КОКСАФЕН 0.9 MG/ML Глазные капли, раствор

Содержание инструкции

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

COXAFEN 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 COXAFEN is and what it is used for
• 2. What you need to know before you use 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 is COXAFEN and what is it 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 after cataract surgery in adults.

2. What you need to know before you use COXAFEN

Do not use COXAFEN

• 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 while 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 COXAFEN.

Children and adolescents
COXAFEN should 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, 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 COXAFEN.
COXAFEN should 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.
COXAFEN can 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 has returned to normal.

3. How to use COXAFEN

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 COXAFENin 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
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 put the others back 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.
• Gently press on the single-dose container to release one drop of COXAFEN.

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

If you use more COXAFEN 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 COXAFEN, a glass of water or other liquid should be drunk 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 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 COXAFEN
Do not stop using COXAFEN without consulting your doctor.
Upon discontinuation of COXAFEN, a resurgence of the inflammatory response, such as retinal swelling, has been observed in rare cases, following cataract surgery.
If you have any doubts about using COXAFEN, 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, 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.

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 that 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.
COXAFEN eye 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 the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

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

• The active substance is bromfenac. One ml of solution contains 0.9 mg of bromfenac (as sodium sesquidrate). 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 COXAFEN and contents of the pack
COXAFEN is a clear yellow liquid (solution) Supplied in a carton containing 20 or 30 single-dose containers
of 0.25 ml divided into strips, 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)

COXAFEN 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 their symptoms are the same as yours, 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 COXAFEN is and what it is used for
• 8. What you need to know before you use 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 is COXAFEN and what is it 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 after cataract surgery in adults.

8. What you need to know before you use COXAFEN

Do not use COXAFEN:

• 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 while 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 undesirable 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 COXAFEN.

Children and adolescents
COXAFEN should 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, 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 COXAFEN.
COXAFEN should 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.
COXAFEN can 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 has returned to normal.

COXAFEN 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 reinserting 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 any abnormal eye sensation, burning
or pain after using this medicine, talk to your doctor.

9. How to use COXAFEN

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 COXAFEN in 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
COXAFEN is for ophthalmic use.
COXAFEN eye 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 facing downwards, between your thumb and other fingers.
• Recline your head backwards.
• 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, the surrounding areas or other surfaces with the dropper.
• Press lightly on the bottle to release one drop of Luminac.
• 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 COXAFENand using another
eye drop.
Duration of treatment
Continue to use the eye drops for the first 2 weeks after surgery. Do not use COXAFEN for more than 2 weeks.

If you use more COXAFEN 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 COXAFEN, a glass of water or other liquid should be drunk 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 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 COXAFEN
Do not stop using COXAFEN without consulting your doctor.
Upon discontinuation of COXAFEN, 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 using COXAFEN, 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
• irritation or pain in the eye
• 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
• 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 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 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 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.
COXAFEN eye 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 designated 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 COXAFEN contains
COXAFEN eye 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 COXAFEN and contents of the pack
COXAFEN is a clear yellow liquid (solution) supplied in a pack containing 1 LDPE dropper bottle
of 5.0 ml.

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

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