Mydriacyl

You should not use tropicamide ophthalmic if you are allergic to it.

To make sure this medicine is safe for you, tell your doctor if you have:

• glaucoma; or

• any drug allergies.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant.

It is not known whether tropicamide ophthalmic passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medicine to a child without medical advice.

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

Tropicamide ophthalmic is most often used only in a doctor's office during an eye examination. Instructions are provided below for giving yourself the medicine if your doctor has prescribed it for home use.

Do not take by mouth. Tropicamide ophthalmic is for use only in the eyes.

Do not use this medicine while wearing contact lenses. Tropicamide ophthalmic may contain a preservative that can discolor soft contact lenses. It may be best to wait until your eyes are no longer dilated before putting in your contact lenses.

Wash your hands before and after using the eye drops. Because a child might rub his or her eyes after the drops are given, wash the child's hands after use.

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 1 to 3 minutes, to keep the liquid from draining into your tear duct.

• Use only the number of drops your doctor has prescribed. If you use more than one drop, wait about 5 minutes between drops.

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.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• unusual changes in mood or behavior;

• a fast, slow, or uneven heart rate;

• shortness of breath; or

• a light-headed feeling, like you might pass out.

Common side effects may include:

• blurred vision;

• mild stinging of the eyes;

• your eyes may be more sensitive to light;

• dry mouth; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• It is used before an eye exam.

• If you have an allergy to tropicamide or any other part of Mydriacyl (tropicamide).
• 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.

• Tell all of your health care providers that you take Mydriacyl. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for clear eyesight while your pupils are dilated.
• Bright lights may bother you. Wear sunglasses.
• Use with care in children. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

For mydriasis and cycloplegia for diagnostic procedures.

NDC 0065-0355-03

ALCON®

DROP-TAINER® DISPENSER

UNIT OF USE

Mydriacyl® 1 %
(tropicamide ophthalmic solution, USP)

3 mL Sterile

INGREDIENTS: Each mL contains:
Active: Tropicamide 1%.
Preservative: benzalkonium chloride 0.01%.
Inactives: sodium chloride, edetate disodium, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water.
pH range 4.0-5.8

Rx Only

USUAL DOSAGE:
One or two drops topically in the eye(s). Read enclosed insert.

STORAGE:
Store at 8°-27°C (46°-80°F).

Do not refrigerate or store at high temperatures.
Keep container tightly closed.

© 2004, 2010 Alcon, Inc.

Alcon®

ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA
Printed in USA

350544-0210

LOT:

EXP.:

NDC 0065-0355-03

ALCON®

Mydriacyl®
(tropicamide ophthalmic solution USP)

1 %

3 mL Sterile

Rx Only

INGREDIENTS: Each mL contains: Active: Tropicamide 1%.

USUAL DOSAGE: One or two drops topically in the eye(s). Read enclosed insert.

STORAGE: Store at 8-27C (46-80F).
Do not refrigerate or store at high temperatures.
Keep container tightly closed.

© 2000, 2004 Alcon, Inc.

ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA
Printed in USA

H13299-0314

LOT:

EXP.:

Applies to tropicamide ophthalmic: ophthalmic solution

Along with its needed effects, tropicamide ophthalmic (the active ingredient contained in Mydriacyl) 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 as soon as possible if any of the following side effects occur while taking tropicamide ophthalmic:

• Clumsiness or unsteadiness
• confusion
• fast heartbeat
• flushing or redness of face
• hallucinations (seeing, hearing, or feeling things that are not there)
• increased thirst or dryness of mouth
• skin rash
• slurred speech
• swollen stomach in infants
• unusual behavior, especially in children
• unusual drowsiness, tiredness, or weakness

Some side effects of tropicamide 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:

• Blurred vision
• headache
• sensitivity of eyes to light
• stinging of the eye when the medicine is applied

Applies to tropicamide ophthalmic: compounding powder, ophthalmic solution

General

Side effects reported with this drug have included transient stinging, blurred vision, photophobia and superficial punctate keratitis. Some patients have experienced prolonged mydriasis.[Ref]

Ocular

Frequency not reported: Headache, drowsiness, somnolence, fatigue, trouble concentrating, central nervous system disturbances, dysphonia
Postmarketing reports: Dizziness[Ref]

Psychiatric

Frequency not reported: Psychotic reaction, behavioral disturbance[Ref]

Behavioral disturbances or psychotic reactions may be more common in children.[Ref]

Nervous system

Frequency not reported: Headache, drowsiness, somnolence, fatigue, trouble concentrating, central nervous system disturbances, dysphonia
Postmarketing reports: Dizziness[Ref]

Cardiovascular

Transient bradycardia followed by tachycardia with palpitations and arrhythmias have been reported.[Ref]

Frequency not reported: Tachycardia, bradycardia, arrhythmias, palpitations
Postmarketing reports: Hypotension, syncope[Ref]

Hypersensitivity

Frequency not reported: Allergic reaction, anaphylaxis[Ref]

Gastrointestinal

Frequency not reported: Dry mouth, thirst, dysphagia, nausea, vomiting, constipation[Ref]

Respiratory

Frequency not reported: Rhinitis, reduced bronchial secretions, bronchospasm
Postmarketing reports: Dryness of mucous membranes[Ref]

Genitourinary

Frequency not reported: Urinary retention, difficult micturition[Ref]

Dermatologic

Frequency not reported: Erythematous rash, pruritus, pallor, flushing, increased sweating, dry skin[Ref]

Musculoskeletal

Frequency not reported: Muscle rigidity[Ref]

Some side effects of Mydriacyl may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.