Trandolapril (Laboratoire Riva): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

TRANDOLAPRIL is used to treat high blood pressure and is also used to treat patients after a heart attack.

Managing your lifestyle:

The "lifestyle" part of your treatment is as important as your medication. By working as a team with your doctor, you can help reduce the risk of hypertension complications to maintain the style of life you are accustomed to.

Together, you and your doctor can determine how each of the following applies to you:

Alcohol: Avoid alcoholic beverages until you have discussed

their use with your doctor. Alcohol consumption may alter your blood pressure and/or increase the possibility of dizziness or fainting.

Diet: Generally, avoid fatty foods and food that is high in

salt or cholesterol.

Exercise: Exercise regularly. It will help to keep your weight

down, make you feel more energetic and is a good way to deal with stress. If you are not exercising regularly, be sure to discuss a fitness plan with your doctor.

Smoking: Avoid it completely.

What it does:

Your doctor has prescribed TRANDOLAPRIL, a medication that helps to control blood pressure. TRANDOLAPRIL prevents blood vessels from constricting and therefore reduces blood pressure. It is not, however, a cure.

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

But it takes more than just medication to reduce blood

pressure. Discuss the risk factors, and how they apply to your lifestyle, with your doctor. You may have to modify some of your daily habits to keep your blood pressure down.

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:

TRANDOLAPRIL should not be used if:

• you are pregnant or planning to become pregnant you are allergic to the drug or any non-medicinal ingredients

• you have a history of angioedema (disfiguring type of temporary swelling which can be hazardous, see Side Effects)

What the medicinal ingredient is:

Trandolapril

What the important nonmedicinal ingredients are:

Colloidal silicon dioxide, dimeticone, lactose, magnesium stearate, microcrystalline cellulose, starch maize and gelatin capsules (black iron oxide, erythrosine, gelatin, indigo carmine, quinoline yellow, red iron oxide, sunset yellow, titanium dioxide, and yellow iron oxide).

What dosage forms it comes in:

Capsules: 0.5 mg, 1.0 mg, 2.0 mg and 4.0 mg.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

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

BEFORE taking TRANDOLAPRIL, it is important that you inform your doctor or pharmacist of the following:

• You are taking salt substitutes or foods containing potassium.

  You should not be taking salt substitutes or foods containing potassium without the advice of your doctor.

• Other medical problems, especially if you have diabetes, liver disease, kidney disease, heart or blood vessel disease.
• You are pregnant, breast-feeding or thinking of becoming pregnant. Taking TRANDOLAPRIL during pregnancy can cause injury and even death to your baby. This medicine should not be used during pregnancy. If you become pregnant while taking TRANDOLAPRIL, stop the medication and report to your doctor as soon as possible. It is possible that TRANDOLAPRIL passes into breast milk. You should not

breast-feed while taking TRANDOLAPRIL If you need to keep breast-feeding, talk to your doctor about taking a different medicine to control your blood pressure.

• You are possibly allergic to TRANDOLAPRIL, including

  any of its non-medicinal ingredients.

• You are currently taking other medications. This is

  especially important if you are taking diuretics (water pills) which may add to the blood pressure lowering effect of TRANDOLAPRIL.

• You perform tasks which may require special attention (for

  example, driving an automobile or operating dangerous machinery). Almost all patients can, but you should not perform these tasks until you know how you tolerate your medicine.

If you are being treated for other conditions by other doctors, keep them all informed of which medications you are taking. Some drugs may reduce the effectiveness of TRANDOLAPRIL or conversely, TRANDOLAPRIL may reduce the effectiveness of other drugs.

If you have to undergo any dental or other surgery, inform the dentist or doctor in charge that you are taking this medication.

INTERACTIONS WITH THIS MEDICATION

Drugs that may interact with TRANDOLAPRIL include:

• Digoxin, lithium, nifedipine SR;
• Diuretics (water tablets) (e.g., hydrochlorothiazide);

• Potassium supplements, spironolactone, triamterene,

  amiloride;

• Any of the group of medicines known as non-steroidal anti-

  inflammatory drugs (NSAIDs);

• Any medication that can affect your immune system (e.g.,

  corticosteroids).

PROPER USE OF THIS MEDICATION

Usual dose:

Most people with high blood pressure need to take only one TRANDOLAPRIL capsule per day. You can take your medication with a meal, or if you prefer, on an empty stomach. It is important to take it at the same time every day as prescribed by your doctor.

Remember, hypertension is a long-term disease without short term symptoms. Just because you feel fine does not mean you can stop taking your medication. If you stop, serious complications of the disease may occur. Therefore, you should continue to take it regularly, as prescribed by your doctor.

With your first dose of TRANDOLAPRIL your blood pressure may drop too low and you may experience a sensation of

lightheadedness. Chances are that some of these side effects will disappear once your system becomes used to the medication. If they persist, discuss this with your doctor. Your medication may need to have the dose reduced or changed.

Overdose:

If you or someone you know accidentally takes more than stated dose, immediately contact the Regional Poison Control Centre, your doctor or go to the nearest hospital with the capsules. Tell your doctor or hospital how much was taken.

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

Missed Dose:

If you forget to take one of your of TRANDOLAPRIL capsules, take one as soon as you remember, if you remember on the same day. If not, do not take your missed capsule at all. Simply wait until it is time for your next dose. Do not take two doses at once.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Along with its intended action, any medication, including of TRANDOLAPRIL, may cause side effects. After you have started taking of 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 of occasional side effects include:

• Headache
• Flu-like symptoms such as sore throat, fever, malaise, muscle pain, rash
• Nausea, vomiting, diarrhea
• Fatigue
• Sensation of lightheadedness
• Abdominal pain
• Loss of appetite (anorexia)
• Sad mood (depression)

If you are suffering from excessive sweating, vomiting or diarrhea, your blood pressure may drop too low. If you feel ill after you have started taking of TRANDOLAPRIL capsules, or notice anything unusual or unexpected, tell your doctor or seek medical assistance.

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

HOW TO STORE IT

Store TRANDOLAPRIL between 15° and 25°C. Protect from moisture.

TRANDOLAPRIL should not be stored beyond the date indicated on the container. Keep this drug out of the reach of children.

REPORTING SIDE EFFECTS

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals, can be obtained by contacting, Laboratoire Riva Inc. at, 1-800-363-7988.

Laboratoire Riva Inc.

Blainville, Quebec

J7C 3V4

.

Last revised: April 30, 2012.

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