Patient Medication Information: uses, side effects, how to take - Teva-Olopatadine
ABOUT THIS MEDICATION
What the medication is used for:
TEVA-OLOPATADINE Solution is used for the prevention and treatment of signs and symptoms of allergic conjunctivitis.
Allergic conjunctivitis: Some materials (allergens) like pollens, house dust or animal fur may cause allergic reactions resulting in itching, redness as well as swelling of the surface of your eye.
What it does:
TEVA-OLOPATADINE Solution is a medicine for treatment and control of allergic conditions of the eye. It works in two different ways by reducing and controlling the intensity of the allergic reaction.
When it should not be used:
TEVA-OLOPATADINE Solution should not be used if you are allergic (hypersensitive) to olopatadine hydrochloride or any of the other ingredients which are listed below. Tell your doctor if you have allergies.
What the medicinal ingredient is:
olopatadine hydrochloride
What the important nonmedicinal ingredients are: Other ingredients include: benzalkonium chloride, sodium chloride, dibasic sodium phosphate, and water for injection. Hydrochloric acid or sodium hydroxide are some times added to maintain proper pH balance.
What dosage forms it comes in:
TEVA-OLOPATADINE Solution is a clear sterile liquid (solution) supplied in a plastic bottle with a screw cap. It is available as 5mL.
WARNINGS AND PRECAUTIONS
This medication must not be taken by mouth.
BEFORE you use TEVA-OLOPATADINE Solution talk to your doctor if:
You have any allergies to TEVA-OLOPATADINE Solution or any of its ingredients or components of the container.
Do not use TEVA-OLOPATADINE Solution in children under the age of three years.
If you wear contact lenses
Do not use the drops while your contact lenses are in your eyes. Wait at least ten minutes after using the eye drops before putting your lenses back into your eyes. A preservative in TEVA-OLOPATADINE Solution (benzalkonium chloride) can affect soft lenses.
Pregnancy or breast-feeding
If you are pregnant, or might get pregnant, talk to your doctor before you use TEVA-OLOPATADINE Solution. If you are breast - feeding, do not use TEVA-OLOPATADINE Solution; it may get into your milk.
Driving and using machines
You may find that your vision is blurred for a time just after you use TEVA-OLOPATADINE Solution. Do not drive or use machines until your vision is clear.
INTERACTION WITH THIS MEDICATION
Please tell your doctor if you are taking or have recently taken any other medicines, even products you have bought yourself without prescription.
PROPER USE OF THIS MEDICATION
Usual dose:
The recommended dose is one to two drops in each affected eye twice daily.
Directions for Use:
- 1. Get the bottle of TEVA-OLOPATADINE Solution ready, along with a mirror, if needed.
- 2. Wash your hands.
- 3. Take the bottle and twist off the cap, being careful not to touch the dropper tip.
- 4. Hold the bottle, pointing it down, between your thumb and middle finger.
- 5. Tilt your head back and look at the ceiling. Pull down your eyelid with a clean finger, until there is a ‘pocket’ between the eyelid and your eye. The drop will go in there.
- 6. Bring the bottle tip close to the eye. Use the mirror if it helps.
- 7. Gently press the bottom of the bottle with your forefinger to release one drop at a time. Don’t touch your eye or eyelid, surrounding areas or other surfaces with the dropper. It could
| IMPORTANT: PLEASE READ |
Page 18 infect the drops left in the bottle. Don’t squeeze the bottle: it is designed so that just a gentle press on the bottom is needed.
- 8. If you use drops in both eyes, repeat the steps for the other eye.
- 9. Put the bottle cap firmly back on immediately after use.
Overdose:
If you get too much in your eyes, rinse it all out with warm water. Don’t put in any more drops until it’s time for your next regular dose. In the event of overdosage, contact your doctor, hospital emergency department or regional Poison Control Centre.
Missed Dose:
If you forget to use TEVA-OLOPATADINE Solution, use a single drop as soon as you remember, and then go back to your regular routine. Do not use a double dose to make up for the one missed.
If you are using other eye drops, wait at least five to ten minutes between putting in TEVA-OLOPATADINE Solution and the other drops.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
A small number of people who use TEVA-OLOPATADINE Solution may get side effects. They can be unpleasant, but most of them disappear rapidly.
You can usually continue using the drops, unless the effects are serious. If you're worried, talk to a doctor or pharmacist.
The most frequent side effect is discomfort in the eye such as burning, stinging, dryness, irritation, swelling and sensitivity to light, or headache. These have been reported by less than one (1) in 100 people.
If you notice any side effects, other than discomfort, please inform your doctor or pharmacist.
HOW TO STORE IT
Store between 4-30°C. Protect from direct sunlight. Discard container at the end of treatment. Keep out of the reach of children.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
-------------------------------------------------------------------------- $ Report online at www.healthcanada.gc.ca/medeffect $ Call toll-free at 1-866-234-2345
$ Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
Mail to: Canada Vigilance Program Health Canada
Postal Locator 0701E
Ottawa, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Teva Canada Limited at:
1-800-268-4127 ext. 5005 (English);
1-877-777-9117 (French)
or druginfo@tevacanada.com
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9