Cyclopentolate Hydrochloride Ophthalmic drops, solution

What is this medicine?

CYCLOPENTOLATE (sye kloe PEN toe late) is used in the eye to widen your pupils, so they won't respond to light. It is normally used for diagnostic procedures.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• Down's Syndrome

• glaucoma

• wear contact lenses

• an unusual or allergic reaction to cyclopentolate or other medications, foods, dyes or preservatives

• pregnant or trying to become pregnant

• breast-feeding

How should I use this medicine?

This medicine is only for use in the eye(s). Do not take by mouth. If used for something other than diagnostic procedures, follow the directions on the prescription label. Wash hands before and after use. Tilt the head back slightly and pull the lower eyelid down with the index finger to form a pouch. Squeeze a single drop into the pouch and close your eyes. Apply gentle pressure to the inside corner of your eye for 1 to 3 minutes. If you are using more than one drop, repeat this process with 5 minutes between the drops. Do not touch dropper tip to any surface to prevent contamination. If more than one eye product is being used, the products should be administered at least 5 minutes apart. Use your medicine at regular intervals. Do not use it more often than directed.

Contact your pediatrician or health care professional regarding the use of this medication in children. Special care is needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for the next dose, use only that dose. Do not use double or extra doses.

What may interact with this medicine?

• carbachol

• medicines for Alzheimer's or Parkinson's disease

• pilocarpine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. Report any serious side effects right away. Stop using this medicine if your eyes become inflamed, painful or have a discharge, and see your doctor or health care professional right away.

If you wear contact lenses, remove them before using this medicine. Contact lenses may be put back in 15 minutes after using this medicine.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this drug affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol can make you more drowsy and dizzy. Avoid alcoholic drinks.

Be careful not to touch the tip of the dispensing container onto the eye, or any other surface. Serious eye infections can result from contamination of eye solution.

If this medicine makes your eyes more sensitive to light, wear dark glasses

In infants feeding intolerance may occur. Infant feedings should be held for 4 hours after administration of this medicine. Observe infants closely for at least 30 minutes following the use of this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• changes in mood or behavior

• fast or irregular heartbeat

• hallucination, loss of contact with reality (especially in children)

• inflamed, swollen, painful, or infected eyes or eyelids

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• blurred vision

• increased sensitivity to sunlight

• temporary stinging or itching after application

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of reach of children.

Store at room temperature, 15 to 30 degrees C (59 to 86 degrees F). Keep the bottle tightly closed. Throw away any unused medicine after the expiration date.