GoodSense Itchy Eye

• Tell all of your health care providers that you take GoodSense Itchy Eye. This includes your doctors, nurses, pharmacists, and dentists.
• Do not use this medicine to treat contact lens irritation.
• This medicine may cause harm if swallowed. If GoodSense Itchy Eye is swallowed, call a doctor or poison control center right away.
• 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.

Use GoodSense Itchy Eye as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• For the eye only.
• Wash hands before and after use.
• Do not use if the solution is cloudy, leaking, or has particles.
• Do not use if solution changes color.
• Take out contact lenses before using this medicine. Lenses may be put back in 10 minutes after GoodSense Itchy Eye is given. Do not put contacts back in if your eyes are irritated or infected.
• Do not touch the container tip to the eye, lid, or other skin.
• Tilt your head back and drop drug into the eye.
• After use, keep your eyes closed. Put pressure on the inside corner of the eye. Do this for 1 to 2 minutes. This keeps the drug in your eye.
• Put the cap back on after you are done using your dose.

What do I do if I miss a dose?

• Use a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses at the same time or extra doses.

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 you have any side effects that bother you or do not go away.

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.

Applies to ketotifen ophthalmic: oral syrup, oral tablet

Other dosage forms:

• ophthalmic solution

Along with its needed effects, ketotifen ophthalmic 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 ketotifen ophthalmic:

• Chills
• cough
• diarrhea
• fever
• general feeling of discomfort or illness
• headache
• joint pain
• loss of appetite
• muscle aches and pains
• nausea
• runny nose
• shivering
• sore throat
• sweating
• trouble sleeping
• unusual tiredness or weakness
• vomiting

• Abdominal or stomach pain
• blistering, itching, peeling, or redness of skin
• bloody or cloudy urine
• clay-colored stools
• convulsions
• dark urine
• difficult, burning, or painful urination
• dizziness
• frequent urge to urinate
• muscle spasm or jerking of all extremities
• rash
• sudden loss of consciousness
• unpleasant breath odor
• vomiting of blood
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking ketotifen ophthalmic:

• Blurred vision
• confusion
• convulsions
• disorientation
• dizziness
• drowsiness (severe)
• faintness or lightheadedness when getting up from a lying or sitting position
• fast, pounding, or irregular heartbeat or pulse
• hyperexcitability
• loss of consciousness
• palpitations
• sweating
• unusual tiredness or weakness

Some side effects of ketotifen 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:

• Weight gain

• Bloody nose
• drowsiness
• dryness of mouth
• excitation
• increased appetite
• irritability
• nervousness
• swelling of eyelids
• unexplained nosebleeds

Applies to ketotifen ophthalmic: ophthalmic solution

Ocular

Common (1% to 10%): Irritation, pain, punctate keratitis, punctate corneal epithelial erosion
Uncommon (0.1% to 1%): Blurred vision, dry eye, eyelid disorder, conjunctivitis, photophobia, conjunctival hemorrhage
Postmarketing reports: Swelling, eyelid pruritus, edema[Ref]

Ketotifen instillation was associated with mild to moderate burning or stinging in 98% of patients (n=35) in one trial.[Ref]

Nervous system

Uncommon (0.1% to 1%): Headache, somnolence
Postmarketing reports: Dizziness[Ref]

Respiratory

Postmarketing reports: Exacerbation of asthma[Ref]

General

The most commonly reported adverse effects have included eye irritation, eye pain, punctate keratitis, and punctate corneal epithelial erosion.[Ref]

Dermatologic

Uncommon (0.1% to 1%): Rash, eczema, urticaria
Postmarketing reports: Contact dermatitis, facial edema, exacerbation of eczema[Ref]

Gastrointestinal

Uncommon (0.1% to 1%): Dry mouth[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity, allergic reactions
Postmarketing reports: Exacerbation of preexisting allergic conditions[Ref]

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