Pataday

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Keep all appointments with your doctor.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Do not use Pataday if you are allergic to any ingredient in it.

Pataday Eye Drops

Do not wear contact lenses if your eyes are red. Pataday should not be used to treat contact lens-related irritation, or redness.

The preservative in Pataday, benzalkonium chloride, may be absorbed by soft contact lenses. Patients who wear soft contact lenses and whose eyes are not red should wait at least ten minutes after instilling Pataday before inserting contact lenses.

Do not allow dropper tip to contact your eye or any other surface.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Wash your hands before using the eye drops.

To apply the eye drops:

• Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper and squeeze out a drop.

• Close your eyes for 2 or 3 minutes with your head tipped down, without blinking or squinting. Gently press your finger to the inside corner of the eye for about 1 minute, to keep the liquid from draining into your tear duct.

• Use only the number of drops your doctor has prescribed.

• Wait at least 10 minutes before using any other eye drops your doctor has prescribed.

Do not touch the tip of the eye dropper or place it directly on your eye. A contaminated dropper can infect your eye, which could lead to serious vision problems.

Do not use the eye drops if the liquid has changed colors or has particles in it. Call your pharmacist for new medicine.

Store at room temperature away from moisture and heat. Do not freeze. Keep the bottle tightly closed when not in use.

Do not use this medicine while wearing contact lenses. Olopatadine ophthalmic may contain a preservative that can discolor soft contact lenses. Wait at least 15 minutes after using this medicine before putting in your contact lenses.

Avoid wearing contact lenses while your eyes are red or irritated.

Avoid using other eye medications not prescribed by your doctor.

It is not likely that other drugs you take orally or inject will have an effect on olopatadine used in the eyes. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

• If you have an allergy to olopatadine or any other part of Pataday (olopatadine (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.

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

Olopatadine administered orally was not carcinogenic in mice and rats in doses up to 500 mg/kg/day and 200 mg/kg/day, respectively. Based on a 40 μL drop size and a 50 kg person, these doses were approximately 150,000 and 50,000 times higher than the maximum recommended ocular human dose (MROHD). No mutagenic potential was observed when olopatadine was tested in an in vitro bacterial reverse mutation (Ames) test, an in vitro mammalian chromosome aberration assay or an in vivo mouse micronucleus test. Olopatadine administered to male and female rats at oral doses of approximately 100,000 times MROHD level resulted in a slight decrease in the fertility index and reduced implantation rate; no effects on reproductive function were observed at doses of approximately 15,000 times the MROHD level.

Pataday™ (olopatadine hydrochloride ophthalmic solution) 0.2% is supplied in a white, oval, low density polyethylene DROP-TAINER® dispenser with a natural low density polyethylene dispensing plug and a white polypropylene cap. Tamper evidence is provided with a shrink band around the closure and neck area of the package.

2.5 mL fill in 4 mL bottle (NDC 0065-0272-25)

Storage

Store at 2°C to 25°C (36°F to 77°F)

NDC 0065-0272-25

Pataday™
(olopatadine hydrochloride ophthalmic solution) 0.2%

Alcon®

2.5 mL

STERILE

Each mL contains:

Active: Olopatadine hydrochloride 2.22 mg, equivalent Olopatadine 2 mg.

Preservative: benzalkonium chloride 0.01%

Inactives: povidone, dibasic sodium phosphate, sodium chloride, edetate disodium, hydrochloric acid / sodium hydroxide (adjust pH) and purified water.

Rx Only

FOR TOPICAL OPHTHALMIC USE ONLY

USUAL DOSAGE: Instill one drop in each affected eye once a day.

Storage: Store at 2°-25°C (36°-77°F).

U.S. Patents Nos. 5,641,805; 6,995,186 and 7,402,609

Alcon®
Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA

Printed in USA

© 2006-2009, 2010 Alcon, Inc.

9013164-0416

LOT:

EXP.:

NDC 0065-0272-25

Pataday™
(olopatadine hydrochloride ophthalmic solution) 0.2%

Alcon®

2.5 mL Sterile

Storage: Store at 2°-25°C (36°-77°F).

Usual Dosage: Read insert

© 2006 Alcon, Inc

Rx Only

FOR TOPICAL OPHTHALMIC USE ONLY

Each mL contains: olopatadine HCl 2.22 mg

ALCON LABORATORIES, INC.
Fort Worth, TX 76134 USA

LOT: EXP.: 

H13485-0314

Applies to olopatadine ophthalmic: ophthalmic solution

Along with its needed effects, olopatadine ophthalmic (the active ingredient contained in Pataday) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking olopatadine ophthalmic:

• Blurred vision
• eye irritation or pain
• swelling of the eyelid

Some side effects of olopatadine ophthalmic 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:

• Headache
• runny or stuffy nose
• sore throat

• Back pain
• body aches or pain
• burning, dryness, itching, or stinging of the eye
• change in taste
• chills
• cough
• diarrhea
• feeling of something in the eye
• general feeling of discomfort or illness
• increased cough
• lack or loss of strength
• loss of appetite
• muscle aches and pains
• nausea
• pain or tenderness around the eyes and cheekbones
• redness of the eye or inside of the eyelid
• sensitivity of the eyes to light
• shivering
• sneezing
• sweating
• tender, swollen glands in the neck
• trouble sleeping
• trouble swallowing
• unusual tiredness or weakness
• voice changes
• vomiting

More Common Side Effects

The more common side effects that can occur with use of Pataday include:

• blurred vision

• burning or stinging in the eye(s)

• dry eye(s)

• abnormal sensation in the eye(s)

• headache

• changes in the way food tastes

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious Side Effects

Call your doctor right away if you have serious side effects. Call 9-1-1 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following: 

• eye pain or itching

• severe irritation in the eye

• change in eyesight