Details for: APO-OLOPATADINE 0.2%
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02402823 | APO-OLOPATADINE | OLOPATADINE (OLOPATADINE HYDROCHLORIDE) | 0.2 % / W/V | SOLUTION | OPHTHALMIC |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
APO-OLOPATADINE is used for the treatment of itchy eyes associated with seasonal 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
APO-OLOPATADINE 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
APO-OLOPATADINE should not be used if you are
allergic (hypersensitive) to olopatadine hydrochloride
or any of the other ingredients (see What the nonmedicinal ingredients are).
Tell your doctor if you have allergies.
Do not use APO-OLOPATADINE in children under
the age of 16 years.
What the medicinal ingredient is
olopatadine hydrochloride
What the non-medicinal ingredients are
Other ingredients include: benzalkonium chloride, sodium phosphate dibasic anhydrous, edetate disodium, povidone, sodium chloride and water for injection. Tiny amounts of hydrochloric acid or sodium hydroxide are sometimes added to maintain proper pH balance.
What dosage form it comes in
Ophthalmic solution (eye drops), 0.2% w/v (means you get 0.2% medicine by weight in each liquid drop).
Warnings and precautions
BEFORE you use APO-OLOPATADINE talk to your doctor or pharmacist:
Pregnancy or breast-feeding
If you are pregnant, or planning to become pregnant, talk to your doctor before you use APOOLOPATADINE. If you are breast-feeding, do not use APO-OLOPATADINE; it may get into your milk
Use of APO-OLOPATADINE and use of contact lenses
- Do not wear contact lenses if your eyes are red.
- APO-OLOPATADINE contains a preservative, benzalkonium chloride, which may cause eye irritation and is known to discolour soft contact lenses. Do not use the drops while wearing contact lenses.
- Remove your contacts before applying APOOLOPATADINE and wait at least 15 minutes before putting your contacts back in.
Use of APO-OLOPATADINE with other eye drops or ointments
- If you use other eye drops, wait at least 5 minutes between putting in APO-OLOPATADINE and the other drops.
- Apply eye ointments last
Driving and using machines:You may find that your vision is blurred for a time just after you use APOOLOPATADINE. Do not drive or use machines until your vision is clear.
Interactions 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 or natural health products.
There are no known drugs that interact with APOOLOPATADINE.
Proper use of this medication
APO-OLOPATADINE is an eye drop. Only use it in your eye (s).
If you are using other eye drops, wait at least 5 minutes before putting in APO-OLOPATADINE and the other eye drops. If you are using an eye ointment, you should apply it last.
Usual Dose
Adults: 1 drop in each affected eye once daily.
Instructions for use:
1. Get the bottle APO-OLOPATADINE and a mirror, if needed
2. Wash your hands.
3. 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. 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 (Figure 1).
6. Bring the bottle tip close to the eye. Use the mirror if it helps. Do not touch your eye or eyelid, or any surface with the dropper. It could contaminate the drops, cause an eye infection and damage the eyes.
7. Gently press the bottom of the bottle with your forefinger to release one drop (Figure 2). Do not squeeze the bottle: it is designed so that just a gentle press on the bottom is all that it needs.
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 think you have used too much APO-OLOPATADINE, contact a healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
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.
Missed Dose
If you forget to use APO-OLOPATADINE, 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.
Side effects and what to do about them
A small number of people who use APOOLOPATADINE 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.
Side effects may include:
In the eye:
- eye problems such as dry, itchy, red, irritated or crusted eyes
- eye surface inflammation with or without surface damage
- eye discharge
- eye pain
- increased tear production
- eyelid redness, swelling
- sensitivity to light
- blurred vision
- staining in your eye
- burning, stinging or gritty feeling or a feeling as if something is trapped in the eye.
Other areas of your body:
- headache
- dizziness
- fatigue or tiredness
- nasal dryness
- increased heart rate
- a dry mouth
- a change in your sense of taste
- nausea
- red or itchy skin.
If you notice any side effects, other than discomfort, please inform your doctor or pharmacist.
| Symptom / effect | Talk with your doctor, nurse or pharmacist only if severe | Talk with your doctor, nurse or pharmacist in all cases | Stop taking drug and talk with your doctor or pharmacist |
|---|---|---|---|
| Rare: Allergic reactions: swelling of the mouth and throat, shortness of breath, hives, severe itching and rash | ✔ |
This is not a complete list of side effects. For any unexpected effects while taking APOOLOPATADINE, contact your doctor or pharmacist.
How to store
Store at room temperature or between 4°C to 30°C. Discard 30 days after opening.
Throw away the bottle at the end of your treatment. Keep 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:
- Visiting the Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax; or
- Call 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.
More information
This leaflet is part III of a three-part “Product Monograph” published when APO-OLOPATADINE was approved for sale in Canada and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about APO-OLOPATADINE. Contact your doctor or pharmacist if you have any questions about the drug.
If you want more information about APOOLOPATADINE:
- 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 www.canada.ca/en/healthcanada/services/drugs-health-products/drugproducts/drug-product-database.html the manufacturer’s website www.apotex.ca/products, or by calling 1-800-667-4708.
This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.
Last revised: November 02, 2018