DOFETILIDE- dofetilide capsule 
Sigmapharm Laboratories, LLC

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MEDICATION GUIDE

DOFETILIDE (doe-FEH-till-ide) CAPSULES

Read the Medication Guide before you start taking dofetilide capsules and each time you get a refill. This information does not take the place of talking with your doctor about your condition or treatment.

What is the most important information I should know about dofetilide capsules?

Dofetilide capsules can cause serious side effects, including a type of abnormal heartbeat called Torsade de Pointes, which can lead to death.

To establish the right dose of dofetilide capsules, treatment with dofetilide capsules must be started in a hospital where your heart rate and kidney function will be checked for the first 3 days of treatment. It is important that when you go home, you take the exact dose of dofetilide capsules that your doctor prescribed for you.

While you take dofetilide capsules always watch for signs of abnormal heartbeat.

Call your doctor and go to the hospital right away if you:

What are dofetilide capsules?

Dofetilide capsules are a prescription medicine that is used to treat an irregular heartbeat (atrial fibrillation or atrial flutter).

It is not known if dofetilide capsules are safe and effective in children under 18 years of age.

Who should not take dofetilide capsules?

Do not take dofetilide capsules if you:

         • cimetidine (TAGAMET, TAGAMET HB)*
         • verapamil (CALAN, CALAN SR, COVERA-HS, ISOPTIN, ISOPTIN SR, VERELAN, VERELAN PM, TARKA)*
         • ketoconazole (NIZORAL, XOLEGEL, EXTINA)*
         • trimethoprim alone (PROLOPRIM, TRIMPEX)* or the combination of trimethoprim and sulfamethoxazole (BACTRIM, SEPTRA SULFATRIM)*
         • prochlorperazine (COMPAZINE, COMPO)*
         • megestrol (MEGACE)*
         • dolutegravir (TIVICAY)
         • hydrochlorothiazide alone or in combination with other medicines (such as ESIDRIX, EZIDE, HYDRODIURIL, HYDRO-PAR, MICROZIDE, or ORETIC)*

         Ask your doctor if you are not sure if any of your medicines are the kind listed above.

•  are allergic to dofetilide in dofetilide capsules. See the end of this leaflet for a complete list of ingredients in dofetilide capsules.

What should I tell my doctor before taking dofetilide capsules?

Before taking dofetilide capsules tell your doctor about all of your medical conditions including if you:

Especially tell your doctor if you take medicines to treat:

Ask your doctor if you are not sure about the medicines you take. Tell your doctor about all prescription and non-prescription medicines, vitamins, dietary supplements, and any natural or herbal remedies. Dofetilide capsules and other medicines may affect each other, causing serious side effects. If you take dofetilide capsules with certain medicines, you will be more likely to have a different type of abnormal heartbeat. See "Who should not take dofetilide capsules?"

Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

How should I take dofetilide capsules?

What are the possible side effects of dofetilide capsules?

Dofetilide capsules can cause serious side effects, including a type of abnormal heartbeat called Torsade de Pointes, which can lead to death. See "What is the most important information I should know about dofetilide capsules?"

The most common side effects of dofetilide capsules include:
      • headache
      • chest pain
      • dizziness

      Call your doctor right away if you have signs of electrolyte imbalance:
      • severe diarrhea
      • unusual sweating
      • vomiting
      • not hungry (loss of appetite)
      • increased thirst (drinking more than normal)

Tell your doctor if you have any side effects that bother you or do not go away.

These are not all the possible side effects of dofetilide capsules. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to Sigmapharm Laboratories, LLC, Pharmacovigilance at 1-855-332-0731 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

How should I store dofetilide capsules?

General information about dofetilide capsules

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use dofetilide capsules for a condition for which it was not prescribed. Do not give dofetilide capsules to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about dofetilide capsules. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about dofetilide capsules that is written for health professionals.

For more about dofetilide capsules, call 1-215-352-6655.

What are the ingredients in dofetilide capsules?

Active ingredient: dofetilide, USP

Inactive ingredients:

Capsule fill: microcrystalline cellulose, pregelatinized starch, silicon dioxide, magnesium stearate, anhydrous citric acid and copovidone 
Capsule shell: titanium dioxide, sodium lauryl sulfate, FD&C Red #40, D&C Yellow #10, gelatin and edible imprinting ink. In addition, the 0.125 mg strength capsule shell also contains D&C Red #28.
Imprinting Ink: ammonia, black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol and shellac.

* Listed trademarks are the property of their respective owners.

Rx only

Sigmapharm Laboratories, LLC
Bensalem, PA 19020

OS046-04 REV.0518

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: 5/2018
Sigmapharm Laboratories, LLC