Label: information for the user

Voltaren 1 mg/ml eye drops in single-dose containers

Diclofenac sodium

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

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

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

• This medication has been prescribed only for you, and you should not give it to others who 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 in single-dose containers contain diclofenac sodium as the active ingredient, a non-steroidal anti-inflammatory agent (NSAID), with anti-inflammatory and pain-relieving properties (analgesics). 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 in single-dose containers are 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 in single-dose containers:

• if you are allergic to diclofenac or any of the other ingredients of this medication (listed in section 6).
• if you suffer from asthma, urticaria, or acute rhinitis when you are administered acetylsalicylic acid or other drugs with similar activity, inhibiting prostaglandin synthetase.
• if you have previously demonstrated sensitivity to acetylsalicylic acid, or to derivatives of phenylacetic acid, which belongs to the same chemical group as the active ingredient of this medication or other nonsteroidal 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 in single-dose containers.

• When there is an infection or risk of infection, an appropriate antibiotic therapy should be administered concurrently with Voltarén eye drops in single-dose containers.
• If you have any problem with bleeding or are taking any medication that may prolong bleeding, inform your doctor before using this medication (see section “Other medications and Voltarén eye drops in single-dose containers").
• If you are using eye drops called corticosteroids, consult your doctor before using this medication.
• Eye drops are not injection preparations. Voltarén eye drops in single-dose containers should never be injected subconjunctivally or directly introduced into the interior of the eye.
• It is not advisable to wear contact lenses during the application of the eye drops. Remove contact lenses before applying Voltarén eye drops in single-dose containers and wait at least 15 minutes before reinserting them.

Children

Voltarén eye drops in single-dose containers are not indicated for use in children. Experience in them is limited.

Other medications and Voltarén eye drops in single-dose containers

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

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

In the event of needing to use other medications by eye drops, 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 medication.

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 it is 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 (e.g., tablets) of diclofenac may cause adverse reactions to the fetus. It is unknown whether 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 in single-dose containers. Do not drive or use machines until this effect has disappeared.

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

This medication is administered via the ophthalmic route.

The dosing of Voltarén eye drops in single-dose containers is governed by the severity of the condition. Except for medical prescription to the contrary, 1 drop of 4 to 5 times a day will be applied to 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 or 2 drops during the 10 minutes following the end of the intervention, followed by 1 drop 4 times a day for 2 days.

Your doctor will indicate the duration of your treatment with Voltarén eye drops in single-dose containers.

Use in elderly patients

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

Use in children

Use of Voltarén eye drops in single-dose containers is not indicated in children.

Administration instructions

• With freshly washed hands, open a single-dose container by twisting its upper end, ensuring that the tip and the stopper of the dropper do not come into contact with any surface
• With the head tilted back, separate the lower eyelid downward and administer one drop to the conjunctival sac (space between the eye and the eyelid) while directing the gaze upward, 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 at the inner angle of the eye near the nose with the tip of the finger or to keep the eyes closed for 5 minutes. As a result, a greater activity and a decrease in the risk of adverse reactions are obtained.
• It is not advisable to wear contact lenses during the application of the eye drops. See the Adverse reactions and precautions section.

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

• Each patient will use their own container
• They should use Voltarén eye drops in single-dose containers immediately after opening each single-dose container
• The application of the eye drops should be carried out with the utmost cleanliness, avoiding contact with the tip of the dropper (e.g., eyelids, fingers, etc.) as much as possible
• They should discard the single-dose container after use and not conserve the unused content.

If you use more Voltarén eye drops in single-dose containers than you should

No cases of overdose have been described in its administration route.

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.

If you forgot to use Voltarén eye drops in single-dose containers

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 will 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 in single-dose containers 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 in the superficial part of the eye), allergic conjunctivitis (inflammation of the surface of the eye), eyelid redness (erythema palpebrarum), eye allergy, eyelid edema (inflammation of the eyelids), eyelid itching (pruritus palpebrarum), appearance of reddish papules with itching (urticaria), skin rash, 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.

Store below 25 °C.

Store the single-dose containers preferably in their original sealed bag, if they do not need to be opened for use.

Once the bag is opened, the single-dose containers remain stable for 28 days when stored at room temperature.

You must use Voltarén eye drops in single-dose containers immediately after opening each single-dose container and discard it after use. This is to avoid the risk of microbial contamination of the product.

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

Medicines should not be thrown away through drains or in the trash. Dispose of the containers and medicines you do not need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you do not need. In this way, you will help protect the environment.

Composition of Voltarén eye drops in single-dose containers

• The active ingredient is diclofenac sodium. Each milliliter of eye drops contains 1 mg of diclofenac sodium. Each container contains approximately 10 drops with 28 micrograms of the active ingredient each.
• The other components are: polyoxylated ricin oil, boric acid (E284), tromethamine, and water for injection preparations.

It does not contain preservatives.

Appearance of the product and content of the container

Voltarén eye drops in single-dose containers are a solution in single-dose containers. These are presented in blocks of 5 units of plastic, packaged in a bag.

There are 2 presentations:

Box of Voltarén eye drops in single-dose containers with 10 single-dose containers of 0.3 ml.

Box of Voltarén eye drops in single-dose containers with 40 single-dose containers of 0.3 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 nº86-88, 2nd floor,

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/