Restasis Multidose

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of cyclosporine eye drops in children younger than 16 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of cyclosporine eye drops in the elderly.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Burning or other discomfort of the eye

• Blurred vision
• clear or yellow fluid from the eye
• difficulty with reading
• eye pain
• feeling of having something in the eye
• halos around lights
• itching skin
• redness of the white part of your eyes or inside of your eyelids
• sticky or matted eyelashes
• stinging
• watery eye

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• It is used to help some patients make more tears.

• If you have an allergy to cyclosporine or any other part of Restasis Multidose (cyclosporine (ophthalmic)).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Burning.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Systemic carcinogenicity studies were conducted in male and female mice and rats. In the 78-week oral (diet) mouse study, at doses of 1, 4, and 16 mg/kg/day, evidence of a statistically significant trend was found for lymphocytic lymphomas in females, and the incidence of hepatocellular carcinomas in mid-dose males significantly exceeded the control value.

In the 24-month oral (diet) rat study, conducted at 0.5, 2, and 8 mg/kg/day, pancreatic islet cell adenomas significantly exceeded the control rate in the low dose level. The hepatocellular carcinomas and pancreatic islet cell adenomas were not dose related. The low doses in mice and rats are approximately 80 times greater (normalized to body surface area) than the daily recommended human dose of one drop (approximately 28 mcL) of cyclosporine ophthalmic emulsion, 0.05% twice daily into each eye of a 60 kg person (0.001 mg/kg/day), assuming that the entire dose is absorbed.

Mutagenesis

Cyclosporine has not been found to be mutagenic/genotoxic in the Ames Test, the V79-HGPRT Test, the micronucleus test in mice and Chinese hamsters, the chromosome-aberration tests in Chinese hamster bone-marrow, the mouse dominant lethal assay, and the DNA-repair test in sperm from treated mice. A study analyzing sister chromatid exchange (SCE) induction by cyclosporine using human lymphocytes in vitro gave indication of a positive effect (i.e., induction of SCE).

Impairment of Fertility

No impairment in fertility was demonstrated in studies in male and female rats receiving oral doses of cyclosporine up to 15 mg/kg/day (approximately 2,000 times the human daily dose of 0.001 mg/kg/day normalized to body surface area) for 9 weeks (male) and 2 weeks (female) prior to mating.

Handling the Container

Advise patients to not allow the tip of the bottle to touch the eye or any surface, as this may contaminate the emulsion. Advise patients to not touch the bottle tip to their eye to avoid the potential for injury to the eye [see Warnings and Precautions (5.1)].

Use with Contact Lenses

Restasis Multidose™ should not be administered while wearing contact lenses. Patients with decreased tear production typically should not wear contact lenses. Advise patients that if contact lenses are worn, they should be removed prior to the administration of the emulsion. Lenses may be reinserted 15 minutes following administration of Restasis Multidose™ ophthalmic emulsion [see Warnings and Precautions (5.2)].

Administration

Advise patients to read the “Instructions for Use” for detailed first-time use instructions.

© 2016 Allergan. All rights reserved.
Irvine, CA 92612, U.S.A.
All trademarks are the property of their respective owners.

Patented: See: www.allergan.com/products/patents
Made in Ireland.

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INSTRUCTIONS FOR USE
Restasis Multidose™(Re stay' sis Mul tee dōs)
(cyclosporine ophthalmic emulsion) 0.05%

Read this Instructions for Use before you start using Restasis Multidose™ and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment.

Important:

• Restasis Multidose™ is for use in the eye
• Wash your hands before using Restasis Multidose™.
• Do not let the bottle tip touch the eye or any other surfaces to avoid contamination or injury to your eye.
• Use 1 drop of Restasis Multidose™ in each eye, 2 times each day, about 12 hours apart.
• If you wear contact lenses, remove them before using Restasis Multidose™. Wait for at least 15 minutes before placing them back in your eyes.
• Restasis Multidose™ can be used with lubricant eye drops, but you should wait at least 15 minutes between using each product.

How do I store Restasis Multidose™?

• Store Restasis Multidose™ between 15-25 °C (59-77 °F).

Keep Restasis Multidose™and all medicines out of the reach of children.

This Instructions for Use has been approved by the Food and Drug Administration.

© 2016 Allergan. All rights reserved. Irvine, CA 92612, U.S.A.
All trademarks are the property of their respective owners.Patented: See: www.allergan.com/products/patents Made in Ireland.

                                    Approved: 10/2016

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Principal Display Panel - Restasis Multidose Carton Label

Allergan™

NDC 0023-5301-05

Restasis

MultiDose™

(Cyclosporine Ophthalmic Emulsion) 0.05%

For Topical Application

In the Eye

PRIOR TO FIRST USE, PLEASE READ

BOTTLE PREPARATION INSTRUCTIONS

Sterile, 5.5 mL

Preservative-Free Rx only