Mavik (Trandolapril)

Usual adult dose:

Take MAVIK exactly as prescribed. Dosage must be individualized. The recommended initial dose of MAVIK 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 MAVIK with a meal, or if you prefer, on an empty stomach.

With your first dose of MAVIK 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 MAVIK. If this effect persist, discuss this with your doctor. Your medication may need to have the dose reduced or changed.

Overdose:

If you think you (or someone you know) may have taken too much MAVIK, contact your doctor, nurse, pharmacist, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. Tell them how much you have taken and show them the capsules.

Overdose symptoms expected with drugs like MAVIK include a severe drop in blood pressure, shock, stupor, and an abnormally slow heart beat.

Missed dose:

If you forget to take your dose of MAVIK, 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.

Like all medicines, MAVIK can cause side effects. After you have started taking MAVIK, 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.

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

Serious Warnings and Precautions—Pregnancy

MAVIK should not be used during pregnancy. If you discover that you are pregnant or you are planning to become pregnant while taking MAVIK, stop the medication and contact your doctor, nurse, or pharmacist as soon as possible.

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

• 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.
• Are dehydrated or suffer from excessive vomiting, diarrhea, or sweating.
• Are possibly allergic to MAVIK (or any drug used to lower blood pressure), including any of its nonmedicinal ingredients. (Refer to “What the nonmedicinal 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 MAVIK is not recommended.
• Are taking an angiotensin receptor blocker (ARB). You can recognize an ARB because its medicinal ingredient ends in “-SARTAN”.
• 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 MAVIK. 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 MAVIK.

Driving and using machines:

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

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 MAVIK:

• 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);
• 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);
• 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;
• 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;
• Systemic corticosteroids used to treat joint pain and swelling.