VOLTAREN 1 mg/ml EYE DROPS IN SINGLE-DOSE CONTAINERS

Introduction

Package Leaflet: Information for the User

Voltaren 1 mg/ml Eye Drops, Solution in Single-Dose Containers

Diclofenac Sodium

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

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

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

• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Voltaren Eye Drops in Single-Dose Containers and what is it used for?
2. What you need to know before starting to use Voltaren Eye Drops in Single-Dose Containers
3. How to use Voltaren Eye Drops in Single-Dose Containers
4. Possible side effects
5. Storage of Voltaren Eye Drops in Single-Dose Containers
6. Contents of the Package and Additional Information

1. What is Voltaren Eye Drops in Single-Dose Containers and what is it used for?

Voltaren Eye Drops in Single-Dose Containers contains the active ingredient diclofenac sodium, a non-steroidal anti-inflammatory agent (NSAID), with anti-inflammatory and pain-relieving properties. 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.

Voltaren Eye Drops in Single-Dose Containers 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, hyperopia, and astigmatism.

2. What you need to know before starting to use Voltaren Eye Drops in Single-Dose Containers

Do not use Voltaren 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 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 derivatives of phenylacetic acid, which belongs to the same chemical group as the active ingredient of this medication 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 Voltaren Eye Drops in Single-Dose Containers.

• When there is an infection or risk of infection, adequate antibiotic therapy should be administered concurrently with Voltaren Eye Drops in Single-Dose Containers.
• If you have any problems with stopping bleeding or are taking any medication that may prolong bleeding time, inform your doctor before using this medication (see section "Other Medications and Voltaren Eye Drops in Single-Dose Containers").
• If you are using corticosteroid eye drops, consult your doctor before using this medication.
• Eye drops are not preparations for injection. Voltaren Eye Drops in Single-Dose Containers should never be injected subconjunctivally or introduced directly into the eye.
• It is not recommended to wear contact lenses during the application of the eye drops. Remove contact lenses before applying Voltaren Eye Drops in Single-Dose Containers and wait at least 15 minutes before putting them back on.

Children

Voltaren Eye Drops in Single-Dose Containers is not indicated for use in children. Experience in children is limited.

Other Medications and Voltaren Eye Drops in Single-Dose Containers

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

If you are receiving concurrent 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 medication.

Voltaren Eye Drops should not be used if you are in the last 3 months of pregnancy. You should not use Voltaren 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 for the shortest possible time.

Oral formulations (e.g., tablets) of diclofenac may cause adverse reactions in the fetus. It is not known if this risk applies to Voltaren Eye Drops when used for the eyes.

Driving and Using Machines

You may experience blurred vision immediately after applying Voltaren Eye Drops in Single-Dose Containers. Do not drive or use machines until this effect has disappeared.

3. How to use Voltaren Eye Drops in Single-Dose Containers

Follow the instructions for administration of this medication exactly as indicated by your doctor. If you have any doubts, consult your doctor or pharmacist again.

This medication is administered via the eye.

The dosage of Voltaren Eye Drops in Single-Dose Containers depends on the severity of the condition. Except for medical prescription to the contrary, apply 1 drop 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 to the eye to be operated on 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 Voltaren Eye Drops in Single-Dose Containers.

Use in Elderly Patients

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

Use in Children

Voltaren Eye Drops in Single-Dose Containers is not indicated for use in children.

Administration Instructions

• With clean hands, open a single-dose container by twisting the top, making sure the tip and the dropper do not touch any surface.
• With your head tilted back, pull down the lower eyelid and administer one drop in the conjunctival sac (space between the eye and the eyelid) while looking up, avoiding any contact between the dropper tip 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 near the nose or keep the eyes closed for 5 minutes. This results in greater activity and a reduction in the risk of adverse reactions.
• It is not recommended to wear contact lenses during the application of the eye drops. See section "Warnings and Precautions".

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

• each patient will use their own container.
• you should use Voltaren Eye Drops in Single-Dose Containers immediately after opening each single-dose container.
• the application of the eye drops should be carried out with maximum cleanliness, avoiding any contact with the dropper tip (e.g., eyelids, fingers, etc.).
• you should discard the single-dose container after use and not keep the unused contents.

If you use more Voltaren Eye Drops in Single-Dose Containers than you should

No cases of overdose have been reported with this route of administration.

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 medication and the amount ingested.

If you forget to use Voltaren Eye Drops in Single-Dose Containers

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 other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience 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 eye itching, eye redness, and blurred vision immediately after applying the eye drops.

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

Rarely, the use of Voltaren 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 (punctate keratitis), defects in the outer layer of the cornea (corneal epithelial defects), 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, 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, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Voltaren Eye Drops in Single-Dose Containers

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

Store below 25°C.

Preferably store the single-dose containers in their original closed bag, if not required for use.

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

You should use Voltaren 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 stated on the container and carton after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of via wastewater or household waste. Return the containers and medications you no longer need to the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

6. Contents of the Package and Additional Information

Composition of Voltaren Eye Drops in Single-Dose Containers

• The active ingredient is diclofenac sodium. Each ml 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 ingredients are: polyoxyethylene castor oil, boric acid (E284), trometamine, and water for injectable preparations.

Does not contain preservatives.

Appearance of the Product and Contents of the Package

Voltaren Eye Drops in Single-Dose Containers is an eye drop solution in single-dose containers. These are presented in blocks of 5 plastic units, packaged in a bag.

There are 2 presentations:

Box of Voltaren Eye Drops in Single-Dose Containers with 10 single-dose containers of 0.3 ml.

Box of Voltaren Eye Drops in Single-Dose Containers with 40 single-dose containers of 0.3 ml.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 medication from the local representative of the marketing authorization holder:

Laboratorios Thea, S.A.

C/Enric Granados nº86-88, 2ª planta,

08008 Barcelona

Date of the Last Revision of this Package Leaflet:September 2024

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