Corzide 80 / 5

You should not use this medicine if you have asthma or if you are unable to urinate. You should not use bendroflumethiazide and nadolol if you have a serious heart condition such as "AV block" (2nd or 3rd degree), uncontrolled heart failure, slow heartbeats that have caused you to faint, or if your heart cannot pump blood properly.

Do not stop using this medicine suddenly, or you could develop serious heart problems. Follow your doctor's instructions.

You should not use this medicine if you are allergic to bendroflumethiazide or nadolol, or if you have:

• asthma;

• slow heartbeats that have caused you to faint;

• a serious heart condition called "AV block" (2nd or 3rd degree), or if your heart cannot pump blood properly;

• severe or uncontrolled heart failure;

• an allergy to sulfa drugs; or

• if you are unable to urinate.

To make sure bendroflumethiazide and nadolol is safe for you, tell your doctor if you have ever had:

• congestive heart failure;

• chest pain;

• asthma or other breathing disorder;

• diabetes;

• a thyroid disorder;

• kidney disease;

• liver disease (or cirrhosis);

• gout;

• lupus; or

• an electrolyte imbalance (such as low levels of sodium, chloride, potassium, calcium, or magnesium in your blood).

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Bendroflumethiazide and nadolol can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Bendroflumethiazide and nadolol is not approved for use by anyone younger than 18 years old.

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

You may take bendroflumethiazide and nadolol with or without food.

You may have very low blood pressure while taking this medicine. Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual. Prolonged illness can lead to a serious electrolyte imbalance, making it dangerous for you to use bendroflumethiazide and nadolol.

Keep using this medicine as directed. High blood pressure often has no symptoms. You may need to use blood pressure medicine for the rest of your life.

Your blood pressure will need to be checked often. Your blood and urine may both be tested if you have been vomiting or are dehydrated.

Do not stop using this medicine suddenly, even if you feel fine. Stopping suddenly may cause serious or life-threatening heart problems. Follow your doctor's instructions about tapering your dose.

If you need surgery or medical tests, tell the doctor ahead of time that you are taking bendroflumethiazide and nadolol. You may need to stop using the medicine for a short time.

If you are diabetic, check your blood sugar carefully. Taking a beta-blocker may make it harder for you to tell when you have low blood sugar. Your insulin or diabetes medication needs may change while you are taking bendroflumethiazide and propranolol. Do not change your medication dose or schedule without your doctor's advice.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• fast, slow, or uneven heartbeat;

• numbness or cold feeling in your hands and feet;

• a light-headed feeling, like you might pass out;

• little or no urination; or

• signs of an electrolyte imbalance--dry mouth, increased thirst, mood changes, confusion, vomiting, muscle pain or weakness, lack of energy, fast heartbeats, little or no urine.

Common side effects may include:

• dizziness; or

• feeling tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Applies to bendroflumethiazide / nadolol: oral tablet

Along with its needed effects, bendroflumethiazide / nadolol may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking bendroflumethiazide / nadolol:

• Blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain or discomfort
• confusion
• cough
• difficulty breathing
• dilated neck veins
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• extreme fatigue
• irregular breathing
• lightheadedness, dizziness, or fainting
• noisy breathing
• paleness or cold feeling in fingertips and toes
• shortness of breath
• slow or irregular heartbeat
• slurred speech
• sweating
• swelling of face, fingers, feet, or lower legs
• tightness in chest
• tingling or pain in fingers or toes when exposed to cold
• unusual tiredness or weakness
• weight gain
• wheezing

• Back or leg pains
• black, tarry stools
• bleeding gums
• bloating
• blood in urine or stools
• chills
• clay-colored stools
• cloudy urine
• cold sweats
• constipation
• coughing up blood
• dark urine
• difficulty swallowing
• drowsiness
• dry mouth
• fast heartbeat
• fever
• flushed, dry skin
• fruit-like breath odor
• general body swelling
• general feeling of discomfort or illness
• general tiredness and weakness
• headache
• hives
• hoarseness
• increased hunger
• increased thirst
• increased urination
• indigestion
• joint pain, stiffness, or swelling
• light-colored stools
• loss of appetite
• lower back or side pain
• muscle tremors
• nausea and vomiting
• nosebleeds
• pain in muscles
• painful or difficult urination
• pains in stomach, side, or abdomen, possibly radiating to the back
• pale skin
• pinpoint red spots on skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid, deep breathing
• rash
• redness, soreness, or itching skin
• restlessness
• skin rash
• sore throat
• sores, ulcers, or white spots on lips or in mouth
• sores, welting or blisters
• stomach cramps
• sugar in the urine
• swollen or painful glands
• tenderness of salivary glands
• thickening of bronchial secretions
• troubled breathing
• unpleasant breath odor
• unusual bleeding or bruising
• unusual weight loss
• upper right abdominal pain
• vomiting of blood
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking bendroflumethiazide / nadolol:

• Change in consciousness
• decreased urination
• diarrhea
• fast, slow, or shallow breathing
• gas
• heartburn
• increase in heart rate
• increased sweating
• indigestion
• loss of consciousness
• low blood pressure
• muscle cramps
• numbness, tingling, pain, or weakness in hands or feet
• pale or blue lips, fingernails, or skin
• seizures
• sunken eyes
• trembling
• unusual drowsiness, dullness, or feeling of sluggishness
• unusual paleness
• weakness and heaviness of legs
• wrinkled skin

Some side effects of bendroflumethiazide / nadolol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Change in behavior
• continuing ringing or buzzing or other unexplained noise in ears
• decreased interest in sexual intercourse
• dry eyes or skin
• excess air or gas in stomach or intestines
• hair loss, thinning of hair
• hearing loss
• inability to have or keep an erection
• loss in sexual ability, desire, drive, or performance
• relaxed and calm
• sleepiness
• stomach soreness or discomfort
• stuffy nose
• weight loss

• Cracks in the skin
• discoloration of skin
• feeling of constant movement of self or surroundings
• increased sensitivity of skin to sunlight
• large, flat, blue or purplish patches in the skin
• loss of heat from the body
• muscle spasm, weakness, or restlessness
• scaly skin
• sensation of spinning
• severe sunburn

Applies to bendroflumethiazide / nadolol: oral tablet

Cardiovascular

Bendroflumethiazide:
Frequency not reported: Necrotizing angiitis, vasculitis, orthostatic hypotension

Nadolol:
Common (1% to 10%): Heart rate less than 40 beats per minute (bpm), symptoms of peripheral vascular insufficiency, cardiac failure, hypotension, rhythm/conduction disturbances
Frequency not reported: Heart rate less than 60 bpm, first degree heart block, third degree heart block[Ref]

Nervous system

Bendroflumethiazide:
Frequency not reported: Dizziness, vertigo, paresthesia, headache

Nadolol:
Common (1% to 10%): Dizziness/fatigue
Uncommon (0.1% to 1%): Paresthesias, sedation, headache, tinnitus, slurred speech[Ref]

Gastrointestinal

Bendroflumethiazide:
Frequency not reported: Nausea, vomiting, cramping, diarrhea, constipation, gastric irritation, abdominal bloating, sialadenitis, pancreatitis

Nadolol:
Uncommon (0.1% to 1%): Nausea, diarrhea, abdominal discomfort, constipation, vomiting, indigestion, bloating, flatulence, dry mouth[Ref]

Dermatologic

Bendroflumethiazide:
Frequency not reported: Purpura, exfoliative dermatitis, pruritus, ecchymosis, urticaria, cutaneous vasculitis, photosensitivity, rash

Nadolol:
Uncommon (0.1% to 1%): Rash, pruritus, dry skin, sweating, facial swelling
Frequency not reported: Reversible alopecia[Ref]

Respiratory

Bendroflumethiazide:
Frequency not reported: Respiratory distress, pneumonitis

Nadolol:
Uncommon (0.1% to 1%): Bronchospasm, cough, nasal stuffiness[Ref]

Metabolic

Bendroflumethiazide:
Frequency not reported: Anorexia, hyperglycemia, metabolic acidosis, hyperuricemia

Nadolol:
Uncommon (0.1% to 1%): Anorexia, weight gain[Ref]

Ocular

Bendroflumethiazide:
Frequency not reported: Xanthopsia, transient blurred vision

Nadolol:
Uncommon (0.1% to 1%): Dry eyes, blurred vision[Ref]

Psychiatric

Bendroflumethiazide:
Frequency not reported: Restlessness

Nadolol:
Uncommon (0.1% to 1%): Change in behavior, impotence or decreased libido[Ref]

Hematologic

Bendroflumethiazide:
Frequency not reported: Leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia, aplastic anemia[Ref]

Hepatic

Bendroflumethiazide:
Frequency not reported: Intrahepatic cholestatic jaundice, hepatitis[Ref]

Immunologic

Bendroflumethiazide:
Frequency not reported: Anaphylactic reactions, allergic glomerulonephritis[Ref]

Other

Bendroflumethiazide:
Frequency not reported: Fever, weakness[Ref]

Genitourinary

Bendroflumethiazide:
Frequency not reported: Glycosuria[Ref]

Musculoskeletal

Bendroflumethiazide:
Frequency not reported: Muscle spasm[Ref]

Some side effects of Corzide 80 / 5 may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.