IRGASS 0.9 MG/ML Eye drops, solution

Зміст інструкції

1. IRGASS 0,9 mg/ml eye drops, solution
   1. What is IRGASS and what is it used for
   2. What you need to know before you use IRGASS
   3. How to use IRGASS
   4. Possible side effects
   5. How to store IRGASS
   6. Contents of the pack and other information
2. IRGASS 0.9 mg/ml eye drops, solution
   1. What is IRGASS and what is it used for
   2. What you need to know before you use IRGASS
   3. How to use IRGASS
   4. Possible side effects
   5. How to store IRGASS
   6. Package Contents and Other Information

IRGASS 0,9 mg/ml eye drops, solution

Bromfenac

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

1. What is IRGASS and what is it used for

IRGASScontains bromfenac and belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). IRGASSworks by blocking certain substances that cause inflammation.

IRGASSis used to reduce inflammation in the eye after cataract surgery in adults.

2. What you need to know before you use IRGASS

Do not use IRGASS

• if you are allergic to bromfenac or any of the other ingredients of this medicine (listed in section 6).
• if you have had asthma, skin allergy or severe nasal inflammation in the past when using other NSAIDs. Examples of NSAIDs include acetylsalicylic acid, ibuprofen, ketoprofen and diclofenac.

Warnings and precautions
Talk to your doctor or pharmacist before using this medicine.

• if you are using topical steroids (e.g. cortisone), as this may cause unwanted effects.
• if you have bleeding problems (e.g. haemophilia) or have had them in the past, or if you are taking other medicines that may prolong bleeding time (e.g. warfarin, clopidogrel, acetylsalicylic acid).
• if you have eye problems (e.g. dry eye syndrome, corneal problems).
• if you have diabetes.
• if you have rheumatoid arthritis.
• if you have undergone repeated eye surgeries in a short period of time.

The use of contact lenses is not recommended after cataract surgery. Therefore, do not wear contact lenses while using IRGASS.

Children and adolescents
IRGASSshould not be used in children and adolescents.

Other medicines and IRGASS
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before using IRGASS.

IRGASSshould not be used in the last three months of pregnancy. Your doctor may prescribe this medicine during pregnancy if the expected benefit for the mother outweighs the possible risk to the baby.

IRGASScan be prescribed during breastfeeding and has no significant effect on fertility.

Driving and using machines
After using this eye drop, your vision may be blurred for a short time. If your vision is blurred after use, do not drive or use machines until your vision has returned to normal.

3. How to use IRGASS

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your doctor or
pharmacist.
Dosage
The recommended dose is one drop of IRGASSin the eye or eyes that have undergone cataract extraction, twice a day (morning and evening). Do not use more than one drop in the eye or eyes 2 times a
day.
Start using the drops the day after cataract surgery.
Method of administration

IRGASSis for ophthalmic use.

IRGASSeye drops, solution – single-dose container

• Wash your hands before using the eye drops.
• Assume a comfortable and stable position.
• Open the aluminum pouch containing the single-dose containers.
• Remove one vial from the strip and replace the others in the aluminum pouch.
• Open the container by detaching the cap
• Tilt your head back.
• Pull down the lower eyelid with a clean finger.
• Bring the tip of the single-dose container close to the eye.
• Do not touch the eye or eyelid, surrounding areas, or other surfaces with the single-dose container.
• Press lightly on the single-dose container to release one drop of IRGASS.

.
If you are using any other eye drops, allow at least five minutes to pass between using IRGASSand using another
eye drop.
Duration of treatment
Continue to use the eye drops for the first 2 weeks after surgery. Do not use IRGASSfor more than 2 weeks.

If you use more IRGASS than you should
Rinse the eye with warm water. Do not apply any more drops until the time of the next dose. In case of
accidental ingestion of IRGASS, a glass of water or other liquid should be drunk to dilute the
medicine.

If you forget to use IRGASS
Apply a single dose as soon as you remember. If it is almost time for the next dose, skip the forgotten
dose. Continue normally with the next dose, as scheduled. Do not use a double dose to
compensate for a missed dose.

If you stop using IRGASS
Do not stop using IRGASSwithout consulting your doctor.
Upon discontinuation of IRGASS, a flare-up of the inflammatory response, for example in the form of retinal edema, has been observed in rare cases, following cataract surgery.
If you have any doubts about the use of IRGASS, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice a reduction or blurring of vision in the week following the end of treatment,
contact your doctor immediately.
Contact your doctor immediately if you experience any of the following side effects while using the eye drops.

Uncommon side effects (may affect up to 1 in 100 people)

• Foreign body sensation in the eye
• redness and inflammation of the eye
• damage and inflammation of the surface of the eye
• eye discharge
• itching
• eye irritation or pain
• swelling or bleeding of the eyelid
• visual disturbances due to inflammation
• “floating” or mobile spots in front of the eyes or reduced vision, which may indicate bleeding or damage to the back of the eye (retina)
• eye discomfort
• sensitivity to light
• reduced or blurred vision
• facial swelling
• cough
• nosebleeds or runny nose.

Rare side effects (may affect up to 1 in 1,000 people)

• damage to the eye surface
• redness of the eye
• asthma.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please 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 IRGASS

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 bottle, on the aluminium pouch of the
single-dose containers and on the package after "EXP.". The expiry date refers to the last day of
that month.
Do not store at a temperature above 25°C.

IRGASSeye drops, solution – single-dose containers
The medicine does not contain preservatives: after opening the single-dose container, use the medicine
immediately; if partially used, discard the remaining medicine.
After the first opening of the aluminium pouch, use the medicine within 7 days; after this period discard the
medicine.
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 IRGASS contains
IRGASSeye drops, solution – single-dose containers

• The active substance is bromfenac. One ml of solution contains 0.9 mg of bromfenac (as sesquihydrate sodium). One drop contains approximately 33 micrograms of bromfenac.
• The other excipients are: boric acid, borax, anhydrous sodium sulfite (E221), tiloxapol, povidone (K30), disodium edetate, water for injections, sodium hydroxide (to maintain normal acidity values).

Description of the appearance of IRGASS and contents of the pack
IRGASSis a clear yellow liquid (solution) Supplied in a pack containing 20 or 30 single-dose containers in
LDPE of 0.25 ml divided into strips, enclosed in an aluminum pouch.

Marketing Authorisation Holder
FB VISION S.P.A.
Via Giovanni Scafa snc
63074 San Benedetto del Tronto (AP)

Manufacturer
Genetic S.p.A.,
Contrada Canfora,
84084 Fisciano (SA)

IRGASS 0.9 mg/ml eye drops, solution

Bromfenac
Generic medicine

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:

• 7. What IRGASSis and what it is used for
• 8. What you need to know before you use IRGASS
• 9. How to use IRGASS
• 10. Possible side effects
• 11. How to store IRGASS
• 12. Contents of the pack and other information

7. What is IRGASS and what is it used for

IRGASScontains bromfenac and belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). IRGASSworks by blocking certain substances that cause inflammation.

IRGASSis used to reduce inflammation in the eye after cataract surgery in adults.

8. What you need to know before you use IRGASS

Do not use IRGASS

• if you are allergic to bromfenac or any of the other ingredients of this medicine (listed in section 6).
• if you have had asthma, skin allergy or severe nasal inflammation in the past when using other NSAIDs. Examples of NSAIDs include acetylsalicylic acid, ibuprofen, ketoprofen and diclofenac.

Warnings and precautions
Talk to your doctor or pharmacist before using this medicine.

• if you are using topical steroids (e.g. cortisone), because it may cause unwanted effects.
• if you have bleeding problems (e.g. hemophilia) or have had them in the past, or if you are taking other medicines that may prolong bleeding time (e.g. warfarin, clopidogrel, acetylsalicylic acid).
• if you have eye problems (e.g. dry eye syndrome, corneal problems).
• if you have diabetes.
• if you have rheumatoid arthritis.
• if you have undergone repeated eye surgeries in a short period of time.

The use of contact lenses is not recommended after cataract surgery. Therefore, do not wear contact lenses while using IRGASS.

Children and adolescents
IRGASSshould not be used in children and adolescents.

Other medicines and IRGASS
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before using IRGASS.

IRGASSshould not be used in the last three months of pregnancy. Your doctor may prescribe this medicine during pregnancy if the expected benefit for the mother outweighs the possible risk to the baby.

IRGASScan be prescribed during breastfeeding and has no significant effect on fertility.

Driving and operating machinery
After using this eye drop, your vision may be blurred for a short time. If your vision is blurred after use, do not drive or operate machinery until your vision is clear.

IRGASS in a 5 ml bottle contains benzalkonium chloride
This medicine, in the multi-dose bottle presentation, contains 0.00185 mg of benzalkonium chloride per single drop, equivalent to 0.05 mg/ml.
Benzalkonium chloride can be absorbed by soft contact lenses and may lead to a change in their color. Remove your contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride can also cause eye irritation, especially if you have dry eyes or corneal disorders (the transparent outermost layer of the eye). If you experience any abnormal eye sensation, burning or pain after using this medicine, talk to your doctor.

9. How to use IRGASS

Use this medicine following exactly the instructions of your doctor. If you have any doubts, ask your doctor or pharmacist.
Dosage
The recommended dose is one drop of IRGASSin the eye or eyes that have undergone cataract extraction, twice a day (morning and evening). Do not use more than one drop in the eye or eyes 2 times a day.
Start using the drops the day after cataract surgery.
Method of administration

IRGASSis for ophthalmic use.

IRGASSeye drops, solution – multi-dose bottle.

• Wash your hands before using the eye drops.
• Assume a comfortable and stable position.
• Unscrew the cap of the bottle.
• Hold the bottle upside down between your thumb and other fingers.
• Tilt your head back.
• Pull down the lower eyelid with a clean finger.
• Bring the tip of the bottle close to the eye.
• Do not touch the eye or eyelid with the dropper, the surrounding areas or other surfaces.
• Press lightly on the bottle to release one drop of IRGASS.
• Close the cap of the bottle tightly immediately after use.
• Keep the bottle tightly closed when not in use.

If you are using any other eye drops, allow at least five minutes to pass between using IRGASSand using another eye drop.
Duration of treatment
Continue to use the eye drops for the first 2 weeks after surgery. Do not use IRGASSfor more than 2 weeks.

If you use more IRGASS than you should
Rinse the eye with warm water. Do not apply any further drops until the time of the next dose. In case of
accidental ingestion of IRGASS, a glass of water or other liquid should be drunk to dilute the
medicine.

If you forget to use IRGASS
Apply a single dose as soon as you remember. If it is almost time for the next dose, skip the forgotten dose.
Continue normally with the next dose, as scheduled. Do not use a double dose to
compensate for a missed dose.

If you stop using IRGASS
Do not stop using IRGASSwithout consulting your doctor.
Upon discontinuation of IRGASS, a flare-up of the inflammatory response, for example in the form of retinal edema, has been observed in rare cases, following cataract surgery.
If you have any doubts about the use of IRGASS, ask your doctor or pharmacist.

10. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice a reduction or blurring of vision in the week following the end of treatment,
contact your doctor immediately.
Contact your doctor immediately if you experience any of the following side effects while using the eye drops.

Uncommon side effects (may affect up to 1 in 100 people)

• Feeling of a foreign body in the eye
• redness and inflammation of the eye
• damage and inflammation of the surface of the eye
• eye discharge
• itching
• eye irritation or pain
• swelling or bleeding of the eyelid
• visual disturbances due to inflammation
• "floating" or moving spots in front of the eyes or reduced vision, which may indicate bleeding or damage to the back of the eye (retina)
• eye discomfort
• sensitivity to light
• reduced or blurred vision
• facial swelling
• cough
• nosebleed or runny nose.

Rare side effects (may affect up to 1 in 1,000 people)

• damage to the eye surface
• redness of the eye
• asthma.

Reporting of side effects
If you get any side effects, talk to 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.

11. How to store IRGASS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the bottle, on the aluminum pouch of the
single-dose containers and on the box after "EXP.". The expiry date refers to the last day of
that month.
Do not store at a temperature above 25°C.

IRGASSeye drops, solution – multi-dose bottle
After the first opening of the bottle, use the medicine within 28 days; after this period, discard the
bottle even if it contains residual solution.
Write the date of opening on the carton label, in the appropriate space.
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.

12. Package Contents and Other Information

What IRGASS contains
IRGASSeye drops, solution – multidose bottle

• The active ingredient is bromfenac. One ml of solution contains 0.9 mg of bromfenac (as sesquihydrate sodium). One drop contains approximately 33 micrograms of bromfenac.
• The other excipients are: boric acid, borax, anhydrous sodium sulfite (E221), benzalkonium chloride (see section 2), tiloxapol, povidone (K30), disodium edetate, water for injections, sodium hydroxide (to maintain normal acidity values).

Description of the appearance of IRGASS and package contents
IRGASSis a clear yellow liquid (solution) supplied in a pack containing 1 dropper bottle made of LDPE
of 5.0 ml.

Marketing Authorisation Holder
FB VISION S.P.A.
Via Giovanni Scafa snc
63074 San Benedetto del Tronto (AP)

Manufacturer
Genetic S.p.A.,
Contrada Canfora,
84084 Fisciano (SA)