Details for: TEVA-LATANOPROST
Company: TEVA CANADA LIMITED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02254786 | TEVA-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
TEVA-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
TEVA-LATANOPROST is a solution for use only in the eyes. The active ingredient in TEVA-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 TEVA-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 nonmedicinal ingredients are).
What the medicinal ingredient is
Latanoprost
What the non-medicinal ingredients are
sodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous, sodium chloride, water for injection, sodium hydroxide and hydrochloric acid and benzalkonium chloride as a preservative.
What dosage form it comes in
TEVA-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 TEVA-LATANOPROST talk to your doctor or pharmacist if:
- You are allergic to any of the ingredients in TEVALATANOPROST.
- 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)
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 latanoprost ophthalmic
solution. 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, TEVA-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 TEVA-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.
TEVA-LATANOPROST is not recommended for use in
children.
Follow these steps to help you use TEVA-LATANOPROST
properly:
- 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.
Overdose
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
TEVA-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.,
blue-brown, grey-brown, green-brown or yellow-brown. If you
use TEVA-LATANOPROST in one eye only, colour changes in
the iris may appear only in the treated eye. These changes may be
permanent.
TEVA-LATANOPROST may also cause your eye lashes to
darken, appear thicker and longer than they usually do and
increase in number. TEVA-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 TEVA-LATANOPROST for
some time. These changes may be more noticeable if you are
only treating one eye. Eyelash changes are reversible after
treatment with TEVA-LATANOPROST is stopped. Eyelid skin
darkening may be permanent.
When using TEVA-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 latanoprost ophthalmic solution
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 TEVA-LATANOPROST and contact your
doctor immediately.
Dizziness and headache have also been reported.
TEVA-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
| 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 |
|---|---|---|---|
| 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 TEVA-LATANOPROST contact your doctor or pharmacist.
How to store
Before TEVA-LATANOPROST is first opened, keep it in a
fridge (between 2ºC and 8ºC/36ºF and 46ºF), out of direct light.
During shipment, the bottle may be maintained at temperatures
up to 40ºC (104ºF) for a period not exceeding 8 days. Once the
bottle has been opened, TEVA-LATANOPROST may be kept at
room temperature up to 25ºC. TEVA-LATANOPROST must be
used within 6 weeks after opening the bottle. Discard the bottle
and/or unused contents after 6 weeks. TEVA-LATANOPROST
should not be used after the expiry date on the bottle. Avoid
freezing.
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 three 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 ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM 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
health professionals can be found by contacting Teva
Canada Limited by:
Phone: 1-800-268-4127 ext. 3;
Email: druginfo@tevacanada.com; or
Fax: 1-416-335-4472
This leaflet was prepared by:
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Canada
www.tevacanada.com
Last revised: January 31, 2019