When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to amiodarone or iodine, or you are pregnant or breastfeeding.

How to Use This Medicine:
Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Take this medicine the same way every day. This means take it at the same time and take it consistently with or without food.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how amiodarone works. Tell your doctor if you are using any of the following:
  
  • Cimetidine, clopidogrel, cyclosporine, dabigatran, dextromethorphan, digoxin, fentanyl, ledipasvir/sofosbuvir, lithium, loratadine, phenytoin, rifampin, simeprevir, sofosbuvir, or St John's wort
  • Blood pressure medicines (including diltiazem, verapamil)
  • Blood thinner (including warfarin)
  • Medicine to lower cholesterol (including atorvastatin, cholestyramine, lovastatin, simvastatin)
  • Medicine to treat depression (including trazodone)
  • Medicine to treat heart rhythm problems (including flecainide, lidocaine, procainamide, quinidine)
  • Medicine to treat HIV/AIDS
  • Medicine to treat an infection
  • Phenothiazine medicine (including chlorpromazine, perphenazine, promethazine, thioridazine)
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Tell your doctor if you have liver problems, heart disease, heart failure, thyroid problems, or lung disease or breathing problems. Tell your doctor if you have a pacemaker or another implanted heart device.
• This medicine may cause the following problems:
  
  • Lung problems
  • Worsening heart rhythm problems
  • Thyroid problems
  • Liver problems
  • Changes in vision
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds. Your skin may become discolored if you use this medicine for a long time.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash
• Blurred vision or other vision changes, eye pain
• Chest pain, cough, trouble breathing
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fast, slow, pounding, or uneven heartbeat (new or worsening)
• Lightheadedness, dizziness, or fainting
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Weight gain or loss, nervousness, tremors, trouble sleeping, unusual tiredness, hair loss

If you notice these less serious side effects, talk with your doctor:

• Mild nausea, vomiting, or constipation

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088