VOLTAREN 0.1% Eye drops, solution

Зміст інструкції

1. VOLTAREN OFTA 0,1% eye drops, solution
   1. WHAT IS VOLTAREN OFTA AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU USE VOLTAREN OFTA
   3. HOW TO USE VOLTAREN OFTA
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE VOLTAREN OFTA
   6. CONTENTS OF THE PACK AND OTHER INFORMATION
2. VOLTAREN OFTA 0.1% eye drops, solution
   1. WHAT IS VOLTAREN OFTA AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU USE VOLTAREN OFTA
   3. HOW TO USE VOLTAREN OFTA
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE VOLTAREN OFTA
   6. CONTENTS OF THE PACK AND OTHER INFORMATION

VOLTAREN OFTA 0,1% eye drops, solution

Diclofenac sodium

Read this leaflet carefully before you start using this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you use VOLTAREN OFTA
• 3. How to use VOLTAREN OFTA
• 4. Possible side effects
• 5. How to store VOLTAREN OFTA
• 6. Contents of the pack and other information

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

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

2. WHAT YOU NEED TO KNOW BEFORE YOU USE 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 had episodes of asthma, itchy skin rash (urticaria), acute rhinitis (swelling and irritation inside the nose) in the past after taking aspirin (acetylsalicylic acid) or other similar medicines called non-steroidal anti-inflammatory drugs.

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 diseases of a part of the eye called the cornea, due to the use of other anti-inflammatory medicines based on substances called “steroid hormones”, for example. In the presence of these conditions, the use of Voltaren Ofta has been associated, in rare cases, with the appearance of corneal diseases (ulcerative keratitis, corneal thinning, punctate keratitis, defects of the corneal epithelium and corneal edema) for which your doctor may prescribe you specific treatment. These effects have occurred in patients who have used Voltaren Ofta for a very long time.
• in the presence, or if there is a risk of infection. Your doctor will administer appropriate therapy (e.g. antibiotics) to you simultaneously with Voltaren Ofta eye drops.

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• if you are using other anti-inflammatory medicines for local use based on steroid hormones (see “Other medicines and VOLTAREN OFTA”). During treatment, do not use 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
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other
medicines.
Caution should be exercised when using Voltaren Ofta if you are using other medicines
against inflammation based on local steroid hormones, as in patients who already have
significant corneal inflammation, the risk of developing corneal complications may increase.
Voltaren Ofta can, if necessary, be combined with antibiotic and beta-blocker eye drops.
If you use another eye drop at the same time as VOLTAREN OFTA, wait 5 minutesbetween treatments
.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding
ask your doctor or pharmacist for advice before using this medicine.
VOLTAREN OFTA should not be used if you are in the last 3 months of pregnancy. Do not use VOLTAREN
OFTA during the first 6 months of pregnancy unless strictly necessary and as directed by your doctor. In case
of need for treatment during this period, the lowest dose should be used for the shortest possible time.
Oral forms (e.g. tablets) of diclofenac can cause adverse effects in the unborn child. It is not known if
the same risk applies with VOLTAREN OFTA when used in the eye.
During breastfeeding, do not use VOLTAREN OFTA unless in particular cases after examination by your doctor.
Anti-inflammatory drugs such as diclofenac can have effects on fertility and childbirth.
This class of drugs can also cause narrowing of a blood vessel called the ductus arteriosus in the fetus.

Driving and using machines
You may experience transient visual impairment after administration of VOLTAREN OFTA. Wait until
normal vision returns before driving or using 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 can be absorbed by soft contact lenses and can lead to a change in their
color. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride can also cause irritation to the eyes, especially if you have dry eyes or corneal disorders (the most superficial transparent layer of the eye). If you experience an abnormal sensation in your eye, burning or pain after using this medicine, talk to your doctor.

3. HOW TO USE VOLTAREN OFTA

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts
consult your doctor or pharmacist.
Dosage
Your doctor will indicate the dose of Voltaren Ofta to be taken.
2/8
Method of administration
This medicine is intended to be administered into the eye (ophthalmic use).

• Wash your hands thoroughly before using the product.
• Avoid contact of the container tip with the eye or eyelids.
• Instill one drop into the affected eye, looking upwards and slightly lowering the lower eyelid.
• Close the bottle immediately after use.

If you use more VOLTAREN OFTA than you should
In case of ingestion/accidental intake of an excessive dose of VOLTAREN OFTA contact your doctor.
Considering the low quantity of diclofenac in the medicine, no undesirable effects are expected in case of
ingestion/accidental intake of an excessive dose.

If you forget to use VOLTAREN OFTA
Do not use a double dose to make up for a missed dose.

If you stop using VOLTAREN OFTA
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody 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):
• Eye itching, eye redness (ocular hyperemia), blurred vision, punctate keratitis (inflammation of the cornea, the clear 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 of the corneal epithelium)
• Impaired vision
• Eye redness (conjunctival hyperemia)
• Allergy and inflammation of the eyes caused by allergies (allergic conjunctivitis)
• Irritation, redness and swelling (edema) of the eyelids Not known (frequency cannot be estimated from available data):
• Eyelid itching

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

Reporting of side effects
3/8
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through 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 which is stated on the package and the bottle after SCAD. The
expiry date refers to the last day of that month.
Voltaren Ofta should not be used for more than 28 days after opening the bottle. Close the
bottle immediately after use.
Store at a temperature below 25°C.
Do not dispose of any medicine in 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 PACK AND OTHER INFORMATION

What VOLTAREN OFTA contains

• The active ingredient is diclofenac sodium at a concentration of 1 mg/ml.
• The other components are benzalkonium chloride, disodium edetate, hydroxypropyl  -cyclodextrin, hydrochloric acid, propylene glycol, trometamol, thiosaprole, 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 Authorisation Holder
LABORATOIRES THEA
12, rue Louis Blériot
63017 CLERMONT-FERRAND CEDEX 2
FRANCE

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:
4/8

VOLTAREN OFTA 0.1% eye drops, solution

Diclofenac sodium

Read this leaflet carefully before you start using this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you use VOLTAREN OFTA
• 3. How to use VOLTAREN OFTA
• 4. Possible side effects
• 6. How to store VOLTAREN OFTA
• 6. Contents of the pack and other information

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

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

4. WHAT YOU NEED TO KNOW BEFORE YOU USE VOLTAREN OFTA

Do not use VOLTAREN OFTA

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

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 diseases of a part of the eye called the cornea, due to the use of other anti-inflammatory medicines based on substances called “corticosteroids”, for example. In the presence of these conditions, the use of Voltaren Ofta has been associated, in rare cases, with the appearance of corneal diseases (ulcerative keratitis, corneal thinning, punctate keratitis, defects of the corneal epithelium and corneal edema) for which your doctor may prescribe specific treatment. These effects have occurred in patients who have used Voltaren Ofta for a very long time.
• in the presence, or if there is a risk of infection. Your doctor will administer appropriate therapy (e.g. antibiotics) together with Voltaren Ofta eye drops. 5/8
• if you are using other anti-inflammatory medicines for local use based on corticosteroids (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
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other
medicines.
Caution should be exercised when using Voltaren Ofta if you are using other anti-inflammatory medicines for local use based on corticosteroids, as in patients who already have
significant inflammation of the cornea, the risk of developing corneal complications may increase.
Voltaren Ofta can, if necessary, be combined with antibiotic and beta-blocker eye drops.
If you use another eye drop at the same time as Voltaren Ofta, wait 5 minutesbetween treatments.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding with breast milk
ask your doctor or pharmacist for advice before using this medicine.
Voltaren Ofta should not be used if you are in the last 3 months of pregnancy. Do not use Voltaren Ofta during
the first 6 months of pregnancy unless strictly necessary and as directed by your doctor. If treatment is necessary
during this period, the lowest dose should be used for the shortest possible time.
Oral forms (e.g. tablets) of diclofenac can cause adverse effects in the unborn child. It is not known if the
same risk occurs with Voltaren Ofta when used in the eye.
Do not use VOLTAREN OFTA during breastfeeding unless in special cases after examination by your doctor.
Anti-inflammatory drugs such as diclofenac can have effects on fertility and childbirth.
This class of drugs can also cause constriction of a blood vessel called the ductus
arteriosus in the fetus.

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

5. HOW TO USE VOLTAREN OFTA

Use this medicine following exactly the instructions of 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.
Route of administration
This medicine is intended to be administered into the eye (ophthalmic use).

• Wash your hands thoroughly before using the product.
• Avoid contact of the container tip with the eye or eyelids.
• Instill one drop into the affected eye, looking upwards and slightly lowering the lower eyelid.

If you use more VOLTAREN OFTA than you should
In case of ingestion/accidental intake of an excessive dose of VOLTAREN OFTA contact your doctor.
6/8
Considering the low quantity of diclofenac in the medicine, no undesirable effects are expected in case of
ingestion/accidental intake of an excessive dose.

If you forget to use VOLTAREN OFTA
Do not use a double dose to make up for a missed dose.

If you stop using VOLTAREN OFTA
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody 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):
• Eye itching, redness of the eyes (ocular hyperemia), blurred vision, punctate keratitis (inflammation of the cornea, the clear front part of the eye) Rare (may affect up to 1 in 1000 people):
• Corneal disorders, (lesions, thinning, hypertrophy and edema of the cornea, defects of the corneal epithelium)
• Impaired vision
• Redness of the eyes (conjunctival hyperemia)
• Allergy and inflammation of the eyes caused by allergies (allergic conjunctivitis)
• Irritation, redness and swelling (edema) of the eyelids Not known (frequency cannot be estimated from available data):
• Eyelid itching

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 which is stated on the package and the bottle after EXP.
The expiry date refers to the last day of that month.
7/8
Store at a temperature below 25°C.
The single-dose containers must not be used for more than 28 days after opening the sachet.
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 in 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 PACK AND OTHER INFORMATION

What VOLTAREN OFTA contains

• The active ingredient is diclofenac sodium 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 presented in single-dose containers of 0.3 ml eye drops, solution. The
pack contains 20 or 30 single-dose containers packaged in pouches of 5 single-dose containers.

Marketing Authorisation Holder
LABORATOIRES THEA
12, rue Louis Blériot
63017 CLERMONT-FERRAND CEDEX 2
FRANCE

Marketing Authorisation Holder
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