Details for: GD-LATANOPROST
Company: UPJOHN CANADA ULC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02373041 | GD-LATANOPROST | LATANOPROST | 50 MCG / ML | 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
GD-LATANOPROST is used to treat ocular hypertension (high pressure in the eye) in patients with open-angle glaucoma or ocular hypertension. These conditions may eventually affect your eyesight.
What it does
GD-LATANOPROST is a solution for use only in the eyes. The active ingredient in GD-LATANOPROST is one of a group of medications known as prostaglandins. It helps to lower the pressure within the eye by increasing the natural outflow of fluid from inside the eye.
When it should not be used
Do not use GD-LATANOPROST if you have a known hypersensitivity to benzalkonium chloride or any other ingredient in this product (see What the medicinal ingredient is and What the important nonmedicinal ingredients are).
What the medicinal ingredient is
Latanoprost
What the non-medicinal ingredients are
benzalkonium chloride, sodium chloride, sodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous, water for injection
What dosage form it comes in
GD-LATANOPROST is supplied in a 5 mL plastic ophthalmic dispenser bottle. Each bottle contains 2.5 mL of solution, approximately 80 drops. Each millilitre (mL) contains 50 micrograms of latanoprost.
Warnings and precautions
BEFORE you use GD-LATANOPROST talk to your doctor or pharmacist if:
- You are allergic to any of the ingredients in GDLATANOPROST.
- You are using any other eye drops or taking any other medication.
- You are pregnant, think you might be pregnant or you are planning a pregnancy.
- You are breast feeding or planning to breastfeed
- You have or have had herpes simplex keratitis (inflammation of the cornea caused by the herpes simplex virus).
- Your eyes are sensitive to light.
- You have liver or kidney problems
- You have or have had eye inflammation (e.g. uveitis, iritis)
GD-LATANOPROST contains a preservative that may be absorbed by contact lenses and stains them a brown colour. Contact lenses can be reinserted 15 minutes after applying the eye drops.
If you are using more than one type of eye drop medication, wait at least 5 minutes between each different eye drop.
Interactions with this medication
Studies have shown that precipitation occurs when eye drops containing thimerosal are mixed with GD-LATANOPROST. If such drugs are used, they should be administered with an interval of at least 5 minutes between applications.
Only on your doctor’s advice, GD-LATANOPROST may be used concomitantly with other topical ophthalmic products to further lower intraocular pressure. If more than one topical ophthalmic drug is being used, the drugs should be administered at least 5 minutes apart.
Proper use of this medication
Usual Dose
One drop of GD-LATANOPROST should be dropped into the affected eye(s) once daily. The best time to do this is in the evening.
Do not allow the dropper tip of the bottle to touch the eye or other surrounding structures, because this could contaminate the tip with common bacteria known to cause eye infections. Serious damage to the eye with subsequent loss of vision may result if you use eye drop solutions that have become contaminated. If you experience any type of eye condition or have surgery, immediately seek your doctor's advice concerning the continued use of the bottle you are using.
If you forget to use your eye drops at the usual time, wait until it is time for your next dose. If you put too many drops in your eye(s), you may feel some slight irritation.
GD-LATANOPROST is not recommended for use in children.
- Wash your hands and sit or stand comfortably. If you wear contact lenses, remove them before using your eye drops.
- Once the bottle is opened, hold it in one hand and steady your thumb against your brow or the bridge of your nose.
- Use your index finger to gently pull down the lower eyelid of the affected eye(s) to create a pocket for the drop.
- Gently press the side of the bottle to allow only a single drop to fall into the pocket. Do not let the tip of the bottle touch your eye.
- Close your eye for 2 to 3 minutes.
- If your doctor has told you to use drops in both eyes, repeat the process for the other eye. GD-LATANOPROST should be used until your doctor tells you to stop.
Overdose
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose
If one dose is missed, treatment should continue with the next dose the following day.
Side effects and what to do about them
GD-LATANOPROST may change the colour of your eye. It may make your iris (the coloured part of your eye) more brown. This happens most commonly if your iris has mixed colours, i.e., bluebrown, grey-brown, green-brown or yellow-brown. If you use GD-LATANOPROST in one eye only, colour changes in the iris may appear only in the treated eye. These changes may be permanent.
GD-LATANOPROST may also cause your eye lashes to darken, appear thicker and longer than they usually do and increase in number. GD-LATANOPROST might cause eye irritation due to the growth of misdirected eyelashes; tell your doctor if this happens. A very small number of people may notice their eyelids look darker after using GD-LATANOPROST for some time. These changes may be more noticeable if you are only treating one eye. Eyelash changes are reversible after treatment with GDLATANOPROST is stopped. Eyelid skin darkening may be permanent.
When using GD-LATANOPROST, you might feel as if there is something in your eye(s). Your eye(s) might water and become red. You may also develop a small cyst in your iris. As with other eye drops, if your vision is blurred when you first put your drops in, wait until this wears off before you drive or operate machinery. A few people using GD-LATANOPROST have developed a skin rash.
A few people may experience changes in their vision, sometimes in combination with a red and sore/painful eye. These changes do not always occur right after administering the drops, and if they occur, you may find that reading and seeing fine details is more difficult. Although unlikely, if you experience any of these changes, stop using GD-LATANOPROST and contact your doctor immediately.
Dizziness and headache have also been reported.
GD-LATANOPROST may cause the following side effects as well.
Common Ocular Side Effects: burning and stinging, blurred vision, red eyes, foreign body sensation, itching, increased iris pigmentation, damage of the cornea in a pinpoint pattern, dry eyes, excessive tearing, eye pain, eye lid crusting, red and swollen eyelid, eyelid discomfort/ pain, photophobia (visual sensitivity to light).
Uncommon Ocular Side Effects: discharge from the eye, diplopia (doubled vision), conjunctivitis, iritis/uveitis (inflammation of the interior of the eye), darkening of the palpebral skin (skin related to the eyelid), iris cyst (small cyst appearing in the colored part of the eye), disorder of the conjunctiva.
Common Systemic Side Effects: upper respiratory tract infection/ cold/ flu, pain in muscle/ joint/ back, chest pain/angina pectoris, rash/ allergic skin reaction
Be sure to tell your doctor (or pharmacist) if you notice any other unwanted side effects.
| 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 |
|---|---|---|---|
| Uncommon ocular adverse events | |||
| Macular edema: blurred or wavy vision in the middle of the eye and colors perception changes | ✔ | ||
| Herpetic keratitis: Infection and infestations of the eyes (blurred vision, pain, redness, tearing, discharge, sensitivity to lights) | ✔ | ||
| Uncommon Systemic Adverse Events | |||
| Asthma/ Asthma aggravation/ Acute asthma attack/ Difficulty to breath | ✔ | ||
| Severe skin reactions including rash and skin degradation in different parts of the body | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking GD-LATANOPROST, contact your doctor or pharmacist.
How to store
Before GD-LATANOPROST is first opened, keep it in a fridge (between 2C and 8C/36F and 46F), out of direct light. Once the bottle has been opened, GD-LATANOPROST may be kept at room temperature up to 25C. GD-LATANOPROST must be used within 6 weeks after opening the bottle. Discard the bottle and/or unused contents after 6 weeks. GD-LATANOPROST should not be used after the expiry date on the bottle.
Keep all medicines in a safe place, out of the reach and sight of children.
Reporting 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 found at: http://www.pfizer.ca or by contacting the sponsor, Upjohn Canada ULC, at: 1-800-463-6001
This leaflet was prepared by Upjohn Canada ULC.
Last revised: May 5, 2020
Upjohn Canada ULC
Kirkland, Québec, H9J 2M5
® Pfizer Canada ULC
Upjohn Canada ULC, Licensee
© Upjohn Canada ULC, 2020