Patient Medication Information: uses, side effects, how to take - Apo-Bromfenac
ABOUT THIS MEDICATION
What the medication is used for:
APO-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:
APO-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:
APO-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.
APO-BROMFENAC contains sodium sulfite, which may cause allergic- type reactions. APO-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 (0.005% as a preservative), boric acid, EDTA dihydrate, povidone, sodium borate, sodium hydroxide (to adjust pH), sodium sulfite, tyloxapol, water for injection.
What dosage forms it comes in:
APO-BROMFENAC is supplied as a sterile bromfenac ophthalmic solution 0.07% w/v (as bromfenac sodium sesquihydrate) in a white opaque LDPE plastic bottle with a white translucent LDPE dropper and gray opaque HDPE plastic cap. Available in 1.6 mL and 3 mL.
WARNINGS AND PRECAUTIONS
BEFORE you use APO-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 APO-BROMFENAC, do not drive or operate machinery until your vision clears.
WHILE taking APO-BROMFENAC talk to your doctor if:
- you are not getting relief, your symptoms worsen, or new eye problems develop.
Do not use APO-BROMFENAC more than two weeks unless advised by your doctor. There is risk of corneal problems if ophthalmic nonsteroidal anti-inflammatory drugs such as APO-BROMFENAC are used beyond 14 days after the surgery.
In rare cases, you may experience a flare-up of inflammation after you stop taking APO-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 APO-BROMFENAC.
IMPORTANT: PLEASE READ
INTERACTIONS WITH THIS MEDICATION
No specific drug interaction studies have been done for APO-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 APO-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 APO-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:
APO-BROMFENAC should not be applied while wearing contact lenses. Remove contact lenses prior to applying APO-BROMFENAC. The preservative in APO-BROMFENAC, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 15 minutes after applying APO-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 APO-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 APO-BROMFENAC, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
|---|
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 APO-BROMFENAC were inflammation of the eye and eye pain.
SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT THEM
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | ||
|---|---|---|---|---|
| Only if severe | In all cases | |||
| Common | Inflamm-ation 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 | √ | |||
IMPORTANT: PLEASE READ
SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT THEM
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |||
|---|---|---|---|---|---|
| Only if severe | In all cases | ||||
| 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 15°C - 25°C.
Discard 28 days after opening.
Keep out of 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. |
|---|
MORE INFORMATION
If you want more information about APO-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). Find the Consumer Information on the manufacturer’s website (http://www.apotex.ca/products), or by calling 1-800-667-4708.
Last Approved: May 4, 2023