IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

KETOTIFEN – OPHTHALMIC

(KEE-toe-TYE-fen)

COMMON BRAND NAME(S): Zaditor

USES: This medication is used to prevent and treat itching of the eyes caused by allergies (allergic/seasonal conjunctivitis). Ketotifen is an antihistamine for the eye that treats allergic symptoms by blocking a certain natural substance (histamine). It is also a mast cell stabilizer that prevents allergic reactions by reducing the release of natural substances that cause an allergic reaction.

HOW TO USE: If you are using the over-the-counter product, read all directions on the product package before using this medication. If your doctor has prescribed this medication, use it exactly as directed.

Apply 1 drop to the affected eye(s), usually twice a day (every 8 to 12 hours) or as directed by the package instructions or your doctor.

Dosage is based on your medical condition and response to treatment.

To apply eye drops, wash your hands first. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface.

Ask your doctor if you can wear contact lenses while you are being treated with this medication. If your doctor says you may continue wearing them, remove them before using the eye drops, and wait at least 10 minutes after each dose before putting in your lenses. Do not use this medication to treat irritation from contact lens wear. Consult your doctor about the use of contact lenses when the eyes are red or irritated.

Tilt your head back, look upward, and pull down the lower eyelid to make a pouch. Hold the dropper directly over your eye and apply 1 drop in the lower eyelid. Look downward and gently close your eyes for 1 to 2 minutes. Place one finger at the corner of your eye (near the nose) and apply gentle pressure. This will prevent the medication from draining out. Try not to blink and do not rub your eye.

Do not rinse the dropper. Replace the dropper cap after each use, and keep the bottle tightly closed.

If you are using another kind of eye medication (drops or ointment), wait at least 5 minutes before applying it. Apply eye drops before eye ointments to allow the eye drops to enter the eye.

If your doctor has prescribed this medication, use it regularly in order to get the most benefit from it. To help you remember, use it at the same times each day. Continue to use this medication as prescribed until pollen season is over or you are no longer exposed to the allergic substance, even when allergic symptoms disappear or improve.

If your condition persists or worsens, if you develop new symptoms, or if you think you have a serious medical problem, seek immediate medical attention. If you are treating yourself with nonprescription ketotifen, consult your doctor if your itching worsens or lasts more than 72 hours. You may need a different medication.

SIDE EFFECTS: Burning/stinging/irritation of the eye, headache, stuffy/runny nose, bad taste in your mouth, and increased sensitivity to light may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: dry eyes, eye pain, increased redness/swelling of the eye, vision problems.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US –

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

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using ketotifen, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as the preservative benzalkonium chloride in the multi-dose container), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye problems (e.g., glaucoma).

After you apply this drug, your vision may become temporarily blurred. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

Do not use this medication in children younger than 3 years unless directed by the doctor.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: If this drug has been prescribed, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.

Avoid allergens (e.g., pollen, animal dander) and other triggering factors (e.g., irritants). Cold compresses and lubricating eye drops may decrease eye irritation.

MISSED DOSE: If you are using this medication on a regular schedule and miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store between 39-77 degrees F (4-25 degrees C) away from light and moisture. If you are using the single-dose container, discard it after use. Discard unused single-dose containers 4 weeks after you first open the blister pack (or 3 months after opening if you store them in the original carton box). Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.