Apo-Quinapril / HCTZ Tablets: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

APO-QUINAPRIL / HCTZ TABLETS lowers high blood pressure.

What it does:

APO-QUINAPRIL / HCTZ TABLETS contains a combination of 2 drugs, quinapril hydrochloride and hydrochlorothiazide:

• Quinapril hydrochloride is an angiotensin converting enzyme (ACE) inhibitor. You can recognize ACE inhibitors because their medicinal ingredient ends in “PRIL”. It lowers blood pressure.
• Hydrochlorothiazide is a diuretic or “water pill” that increases urination. This lowers blood pressure.

This medicine does not cure high blood pressure. It helps to control it. Therefore, it is important to continue taking APO-QUINAPRIL / HCTZ TABLETS regularly even if you feel fine.

When it should not be used:

Do not take APO-QUINAPRIL / HCTZ TABLETS if you:

• Are allergic to quinapril hydrochloride or hydrochlorothiazide or to any non-medicinal ingredients in the formulation
• Are allergic to any sulfonamide-derived drugs (sulfa drugs); most of them have a medicinal ingredient that ends in “-MIDE”
• 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 / HCTZ TABLETS.
  • Have difficulty urinating or produce no urine

  • Are pregnant or intend to become pregnant. Taking APO-QUINAPRIL / HCTZ TABLETS during pregnancy can cause injury and even death to your baby

  • Are breastfeeding. APO-QUINAPRIL / HCTZ TABLETS passes into breast milk.

  • 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”.

What the medicinal ingredients are:

Quinapril (as quinapril hydrochloride). Hydrochlorothiazide

What the non-medicinal ingredients are:

Copovidone, crospovidone, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, hypromellose, magnesium carbonate, polyethylene glycol, titanium dioxide, and zinc stearate.

What dosage forms it comes in:

Tablets:

• 10 mg quinapril (as quinapril hydrochloride) and 12.5 mg hydrochlorothiazide;
• 20 mg quinapril (as quinapril hydrochloride) and 12.5 mg hydrochlorothiazide;
• 20 mg quinapril (as quinapril hydrochloride) and 25 mg hydrochlorothiazide.

WARNINGS AND PRECAUTIONS

BEFORE you use APO-QUINAPRIL / HCTZ TABLETS, talk to your doctor, nurse or pharmacist if you:

• Are allergic to any drug used to lower blood pressure or penicillin
• 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
• Have lupus or gout
• 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-QUINAPRIL / HCTZ TABLETS is not recommended.
• Are taking an aliskiren-containing medicine such as Rasilez, used to lower high blood pressure. The combination with APO-QUINAPRIL / HCTZ TABLETS is not recommended.
• Are taking an angiotensin receptor blocker (ARB). You can recognize an ARB because its medicinal ingredient ends in “-SARTAN”
• Are taking a medicine that contains aliskiren, such as Rasilez, an angiotensin receptor blocker (ARB), or another ACE inhibitor (in addition to APO-QUINAPRIL / HCTZ TABLETS. The combination with APO-QUINAPRIL / HCTZ TABLETS is not recommended.

• Are currently taking anti-cancer (temsirolimus, everolimus), anti-rejection (sirolimus) or anti-diabetic (gliptins) drugs. Use of ACE inhibitors,

  • such as APO-QUINAPRIL / HCTZ TABLETS, with these drugs may increase the chance of having an allergic reaction.
  • Have had skin cancer or have a family history of skin cancer.
  • Have a greater chance of developing skin cancer because you have light-coloured skin, get sunburned easily, or are taking drugs to suppress your immune system.

Risk of skin cancer:

• APO-QUINAPRIL / HCTZ TABLETS contains hydrochlorothiazide. Treatment with hydrochlorothiazide may increase the risk of developing non-melanoma skin cancer. The risk is higher if you have been taking APO-QUINAPRIL / HCTZ TABLETS for many years (more than 3) or at a high dose.

• While taking APO-QUINAPRIL / HCTZ TABLETS:

  • Make sure to regularly check your skin for any new lesions. Check areas that are most exposed to the sun, such as the face, ears, hands, shoulders, upper chest and back.
  • Limit your exposure to the sun and to indoor tanning. Always use sunscreen (SPF-30 or higher) and wear protective clothing when going outside.
  • Talk to your doctor immediately if you get more sensitive to the sun or UV light or if you develop an unexpected skin lesion (such as a lump, bump, sore, or patch) during the treatment.

Hydrochlorothiazide in APO-QUINAPRIL / HCTZ TABLETS can cause sudden eye disorders:

• Choroidal effusion: an abnormal buildup of liquid behind the white outer layer of your eye that may result in vision changes.
• Myopia: sudden nearsightedness or blurred vision
• Glaucoma: an increased pressure in your eye, eye pain. Untreated, it may lead to permanent vision loss

If your vision changes, stop taking APO-QUINAPRIL / HCTZ TABLETS and seek immediate medical help. These eye disorders are related and can develop within hours to weeks of starting APO-QUINAPRIL / HCTZ TABLETS.

You may become sensitive to the sun while taking APO-QUINAPRIL / HCTZ TABLETS. 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 / HCTZ TABLETS.

Driving and using machines: before you perform tasks which may require special attention, wait until you know how you respond to APO-QUINAPRIL / HCTZ TABLETS. 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 the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.

The following may interact with APO-QUINAPRIL / HCTZ TABLETS:

• Adrenocorticotropic hormone (ACTH) used to treat West Syndrome
• Alcohol, narcotics (strong pain medications) or barbiturates (sleeping pills). They may cause low blood pressure and dizziness when you go from lying down or sitting to standing up.
• Amphotericin B, an antifungal drug
• Anti-cancer drugs, including cyclophosphamide, methotrexate, temsirolimus and everolimus.
• Anti-rejection drugs, such as sirolimus (Rapamune)
• Antidepressants, in particular selective serotonin reuptake inhibitors (SSRIs), including citalopram, escitalopram, and sertraline
• Anti-diabetic drugs including insulin and oral medicines (e.g. metformin, gliptins, sulfonylureas)
• Bile acid resins used to lower cholesterol
• Calcium or vitamin D supplements
• Corticosteroids used to treat joint pain and swelling
• Digoxin, a heart medication
• Drugs known to increase the potassium level in the blood such as a salt substitute that contains potassium, potassium supplements, potassium-sparing diuretic (a specific kind of “water pill”) (e.g. spironolactone, triamterene, amiloride, sulfamethoxazole/trimethoprim).
• Drugs that slow down or speed up bowel function, including atropine, metoclopramide, and domperidone
• Drugs used to treat epilepsy, including carbamazepine and topiramate
• Gold for the treatment of rheumatoid arthritis
• Gout medications, including allopurinol and probenecid
• Lithium used to treat bipolar disease

• Non-steroidal anti-inflammatory drugs (NSAIDs) used to reduce pain and swelling. Examples include

  • ibuprofen, naproxen, and celecoxib
  • 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 / HCTZ TABLETS).
  • Pressor amines (drugs which increase blood pressure, such as adrenaline)
  • Skeletal muscle relaxants used to relieve muscle spasms, including tubocurare
  • Tetracycline (a type of antibiotic)

PROPER USE OF THIS MEDICATION

APO-QUINAPRIL / HCTZ TABLETS is not for initial therapy. You must first be stabilized on the individual medicinal ingredients (quinapril hydrochloride and hydrochlorothiazide) of APO-QUINAPRIL / HCTZ TABLETS. If your dosage matches the dosages in APO-QUINAPRIL / HCTZ TABLETS, your doctor may prescribe APO-QUINAPRIL / HCTZ TABLETS taken once a day (instead of each medicinal ingredient as a separate pill).

Take APO-QUINAPRIL / HCTZ TABLETS exactly as prescribed. It is recommended to take your dose at about the same time every day.

APO-QUINAPRIL / HCTZ TABLETS can be taken with or without food. If APO-QUINAPRIL / HCTZ TABLETS causes upset stomach, take it with food or milk.

Usual Adult Dose:

The recommended starting dose is one 10 mg/12.5 mg tablet daily.

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, upset stomach, decreased appetite, constipation,
• Muscle pain, spasms, back pain, restlessness
• Pins and needles in your fingers
• Nausea, vomiting, diarrhea
• Sore throat
• Stuffy, runny nose
• Reduced libido
• Rash, red patches on the skin

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

APO-QUINAPRIL / HCTZ TABLETS can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.

This is not a complete list of side effects. For any unexpected effects while taking APO-QUINAPRIL / HCTZ TABLETS, contact your doctor, nurse or pharmacist.

HOW TO STORE IT

Protect from moisture. Keep container tightly closed and store between 15°C and 25°C. Keep APO-QUINAPRIL / HCTZ TABLETS out of the reach and sight of children.

Reporting Side Effects

MORE INFORMATION

If you want more information about APO-QUINAPRIL / HCTZ TABLETS:

• 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://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (http://www.apotex.ca/products), or by calling 1-800-667-4708.

Last Approved: December 13, 2022