Teva-Quinapril/HCTZ (Teva Canada, 20 mg / 12.5 mg, 20 mg / 25 mg): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

TEVA-QUINAPRIL/HCTZ (Quinapril

hydrochloride/Hydrochlorothiazide) lowers high blood pressure.

What it does:

TEVA-QUINAPRIL/HCTZ 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 TEAV-QUINAPRIL/HCTZ regularly even if you feel fine.

When it should not be used:

Do not take TEVA-QUINAPRIL/HCTZ 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 TEVA-QUINAPRIL/HCTZ.

  • Have difficulty urinating or produce no urine

  • Are pregnant or intend to become pregnant. Taking

    TEVA-QUINAPRIL/HCTZ during pregnancy can cause injury and even death to your baby

  • Are breastfeeding, TEVA-QUINAPRIL/HCTZ 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 hydrochloride and Hydrochlorothiazide

What the non-medicinal ingredients are:

Calcium phosphate (dibasic) anhydrous, Crospovidone, Hydroxypropyl cellulose, Hydroxypropyl methylcellulose, Iron oxide red, Iron oxide yellow, Magnesium Carbonate, Magnesium Stearate, Polyethylene glycol, Povidone and Titanium Dioxide.

What dosage forms it comes in:

10 mg/12.5 mg, 20 mg/12.5 mg and 20 mg/25 mg Tablets

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions - Pregnancy

TEVA-QUINAPRIL/HCTZ should not be used during pregnancy. If you discover that you are pregnant while taking TEVA-QUINAPRIL/HCTZ, stop the medication and contact your doctor, nurse, or pharmacist as soon as possible.

Before you use TEVA-QUINAPRIL/HCTZ, 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 TEVA-QUINAPRIL/HCTZ is not recommended.

• Are taking an aliskiren-containing medicine, such as

  Rasilez, used to lower high blood pressure. The combination with TEVA-QUINAPRIL/HCTZ 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 TEVA-QUINAPRIL/HCTZ). The combination with TEVA-QUINAPRIL/HCTZ is not recommended.

• Are currently taking anti-cancer (temsirolimus,

  everolimus), anti-rejection (sirolimus) or anti-diabetic (gliptins) drugs. Use of ACE inhibitors, such as TEVA-QUINAPRIL/HCTZ, with these drugs may increase the chance of having an allergic reaction.

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

• Myopia: sudden nearsightedness or blurred vision

• Glaucoma: an increased pressure in your eye, eye

  pain. Untreated, it may lead to permanent vision loss These eye disorders are related and can develop within hours to weeks of starting TEVA-QUINAPRIL/HCTZ.

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

Driving and using machines: before you perform tasks which may require special attention, wait until you know how you respond to TEVA-QUINAPRIL/HCTZ. 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 TEVA-

QUINAPRIL/HCTZ:

• 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
• Anticancer 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 TEVA-QUINAPRIL/HCTZ).

• 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

TEVA-QUINAPRIL/HCTZ is not for initial therapy. You must first be stabilized on the individual medicinal ingredients (quinapril hydrochloride and

hydrochlorothiazide) of TEVA-QUINAPRIL/HCTZ. If your dosage matches the dosages in TEVA-QUINAPRIL/HCTZ, your doctor may prescribe TEVA-QUINAPRIL/HCTZ taken once a day (instead of each medicinal ingredient as a separate pill).

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

TEVA-QUINAPRIL/HCTZ can be taken with or without food. If TEVA-QUINAPRIL/HCTZ 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:

If you think you have taken too much TEVA-QUINAPRIL/HCTZ 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, upset stomach, decreased appetite, constipation
• Muscle pain, spasms, back pain, restlessness
• Pins and needles in your fingers
• Nausea, vomiting, diarrhea
• Sore throat
• Reduced libido
• Rash, red patches on the skin

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

TEVA-QUINAPRIL/HCTZ 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 TEVA-QUINAPRIL/HCTZ, contact your doctor, nurse or pharmacist.

HOW TO STORE IT

Store TEVA-QUINAPRIL/HCTZ at room temperature, between 15°C and 30°C. Protect from moisture. Keep in well closed container.

Keep TEVA-QUINAPRIL/HCTZ out of 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/health-canada/services/drugs-health-products/medeffect-canada/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

This document plus the full product monograph, prepared for health professionals can be found by contacting Teva Canada Limited by:

Phone: 1-800-268-4127 ext. 3;

Email: druginfo@tevacanada.com; or

Fax: 1-416-335-4472

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

Canada, M1B 2K9

Prepared on: December 17, 2018