Consumer Information for: TEVA-CYCLOSPORINE
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
TEVA-CYCLOSPORINE is used to treat certain patients whose eyes are not producing enough tears to keep the eye moist and comfortable.
What it does
TEVA-CYCLOSPORINE acts as a topical immunomodulator with anti-inflammatory effects.
When it should not be used
TEVA-CYCLOSPORINE should not be used if
- you have an eye infection
- you are hypersensitive to cyclosporine or any of the other ingredients in the formulation (see What the non-medicinal ingredients are).
What the medicinal ingredient is
The active ingredient is cyclosporine.
What the non-medicinal ingredients are
The other ingredients in the formulation are carbomer copolymer type A, castor oil, glycerin, polysorbate 80, purified water and sodium hydroxide (to adjust pH).
What dosage form it comes in
TEVA-CYCLOSPORINE is available as a sterile ophthalmic emulsion, in a 0.4 mL single use plastic ampoule.
Warnings and precautions
BEFORE you use TEVA-CYCLOSPORINE, talk to your doctor or pharmacist if:
You have a history of herpes keratitis. Cyclosporine ophthalmic emulsion has not been tested for use in people with this condition
Your dry eyes are the result of Vitamin A deficiency or scarring. Cyclosporine ophthalmic emulsion has not been studied in people with these causes of dry eyes.
You drive or operate machinery. TEVA-CYCLOSPORINE may cause your vision to blur right after you put the drops in. Wait a few minutes until your vision clears before you try to drive or operate a machine.
You are breast feeding a baby. It is not known whether or not cyclosporine is passed into breast milk.
You are pregnant or planning to become pregnant. While there are no known adverse effects on human pregnancy, there is very little information available, and you should decide with your doctor how best to proceed.
Do not administer TEVA-CYCLOSPORINE while you wear contact lenses. If you must wear contact lenses, remove the lenses before applying TEVA-CYCLOSPORINE. Wait for 15 minutes before you put your contact lenses back in.
You should also avoid touching the tip of the ampoule to the eye or any surface as this may contaminate the emulsion, or touching the eye may cause injury.
Interactions with this medication
No drug interaction studies have been performed with cyclosporine ophthalmic emulsion . Concomitant use with other eye products should be discussed with your doctor beforehand.
Proper use of this medication
Usual Adult Dose
The usual adult dose of TEVA-CYCLOSPORINE is one drop into each affected eye. This dose should be applied twice a day – about 12 hours apart.
Before using, gently shake the ampoule by tipping it up and down a few times until the emulsion is white and appears the same throughout the ampoule.
Each individual, single-use ampoule should be used immediately after opening for administration to one or both eyes, and the remaining contents discarded immediately after administration.
TEVA-CYCLOSPORINE may be used together with artificial tears. Wait 15 minutes between using TEVA-CYCLOSPORINE and the artificial tear product.
Overdose
Missed Dose
If you miss a dose, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule. Do not double your dose.
Side effects and what to do about them
Ocular burning is a very common (≥1/10) adverse event with TEVA-CYCLOSPORINE. Other common events (≥1/100) are eye irritation, headache, foreign body sensation in eye, ocular / conjunctival hyperaemia (redness), eye pain, eye stinging, eye discharge, photophobia, eye pruritus, blurred vision, dry eye. These events usually get better on their own, as your eye becomes used to treatment with TEVA-CYCLOSPORINE.
There is the potential to experience an allergic reaction to TEVA-CYCLOSPORINE. Reactions of face swelling, tongue swelling, throat swelling, shortness of breath and itchy skin rash have been reported with the use of cyclosporine ophthalmic emulsion. If an allergic reaction occurs, discontinue the drug and contact your physician.
This is not a complete list of side effects. For any unexpected effects while taking TEVA-CYCLOSPORINE, contact your doctor or pharmacist.
How to store
TEVA-CYCLOSPORINE should be stored at 15-25ºC. Keep unused ampoules in foil envelope until use.
Keep out of 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 (www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) for information on how to report online, by mail or by fax; or
- Calling 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 document plus the full product monograph, prepared for 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
Canada, M1B 2K9
www.tevacanada.com
Date prepared: March 14, 2017
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