Patient Medication Information: uses, side effects, how to take - Restasis Multidose
What is RESTASIS MULTIDOSE used for?
- It is used to treat certain patients who have a condition called aqueous deficient dry eye disease. If you have this condition your eyes do not produce enough tears to keep the eyes moist and comfortable. Your healthcare professional will decide if RESTASIS MULTIDOSE is right for you.
How does RESTASIS MULTIDOSE work?
RESTASIS MULTIDOSE contains cyclosporine. Cyclosporine is a medicine that changes your immune system. It reduces inflammation in the eye.
What are the ingredients in RESTASIS MULTIDOSE?
Medicinal ingredient: cyclosporine
Non-medicinal ingredients: carbomer copolymer type A, castor oil, glycerin, polysorbate 80, purified water and sodium hydroxide.
RESTASIS MULTIDOSE comes in the following dosage forms:
Ophthalmic emulsion, 0.05% w/v
Do NOT use RESTASIS MULTIDOSE if:
- you have an eye infection.
- you are allergic to cyclosporine or any of the other ingredients in RESTASIS MULTIDOSE.
- you are allergic to any component of the RESTASIS MULTIDOSE container.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take RESTASIS MULTIDOSE. Talk about any health conditions or problems you may have, including if you:
- have or have had herpes keratitis (infection of the cornea). RESTASIS MULTIDOSE has not been tested for use in people with this condition.
- have been told that you have a condition where you are not producing enough tears (called end stage lacrimal gland disease).
- have dry eyes (also known as keratoconjunctivitis sicca) that are the result of Vitamin A deficiency or scarring (which could occur as a result of a blistering disorder, chemical burns, skin disorders, eye infections, or being exposed to radiation). RESTASIS MULTIDOSE has not been studied in people with these causes of dry eyes.
drive or operate machinery. RESTASIS MULTIDOSE may cause your vision to blur right after you put the drops in. Wait until your vision clears before you drive or operate a machine.
are breastfeeding a baby. It is not known if RESTASIS MULTIDOSE passes into breast milk.
- are pregnant or planning to become pregnant.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with RESTASIS MULTIDOSE:
No drug interaction studies have been performed with RESTASIS MULTIDOSE. Concomitant use with other eye products should be discussed with your healthcare professional beforehand.
How to take RESTASIS MULTIDOSE:
- Before using, gently shake the bottle by turning it upside down a few times to make sure the emulsion is mixed well. When mixed well, the emulsion will be white and appear the same throughout the bottle.
- You should avoid touching the tip of the bottle to the eye or any surface as this may contaminate the emulsion and touching the eye may cause injury.
- RESTASIS MULTIDOSE may be used together with artificial tears. Wait 15 minutes between using RESTASIS MULTIDOSE and the artificial tear product.
- Do not administer RESTASIS MULTIDOSE while you wear contact lenses. If you must wear contact lenses, remove the lenses before applying RESTASIS MULTIDOSE. Wait for 15 minutes before you put your contact lenses back in.
Parts of your RESTASIS MULTIDOSE bottle
Preparation for First-Time Use
Step 1: Pull off shipping cover by pulling straight up. Throw the shipping cover away. Do not use RESTASIS MULTIDOSE if shipping cover or pull tabs are damaged or missing.
Step 2: Remove the pull tab on the olive green colored protective cap by pulling the end of the pull tab away from the bottle then winding it counterclockwise. Throw away the pull tab.
Step 3: Remove the olive green colored protective cap by pulling it straight up. Keep the colored protective cap.
Step 4: Prime the bottle for first time use by holding the bottle with the tip pointing down. Slowly squeeze the bottle to deliver one drop onto a tissue to get used to the pressure and time required to deliver one drop. Do this twice. Let the bottle reinflate between drops. Do not let the bottle tip touch the tissue.
Step 5: The bottle is now ready for use. After use, recap the bottle with the olive green colored protective cap by pushing straight down onto the bottle.
Preparation for Use:
Step 6: Turn the bottle upside down a few times before giving your dose to make sure the medicine is mixed well.
Step 7: Hold the bottle with the tip pointing down and squeeze the bottle gently in the middle to let one drop fall into the eye you are treating. Please note that there might be a few seconds delay between squeezing and the drop coming out.
Do NOT squeeze the bottle too hard to avoid releasing too many drops. Once administered, replace the olive green colored protective cap.
By design, there may be a small quantity of RESTASIS MULTIDOSE remaining in the bottle at the end when used as directed. Do NOT try to use the remaining quantity in the bottle.
Follow these steps to use RESTASIS MULTIDOSE properly:
- Wash your hands. Tilt your head back and look at the ceiling. (See Picture 1)
- Gently pull down the lower eyelid to create a small pocket. (See Picture 2)
- Turn the vial upside down and squeeze it gently to release one drop into the eyelid pocket. If a drop misses your eye, try again. (See Picture 3)
- Let go of the lower lid and close your eye for 30 seconds. (See Picture 4)
- Repeat steps 1 to 4 in the other eye if both eyes need treatment.
Usual dose:
The usual adult dose of RESTASIS MULTIDOSE is one drop into each eye you are treating. This dose should be applied twice a day, about 12 hours apart.
Overdose:
If you use more RESTASIS MULTIDOSE than you should, rinse your eye with warm water. Do not put in any more drops until it is time for your next regular dose.
| If you think you, or a person you are caring for, have used too much RESTASIS MULTIDOSE, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
|---|
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 take a double dose to make up for a missed dose.
What are possible side effects from using RESTASIS MULTIDOSE?
These are not all the possible side effects you may have when taking RESTASIS MULTIDOSE. If you experience any side effects not listed here, tell your healthcare professional.
- accidental injury to the surface of the eye caused by the tip of bottle touching the eye
- burning sensation in the eye
- blurred vision
- dry eye
- eye discharge
- eye irritation
- eye itching
- eye pain
- eye redness
- eye sensitivity to light
- eye swelling
- feeling of grittiness or having something in the eye
- headache
- sore throat
- runny nose
- ear pain
| Serious side effects and what to do about them | |||
|---|---|---|---|
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| UNKNOWN | |||
| Allergic reactions: difficulty breathing, hives, shortness of breath, tongue swelling, throat swelling, face swelling. | ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
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. |
Storage:
RESTASIS MULTIDOSE should be stored between 15 to25°C. Do not freeze. Discard unused emulsion 30 days after opening.
Keep out of reach and sight of children.
If you want more information about RESTASIS MULTIDOSE:
- 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/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.abbvie.ca, or by calling 1-888-704-8271.
Last Revised: FEB 16, 2023
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RESTASIS MULTIDOSE and its design are trademarks of AbbVie Corporation.