Label: Information for the User

Voltaren 1 mg/ml Eye Drops in Solution

Diclofenac Sodium

Read this label carefully before starting to use this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.

If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed only for you, and you should 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 label. See section 4.

Voltarén eye drops contain diclofenaco sodium as its active ingredient, a non-steroidal anti-inflammatory agent (NSAID), with anti-inflammatory and pain-relieving properties (analgesic).

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

Voltarén eye drops is indicated for:

Treatment of post-operative inflammation of the anterior segment of the eye, as well as inhibition of intraoperative pupil constriction (miosis) in cataract surgery.

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

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 suffer from asthma, urticaria or acute rhinitis when you are given acetylsalicylic acid or other drugs with similar activity, prostaglandin synthetase inhibitors.
• 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 ingredient of this medicine or 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 use Voltarén eye drops.

• When there is an infection or risk of infection, an appropriate antibiotic therapy should be administered together with Voltarén eye drops.
• If you have any problems with bleeding or are taking any medication that may prolong bleeding, inform your doctor before using Voltarén eye drops (see section “Other medicines and Voltarén eye drops”).
• If you are using eye drops called corticosteroids, consult your doctor before using this medicine.
• Eye drops are not injection preparations. Voltarén eye drops should never be injected subconjunctivally or directly into the eye.
• Do not exceed the recommended dose in the posology as frequent application of more than the recommended dose 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 section "Voltarén eye drops contain benzalkonium chloride").

Children :

Voltarén eye drops are not indicated for use in children. The experience in them is limited.

Other medicines and Voltarén eye drops :

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

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

In case you need to use other eye medications, you should wait at least 5 minutes between applications.

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 medicine.

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

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

Driving and operating machinery :

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 contain 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 contact lenses. Remove contact lenses before using this medicine 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 at the front of the eye). Consult your doctor if you feel a strange sensation, burning or pain in the eye after using this medicine.

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

Your doctor will inform you of the duration of your treatment.

Ophthalmic route.

The dosage of Voltarén eye drops is determined 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).

For the treatment of pain and photophobia, apply 1 drop to the operated eye 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

It is not indicated for the use of Voltarén eye drops in children.

Administration instructions

• with freshly washed hands, open the container ensuring that the stopper and dropper do not touch any surface
• with the head tilted back, separate the lower eyelid and administer one drop in the conjunctival sac (space between the eye and the eyelid) while directing the gaze upwards, 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 with the tip of the finger the nasolacrimal duct located at the inner angle of the eye near the nose, or keep the eyes closed for 5 minutes. As a result, a greater activity and a reduction in the risk of adverse reactions are obtained.

As this is a sterile medication, the following instructions are recommended:

• each patient will use their own container
• the application of the eye drops must be carried out with the utmost cleanliness, avoiding contact with the dropper (e.g. eyelids, fingers, etc.) as much as possible
• after each application, close the container well
• once the treatment is completed, discard the medication even if it has not been consumed in its entirety.

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 Toxicological Information Service, Tel. 91 562 04 20, indicating the medication and the amount ingested.

No cases of topical overdose have been described.

If you forgot to use Voltarén eye drops

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 return 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 produce adverse effects, although not all people may experience them.

Eye disorders:

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

Small marks on the surface of the eye (keratitis punctata) or corneal alterations have been observed, usually after frequent application.

Rarely, the use of Voltarén eye drops has been associated with corneal inflammation and ulceration (ulcerative keratitis), corneal thinning, small marks on the surface of the eye (keratitis punctata), defect in the outermost layer of the cornea (epithelial corneal defect), and corneal inflammation, which could pose 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 (redness of the superficial part of the eye), allergic conjunctivitis, eyelid redness (erythema palpebrarum), eye allergy, eyelid inflammation (edema palpebrarum), eyelid itching (pruritus palpebrarum), appearance of reddish papules with itching (urticaria), skin eruption, eczema, redness (erythema), itching, hypersensitivity, cough, and rhinitis have been reported.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the bottle and on the box after CAD. The expiration date is the last day of the month indicated.

Once the bottle is opened, it should be used for the period of time established by the doctor and, at most, discarded within 28 days.

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 point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Voltarén Eye Drops

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

Appearance of the product and contents of the packaging

Voltarén eye drops are a solution in eye drops, presented in a dropper bottle (plastic bottle).

Each package contains 5 ml.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratoires THEA

12, rue Louis Blériot

63017 Clermont-Ferrand Cedex 2 / France

Responsible for manufacturing

Excelvision

Rue de la Lombardière

07100 Annonay / France

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

Laboratorios Thea, S.A.

C/ Enric Granados nº 86-88, 08008 Barcelona

Last review date of this leaflet:September 2024

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/