Coxafen

Package leaflet: Information for the user

COXAFEN 0.9 mg/ml eye drops, solution

Bromfenac
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 other people, even if they have the same symptoms as you, because it may 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:

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

1. What COXAFEN is and what it is used for

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

2. What you need to know before using COXAFEN

Do not use COXAFEN

• 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 COXAFEN.
Children and adolescents
COXAFEN must not be used in children and adolescents.
Other medicines and COXAFEN
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 a pregnancy, or breastfeeding, consult your doctor or pharmacist before using COXAFEN.
COXAFEN 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.
COXAFEN may be prescribed during breastfeeding and has no relevant effect on fertility.
Driving and using machines
For a short time after using this eye drop, your vision may become blurred. If you experience blurred vision after using the drops, do not drive and do not operate machinery until your vision is clear again.

3. How to use COXAFEN

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

Dosage
The recommended dose is one drop of COXAFEN 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 a day.
Begin using the drops the day after cataract surgery.

Method of administration
COXAFEN is for ophthalmic use.
COXAFEN 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 ones back in the aluminum pouch.
• Open the container by twisting off 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 surface with the single-dose container.
• Gently squeeze the single-dose container to release one drop of COXAFEN into the eye.

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

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

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

If you forget to use COXAFEN
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 as scheduled. Do not use a double dose to make up for the missed dose.

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

If you have any questions about the use of COXAFEN, 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 blurred 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
• facial swelling
• cough
• nosebleeds or runny nose.

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

• damage to the eye surface
• redness of the eye
• 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 COXAFEN

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 aluminum 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.
COXAFEN 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 the first opening of the aluminum pouch, use the medicine within 7 days; after this period, discard the medicine.
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.

6. Package contents and other information

What COXAFEN contains
COXAFEN ophthalmic 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), edetate disodium, water for injections, sodium hydroxide (to adjust pH to normal values).

Description of the appearance of COXAFEN and contents of the pack
COXAFEN 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 aluminum pouch.

Marketing Authorisation Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milan
Italy

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

Package leaflet: Information for the user

COXAFEN 0.9 mg/ml eye drops, solution

Bromfenac
Generic medicine
Please read all of 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 give it to other people, 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:

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

7. What COXAFEN is and what it is used for

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

8. What you need to know before using COXAFEN

Do not use COXAFEN:

• 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. 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 side effects.
• 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).
• you have eye problems (e.g. dry eye syndrome, corneal disorders).
• you have diabetes.
• you have rheumatoid arthritis.
• 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 COXAFEN.

Children and adolescents
COXAFEN must not be used in children and adolescents.

Other medicines and COXAFEN
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 are breastfeeding, consult your doctor or pharmacist before using COXAFEN.
COXAFEN 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 fetus.
COXAFEN 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 using the medicine, do not drive and do not operate machinery until your vision is clear again.

COXAFEN 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 discoloration. 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 unusual sensations, burning, or pain in the eye after using this medicine, speak with your doctor.

9. How to use COXAFEN

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or
pharmacist.
Dose
The recommended dose is one drop of COXAFEN in the eye or eyes that have undergone cataract surgery, 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
COXAFEN is for ophthalmic use.
COXAFEN 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 other surfaces with the dropper tip.
• Gently press the bottle to release one drop of Luminac.
• Immediately close the closure cap tightly after use.
• Keep the bottle tightly closed when not in use.

If you are using any other eye drops, wait at least five minutes between using COXAFEN and the other
eye drops.
Duration of treatment
Continue using the eye drops during the first 2 weeks after surgery. Do not use COXAFEN for longer than 2 weeks.
If you use more COXAFEN than you should
Rinse the eye with warm water. Do not apply further drops until the time of the next scheduled dose. In case of
accidental ingestion of COXAFEN, drink a glass of water or another liquid to dilute the medicine.
If you forget to use COXAFEN
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 COXAFEN
Do not stop using COXAFEN without consulting your doctor.
After stopping COXAFEN, 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 questions about the use of COXAFEN, 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 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 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
• 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 surface of the eye
• redness of the eye
• asthma

Reporting of side effects
If you get any side effects, 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 COXAFEN

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 aluminum 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.
COXAFEN eye drops, solution – multidose bottle:
After first opening of the bottle, use the medicine within 28 days; after this period, discard the bottle even if
there is some solution left.
Write the date of opening on the label of the carton, in the designated space.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. This will help protect the environment.

12. Package contents and other information

What COXAFEN contains
COXAFEN ophthalmic solution – multidose bottle:

• 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 pH to the appropriate range).

Description of the appearance of COXAFEN and contents of the pack
COXAFEN is a clear yellow liquid (solution) supplied in a carton containing 1 dropper bottle in LDPE of 5.0 ml.
Marketing Authorization Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milan
Italy
Manufacturer
Genetic S.p.A.,
Contrada Canfora,
84084 Fisciano (SA)