Patient Medication Information: uses, side effects, how to take - Eugia-Bromfenac
ABOUT THIS MEDICATION
What the medication is used for:
Eugia-Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) used for treatment of pain and inflammation (swelling and redness) following cataract eye surgery.
What it does:
Eugia-Bromfenac eye drops work by reducing the production of certain substances (for example, prostaglandins) that cause inflammation and pain.
When it should not be used:
Eugia-Bromfenac should not be used if you are allergic (hypersensitive) to bromfenac, or any of its nonmedicinal ingredients (See What the nonmedicinal ingredients are), or to other nonsteroidal anti- inflammatory medicines such as acetylsalicylic acid, difusinal, fenoprofen, flurbiprofen, ketoprofen, indomethacin, mefenamic acid, piroxicam, sulindac, tiaprofenic acid or tolmetin.
Eugia-Bromfenac contains sodium sulfite, which may cause allergic- type reactions. Eugia-Bromfenac should not be used if you are allergic or sensitive to sulfite.
What the medicinal ingredient is:
Bromfenac sodium sesquihydrate
What the nonmedicinal ingredients are:
Benzalkonium chloride, boric acid, edetate disodium, povidone, sodium borate, sodium sulfite, tyloxapol, sodium hydroxide, sodium sulfite and water.
What dosage forms it comes in:
Eugia-Bromfenac 0.07% is supplied in a 5 mL opaque white LDPE container with white LDPE nozzle and gray HDPE cap with a tamper-evident ring of 3 mL for commercial sizes.
WARNINGS AND PRECAUTIONS
BEFORE you use Eugia-Bromfenac talk to your doctor or pharmacist if:
- you have an allergy or sensitivity to sodium sulfite
- you have any allergies to any medications
- you take any blood thinning medications, or if you have any bleeding problems, or if you bruise easily
- you are allergic to acetylsalicylic acid or to any other nonsteroidal anti-inflammatory drugs (NSAIDS)
- you wear contact lenses
you are pregnant or intend to become pregnant
- you are breastfeeding or intend to breast-feed
- you have been recently had major ocular surgeries or repeated ocular surgeries within a short period of time,
- you have corneal problems, ocular surface diseases (e.g., dry eye syndrome)
- you suffer from diabetes mellitus or rheumatoid arthritis
your vision is blurred after taking Eugia-Bromfenac, do not drive or operate machinery until your vision clears.
WHILE taking Eugia-Bromfenac talk to your doctor if:
- you are not getting relief, your symptoms worsen, or new eye problems develop.
Do not use Eugia-Bromfenac more than two weeks unless advised by your doctor. There is risk of corneal problems if ophthalmic nonsteroidal anti-inflammatory drugs such as Eugia-Bromfenac are used beyond 14 days after the surgery.
In rare cases, you may experience a flare-up of inflammation after you stop taking Eugia-Bromfenac, due to your cataract surgery. Your doctor may need to monitor your eyes for signs of macular oedema (a build up of fluid in the eye) after you stop taking Eugia-Bromfenac.
INTERACTIONS WITH THIS MEDICATION
No specific drug interaction studies have been done for Eugia-Bromfenac.
Tell your doctor or pharmacist if you are taking any blood- thinning medication.
PROPER USE OF THIS MEDICATION
Usual adult dose:
The day before cataract surgery, one drop of Eugia-Bromfenac ophthalmic solution should be applied to the affected eye. On the day of cataract surgery, and for up to 14 days after cataract surgery, one drop of Eugia-Bromfenac once daily should be applied to the affected eye. Follow your physician instructions.
If you are using other eye medicines as directed by your doctor, these medicines should be applied at least 5 minutes apart.
Proper Use:
Eugia-Bromfenac should not be applied while wearing contact lenses. Remove contact lenses prior to applying Eugia-Bromfenac. The preservative in Eugia-Bromfenac, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 15 minutes after applying Eugia-Bromfenac.
To minimise the chance of contamination of the content, replace the bottle cap immediately after use and avoid touching the eyelids, surrounding areas or other surfaces with the dropper tip of the bottle. A single bottle of Eugia-Bromfenac is used to treat only one eye.
Discard any unused eye drops 28 days after opening.
How to Use:
- 1. Wash your hands well with soap and water before you start.
- 2. Tilt your head back or lie down.
- 3. Pull down your eyelid to create a “pocket” between the eyelid and the eye. The drop will go in here.
- 4. Hold the bottle upside down, not touching the eye, and allow the drop to fall in the “pocket”.
- 5. Let go of the eyelid, close the eye for about 30 seconds. Try not blink or squeeze your eyelids.
- 6. Put the cap (top) back on the bottle.
- 7. If a drop misses your eye, try again.
Overdose:
| If you think you, or a person you are caring for, have taken too much Eugia-Bromfenac, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. |
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Missed Dose:
If a dose is missed, it should be applied as soon as possible.
Do not take 2 doses to make up for the missed dose.
If it is almost time for the next dose, the missed dose should be skipped, and you should go back to your regular dosing schedule.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
The most common side effects experienced by patients taking Eugia-Bromfenac were inflammation of the eye and eye pain.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
|---|---|---|---|---|
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and seek immediate medical help | ||
| Only if severe | In all cases | |||
| Common | inflammation of the eye | √ | ||
| eye pain | √ | |||
| Macular oedema (swelling and build-up of fluid in the center of the retina): blurry vision, blurry or wavy vision near or in the center of your field of vision, colors may appear washed out or faded. | √ | |||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
HOW TO STORE IT
Store at room temperature between 15ºC - 25ºC. Discard 28 days after opening.
Keep this medication out of the reach and sight of children.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
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MORE INFORMATION
If you want more information about Eugia-Bromfenac:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website:
(https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website http://www.eugiapharma.com or by calling at 1-855-648-6681.
Eugia Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.