BROMOFTIL 0.9 MG/ML Krople do oczu, roztwór

Treść ulotki

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

BROMOFTIL 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 BROMOFTILis and what it is used for
• 2. What you need to know before you use 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 is BROMOFTIL and what is it used for

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

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

2. What you need to know before you use BROMOFTIL

Do not use BROMOFTIL

• 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 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 had 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 BROMOFTIL.

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

Other medicines and BROMOFTIL
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 BROMOFTIL.

BROMOFTILshould not be used during 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 child.

BROMOFTILcan 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 is clear.

3. How to use BROMOFTIL

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 BROMOFTILin 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

BROMOFTILis for ophthalmic use.

BROMOFTILeye 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, the surrounding areas, or other surfaces with the single-dose container.
• Press lightly on the single-dose container to release one drop of BROMOFTIL.

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

If you use more BROMOFTIL 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 BROMOFTIL, a glass of water or other liquid should be drunk 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 forgotten dose.
Continue normally with the next dose, as scheduled. Do not use a double dose to make up for a missed dose.

If you stop using BROMOFTIL
Do not stop using BROMOFTILwithout consulting your doctor.
Upon discontinuation of BROMOFTIL, a flare-up of the inflammatory response, such as retinal edema, has been observed in rare cases, following cataract surgery.
If you have any doubts about the use of BROMOFTIL, 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)

• 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 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
• reduction or blurring of vision
• facial swelling
• cough
• nosebleeds or runny nose.

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

• damage to the surface of the eye
• 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 BROMOFTIL

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 box after "EXP.". The expiry date refers to the last day of
that month.
Do not store at a temperature above 25°C.

BROMOFTILeye 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 waste water 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 BROMOFTIL contains
BROMOFTILeye drops, solution – single-dose containers

• 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), tiloxapol, povidone (K30), disodium edetate, water for injections, sodium hydroxide (to maintain normal acidity values).

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

Marketing Authorisation 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)

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

7. What is BROMOFTIL and what is it used for

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

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

8. What you need to know before you use BROMOFTIL

Do not use BROMOFTIL

• 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 had 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 BROMOFTIL.

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

Other medicines and BROMOFTIL
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 BROMOFTIL.

BROMOFTILshould not be used during 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 child.

BROMOFTILcan 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 is clear.

BROMOFTIL 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 can lead to a change in their color. Remove your contact lenses before using this medicine and wait 15 minutes before re-applying them.
Benzalkonium chloride can also cause eye irritation, especially if you have dry eyes or corneal disorders (the outermost 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.

9. How to use BROMOFTIL

Use this medicine following exactly the instructions of your doctor. If you have any doubts, consult your doctor or
pharmacist.
Dosage
The recommended dose is one drop of BROMOFTILin 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

BROMOFTILis for ophthalmic use.

BROMOFTILeye 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 BROMOFTIL.
• 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 BROMOFTILand using another
eye drop.
Duration of treatment
Continue to use the eye drops for the first 2 weeks after surgery. Do not use BROMOFTILfor more than 2
weeks.

If you use more BROMOFTIL 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 BROMOFTIL, a glass of water or other liquid should be drunk 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 forgotten dose.
Continue normally with the next dose, as scheduled. Do not use a double dose to make up for a missed dose.

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

10. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience 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.

• 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
• irritation or pain in the eye
• 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
• reduction or blurring of vision
• facial swelling
• cough
• nosebleeds or runny nose.

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

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

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform 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 to 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 which is stated on the bottle, on the aluminium 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.

BROMOFTILeye 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 BROMOFTIL contains
BROMOFTILeye drops, solution – multi-dose 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 paragraph 2), tiloxapol, povidone (K30), disodium edetate, water for injections, sodium hydroxide (to maintain normal acidity values).

Description of the appearance of BROMOFTIL and package contents
BROMOFTILis a clear yellow liquid (solution) supplied in a carton containing 1 dropper bottle in
LDPE of 5.0 ml.

Marketing Authorisation 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)