Irgrass

Patient Information Leaflet

IRGASS 0.9 mg/ml eye drops, solution

Bromfenac
Please read all of this leaflet carefully before you start 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 may 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 IRGASS is and what it is used for
2. What you need to know before using 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 IRGASS is and what it is used for

IRGASS contains bromfenac and belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). IRGASS works by blocking certain substances that cause inflammation.
IRGASS is used to reduce inflammation of the eye following cataract surgery in adults.

2. What you need to know before using IRGASS

Do not use IRGASS

• if you are allergic to bromfenac or to any of the other ingredients of this medicine (listed in section 6).
• if you have previously experienced asthma, skin allergy, or severe nasal inflammation while taking other NSAIDs. NSAIDs include, for example, 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 adverse effects.
• if you have bleeding disorders (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 disorders).
• if you have diabetes.
• if you have rheumatoid arthritis.
• if you have undergone repeated eye surgeries within a short period of time.

Wearing contact lenses is not recommended after cataract surgery. Therefore, do not wear contact lenses while using IRGASS.
Children and adolescents
IRGASS must 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, breast-feeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breast-feeding, consult your doctor or pharmacist before using IRGASS.
IRGASS must not be used during the last three months of pregnancy. Your doctor may prescribe this medicine during pregnancy only if the expected benefit to the mother outweighs the potential risk to the foetus.
IRGASS may be prescribed during breast-feeding and has no significant influence on fertility.
Driving and using machines
For a short time after instillation of this eye drop, your vision may become blurred. If you experience blurred vision after using the eye drops, do not drive or operate machinery until your vision has cleared.

3. How to use IRGASS

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Dosage

The recommended dose is one drop of IRGASS in the eye or eyes that have undergone cataract extraction, twice daily (morning and evening). Do not use more than one drop in the eye or eyes twice daily.

Start using the drops the day after cataract surgery.

Method of administration

IRGASS is for ophthalmic use.

IRGASS eye 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 store the remaining vials back in the aluminum pouch.
• Open the container by detaching the cap.
• Tilt your head backward.
• Pull down the lower eyelid with a clean finger.
• Bring the tip of the single-dose container close to the eye.
• Do not let the single-dose container touch the eye, eyelid, surrounding areas, or any other surfaces.
• Gently press the single-dose container to release one drop of IRGASS.

If you are using any other eye drops, wait at least five minutes between using IRGASS and the other eye drops.

Duration of treatment

Continue using the eye drops for the first 2 weeks after surgery. Do not use IRGASS for longer than 2 weeks.

If you use more IRGASS than you should

Rinse the eye with warm water. Do not apply further drops until the time of your next scheduled dose. In case of accidental ingestion of IRGASS, drink a glass of water or another liquid 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 your next dose, skip the missed dose. Continue with your next dose at the usual time. Do not use a double dose to make up for the missed dose.

If you stop using IRGASS

Do not stop using IRGASS without consulting your doctor.
After discontinuation of IRGASS, in rare cases, a recurrence of the inflammatory response has been observed, for example, as retinal swelling following cataract surgery.

If you have any doubts about how to use IRGASS, consult 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 during the week following the end of treatment, contact your doctor immediately.
Contact your doctor immediately if you notice any of the following side effects while using the eye drops.

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

• Sensation of a foreign body in the eye
• redness and inflammation of the eye
• damage and inflammation of the eye surface
• 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
• swelling of the face
• cough
• nosebleed or runny nose

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

• damage to the eye surface
• eye redness
• asthma

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 IRGASS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle, on the aluminium pouch of the
single-dose containers, and on the carton after "EXP.". The expiry date refers to the last day of that month.
Do not store above 25°C.
IRGASS eye drops, solution – single-dose containers
This medicine does not contain preservatives: after opening the single-dose container, use the medicine
immediately; if only partially used, discard the remaining medicine.
After first opening the aluminium pouch, use the medicine within 7 days; after this period, discard the medicine.
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 pack and other information

What IRGASS contains
IRGASS eye drops, solution – single-dose containers

• The active substance is bromfenac. One ml of solution contains 0.9 mg of bromfenac (as sodium sesquihydrate). 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 pH within normal range).

Description of the appearance of IRGASS and contents of the pack
IRGASS is a clear yellow liquid (solution). Supplied in a carton containing 20 or 30 single-dose containers made of LDPE with a volume of 0.25 ml each, divided into strips and enclosed in an aluminium pouch.
Marketing Authorization 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)

Package leaflet: Information for the user

IRGASS 0.9 mg/ml eye drops, solution

Bromfenac
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, 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

7. What IRGASS is and what it is used for
8. What you need to know before using 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 IRGASS is and what it is used for

IRGASS contains bromfenac and belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). IRGASS works by blocking certain substances that cause inflammation.
IRGASS is used to reduce inflammation of the eye following cataract surgery in adults.

8. What you should know before using IRGASS

Do not use IRGASS

• if you are allergic to bromfenac or to any of the other ingredients of this medicine (listed in section 6).
• if in the past you have had asthma, skin allergy, or severe nasal inflammation while taking other NSAIDs. NSAIDs include, for example, 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 disorders).
• if you have diabetes.
• if you have rheumatoid arthritis.
• if you have undergone repeated eye surgeries within a short period of time.

Wearing contact lenses is not recommended after cataract surgery. Therefore, do not wear contact lenses while using IRGASS.
Children and adolescents
IRGASS must 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, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using IRGASS.
IRGASS must not be used during the last three months of pregnancy. Your doctor may prescribe this medicine during pregnancy if the expected benefit to the mother outweighs the potential risk to the unborn child.
IRGASS may be prescribed during breastfeeding and has no relevant effect on fertility.
Driving and using machines
After using this eye drop, your vision may be blurred for a short time. If you experience blurred vision after using the drops, do not drive or operate machinery until your vision is clear again.
IRGASS in 5 ml bottle contains benzalkonium chloride
This medicine, in the multidose bottle presentation, contains 0.00185 mg of benzalkonium chloride per single drop, equivalent to 0.05 mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause a change in their colour. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or corneal disorders (the transparent outer layer of the eye). If you experience any unusual sensation, burning, or pain in the eye after using this medicine, speak with your doctor.

9. How to use IRGASS

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Dosage
The recommended dose is one drop of IRGASS in the eye or eyes that have undergone cataract extraction, twice daily (morning and evening). Do not use more than one drop in the eye or eyes twice daily.
Begin using the drops the day after cataract surgery.

Method of administration
IRGASS is for ophthalmic use only.
IRGASS eye drops, solution – multidose container.

• Wash your hands before using the eye drops.
• Assume a comfortable and stable position.
• Unscrew the closure cap of the bottle.
• Hold the bottle upside down between your thumb and fingers.
• Tilt your head backward.
• Gently pull down the lower eyelid with a clean finger.
• Bring the tip of the bottle close to the eye.
• Do not touch the dropper tip to the eye, eyelid, surrounding areas, or any other surface.
• Gently press the bottle to release one drop of IRGASS.
• Immediately after use, tightly close the bottle with the closure cap.
• Keep the bottle securely closed when not in use.

If you are using any other eye drops, wait at least five minutes between applying IRGASS and the other eye drops.

Duration of treatment
Continue using the eye drops for the first 2 weeks after surgery. Do not use IRGASS for longer than 2 weeks.

If you use more IRGASS than you should
Rinse the eye with warm water. Do not apply further drops until the next scheduled dose. In case of accidental ingestion of IRGASS, drink a glass of water or another liquid 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 missed dose. Continue with your next dose at the regular time. Do not use a double dose to make up for a forgotten dose.

If you stop using IRGASS
Do not stop using IRGASS without consulting your doctor.
After discontinuation of IRGASS, in rare cases, a recurrence of the inflammatory response has been observed, for example, as swelling of the retina, following cataract surgery.

If you have any questions about the use of IRGASS, consult 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 during the week following the end of treatment, contact your doctor immediately.
Contact your doctor immediately if you notice any of the following side effects while using the eye drops.

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

• Sensation of a foreign body in the eye
• redness and inflammation of the eye
• damage and inflammation of the eye surface
• 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
• eye redness
• asthma

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.

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 stated on the bottle, on the aluminium sachet of the single-dose containers, and on the carton after "EXP.". The expiry date refers to the last day of that month.
Do not store above 25°C.
IRGASS eye drops, solution – multidose bottle
After first opening the bottle, use the medicine within 28 days; after this period, discard the bottle even if some solution remains.
Write the date of opening on the carton label, in the designated space.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

12. Package contents and other information

What IRGASS contains
IRGASS eye drops, solution – multidose container

• The active substance is bromfenac. One ml of solution contains 0.9 mg of bromfenac (as sodium sesquihydrate). 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 adjust and maintain pH).

Description of the appearance of IRGASS and contents of the pack
IRGASS is a clear yellow liquid (solution) supplied in a carton containing 1 dropper bottle made of LDPE with a capacity of 5.0 ml.
Marketing Authorization 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)