Consumer Information for: APO-OLOPATADINE

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

APO-OLOPATADINE 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

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, any of the other ingredients or components of the container (see What the non-medicinal ingredients are)

Tell your doctor if you have allergies.

Do not use APO-OLOPATADINE in children under the age of three years.

What the medicinal ingredient is

Olopatadine hydrochloride

What the non-medicinal ingredients are

Other ingredients include: benzalkonium chloride, sodium chloride, dibasic sodium phosphate, 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

APO-OLOPATADINE is a sterile clear, colourless liquid supplied in a plastic bottle with a screw cap. It is available as 5 mL (partial fill).

Warnings and precautions

Pregnancy or breast-feeding: If you are pregnant, or planning to become pregnant, talk to your doctor before you use APO-OLOPATADINE.

If you are breast-feeding, do not use APOOLOPATADINE; it may get into your breast 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 other eye drops. If you are using an eye ointment, you should apply it last.

Remove your contacts before applying APOOLOPATADINE and wait at least 15 minutes before putting your contacts back in.

Usual Dose

The recommended dose is one to two drops in each affected eye twice daily.

Instructions for use:

  1. Get the bottle of APO-OLOPATADINE 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. Press the side of the bottle lightly until a single drop is dispensed into the eye as directed by your doctor. Don’t touch your eye or eyelid, surrounding areas or other surfaces with the dropper. It could infect the drops left in the bottle.
  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 APOOLOPATADINE, 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 Ophthalmic 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.

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, spasm, swelling or dryness
  • 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
  • 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.

Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate medical help
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 APO-OLOPATADINE, contact your doctor or pharmacist.

How to store

Store at room temperature or between 4°C to 30°C. Discard the container at the end of 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:

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 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 ( https://www.canada.ca/en/healthcanada/services/drugs-health-products/drugproducts/drug-product-database.html); the manufacturer’s website http://www.apotex.ca/products, or by calling 1- 800-667-4708.

This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.

Last revised: August 7, 2018