What Accupril is used for and how to use it
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Accupril - Consumer Medicine Information

Manufacture: Pfizer Inc.
Country: Canada
Condition: Diabetic Kidney Disease (Diabetic Nephropathy), Heart Failure (Congestive Heart Failure), High Blood Pressure (Hypertension), Left Ventricular Dysfunction
Class: Angiotensin converting enzyme inhibitors
Form: Tablets
Ingredients: quinapril hydrochloride, candelilla wax, crospovidone, gelatin, hydroxypropylcellulose, hydroxypropylmethylcellulose, lactose, magnesium carbonate, magnesium stearate, polyethylene glycol, synthetic red iron oxide, titanium dioxide

ACCUPRIL

(quinapril hydrochloride tablets)

About this Medication

What the Medication Is Used For

High Blood Pressure (Hypertension)

ACCUPRIL lowers high blood pressure. It can be used alone or together with a diuretic (“water pill”).

Congestive Heart Failure

ACCUPRIL is used for congestive heart failure (a condition where the heart is unable to pump enough blood for the body`s needs), when it is combined with either a diuretic (“water pill”) and/or digitalis glycosides (drugs which help the heart beat more normally).

What It Does

ACCUPRIL is an angiotensin converting enzyme (ACE) inhibitor. You can recognize ACE inhibitors because their medicinal ingredient ends in ‘-PRIL’.

This medicine does not cure your disease. It helps to control it. Therefore, it is important to continue taking ACCUPRIL regularly even if you feel fine.

When It Should not be Used

Do not take ACCUPRIL if you:

  • Are allergic to quinapril hydrochloride or to any non-medicinal ingredient in the formulation.
  • Have experienced an allergic reaction (angioedema) with swelling of the hands, feet, or ankles, face, lips, tongue, throat, or sudden difficulty breathing or swallowing, to any ACE inhibitor or without a known cause. Be sure to tell your doctor, nurse, or pharmacist that this has happened to you.
  • Have been diagnosed with hereditary angioedema: an increased risk of getting an allergic reaction that is passed down through families. This can be triggered by different factors, such as surgery, flu, or dental procedures.
  • Are pregnant or intend to become pregnant. Taking ACCUPRIL during pregnancy can cause injury and even death to your baby.
  • Are breastfeeding. ACCUPRIL passes into breast milk.
  • Have renovascular hypertension (a form of high blood pressure that affects the blood vessels leading to the kidney’s).
  • Are taking aliskiren-containing medicines, such as Rasilez, and have one of the following conditions:
    • Diabetes
    • Kidney disease
    • High levels of potassium
    • Congestive heart failure combined with hypotension.
  • Are taking an angiotensin receptor blocker (ARB), another medicine to treat your high blood pressure, or another ACE inhibitor and have one of the following conditions:
    • Diabetes with end organ damage
    • Kidney disease
    • High levels of potassium
    • Congestive heart failure combined with hypotension.
    You can recognize ARBs because their medicinal ingredient ends in “-SARTAN”.
  • Have one of the following rare hereditary diseases:
    • Galactose intolerance
    • Lapp lactase deficiency
    • Glucose-galactose malabsorption

Because lactose is a non-medicinal ingredient in ACCUPRIL.

What the Medicinal Ingredient Is

Quinapril hydrochloride.

What the Nonmedicinal Ingredients Are

Candelilla wax, crospovidone, gelatin, hydroxypropylcellulose, hydroxypropylmethylcellulose, lactose, magnesium carbonate, magnesium stearate, polyethylene glycol, synthetic red iron oxide, titanium dioxide.

What Dosage Forms It Comes In

Tablets; 5, 10, 20, 40 mg.

Warnings and Precautions

Serious Warnings and Precautions

Serious Warnings and Precautions - Pregnancy ACCUPRIL® should not be used during pregnancy. If you discover that you are pregnant while taking ACCUPRIL®, stop the medication and contact your doctor, nurse, or pharmacist as soon as possible.

BEFORE you use ACCUPRIL talk to your doctor, nurse, or pharmacist if you:

  • Are allergic to any drug used to lower blood pressure.
  • Have recently received or are planning to get allergy shots for bee or wasp stings.
  • Have narrowing of an artery or a heart valve. Have had a heart attack or stroke.
  • Have heart failure.
  • Have diabetes, liver or kidney disease.
  • Are on dialysis or receiving LDL apheresis (treatment to remove “bad cholesterol” from the blood).
  • Are dehydrated or suffer from excessive vomiting, diarrhea, or sweating.
  • Are taking a salt substitute that contains potassium, potassium supplements, or a potassium-sparing diuretic (a specific kind of “water pill”).
  • Are taking an antibiotic containing trimethoprim. Are on a low-salt diet.
  • Are receiving gold (sodium aurothiomalate) injections.
  • Are less than 18 years old.
  • Are taking a medicine that contains aliskiren, such as Rasilez, an angiotensin receptor blocker (ARB) or another ACE inhibitor (in addition to ACCUPRIL). The combination with ACCUPRIL is not recommended.
  • Are taking anti-cancer (temsirolimus, everolimus), anti-rejection (sirolimus) or anti-diabetic (gliptins) drugs. Use of ACE inhibitors, such as ACCUPRIL, with these drugs may increase the chance of having an allergic reaction.

You may become sensitive to the sun while taking ACCUPRIL. Exposure to sunlight should be minimized until you know how you respond.

If you are going to have surgery and will be given an anesthetic, be sure to tell your doctor or dentist that you are taking ACCUPRIL.

Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to ACCUPRIL. Dizziness, lightheadedness, or fainting can especially occur after the first dose and when the dose is increased.

Interactions with this Medication

As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.

The following may interact with ACCUPRIL:

  • Agents increasing serum potassium, such as a salt substitute that contains potassium, potassium supplements, a potassium-sparing diuretic (a specific kind of “water pill”) or sulfamethoxazole/trimethoprim.
  • Alcohol
  • Allopurinol used to treat gout.
  • Anti-cancer drugs, including cyclophosphamide, methotrexate and temsirolimus and everolimus
  • Anti-rejection drugs, such as sirolimus (Rapamune)
  • Anti-diabetic drugs including insulin and oral medicines (e.g. metformin, gliptins, sulfonylureas)
  • Blood pressure-lowering drugs, including diuretics (“water pills”), aliskiren-containing products (e.g. Rasilez), angiotensin receptor blockers (ARBs) or other ACE inhibitors (in addition to ACCUPRIL).
  • Gold for the treatment of rheumatoid arthritis.
  • Lithium used to treat bipolar disease.
  • Nonsteroidal anti-inflammatory drugs (NSAIDs), used to reduce pain and swelling. Examples include ibuprofen, naproxen, and celecoxib.
  • Tetracycline (a type of antibiotic)

Proper Use of this Medication

Take ACCUPRIL exactly as prescribed. It is recommended to take your dose at about the same time every day.

Usual Adult Dose

High Blood Pressure (Hypertension)

For patients not taking a diuretic (“water pills”): The recommended starting dose is 10 mg once a day.

For patients also taking a diuretic (“water pill”): The recommended starting dose is 5 mg once a day.

Congestive Heart Failure

The recommended starting dose is 5 mg once a day.

Overdose

If you think you have taken too much ACCUPRIL contact your doctor, nurse, pharmacist, hospital emergency department or regional Poison control Centre immediately, even if there are no symptoms.

Missed Dose

If you have forgotten to take your dose during the day, carry on with the next one at the usual time. Do not double dose.

Side Effects and what to Do About Them

Side effects may include:

  • Dizziness, headache, trouble sleeping
  • drowsiness, fatigue, weakness
  • cough, stuffy and runny nose
  • rash, itching
  • abdominal pain, diarrhea, indigestion, nausea, vomiting
  • back pain

If any of these affects you severely, tell your doctor, nurse or pharmacist.

ACCUPRIL can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.

Serious Side Effects, how Often they Happen and what to Do About Them

Symptom / effectTalk with your doctor, nurse or pharmacistStop taking drug and seek immediate medical help
Only if severeIn all cases
CommonLow blood pressure: dizziness, fainting, lightheadedness.
May occur when you go from lying or sitting to standing up.
Increased levels of potassium in the blood: irregularheartbeat, muscle weakness and generally feeling unwell
UncommonAllergic reaction, including angioedema: rash, hives,swelling of the face, lips, tongue or throat, difficulty swallowing or breathing
Kidney disorder: change in frequency of urination, nausea, vomiting, swelling of extremities, fatigue
Liver disorder: yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite
Electrolyte imbalance: weakness, drowsiness, muscle pain or cramps, irregular heartbeat
Tachycardia: Fast heart beat
Edema: Swelling of hands, ankles or feet
RareDecreased platelets: bruising, bleeding, fatigue and weakness
Decreased white blood cells: infections,
В fatigue, fever, aches, pains, and flu-like symptoms
Chest Pain, heart attack
Shortness of breath
Coughing up  blood
High nitrogen compound found in blood (Azotemia): rapid heart rate, high blood pressure, fatigue, confusion, lightheadedness, dizziness, decreased urine production

This is not a complete list of side effects. For any unexpected effects while taking ACCUPRIL, contact your doctor, nurse, or pharmacist.

How to Store It

Store ACCUPRIL at room temperature, between 15° and 30o C. Protect from moisture. Keep in well closed container.

Keep ACCUPRIL out of the reach and sight of children.

Reporting Suspected Side Effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to: Canada Vigilance Program
      Health Canada
      Postal Locator 0701E
      Ottawa, Ontario
      K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More Information

This document plus the full product monograph, prepared for health professionals can be found at: http://www.pfizer.ca.or by contacting the sponsor, Pfizer Canada Inc., at:

1-800-463-6001