What Mavik is used for and how to use it
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Mavik - Consumer Medicine Information

Manufacture: Abbott
Country: Canada
Condition: Diabetic Kidney Disease (Diabetic Nephropathy), Heart Attack (Myocardial Infarction), Heart Failure (Congestive Heart Failure), High Blood Pressure (Hypertension), Left Ventricular Dysfunction
Class: Angiotensin converting enzyme inhibitors
Form: Tablets, Capsules
Ingredients: trandolapril, erythrosine, gelatin, iron oxides and hydroxides, lactose, maize starch, povidone, sodium lauryl sulphate, sodium stearyl fumarate, titanium dioxide

MAVIK

Trandolapril Capsules

About this Medication

What the medication is used for

MAVIK 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 reducethe 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

MAVIK 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 MAVIK 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 MAVIK 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.
  • You have diabetes or kidney disease and are already taking a blood pressure-lowering medicine that contains aliskiren (such as Rasilez) or an angiotensin II receptor blocker (ARB). You can recognize ARBs because the name of their medicinal ingredient ends in “-sartan”.
  • Are pregnant or intend to become pregnant. Taking MAVIK during pregnancy can cause injury and even death to your baby.
  • Are breastfeeding. MAVIK 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 MAVIK

What the medicinal ingredient is

Trandolapril

What the non-medicinal ingredients are

Erythrosine, gelatin, iron oxides and hydroxides, lactose, maize starch, povidone, sodium lauryl sulphate, sodium stearyl fumarate, titanium dioxide.

What dosage forms it comes in

Capsules: 0.5 mg, 1 mg, 2 mg, and 4 mg.

Warnings and Precautions

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 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.
  • 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 non-medicinal 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 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.

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 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;

Proper Use of this Medication

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.

Side Effects and what to do about them

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 Side Effects, How Often They Happen and what to do about them

Symptom/effect Talk with your
doctor or
pharmacist
Stop taking
drug and
seek
immediate
emergency
medical
attention
Only if
severe
In all
cases
Common Hypersensitivity
reactions

Skin rash, skin
eruption or other
effect of the skin or
eyes, itching or fever
Low blood pressure
Fainting, dizziness,
lightheadedness, may
occur when you go
from lying or sitting
to standing up.
Increased levels of
potassium in the
blood:

Irregular or skipped
heart beats, muscle
weakness and
generally feeling
unwell
Uncommon Allergic Reactions
(angioedema)

Swollen mouth, lips,
tongue, eyes,
extremities, throat or
difficulty swallowing
or breathing
Intestinal
angioedema

Abdominal pain that
may become more
severe after eating,
nausea, vomiting,
intestinal cramps
Kidney Disorder:
change in frequency
of urination, nausea,
vomiting, swelling of
extremities, fatigue
Jaundice (Liver
Disorder)

Yellowing of the eyes
and skin, dark urine,
abdominal pain,
nausea, vomiting,
loss of appetite
Electrolyte
Imbalance:

weakness,
drowsiness, muscle
pain or cramps,
irregular heartbeat
Rare Decreased Platelets:
bruising, bleeding,
fatigue and weakness
Decreased White
Blood Cells:

infections, fatigue,
fever, aches, pains,
and flu-like
symptoms
Unknown Toxic Epidermal
Necrolysis:

Severe skin peeling,
especially in mouth
and eyes
Stevens-Johnson
Syndrome:

Blistering of the
mucous membranes
of the skin including
mouth, lips, eyelids,
and genitals

This is not a complete list of side effects. For any unexpected effects while taking MAVIK, contact your doctor, nurse, or pharmacist.

How to Store it

Store MAVIK between 15° and 25°C in original container. MAVIK should not be stored beyond the date indicated on the container. Keep this drug out of reach and sight of children.

Reporting Suspected Side Effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:


  • Report on line at:

    www.healthcanada.gc.ca/medeffect

  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789
    • Mail to: Canada Vigilance Program

      Health Canada

      Postal Locator 0701D

      Ottawa, ON K1A 0K9


Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at

http://www.healthcanada.gc.ca/medeffect


NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More Information

The most recent version of this document plus the full Product Monograph, prepared for health professionals can be found at:

http://www.abbott.ca

or by contacting the sponsor, BGP Pharma ULC, Saint-Laurent,

Qc H4S 1Z1 at:

1-800-699-9948