When This Medicine Should Not Be Used:
You should not use this medicine if you have had an allergic reaction to penbutolol or to any similar medicines (such as atenolol, metoprolol, propranolol, Corgard®, Inderal®, Lopressor®, Toprol®, or Tenormin®), or if you have asthma or certain heart problems such as heart block or slow heartbeat.

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.
• You may take this medicine with or without food.
• Carefully follow your doctor's instructions about any special diet.

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

• There are many drugs that can interact with penbutolol. This especially includes medicines for asthma, chest pain (angina), diabetes, or heart rhythm problems, or epinephrine to treat severe allergic reactions. Tell your doctor if you are using any of these medicines, or if you are using other medicines to treat your high blood pressure.
• Make sure your doctor knows if you are also using digoxin (Digitek®, Lanoxin®), reserpine (Ser-ap-es®), other blood pressure medicine (such as nifedipine, verapamil, Cardizem®, Lotrel®, Norvasc®, or Plendil®), or medicine to make you numb (such as cyclopropane, ether, lidocaine, trichloroethylene, Trilene®, or Xylocaine®).
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, heart or blood vessel disease, heart failure, angina (severe chest pain), or a recent heart attack. Tell your doctor if you have diabetes, lung disease (such as bronchitis or emphysema), an overactive thyroid, or a history of severe allergic reactions.
• This medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life.
• This medicine may cause heart failure in some patients. Stop using this medicine and check with your doctor right away if you are having chest pain or discomfort; dilated neck veins; extreme fatigue; irregular breathing; an irregular heartbeat; shortness of breath; swelling of the face, fingers, feet, or lower legs; weight gain; or wheezing.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• If you stop using this medicine, your blood pressure may go up or your angina may get worse. High blood pressure usually has no symptoms. Even if you feel well, do not stop using this medicine suddenly without asking your doctor.
• This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.
• This medicine may raise or lower your blood sugar level.
• This medicine may make you dizzy, drowsy, or lightheaded. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. Do not stop taking this medicine before surgery without your doctor's approval.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.

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
• Chest pain (may be related to your disease and not a side effect).
• Fainting or severe dizziness.
• Shortness of breath, cold sweat, and bluish-colored skin.
• Slow, fast, or uneven heartbeat.
• Swelling of your hands, ankles, or feet.
• Unusual bleeding or bruising.
• Unusual tiredness or weakness.
• Wheezing or trouble breathing.

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

• Cold hands and feet.
• Cough, runny or stuffy nose, or sore throat.
• Diarrhea, nausea, or stomach upset.
• Feeling dizzy, drowsy, or depressed.
• Headache.
• Trouble having sex.
• Trouble sleeping.
• Weakness.

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