Voltaren Ofta

PACKAGE LEAFLET: INFORMATION FOR THE USER

VOLTAREN OFTA 0.1% eye drops, solution

Sodium diclofenac
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, ask your doctor or pharmacist.
• 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 side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What VOLTAREN OFTA is and what it is used for
2. What you need to know before using VOLTAREN OFTA
3. How to use VOLTAREN OFTA
4. Possible side effects
5. How to store VOLTAREN OFTA
6. Package contents and other information

1. WHAT VOLTAREN OFTA IS AND WHAT IT IS USED FOR

VOLTAREN OFTA contains the active substance diclofenac. It belongs to a group of medicines called
non-steroidal anti-inflammatory drugs (NSAIDs) which act against inflammation.
VOLTAREN OFTA is used to reduce inflammation and, if necessary, pain in the eye, when not caused
by infections, particularly after cataract surgery (clouding of a part of the eye called the
lens).

2. WHAT YOU NEED TO KNOW BEFORE USING VOLTAREN OFTA

Do not use VOLTAREN OFTA

• if you are allergic to diclofenac or to any of the other ingredients of this medicine (listed in section 6);
• if you have previously experienced episodes of asthma, itchy skin rash (urticaria), or acute rhinitis (swelling and irritation inside the nose) after taking aspirin (acetylsalicylic acid) or other similar medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).

Warnings and precautions
Talk to your doctor or pharmacist before using VOLTAREN OFTA:

• if you suffer from a systemic autoimmune disease called rheumatoid arthritis;
• if you are at increased risk of eye conditions affecting a part of the eye called the cornea, for example due to the use of other anti-inflammatory medicines containing substances known as corticosteroid hormones. In such cases, the use of Voltaren Ofta has been rarely associated with corneal disorders (such as ulcerative keratitis, corneal thinning, punctate keratitis, corneal epithelial defects, and corneal edema), for which your doctor may prescribe specific treatment. These effects have occurred in patients who used Voltaren Ofta for a prolonged period of time.
• if you currently have, or are at risk of, an eye infection. Your doctor will prescribe appropriate concomitant therapy (e.g. antibiotics) alongside Voltaren Ofta eye drops.

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• if you are using other locally administered anti-inflammatory steroid hormone medicines (see "Other medicines and VOLTAREN OFTA"). During treatment, you must not wear soft contact lenses (see "VOLTAREN OFTA contains benzalkonium chloride").

Children
VOLTAREN OFTA is not recommended for use in children, as safety and efficacy in this population have not been established.

Other medicines and VOLTAREN OFTA
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
Caution is advised when using Voltaren Ofta together with other locally administered anti-inflammatory steroid medicines, as in patients who already have significant corneal inflammation, the risk of developing corneal complications may increase.
Voltaren Ofta may, if necessary, be used together with antibiotic eye drops and beta-blockers.
If you are using another eye drop alongside VOLTAREN OFTA, wait 5 minutes between each application.

Pregnancy, breast-feeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breast-feeding, consult your doctor or pharmacist before using this medicine.
VOLTAREN OFTA must not be used during the last 3 months of pregnancy. Do not use VOLTAREN OFTA during the first 6 months of pregnancy unless strictly necessary and under medical advice. If treatment is required during this period, the lowest effective dose for the shortest possible duration should be used.
Oral formulations (e.g. tablets) of diclofenac may cause adverse effects in the unborn child. It is not known whether the same risk applies with VOLTAREN OFTA when used in the eye.
Do not use VOLTAREN OFTA during breast-feeding, except in special circumstances and only after consulting your doctor.
Anti-inflammatory medicines such as diclofenac may affect fertility and labour.
This class of medicines may also cause fetal complications, including constriction of a blood vessel called the ductus arteriosus.

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

VOLTAREN OFTA contains Benzalkonium chloride
This medicine contains 0.0014 mg of benzalkonium chloride per drop, equivalent to 0.05 mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may alter their colour. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, particularly if you have dry eye or corneal disorders (affecting the transparent outer layer of the eye). If you experience unusual sensations in the eye, such as burning or pain after using this medicine, speak to your doctor.

3. HOW TO USE VOLTAREN OFTA

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Dosage
Your doctor will tell you the dose of Voltaren Ofta to use.
2/8
Method of administration
This medicine is intended for ocular administration (ophthalmic use).

• 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 upward and gently pulling down the lower eyelid.
• Close the bottle immediately after use.

If you use more VOLTAREN OFTA than you should
In case of accidental ingestion/overdose of VOLTAREN OFTA, contact your doctor.
Due to the low amount of diclofenac in the medicine, adverse effects are not expected following accidental ingestion/overdose.
If you forget to use VOLTAREN OFTA
Do not use a double dose to make up for the missed dose.
If you stop using VOLTAREN OFTA
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects have been reported with the use of Voltaren Ofta:
Very common (may affect more than 1 in 10 people):

• Eye pain
  Common (may affect up to 1 in 10 people):
• Eye irritation
  Uncommon (may affect up to 1 in 100 people):
• Itching of the eye, eye redness (ocular hyperemia), blurred vision, punctate keratitis (inflammation of the cornea, the transparent front part of the eye)
  Rare (may affect up to 1 in 1,000 people):
• Corneal disorders (lesions, thinning, hypertrophy and edema of the cornea, defects in the corneal epithelium)
• Weakening of vision
• Eye redness (conjunctival hyperemia)
• Allergic and inflammatory eye conditions due to allergies (allergic conjunctivitis)
• Irritation, erythema, and swelling (edema) of the eyelids
  Not known (frequency cannot be estimated from the available data):
• Itching of the eyelids

A mild or moderate transient burning sensation and/or the appearance of dark spots disturbing vision (scotomata) have occasionally been reported immediately after instillation of the eye drops.
With the use of Voltaren Ofta, breathing difficulties (dyspnea) and worsening of asthma, cough, nasal swelling and irritation (rhinitis), itching, skin rashes (erythema, urticaria, rash, eczema), and allergic reaction upon exposure to sunlight (photosensitivity reaction) have also been reported.

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

5. HOW TO STORE VOLTAREN OFTA

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 on the bottle after EXP. The expiry date refers to the last day of that month.
Voltaren Ofta must not be used for more than 28 days after opening the bottle. Close the bottle immediately after use.
Store below 25°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What VOLTAREN OFTA contains

• The active substance is sodium diclofenac at a concentration of 1 mg/ml.
• The other components are benzalkonium chloride, disodium edetate, hydroxypropyl γ-cyclodextrin, hydrochloric acid, propylene glycol, tromethamine, tyloxapol, water for injections.

Description of the appearance of VOLTAREN OFTA and contents of the pack
VOLTAREN OFTA is a liquid presented in a bottle containing 5 ml of eye drops, solution.
Marketing Authorization Holder
LABORATOIRES THEA
12, rue Louis Blériot
63017 CLERMONT-FERRAND CEDEX 2
FRANCE
Sales Licensee
THEA FARMA S.p.A. – Via Tiziano, 32 – 20145 MILAN
Manufacturer and batch release
EXCELVISION
Rue de la Lombardière
07100 ANNONAY
FRANCE
This leaflet was last updated on:
4/8

PACKAGE LEAFLET: INFORMATION FOR THE USER

VOLTAREN OFTA 0.1% eye drops, solution

Sodium diclofenac
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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What VOLTAREN OFTA is and what it is used for
2. What you need to know before using VOLTAREN OFTA
3. How to use VOLTAREN OFTA
4. Possible side effects
5. How to store VOLTAREN OFTA
6. Package contents and other information

2. WHAT VOLTAREN OFTA IS AND WHAT IT IS USED FOR

VOLTAREN OFTA contains the active substance diclofenac. It belongs to a group of medicines called non-steroidal anti-inflammatory drugs which work against inflammation.
VOLTAREN OFTA is used to reduce inflammation and, if necessary, pain in the eye, when not caused by infections, particularly after cataract surgery (clouding of a part of the eye called the lens).

4. WHAT YOU NEED TO KNOW BEFORE USING VOLTAREN OFTA

Do not use VOLTAREN OFTA

• if you are allergic to sodium diclofenac or to any of the other ingredients of this medicine (listed in section 6);
• if you have previously experienced episodes of asthma, allergy, itchy skin rash (urticaria), or acute rhinitis (swelling and irritation inside the nose) after taking aspirin (acetylsalicylic acid) or other similar medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).

Warnings and precautions
Talk to your doctor or pharmacist before using VOLTAREN OFTA:

• if you suffer from an autoimmune disease called rheumatoid arthritis;
• if you have an increased risk of eye conditions affecting a part of the eye called the cornea, for example due to using other anti-inflammatory medicines containing substances known as "steroid hormones". In such cases, use of Voltaren Ofta has rarely been associated with corneal disorders (such as ulcerative keratitis, corneal thinning, punctate keratitis, corneal epithelial defects, and corneal edema), for which your doctor may prescribe specific treatment. These effects have occurred in patients who used Voltaren Ofta for a very long time.
• if you currently have, or are at risk of, an infection. Your doctor will prescribe appropriate concomitant therapy (e.g., antibiotics) alongside Voltaren Ofta. 5/8
• if you are using other locally administered anti-inflammatory medicines based on steroid hormones (see "Other medicines and VOLTAREN OFTA").

Children
VOLTAREN OFTA is not recommended for use in children, as safety and efficacy in this population have not been established.

Other medicines and VOLTAREN OFTA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Caution is advised when using Voltaren Ofta together with other locally administered anti-inflammatory steroid medicines, as this may increase the risk of corneal complications in patients who already have significant corneal inflammation.
Voltaren Ofta may, if necessary, be used together with antibiotic eye drops and beta-blockers.
If you are using another eye drop at the same time as Voltaren Ofta, wait 5 minutes between each treatment.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Voltaren Ofta must not be used during the last 3 months of pregnancy. Do not use Voltaren Ofta during the first 6 months of pregnancy unless strictly necessary and under medical advice. If treatment is required during this period, the lowest dose for the shortest possible duration should be used.
Oral formulations (e.g., tablets) of diclofenac may cause adverse effects in the unborn child. It is not known whether the same risk applies with Voltaren Ofta when used in the eye.
Do not use VOLTAREN OFTA during breastfeeding, except in specific cases and only after consulting your doctor.
Anti-inflammatory medicines such as diclofenac may affect fertility and labor.
This class of medicines may also cause fetal constriction of a blood vessel called the ductus arteriosus.

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

5. HOW TO USE VOLTAREN OFTA

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Dosage
Your doctor will tell you the dose of Voltaren Ofta to take.
Method of administration
This medicine is intended for ocular administration (ophthalmic use).

• 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 upward and gently pulling down the lower eyelid.

If you use more VOLTAREN OFTA than you should
If you accidentally ingest/absorb an excessive dose of VOLTAREN OFTA, contact your doctor.
6/8
Due to the low amount of diclofenac in the medicine, no adverse effects are expected in case of
accidental ingestion/absorption of an excessive dose.
If you forget to use VOLTAREN OFTA
Do not use a double dose to make up for the missed dose.
If you stop using VOLTAREN OFTA
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects have been reported with the use of Voltaren Ofta:
Very common (may affect more than 1 in 10 people):

• Eye pain
  Common (may affect up to 1 in 10 people):
• Eye irritation
  Uncommon (may affect up to 1 in 100 people):
• Itching of the eye, eye redness (ocular hyperemia), blurred vision, punctate keratitis (inflammation of the cornea, the transparent front part of the eye)
  Rare (may affect up to 1 in 1,000 people):
• Corneal disorders (lesions, thinning, hypertrophy and edema of the cornea, corneal epithelial defects)
• Weakening of vision
• Redness of the eyes (conjunctival hyperemia)
• Allergic reaction and inflammation of the eyes due to allergies (allergic conjunctivitis)
• Irritation, erythema and swelling (edema) of the eyelids
  Not known (frequency cannot be estimated from the available data):
• Itching of the eyelids

Occasionally, a mild or moderate transient burning sensation and/or appearance of dark spots interfering with vision (scotomata) have been reported immediately after instillation of the eye drops.
With the use of Voltaren Ofta, breathing difficulties (dyspnea) and worsening of asthma, cough, nasal swelling and irritation (rhinitis), itching, skin eruptions (erythema, urticaria, rash, eczema), and allergic reactions following exposure to sunlight (photosensitivity reaction) have also been reported.

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

5. HOW TO STORE VOLTAREN OFTA

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 after EXP.
The expiry date refers to the last day of that month.
7/8
Store below 25°C.
Single-dose containers must not be used beyond 28 days after opening the pouch.
After opening the single-dose container: use immediately and discard the single-dose container with the remaining solution immediately after use.
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 OFTA contains

• The active substance is sodium diclofenac at a concentration of 1 mg/ml.
• The other components are boric acid, polyoxyl castor oil, tromethamine, water for injections.

Description of the appearance of VOLTAREN OFTA and contents of the pack
VOLTAREN OFTA is a liquid supplied in single-dose containers containing 0.3 ml of eye drops, solution.
The pack contains 20 or 30 single-dose containers, packed in sachets of 5 single-dose containers.

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 and batch release
EXCELVISION
Rue de la Lombardière
07100 ANNONAY
FRANCE

This leaflet was last updated on:
8/8