Bromoftil

Package leaflet: Information for the user

BROMOFTIL 0.9 mg/ml eye drops, solution

Bromfenac
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 may be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What BROMOFTIL is and what it is used for

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

2. What you need to know before using BROMOFTIL

Do not use BROMOFTIL

• 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. 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 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.

The use of contact lenses is not recommended after cataract surgery. Therefore, do not wear contact lenses while using BROMOFTIL.
Children and adolescents
BROMOFTIL must not be used in children and adolescents.
Other medicines and BROMOFTIL
Inform 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 or are planning to become pregnant, or if you are breastfeeding, consult your doctor or pharmacist before using BROMOFTIL.
BROMOFTIL must not be used during the last three months of pregnancy. Your doctor may prescribe this medicine during pregnancy only if the expected benefit for the mother outweighs the potential risk to the unborn child.
BROMOFTIL may 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 you experience blurred vision after instillation, do not drive and do not operate machinery until your vision has cleared.

3. How to use BROMOFTIL

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or
pharmacist.
Dose
The recommended dose is one drop of BROMOFTIL 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
BROMOFTIL is for ophthalmic use.
BROMOFTIL 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 in the aluminum pouch.
• Open the container by removing 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 touch the eye, eyelid, surrounding areas, or any other surfaces with the single-dose container.
• Gently press the single-dose container to release one drop of BROMOFTIL.

If you use any other eye drops, wait at least five minutes between using BROMOFTIL and the other eye drops.
Duration of treatment
Continue using the eye drops during the first 2 weeks after surgery. Do not use BROMOFTIL for more than 2
weeks.
If you use more BROMOFTIL 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 BROMOFTIL, drink a glass of water or another liquid to dilute the medicine.
If you forget to use BROMOFTIL
Apply a single dose as soon as you remember. If it is almost time for the next dose, skip the missed dose. Continue
with the next dose as scheduled. Do not use a double dose to make up for the missed dose.
If you stop using BROMOFTIL
Do not stop using BROMOFTIL without consulting your doctor.
After discontinuation of BROMOFTIL, in rare cases a recurrence of the inflammatory response has been observed, for example in the form of retinal swelling, following cataract surgery.
If you have any doubts about how to use BROMOFTIL, 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 in 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 get any side effects, including ones 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 BROMOFTIL

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.
BROMOFTIL 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 any remaining medicine.
After first opening the aluminium sachet, 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 no longer in use. This will help protect the environment.

6. Package contents and other information

What BROMOFTIL contains
BROMOFTIL eye 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), edetate disodium, water for injections, sodium hydroxide (to adjust and maintain pH).

Description of the appearance of BROMOFTIL and contents of the pack
BROMOFTIL is a clear yellow liquid (solution). Supplied in a carton containing 20 or 30 single-dose containers made of LDPE, each with a volume of 0.25 ml, divided into strips, enclosed in an aluminum pouch.
Marketing Authorization Holder
Bionativa S.p.A.,
Via Raffaello 15 - Loc. Sambuca V.P.
50028 Florence
Italy
Manufacturer
Genetic S.p.A.,
Contrada Canfora,
84084 Fisciano (SA)
Italy

Package leaflet: Information for the user

BROMOFTIL 0.9 mg/ml eye drops, solution

Bromfenac
Equivalent medicinal product
Please read all of this leaflet carefully before 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 give it to other people, even if their symptoms are the same as yours, as it may 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 BROMOFTIL is and what it is used for
2. What you need to know before using BROMOFTIL
3. How to use BROMOFTIL
4. Possible side effects
5. How to store BROMOFTIL
6. Contents of the pack and other information

7. What BROMOFTIL is and what it is used for

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

8. What you should know before using BROMOFTIL

Do not use BROMOFTIL

• 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 experienced asthma, skin allergy, or severe nasal inflammation while taking 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 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.

The use of contact lenses is not recommended after cataract surgery. Therefore, do not wear contact lenses while using BROMOFTIL.
Children and adolescents
BROMOFTIL must not be used in children and adolescents.
Other medicines and BROMOFTIL
Inform 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, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using BROMOFTIL.
BROMOFTIL must not be used during the last three months of pregnancy. Your doctor may prescribe this medicine during pregnancy only if the expected benefit for the mother outweighs the potential risk to the fetus.
BROMOFTIL may 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 you experience blurred vision after instillation, do not drive or operate machinery until your vision is clear again.
BROMOFTIL 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 your 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 outermost layer of the eye). If you experience any abnormal sensation, burning, or pain in the eye after using this medicine, speak with your doctor.

9. How to use BROMOFTIL

Use this medicine exactly as your doctor has instructed you. If you have any doubts, consult your doctor or pharmacist.
Dosage
The recommended dose is one drop of BROMOFTIL 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
BROMOFTIL is for ophthalmic use.
BROMOFTIL eye drops, solution – multidose bottle.

• 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 other fingers.
• Tilt your head backward.
• Pull down the lower eyelid with a clean finger.
• Bring the tip of the bottle close to the eye.
• Do not touch the eye, eyelid, surrounding areas, or any other surfaces with the dropper tip.
• Gently press the bottle to release one drop of BROMOFTIL.
• Immediately after use, tightly replace the closure cap.
• Keep the bottle tightly closed when not in use.

If you are using any other eye drops, wait at least five minutes between using BROMOFTIL and the other eye drops.
Duration of treatment
Continue using the eye drops during the first 2 weeks after surgery. Do not use BROMOFTIL for longer than 2 weeks.

If you use more BROMOFTIL 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 BROMOFTIL, drink a glass of water or another liquid to dilute the medicine.

If you forget to use BROMOFTIL
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 usual time. Do not use a double dose to make up for the missed dose.

If you stop using BROMOFTIL
Do not stop using BROMOFTIL without first consulting your doctor.
Upon discontinuation of BROMOFTIL, 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 BROMOFTIL, consult your doctor or pharmacist.

10. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone 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)

• Foreign body sensation 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
• nosebleeds 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, please inform 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 BROMOFTIL

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.
BROMOFTIL eye drops, solution – multidose bottle
After first opening the bottle, use the medicine within 28 days; after this period, discard the bottle even if there is solution remaining.
Write the date of opening on the label of the carton, in the designated space.
Do not dispose of medicines via 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 BROMOFTIL contains
BROMOFTIL eye drops, solution – multidose bottle

• 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), benzalkonium chloride (see section 2), tiloxapol, povidone (K30), disodium edetate, water for injections, sodium hydroxide (to maintain pH within normal limits).

Description of the appearance of BROMOFTIL and contents of the pack
BROMOFTIL is a clear yellow liquid (solution) supplied in a carton containing 1 dropper bottle made of
LDPE with a volume of 5.0 ml.
Marketing Authorization Holder
Bionativa S.p.A.,
Via Raffaello 15 - Loc. Sambuca V.P.
50028 Florence
Italy
Manufacturer
Genetic S.p.A.,
Contrada Canfora,
84084 Fisciano (SA)