Product Information

Eplerenone tablets

What is this medicine?

Eplerenone blocks the actions of the hormone aldosterone in the body. Aldosterone is important for the regulation of blood pressure. Eplerenone is used to treat congestive heart failure after a heart attack. Eplerenone is also used to treat high blood pressure (hypertension). Eplerenone may also be used for purposes not listed in this medication guide.

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

You may not be able to take this medicine if you are allergic to eplerenone, or if you have:

• high potassium levels in your blood (hyperkalemia);

• severe kidney disease; or

• type 2 diabetes with protein in your urine.

Some medicines can interact with eplerenone and should not be used at the same time. Your doctor may need to change your treatment plan if you use any of the following drugs:

• nefazodone;

• verapamil;

• a diuretic or "water pill"--amiloride, spironolactone, triamterene;

• an antibiotic--clarithromycin, erythromycin, telithromycin;

• antifungal medication--itraconazole, ketoconazole;

• hepatitis C medications--boceprevir, telaprevir; or

• HIV/AIDS medication--nelfinavir, ritonavir.

To make sure eplerenone is safe for you, tell your doctor if you have:

• kidney disease;

• liver disease;

• high cholesterol or triglycerides; or

• if you take other heart or blood pressure medication, such as benazepril, candesartan, captopril, lisinopril, losartan, olmesartan, ramipril, telmisartan, trandolapril, valsartan, and others.

FDA pregnancy category B. Eplerenone is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether eplerenone passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How should I use this medicine?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended. Eplerenone may be taken with or without food. While using eplerenone, you may need blood tests, and your blood pressure will need to be checked often. If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

What if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What may interact with this medicine?

Many drugs can interact with eplerenone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

What side effects may I notice from this medicine?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• mood changes, vomiting, little or no urinating;

• swelling, rapid weight gain;

• high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling); or

• low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling).

Common side effects may include:

• diarrhea;

• cough;

• dizziness;

• tired feeling; or

• fever, chills, body aches, flu symptoms.

This is not a complete list of side effects and others may occur.

Where should I keep this medicine?

Store at room temperature away from moisture, heat, and light.