VOLTAREN OFTABAK

Patient Information Leaflet: Information for the User

VOLTAREN OFTABAK 1 mg/ml, eye drops, solution

Diclofenac sodium
Generic medicine
Please read this leaflet carefully before using this medicine because it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What VOLTAREN OFTABAK is and what it is used for
2. What you need to know before using VOLTAREN OFTABAK
3. How to use VOLTAREN OFTABAK
4. Possible side effects
5. How to store VOLTAREN OFTABAK
6. Contents of the pack and other information

1. What VOLTAREN OFTABAK is and what it is used for

This medicinal product contains a non-steroidal anti-inflammatory drug ( NSAID ) for ophthalmic use.
It is used during certain eye surgeries and in the postoperative period:

• inhibition of miosis (pupillary constriction) during cataract surgery,
• prevention of inflammation in cataract surgery and anterior segment eye surgery,
• treatment of ocular pain following photorefractive keratectomy (corrective corneal surgery for myopia) within the first 24 hours after surgery.

2. What you need to know before using VOLTAREN OFTABAK

Do not use VOLTAREN OFTABAK

• if you are allergic (hypersensitive) to sodium diclofenac or to any of the excipients of this medicine (listed in section 6),
• if you have previously experienced allergic reactions, urticaria (skin rash with itching), acute rhinitis (swelling and irritation inside the nose), or asthma after using this eye drop or a similar medicine, such as other NSAIDs or aspirin.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using VOLTAREN OFTABAK.

• You should use this medicine with caution:
• Like other NSAIDs, VOLTAREN OFTABAK may rarely cause allergic reactions, including anaphylactic reactions (serious allergic reactions causing breathing difficulties or dizziness), even without prior exposure to the drug.
• If you experience hypersensitivity reactions or signs of allergy to this medicine, especially asthma attacks or sudden swelling of the face and neck, stop treatment immediately and contact your doctor or seek emergency medical help.
• Before using this medicine, inform your doctor if you have asthma associated with chronic rhinitis, chronic sinusitis, and/or nasal polyps.
• Acute ocular infection may be masked by the topical use of anti-inflammatory medicines. NSAIDs do not have antibacterial properties. If an ocular infection is present, use of NSAIDs together with one or more anti-infective agents should be done with caution.
• Concomitant use of topical NSAIDs and topical steroids (e.g., dexamethasone) may increase the potential for healing problems.
• NSAIDs may delay corneal repair.
• If you have a tendency to bleed or are taking anticoagulant medicines (blood-thinning medicines).
• With high doses and prolonged use, topical NSAIDs may cause keratitis.
• Patients who have undergone repeated eye surgeries within a short time, or who have diabetes, ocular surface disease (e.g., dry eye syndrome), or rheumatoid arthritis may be at higher risk of corneal adverse events.
• Contact lens use is not recommended after cataract surgery. Your doctor will advise you when you can resume wearing contact lenses.
  • If your symptoms worsen or do not improve, you should see a doctor.

Other medicines and VOLTAREN OFTABAK
If you are using another eye drop at the same time as VOLTAREN OFTABAK, wait 15 minutes between each treatment.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, if you suspect you may be pregnant or are planning a pregnancy, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
VOLTAREN OFTABAK must not be used from the beginning of the sixth month (24 weeks of amenorrhea) until the end of pregnancy. Do not use VOLTAREN OFTABAK during the first five months of pregnancy (up to 24 weeks of amenorrhea) unless strictly necessary and as directed by your doctor. If treatment is required during this period, the lowest dose for the shortest possible duration should be used.
Oral forms (e.g., tablets) of diclofenac may cause adverse effects in the unborn child. It is not known whether the same risk applies with VOLTAREN OFTABAK when used in the eye.
Breastfeeding
VOLTAREN OFTABAK may be used during breastfeeding.
Fertility
Like all non-steroidal anti-inflammatory drugs (NSAIDs), this medicine may affect fertility in women and make conception more difficult. This effect reverses when treatment is stopped. Inform your doctor if you are planning a pregnancy or if you have difficulty conceiving.

Driving and using machines
You may experience transient visual disturbances after administration of VOLTAREN OFTABAK. Wait until your vision returns to normal before driving or operating dangerous machinery.

VOLTAREN OFTABAK contains macrogol glycerol ricinoleate
VOLTAREN OFTABAK contains macrogol glycerol ricinoleate, which may cause contact eczema (skin reaction).

3. How to use VOLTAREN OFTABAK

Use VOLTAREN OFTABAK exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Dosage
The recommended dose in adults and elderly patients is as follows:
Inhibition of miosis during cataract surgery:
Pre-operative: Apply one drop up to five times within the three hours before surgery.
Anterior segment eye surgery including cataract surgery:

• Pre-operative: Instill 1 drop up to 5 times during the 3 hours prior to surgery;
• Post-operative: Instill 1 drop 3 times immediately after surgery, then 1 drop 3 to 5 times daily for no longer than 4 weeks.

Ocular pain following photorefractive keratectomy (corrective surgery for myopia):

• Pre-operative: Instill 2 drops within the hour before surgery;
• Post-operative: Instill 2 drops within the hour after surgery, followed by 4 drops within the 24 hours post-operatively.

Do not exceed the recommended dose.
Use in children:
Specific studies have not been conducted.
Method of administration
This medicinal product is intended for ocular administration (ophthalmic use).
Do not inject, do not swallow.
The eye drops must not be used for peri- or intraocular injection.
 Wash your hands thoroughly before using the product.
 Avoid contact between the tip of the container and the eye or eyelids.
 Instill one drop into the affected eye, looking upwards and gently pulling down the lower eyelid.
Close the bottle after use.
 After instillation, press gently with a finger at the inner corner of the eye near the nose and close the eyelids gently for 2 minutes. This helps prevent VOLTAREN OFTABAK from entering the rest of the body.
If you forget to use VOLTAREN OFTABAK
Do not take a double dose to make up for the missed dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following side effects have been reported:
Uncommon: may affect up to 1 in 100 people

• Burning sensation following instillation
• Visual disturbances following instillation

Rare: may affect up to 1 in 1,000 people

• Hypersensitivity reactions, itching, and redness
• Photosensitivity reactions (allergic reaction after exposure to sunlight)
• Punctate keratitis (lesions on the cornea), corneal ulceration, corneal thinning
• Dyspnea (difficulty breathing)
• Worsening of asthma

Not known: frequency cannot be estimated from the available data

• Rhinitis (swelling and irritation inside the nose)
• Conjunctival hyperemia (redness of the eyes), allergic conjunctivitis (inflammation of the surface of the eye), eyelid edema (swelling of the eyelids)
• Cough
• Urticaria (itching), skin rash, contact eczema
• Due to the presence of macrogol glycerol ricinoleate, risk of contact eczema

If any of the adverse reactions worsens, or if you notice any adverse reaction not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE VOLTAREN OFTABAK

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle. The expiry date refers to the last day of the month.
Do not store above 25°C.
The bottle must not be kept for longer than eight weeks after first opening.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What VOLTAREN OFTABAK contains

• The active substance is diclofenac sodium at a concentration of 1 mg/ml.
• The excipients are macrogol glycerol hydroxystearate, trometamol, boric acid and water (water for preparations for injection).

Description of the appearance of VOLTAREN OFTABAK and contents of the package
VOLTAREN OFTABAK is a clear yellow liquid supplied in a bottle containing 10 ml of eye drops,
solution.
Marketing Authorization Holder
LABORATOIRES THEA
12, rue Louis Blériot
63017 CLERMONT-FERRAND CEDEX 2
FRANCE
Local Distributor:
THEA FARMA S.p.A. – Via Tiziano, 32 – 20145 MILANO
Manufacturer
EXCELVISION
Rue de la Lombardière
07100 ANNONAY
FRANCE
This medicinal product is authorized in the European Economic Area Member States under the following
names:
Austria, Norway……………………………………………………………… VOLTAREN OPHTHA ABAK
Belgium, Bulgaria, Czech Republic, Finland, Greece, Luxembourg, Netherlands, Poland, Portugal, Spain,
Sweden ............................................................................................................. DICLOABAK
Denmark .......................................................................................... VOLTABAK
France .............................................................................................. VOLTARENOPHTABAK
Italy ............................................................................................... VOLTAREN OFTABAK
This leaflet was last updated in February 2025