Alaway

Instill the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not instill a double dose to make up for a missed one.

Alaway eyedrop solution is generally well tolerated and side effects are usually mild. However, you should stop using it and ask a doctor if you experience any of the following:

• eye pain
• changes in vision
• redness of the eye
• itching worsens or lasts more than 72 hours

• Only for use in the eye
• Store between 4-25°C (39-77°F).
• Keep this and all medications out of the reach of children

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

• It is used to treat eye irritation.

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.

Applies to ketotifen ophthalmic: oral syrup, oral tablet

Other dosage forms:

• ophthalmic solution

Along with its needed effects, ketotifen ophthalmic (the active ingredient contained in Alaway) 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

Age: 3 years and older
Instill 1 drop in the affected eye(s) 2 times a day

Comments: May administer eye drops every 8 to 12 hours, but should not administer more than twice a day.

Use: For the treatment of itching related to pollen, ragweed, grass, animal hair and dander.

Safety and efficacy have not been established in patients younger than 3 years.

Consult WARNINGS section for additional precautions.

Data not available.