Details for: APO-QUINAPRIL
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02248500 | APO-QUINAPRIL | QUINAPRIL (QUINAPRIL HYDROCHLORIDE) | 10 MG | TABLET | ORAL |
| 02248501 | APO-QUINAPRIL | QUINAPRIL (QUINAPRIL HYDROCHLORIDE) | 20 MG | TABLET | ORAL |
| 02248502 | APO-QUINAPRIL | QUINAPRIL (QUINAPRIL HYDROCHLORIDE) | 40 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
High Blood Pressure (Hypertension):
APO-QUINAPRIL lowers high blood pressure. It can be used
alone or together with a diuretic (“water pill”).
Congestive Heart Failure
APO-QUINAPRIL 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
APO-QUINAPRIL 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 APO-QUINAPRIL regularly even if you feel fine.
When it should not be used
Do not take APO-QUINAPRIL if you:
- Are allergic to quinapril hydrochloride or to any nonmedicinal 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 taking Entresto (Sacubitril/valsartan), due to the increased risk of serious allergic reaction which causes swelling of the face or throat (ANGIOEDEMA) when taken with APO-QUINAPRIL
- Are pregnant or intend to become pregnant. Taking APOQUINAPRIL during pregnancy can cause injury and even death to your baby.
- Are breastfeeding. APO-QUINAPRIL 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 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”.
What the medicinal ingredient is
Quinapril hydrochloride
What the non-medicinal ingredients are
Each tablet contains the following non-medicinal ingredients (in alphabetical order): copovidone, crospovidone, iron oxide red, iron oxide yellow, lecithin, magnesium carbonate, polyvinyl alcohol, talc, titanium dioxide, xanthan gum and zinc stearate.
What dosage form it comes in
Tablets; 5 mg, 10 mg, 20 mg and 40 mg
Warnings and precautions
Serious Warnings and Precautions - Pregnancy
APO-QUINAPRIL should not be used during pregnancy. If you discover that you are pregnant while taking APOQUINAPRIL, stop the medication and contact your doctor, nurse, or pharmacist as soon as possible.
BEFORE you use APO-QUINAPRIL 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 neutral endopeptidase inhibitor.The combination with APO-QUINAPRILis not recommended
- Are taking a medicine that contains aliskiren, such as Rasilez, an angiotensin receptor blocker (ARB) or another ACE inhibitor (in addition to APOQUINAPRIL). The combination with APOQUINAPRIL is not recommended.
- Are taking anti-cancer (temsirolimus, everolimus), antirejection (sirolimus) or anti-diabetic (gliptins) drugs. Use of ACE inhibitors, such as APO-QUINAPRIL, with these drugs may increase the chance of having an allergic reaction.
You may become sensitive to the sun while taking APOQUINAPRIL. 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 APO-QUINAPRIL.
Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to APO-QUINAPRIL. 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 APO-QUINAPRIL:
- Agents increasing serum potassium, such as a salt substitute that contains potassium, potassium supplements, or 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 APO-QUINAPRIL).
- 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 APO-QUINAPRIL exactly as prescribed. It is recommended to take your dose at about the same time every day
Usual 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
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.
APO-QUINAPRIL can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and talk with your doctor or pharmacist |
|---|---|---|---|
| Common | |||
| Low blood
pressure:
dizziness, fainting,
lightheadedness May occur when you go from lying or sitting to standing up. |
✔ | ||
| Increased levels of
potassium in the
blood: irregular heartbeat, muscle weakness and generally feeling unwell |
✔ | ||
| Uncommon | |||
| Allergic 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 | ✔ | ||
| Rare | |||
| Decreased platelets: bruising, bleeding, fatigue and weakness | ✔ | ||
| Decreased white blood cells: infections, 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 APO-QUINAPRIL, contact your doctor, nurse, or pharmacist.
How to store
Store in tightly closed containers between 15°C and 25°C. Protect from moisture. Product should be stored in the original closed container with the desiccant. If re-dispensed, ensure desiccant is added to the original container.
Keep APO-QUINAPRIL out of the reach and sight of children.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
If you want more information about APO-QUINAPRIL:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/indexeng.jsp). Find the Consumer Information on the manufacturer’s website (http://www.apotex.ca/products) or by calling 1-800- 667-4708
This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.
Last revised: July 10, 2019