Teva-Trandolapril: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

TEVA-TRANDOLAPRIL is used to treat:

• High blood pressure.
• Patients after a heart attack.

Managing your lifestyle:

The "lifestyle" part of your treatment is as important as your medication. In collaboration with your doctor, you can help reduce the risk of high blood pressure complications to maintain the lifestyle you are accustomed to. To do this, your doctor may discuss changes to your alcohol consumption and your diet. Your doctor will also probably recommend regular exercise and to completely avoid smoking.

What it does:

TEVA-TRANDOLAPRIL 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 TEVA-TRANDOLAPRIL regularly even if you feel fine.

Although you may not feel any symptoms for years, high blood pressure can lead to stroke, heart attack, kidney disease and other serious conditions.

Hypertension is the medical term for high blood pressure. When blood flows through the blood vessels it pushes against their walls, almost like water pushing against the sides of a hose. Blood pressure is like that "push". When blood pressure is high (like the water pressure in a hose when the nozzle is partially shut), damage can occur to the heart and blood vessels.

When it should not be used:

Do not take TEVA-TRANDOLAPRIL if you:

• Are allergic to trandolapril or any non-medicinal ingredients.

  • 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 trandolapril.

    You must wait at least 36 hours after your last dose of sacubritril/valsartan before taking TEVA-TRANDOLAPRIL.

  • Are already taking a blood pressure-lowering medicine that contains aliskiren (such as Rasilez^®), or an angiotensin receptor blocker (ARB) which is another medicine to treat your high blood pressure [you can recognize ARBs because their medicinal ingredient ends in “-SARTAN”]; or another ACE inhibitor and you have one of the following conditions:

    • diabetes,
    • kidney disease,
    • high potassium levels,
    • heart failure combined with low blood pressure.
  • Have narrowing of the arteries to one or both kidneys (renal artery stenosis).
  • Have hypotension (low blood pressure).

  • Are pregnant or intend to become pregnant. Taking TEVA-TRANDOLAPRIL during pregnancy can cause injury and even death to your baby.

  • Are breastfeeding. TEVA-TRANDOLAPRIL passes into breast milk.

  • Have one of the following rare hereditary diseases:

    • Galactose intolerance,
    • Lapp lactase deficiency,
    • Glucose-galactose malabsorption,

Because lactose is a non-medicinal ingredient in TEVA-TRANDOLAPRIL.

What the medicinal ingredient is:

Trandolapril

What the non-medicinal ingredients are:

black iron oxide (4 mg only), erythrosine, FD&C red 3 (1 mg and 4 mg only), FD&C red 40 (0.5 mg and 2 mg only), FD&C yellow 6 (1 mg only), gelatin, lactose anhydrous, povidone, sodium stearyl fumarate, starch pregelatinized, titanium dioxide, yellow iron oxide (0.5 mg, 1 mg and 4 mg only).

What dosage forms it comes in:

TEVA-TRANDOLAPRIL is available in 0.5 mg, 1.0 mg, 2.0 mg and 4.0 mg capsules.

WARNINGS AND PRECAUTIONS

BEFORE you use TEVA-TRANDOLAPRIL talk to your doctor, nurse or pharmacist if you:

• Are taking salt substitutes or foods containing potassium, potassium supplements, or a potassium-sparing diuretic (a specific kind of ‘water pill’).
• Have diabetes, liver, or kidney disease.
• Have narrowing of an artery or heart valve disease
• Have had a heart attack or stroke.
• Have heart failure.
• Are on dialysis or LDL apheresis (a treatment to remove LDL cholesterol from the blood).
• Are dehydrated or suffer from excessive vomiting, diarrhea, or sweating.
• Are possibly allergic to TEVA-TRANDOLAPRIL (or any drugs used to lower blood pressure), including any of its nonmedicinal ingredients. (Refer to the subheading “What the non-medicinal ingredients are” for a complete listing).
• Have recently received or are planning to get allergy shots for bee or wasp stings.
• Are on a low salt diet
• Are taking a medicine that contains aliskiren, such as Rasilez^®, used to lower high blood pressure. The combination with TEVA-TRANDOLAPRIL is not recommended.
• Are taking an angiotensin receptor blocker (ARB). You can recognize an ARB because its medicinal ingredient ends in “-SARTAN”. The combination with TEVA-TRANDOLAPRIL is not recommended.

• Are taking an antibiotic containing trimethoprim and sulfamethoxazole.

  Are taking any of the following medicines, the risk of angioedema may be increased:

  • Medicines used to prevent organ transplant rejection (e.g. sirolimus) and for cancer (e.g. everolimus and temsirolimus).
  • Sitagliptin or other gliptins (to treat Type II diabetes)
  • neutral endopeptidase (NEP) inhibitors.
• Are taking medicines called neutral endopeptidase (NEP) inhibitors
• Are receiving gold (sodium aurothiomalate) injections.
• Are less than 18 years old.
• Have lupus or scleroderma.

You may become sensitive to the sun while taking TEVA-TRANDOLAPRIL. 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-TRANDOLAPRIL.

Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to TEVA-TRANDOLAPRIL. 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 TEVA-TRANDOLAPRIL:

• 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”); examples include spironolactone, triamterene or amiloride or co-trimoxazole (trimethoprim/sulfamethoxazole); cyclosporine, an immunosuppressant medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin blood to prevent clots;
• Alcohol. It may cause low blood pressure, dizziness and fainting;
• Allopurinol, used to treat gout;
• Antacids;
• Antidepressants, used to control your depression;
• Antidiabetic agents, including insulin and oral medicines used to control your blood glucose;
• Bee or wasp venom, found in allergy shots for bee or wasp stings;
• Blood pressure lowering drugs, including diuretics (“water pills” e.g., hydrochlorothiazide), aliskiren-containing products (e.g. Rasilez^®), or angiotensin receptor blockers (ARBs);
• corticosteroids used to treat joint pain and swelling;
• Cytostatic agents used to treat cancers;
• Dextran sulphate used in low density lipoprotein apheresis to remove cholesterol from the blood;
• Digoxin used to treat irregular heartbeats;
• Gold for the treatment of rheumatoid arthritis
• Immunosuppressive agents used to prevent rejection of a transplanted organ or treat autoimmune diseases;
• Inhalation anesthetics;
• mTOR (mammalian target of rapamycin) inhibitor therapy used to lower the body’s ability to reject a transplant (e.g. sirolimus) or to treat certain types of cancer (e.g. temsirolimus, everolimus);
• Lithium used to treat bipolar disease;
• Nifedipine SR used to treat chest pain or lower blood pressure;
• Non-steroidal anti-inflammatory drugs (NSAIDs) used to reduce pain and swelling. Examples include ibuprofen, naproxen, celecoxib, and acetylsalicylic acid (aspirin) used in higher doses;
• Procainamide used to treat irregular heartbeats;
• Co-trimoxazole (trimethoprim/sulfamethoxazole);
• Neutral endopeptidase (NEP inhibitors).

PROPER USE OF THIS MEDICATION

Usual Adult Dose:

Take TEVA-TRANDOLAPRIL exactly as prescribed. Dosage must be individualized. The recommended initial dose of TEVA-TRANDOLAPRIL is 1 mg once daily. The dose can be increased over time by your doctor, up to a maximum dose of 4 mg once daily. For patients with kidney or liver impairment, the recommended initial dose is 0.5 mg once daily.

It is recommended to take your dose at about the same time every day. You can take TEVA-TRANDOLAPRIL with a meal, or if you prefer, on an empty stomach.

With your first dose of TEVA-TRANDOLAPRIL your blood pressure may drop too low and you may experience a sensation of lightheadedness. This effect should disappear once your system becomes used to TEVA-TRANDOLAPRIL. If this effect persists, discuss this with your doctor. Your medication may need to have the dose reduced or changed.

Overdose:

Overdose symptoms expected with drugs like TEVA-TRANDOLAPRIL include a severe drop in blood pressure, shock, stupor, and an abnormally slow heartbeat.

Missed Dose:

If you forget to take your dose of TEVA-TRANDOLAPRIL, take it as soon as you remember, if you remember on the same day. If not, do not take your missed dose at all. Simply wait until it is time for your next dose. Do not double dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medicines, TEVA-TRANDOLAPRIL can cause side effects. After you have started taking TEVA-TRANDOLAPRIL, it is important that you tell your doctor at once about any unexplained symptom you might experience.

Frequent side effects include coughing and dizziness. Other occasional side effects include:

• Headache
• Flu-like symptoms such as sore throat, fever, malaise, muscle pain or weakness,
• Rash
• Nausea, vomiting, diarrhea, abdominal pain, loss of appetite (anorexia)
• Fatigue
• Sensation of lightheadedness, confusion
• Sad mood (depression)
• Blurred vision
• Confusion
• Dermatitis

• Sinusitis and rhinitis

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

  TEVA-TRANDOLAPRIL 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-TRANDOLAPRIL, contact your doctor, nurse or pharmacist.

HOW TO STORE IT

Store TEVA-TRANDOLAPRIL between 15º and 30ºC in the original container. TEVA-TRANDOLAPRIL should not be stored beyond the date indicated on the container. Keep this drug out of the reach and sight of children.

REPORTING SUSPECTED SIDE EFFECTS

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

M1B 2K9

Canada

www.tevacanada.com

Last revised: October 29, 2020