhinitis when administered acetylsalicylic acid or other drugs with similar activity, inhibiting prostaglandin synthetase.
• if you have previously shown sensitivity to acetylsalicylic acid, or to derivatives of phenylacetic acid that belong to the same chemical group as the active substance of this medicine or other non-steroidal anti-inflammatory agents (NSAIDs), as there is a possibility of cross-sensitivity with these drugs.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Voltarén Eye Drops.

• When there is an infection or risk of infection, adequate antibiotic therapy should be administered together with Voltarén Eye Drops.
• If you have any problems with stopping bleeding or are taking any medication that may prolong bleeding time, inform your doctor before using Voltarén Eye Drops (see "Other medicines and Voltarén Eye Drops").
• If you are using eye drop medications called corticosteroids, consult your doctor before using this medicine.
• Eye drops are not preparations for injection. Voltarén Eye Drops should never be injected subconjunctivally or introduced directly into the eye.
• Do not exceed the recommended dose in the posology, as more frequent application than recommended may cause complications in the cornea.
• The use of the same container by more than one person may lead to contagion.
• Do not wear contact lenses during the application of this medicine (see "Voltarén Eye Drops contains benzalkonium chloride").

Children

Voltarén Eye Drops is not indicated for use in children. Experience in them is limited.

Other medicines and Voltarén Eye Drops

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

If you are receiving simultaneous treatment with corticosteroid eye drops, inform your doctor, as there may be a risk of complications.

If you need to use other eye medications, 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.

Voltarén Eye Drops should not be used if you are in the last 3 months of pregnancy. Do not use Voltarén 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 may cause adverse reactions in the fetus. It is not known if this same risk applies to Voltarén Eye Drops when used for the eyes.

Driving and using machines

You may notice blurred vision immediately after applying Voltarén Eye Drops. Do not drive or use machines until this effect has disappeared.

Voltarén Eye Drops contains benzalkonium chloride

This medicine contains 0.0014 mg of benzalkonium chloride in each drop, equivalent to 0.05 mg/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.

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.

3. How to use Voltarén Eye Drops

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

Your doctor will indicate the duration of your treatment.

Ophthalmic use.

The dosage of Voltarén Eye Drops is governed by the severity of the condition. Except for medical prescription to the contrary, apply 1 drop (0.03 mg of diclofenac sodium) 4 to 5 times a day in the conjunctival sac (space between the eye and the eyelid).

In the treatment of pain and photophobia, apply 1 drop in the eye to be operated on 30 to 60 minutes before the intervention and after the operation 1 drop one or two times in the 10 minutes following the end of the intervention, followed by 1 drop 4 times a day for 2 days.

Use in elderly patients

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

Use in children

Voltarén Eye Drops is not indicated for use in children.

Administration instructions

• With clean hands, open the container, making sure the cap and dropper do not touch any surface.
• With your head tilted back, separate the lower eyelid and administer a drop in the conjunctival sac (space between the eye and the eyelid) while looking up, avoiding any contact between the tip of the dropper and the eye or surrounding structures.
• Immediately after applying the eye drops, it is recommended to gently press the lacrimal duct located in the inner corner of the eye next to the nose, or keep the eyes closed for 5 minutes. As a result, greater activity and a decrease in the risk of adverse reactions are obtained.

Since this is a sterile medicine, it is recommended to follow the following instructions:

• Each patient will use their own container.
• The application of the eye drops should be carried out with the greatest cleanliness, avoiding as much as possible any contact with the dropper (e.g., eyelids, fingers, etc.).
• After each application, close the container well.
• Once the treatment is finished, discard the medicine even if it has not been fully consumed.

If you use more Voltarén Eye Drops than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, Tel. 91 562 04 20, indicating the medicine and the amount ingested.

No cases of topical overdose have been described.

If you forget to use Voltarén Eye Drops

Do not apply a double dose to make up for forgotten doses.

If you forget a dose, apply it as soon as you can, unless it is almost time for the next dose; then return to your regular dosing schedule. If you forget several doses, consult your doctor.

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

4. Possible side effects

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

Ocular disorders:

Very common: eye pain. The most frequently observed adverse reaction is transient, mild or moderate eye irritation. Other reactions observed with lower frequency are itching in the eye, redness of the eye, and blurred vision immediately after applying the eye drops.

There have been cases of small marks on the surface of the eye (punctate keratitis) or corneal changes, usually after frequent application.

Rarely, the use of Voltarén Eye Drops has been associated with inflammation and ulceration of the cornea (ulcerative keratitis), corneal thinning, small marks on the surface of the eye (punctate keratitis), defect in the outermost layer of the cornea (corneal epithelial defect), and corneal inflammation, which could mean a risk to vision. Most of these patients were treated for prolonged periods and were also receiving corticosteroids. Rarely, cases of dyspnea (difficulty breathing) and worsening of asthma have been reported.

Allergic reactions such as conjunctival hyperemia, allergic conjunctivitis, eyelid erythema, eye allergy, eyelid edema, eyelid pruritus, urticaria, skin rash, eczema, erythema, pruritus, hypersensitivity, cough, and rhinitis have been reported.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Voltarén Eye Drops

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

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the bottle and carton after EXP. The expiry date is the last day of the month stated.

Once the bottle is opened, it should be used within the time period established by the doctor and a maximum of 28 days. Discard the medicine after this period.

Medicines should not be disposed of via wastewater or household waste. Place the container and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the container and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Voltarén Eye Drops

• The active substance is diclofenac sodium. Each ml of eye drops contains 1 mg of diclofenac sodium.
• The other ingredients are: benzalkonium chloride, disodium edetate, gamma-cyclodextrin, hydrochloric acid, propylene glycol, trometamol, tyloxapol, and water for injectable preparations.

Appearance of the product and contents of the pack

Voltarén Eye Drops is an eye drop solution, presented in a dropper container (plastic bottle).

Each container contains 5 ml.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Laboratoires THEA

12, rue Louis Blériot

63017 Clermont-Ferrand Cedex 2 / France

Manufacturer

Excelvision

Rue de la Lombardière

07100 Annonay / France

You can request more information about this medicine by contacting the local representative of the marketing authorisation holder:

Laboratorios Thea, S.A.

C/ Enric Granados nº 86-88, 08008 Barcelona

Date of the last revision of this leaflet:September 2024

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