Mexiletine Hydrochloride Oral capsule

What is this medicine?

MEXILETINE (mex IL e teen) is an antiarrhythmic agent. This medicine is used to treat irregular heart rhythm and can slow rapid heartbeats. It can help your heart to return to and maintain a normal rhythm. Because of the side effects caused by this medicine, it is usually used for heartbeat problems that may be life-threatening.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• liver disease

• other heart problems

• previous heart attack

• an unusual or allergic reaction to mexiletine, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. It is recommended that you take this medicine with food or an antacid. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on the advice of your doctor or health care professional.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• dofetilide

This medicine may also interact with the following medications:

• caffeine

• cimetidine

• medicines for depression, anxiety, or psychotic disturbances

• medicines to control heart rhythm

• phenobarbital

• phenytoin

• rifampin

• theophylline

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Your condition will be monitored closely when you first begin therapy. Often, this drug is first started in a hospital or other monitored health care setting. Once you are on maintenance therapy, visit your doctor or health care professional for regular checks on your progress. Because your condition and use of this medicine carry some risk, it is a good idea to carry an identification card, necklace or bracelet with details of your condition, medications, and doctor or health care professional.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol can make you more dizzy, increase flushing and rapid heartbeats. Avoid alcoholic drinks.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• chest pain, continued irregular heartbeats

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• seizures

• skin rash

• trembling, shaking

• unusual bleeding or bruising

• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• blurred vision

• difficulty walking

• heartburn

• nausea, vomiting

• nervousness

• numbness, or tingling in the fingers or toes

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.