Patient Medication Information: uses, side effects, how to take - Pro-Bimatoprost Rc
What is PRO-BIMATOPROST RC used for?
PRO-BIMATOPROST RC eye drops are used to reduce high pressure in the eye in adult patients with open-angle glaucoma or ocular hypertension. If the high pressure is not reduced, it could eventually damage your sight.
How does PRO-BIMATOPROST RC work?
PRO-BIMATOPROST RC is an antiglaucoma preparation. It belongs to a group of medicines called prostamides. Your eye contains a clear, watery liquid that feeds the inside of the eye. Liquid is constantly being drained out of the eye and new liquid is made to replace this. If the liquid cannot drain out quickly enough, the pressure inside the eye builds up. PRO-BIMATOPROST RC works by increasing the flow of liquid that is drained. This reduces the pressure inside the eye.
What are the ingredients in PRO-BIMATOPROST RC?
Medicinal ingredient: bimatoprost
Non-medicinal ingredients: benzalkonium chloride 0.02 % w/v as preservative, citric acid monohydrate, sodium chloride, sodium phosphate dibasic (heptahydrate), and water for injection. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH.
PRO-BIMATOPROST RC comes in the following dosage forms:
Ophthalmic solution, 0.01% w/v
Do not use PRO-BIMATOPROST RC if:
- you are allergic to bimatoprost, to any of the other ingredients, or to any of the parts of the container (see section What are the ingredients in PRO-BIMATOPROST RC?).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you use PRO-BIMATOPROST RC. Talk about any health conditions or problems you may have, including if you:
- are taking, or have recently taken, any other medicines. Using PRO-BIMATOPROST RC with other medicines or other antiglaucoma products may reduce their effectiveness.
are pregnant or planning to become pregnant. You should ask your healthcare professional for advice before taking any medicine.
- are breastfeeding or plan to breastfeed. Ask your healthcare professional how to feed your baby while using PRO-BIMATOPROST RC.
- have an active eye infection, inflammation (e.g. uveitis) or any other eye or eyelid condition.
- develop another eye condition (an injury or an infection).
- have severe dry eyes.
- need to have eye surgery.
- have liver or kidney problems.
Other warnings you should know about:
Changes in eye and eyelid color:
PRO-BIMATOPROST RC has been associated with iris pigmentation (change in the colored part of the eye). This is likely to be permanent. The change may be more noticeable if you are only treating one eye. Using too much PRO-BIMATOPROST RC (overdose) may contribute to iris pigmentation. PRO-BIMATOPROST RC use may also cause darkening of the eyelid skin which may be reversible in most patients.
Hair growth:
It is possible for hair growth to occur in areas of your skin that PRO-BIMATOPROST RC frequently touches. Any excess solution that drips from the eye should be blotted with a tissue or other absorbent material to reduce the chance of this from happening. It is also possible for a difference in eyelash length, thickness, fullness, pigmentation, number of eyelash hairs, and/or direction of eyelash growth to occur between eyes. These differences, should they occur, will usually go away if you stop using PRO-BIMATOPROST RC.
Changes in vision:
Using PRO-BIMATOPROST RC may temporarily blur your vision. Do not drive or use machines until your vision has cleared.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with PRO-BIMATOPROST RC:
No drug interaction studies have been done with PRO-BIMATOPROST RC.
How to use PRO-BIMATOPROST RC:
- Do not use the bottle if the tamper-proof seal on the bottle neck is broken before you first use it.
- Always use PRO-BIMATOPROST RC exactly as your healthcare professional has instructed you.
- PRO-BIMATOPROST RC contains a preservative called benzalkonium chloride which may discolor soft contact lenses. If you wear contact lenses, remove them before using PRO-BIMATOPROST RC. Wait 15 minutes after using the drops before you put your lenses back in.
- If you use PRO-BIMATOPROST RC with another eye drop, wait at least five minutes after using PRO-BIMATOPROST RC before using the other drops.
- To help prevent infections, do not let the tip of the bottle touch your eye or anything else. Put the cap back on and close the bottle immediately after you have used it.
Follow these steps to use PRO-BIMATOPROST RC properly:
- Wash your hands. Tilt your head back and look at the ceiling. (See Illustration 1)
- Gently pull down the lower eyelid to create a small pocket. (See Illustration 2)
- Turn the bottle upside down and squeeze it gently to release one drop into the eyelid pocket. If a drop misses your eye, try again. (See Illustration 3)
- Let go of the lower lid, and close your eye for 30 seconds. (See Illustration 4)
- Repeat steps 1 to 4 in the other eye if both eyes need treatment.
Usual dose:
Adults: One drop of PRO-BIMATOPROST RC in each eye that needs treatment, once every day, in the evening.
Overdose:
If you accidentally use too many drops, just go back to your regular once a day dosing the next day.
If you think you, or a person you are caring for, have taken too much PRO-BIMATOPROST RC, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed Dose:
If you forget to take PRO-BIMATOPROST RC, use a single drop as soon as you remember, and then go back to your regular routine. Do not take two doses to make up for the one that you missed.
What are possible side effects from using PRO-BIMATOPROST RC?
These are not all the possible side effects you may have when using PRO-BIMATOPROST RC. If you experience any side effects not listed here, tell your healthcare professional.
Like all medicines, PRO-BIMATOPROST RC can have side effects. Most of the side effects are not serious. If these persist or cause you concern, consult your healthcare professional.
Side effects may include:
- Darkening of the eyelid
- Eye irritation, redness, itching
- Excessive hair growth
- Longer eyelashes, change in eyelash color
- Red and/or itchy eyelids
- Small breaks in the surface of the eye
- Deepening and drooping of the eyelid
Some patients (fewer than 2 in every 100) experience a change in iris color (iris pigmentation). The change is a darkening, with the eyes becoming browner. This usually happens during the first year of treatment. Eye color darkening is expected to increase as long as PRO-BIMATOPROST RC is used. It is not known what this change means over the long term. Talk to your healthcare professional if you notice a change in your iris color.
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.
Reporting Side Effects You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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.
Storage:
PRO-BIMATOPROST RC should be stored in the original container at 2°C to 25°C.
Discard 28 days after opening
Do not use the drops after the expiry date (marked “EXP”) on the bottle and the box.
Keep out of reach and sight of children.
If you want more information about PRO-BIMATOPROST RC:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug- products/drug-product-database.html; or by contacting Pro Doc Ltée at 1-800-361-8559, www.prodoc.qc.ca or medinfo@prodoc.qc.ca.