VOLTAREN 1 MG/ML EYE DROPS SOLUTION IN SINGLE-DOSE CONTAINERS

Patient Information Leaflet

Introduction

Patient Information Leaflet

Voltarén 1 mg/ml eye drops solution in single-dose containers

Diclofenac sodium

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

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

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

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet Contents

1. What Voltarén eye drops in single-dose containers are and what they are used for
2. What you need to know before using Voltarén eye drops in single-dose containers
3. How to use Voltarén eye drops in single-dose containers
4. Possible adverse effects
5. How to store Voltarén eye drops in single-dose containers
6. Contents of the pack and other information

1. What Voltarén eye drops in single-dose containers is and what it is used for

Voltarén eye drops in single-dose containers contains as the active substance sodium diclofenac, a non-steroidal anti-inflammatory agent (NSAID) with anti-inflammatory and pain-relieving (analgesic) properties. The mechanism of action of non-steroidal anti-inflammatory drugs is based on the inhibition of prostaglandin biosynthesis, which play an essential role in the development of inflammation and pain.

Voltarén eye drops in single-dose containers is indicated for:

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

Treatment of ocular pain and light sensitivity (photophobia) following surgery for the correction of myopia, hyperopia, and astigmatism.

2. What you need to know before using Voltarén eye drops in single-dose containers

Do not use Voltarén eye drops in single-dose containers:

• if you are allergic to diclofenac or to any of the other components of this medicine (listed in section 6).
• if you suffer from asthma attacks, urticaria, or acute rhinitis when given acetylsalicylic acid or other drugs with similar prostaglandin synthetase-inhibiting activity.
• if you have previously shown hypersensitivity to acetylsalicylic acid or to phenylacetic acid derivatives, which belong to the same chemical group as the active substance in this medicine or other non-steroidal anti-inflammatory drugs (NSAIDs), since cross-sensitivity to these drugs may occur.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Voltarén eye drops in single-dose containers.

• When infection is present or there is a risk of infection, appropriate antibiotic therapy should be administered alongside Voltarén eye drops in single-dose containers.
• If you have problems with stopping bleeding or are taking any medication that may prolong bleeding time, inform your doctor before using this medicine (see section “Other medicines and Voltarén eye drops in single-dose containers”).
• If you are using eye drop medications known as corticosteroids, consult your doctor before using this medicine.
• Eye drops are not intended for injection. Voltarén eye drops in single-dose containers must never be injected subconjunctivally or introduced directly into the interior of the eye.
• It is not advisable to wear contact lenses during 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 this population is limited.

Other medicines and Voltarén eye drops in single-dose containers

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

If you are receiving concomitant treatment with eye drop medications known as corticosteroids, inform your doctor, as there may be a risk of complications.

If you need to use other ophthalmic 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Voltarén eye drops must not be used during the last three months of pregnancy. You should not use Voltarén eye drops during the first six months of pregnancy unless strictly necessary and recommended by your doctor. If treatment during this period is required, the lowest possible dose for the shortest possible duration should be used.

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

Driving and using machines

You may experience blurred vision immediately after applying Voltarén eye drops in single-dose containers. Do not drive or operate machinery until this effect has disappeared.

3. How to use Voltarén eye drops in single-dose containers

Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, please consult your doctor or pharmacist again.

This medicine is administered by the ophthalmic route.

The dosage of Voltarén eye drops in single-dose containers depends on the severity of the condition. Unless otherwise prescribed by your doctor, instill 1 drop into the conjunctival sac (the space between the eye and the eyelid) 4 to 5 times a day.

For the treatment of pain and photophobia, administer 1 drop into the eye to be operated on 30 to 60 minutes before surgery, and 1 or 2 drops within 10 minutes after completion of the procedure, followed by 1 drop 4 times daily for 2 days.

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

Use in elderly patients

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

Use in children

Voltarén eye drops in single-dose containers are not indicated for use in children.

Administration instructions

• With freshly washed hands, open a single-dose container by twisting off the top end, taking care that the dropper tip and cap do not touch any surface
• Tilt your head backward, gently pull down the lower eyelid and instill 1 drop into the conjunctival sac (the space between the eye and the eyelid) while looking upward, avoiding any contact between the dropper tip and the eye or surrounding structures
• Immediately after instilling the eye drop, gently press with the fingertip on the tear duct located at the inner corner of the eye near the nose, or keep the eyes closed for 5 minutes. This increases effectiveness and reduces the risk of adverse reactions.
• It is not advisable to wear contact lenses during instillation of the eye drops. See section Warnings and precautions.

As this is a sterile medicine, please follow these instructions:

• Each patient should use their own container
• Use Voltarén eye drops in single-dose containers immediately after opening each single-dose container
• The eye drops should be administered with maximum care, avoiding contact with the dropper tip (e.g., eyelids, fingers, etc.) as much as possible
• The single-dose container must be discarded after use, and any unused content should not be kept.

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

Cases of overdose via this route of administration have not been reported.

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

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

Do not use a double dose to make up for missed doses.

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Ocular disorders:

Very common: eye pain

The most frequently observed adverse reaction is transient eye irritation of mild to moderate intensity. Other less common reactions include eye itching, eye redness, and blurred vision immediately after instillation of the eye drops.

Cases of development of small spots on the surface of the eye (punctate keratitis) or corneal disorders have been observed, usually after frequent application.

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

Allergic-type reactions have been reported, such as redness of the surface of the eye (conjunctival hyperemia), inflammation of the eye surface (allergic conjunctivitis), eyelid redness (eyelid erythema), eye allergy, eyelid swelling (eyelid edema), eyelid itching (eyelid pruritus), appearance of red, itchy rash (urticaria), skin rash, eczema, redness (erythema), itching, hypersensitivity, cough, and rhinitis.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Voltarén eye drops in single-dose containers

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

Store below 25 °C.

Single-dose containers should preferably be kept in their original closed pouch, unless opened for use.

After opening the pouch, the single-dose containers remain stable for 28 days when stored at room temperature.

Use Voltarén eye drops 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 medicine after the expiry date stated on the container and carton after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Voltarén eye drops in single-dose containers

• The active substance is diclofenac sodium. Each ml of eye drops contains 1 mg of diclofenac sodium. Each container contains approximately 10 drops, each drop containing 28 micrograms of the active substance.
• The other components are: polyoxyl 40 hydrogenated castor oil, boric acid (E284), tromethamine, and water for injections.

It does not contain preservatives.

Appearance of the product and pack contents

Voltarén eye drops in single-dose containers is an eye drop solution in single-dose containers. These are presented in plastic units of 5, packed in a sachet.

There are 2 presentations:

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

Box of Voltarén eye drops in single-dose containers containing 40 units 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Laboratorios Thea, S.A.
C/Enric Granados nº86-88, 2nd floor,
08008 Barcelona, Spain

Date of the latest revision of this leaflet: September 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/