Uses

This medication is used to prevent a certain type of headache (vascular headaches such as migraine headaches). It helps to reduce the frequency and severity of your headaches.

This medication should not be used to treat a migraine headache after it has started or to prevent other types of headaches such as tension headaches.

How To Use

Take this medication by mouth with or without food as directed by your doctor, usually 3 times daily. Your doctor may direct you to start with 1 dose at bedtime, then slowly increase your dose.

The dosage is based on your medical condition and response to treatment.

Do not suddenly stop taking this medication without consulting your doctor. "Rebound headaches" may occur when the drug is suddenly stopped. Your dose should be gradually decreased over a 2-week period.

When used for an extended period, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well.

It may take up to 4 weeks to see whether the medication will be effective for you. Tell your doctor if your headaches last, get worse, or increase in number.

Side Effects

Drowsiness, increased appetite, weight gain, tiredness, nausea, headache, or dry mouth may occur. 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:

• nausea/vomiting that doesn't stop
• eye pain
• dark urine
• severe stomach/abdominal pain
• yellowing eyes/skin
• vision changes
• mental/mood changes (such as confusion, depression, nervousness)
• swelling of the ankles/feet
• decreased sexual ability

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.

Precautions

Before taking pizotifen, 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 drug, tell your doctor your medical history, especially of:

• stomach/intestinal blockage
• glaucoma (narrow-angle)
• difficulty urinating (such as due to enlarged prostate)
• breathing problems (such as asthma, emphysema)
• diabetes
• heart/blood vessel disease (such as stroke, coronary artery disease, irregular heart rhythm)
• high blood pressure (hypertension)
• overactive thyroid (hyperthyroidism)
• kidney disease
• liver disease

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

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

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

This drug may pass into breast milk and could have undesirable effects on a nursing infant. Breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

Drug Interactions

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.

Some products that may interact with this drug are:

• antihistamines applied to the skin (such as diphenhydramine cream, ointment, spray)

Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.

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 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.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 9-1-1. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: extreme drowsiness, fast heartbeat, nausea, loss of coordination.

Notes

Do not share this medication with others.

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

Missed Dose

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.

Storage

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.