Ketotifen is used as a long-term (maintenance) treatment in children to prevent or decrease wheezing and troubled breathing caused by allergic-type asthma. It is usually used along with other medications for asthma (including corticosteroids such as prednisone, inhaled beta agonists such as salbutamol). This medication is an antihistamine. It improves breathing by decreasing swelling and inflammation of the airways in the lungs. Controlling symptoms of asthma can increase the ability to exercise/play and decrease time lost from school.

This medication does not work right away and should not be used for sudden attacks of shortness of breath/asthma. Your doctor must prescribe a quick-relief medicine/inhaler (such as salbutamol, albuterol) for sudden shortness of breath/asthma attacks while you are on this medication. You should always have a quick-relief inhaler with you. Consult your doctor or pharmacist for more details.

Take this medication by mouth with or without food as directed by your doctor, usually twice daily. Do not crush or chew the tablets. Doing so may increase side effects.

Dosage is based on your age and response to treatment. Your doctor may start you at a lower dose and slowly adjust the dose to lessen side effects (such as drowsiness). Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Do not stop using this medication or change your dose without consulting your doctor. Some conditions may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased.

This medication does not work right away. It may take 2 to 3 months for this medication to have an effect. Your doctor may also adjust the dosage of your other asthma medications while you are taking ketotifen. If you are regularly taking corticosteroids (such as prednisone, fluticasone), you should not stop using them, and you should not replace them with ketotifen. Carefully follow your doctor's directions for taking all your medicines.

Drowsiness, increased appetite/weight, irritability, trouble sleeping, and nervousness may occur. Infrequent side effects include temporary dry mouth or slight dizziness. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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 right away if you have any serious side effects, including:

• easy bruising/bleeding
• symptoms of liver disease (such as nausea/vomiting that doesn't stop, dark urine, stomach/abdominal pain, yellowing eyes/skin)
• urination problems (especially symptoms of frequent/burning/painful urination)

A very serious allergic reaction to this drug is rare. However, get medical help right away 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 or at www.fda.gov/medwatch.

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

Before taking 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, 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:

• diabetes
• seizure disorders (such as epilepsy)

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, ride a bicycle, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

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

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or other antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: unusual drowsiness, confusion, fast heartbeat, fainting, seizures.

Do not share this medication with others.

Lab and/or medical tests (such as complete blood count, pulmonary function) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications 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.