Ava-Ramipril: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

For Patients with High Blood Pressure

Your doctor has prescribed Ava-Ramipril, a medication that helps to control blood pressure.

Take your medication as instructed by your doctor.

Managing your lifestyle:

Keeping your blood pressure controlled

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.

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.

Remember, hypertension is a long-term disease without 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 Ava-Ramipril regularly, as prescribed by your doctor.

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 complications to maintain the style of life you are accustomed to.

• 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.

• Smoking: Avoid it completely.

What it does:

Ava-Ramipril opens blood vessels to reduce blood pressure, like the way opening a hose reduces water pressure. It is not, however, a cure.

When it should not be used:

• You have had an allergic reaction to ramipril and/or any components of Ava-Ramipril tablets (see what are the important nonmedicinal ingredients) or to any other medication of the same group of medicines called ACE (angiotensin converting enzyme) inhibitors. (see WARNINGS AND PRECAUTIONS.)
• You are pregnant or breast feeding

• You have a history of a condition called angioedema

  (dysfiguring type of temporary swelling which can be hazardous) (see SIDE EFFECTS).

What the medicinal ingredient is:

ramipril

What the important nonmedicinal ingredients are:

Hypromellose, microcrystalline cellulose, pregelatinized starch, sodium hydrogen carbonate and sodium stearyl fumarate.

For a full listing of nonmedicinal ingredients see Part I of the Product Monograph.

What dosage forms it comes in:

Tablets 1.25 mg, 2.5 mg, 5 mg and 10 mg.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

Ava-Ramipril should not be used during pregnancy. If you discover that you are pregnant while taking ramipril, stop the medications and please contact your physician as soon as possible.

BEFORE you use Ava-Ramipril talk to your doctor or pharmacist if:

You are currently taking any other medications, whether on prescription or otherwise (see INTERACTIONS WITH THIS MEDICATION)?

You should not be taking salt substitutes, potassium supplements or potassium containing medicine without the advice of your doctor. If you have to undergo any dental or other surgery, inform the dentist or physician in charge that you are taking this medicine.

You suffer from any other condition?

The presence of other medical problems may affect the use of ramipril. If you have developed heart failure after a heart attack, you may have to limit your physical activities: before you begin exercising, be sure to consult with your doctor. Make sure you tell your doctor if you have any 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 ramipril 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 ramipril, stop the medication and report promptly to your doctor as soon as possible.It is possible that ramipril passes into breast milk. You should not breast feed while taking ramipril.

Remember

Use this drug as directed by your doctor. All drugs can have both helpful and harmful effects. Both depend on the person and his or her condition. This leaflet alerts you to some of the times you should call your doctor. Other situations, which cannot be predicted, can arise. Nothing in this leaflet should stop you from calling your doctor or pharmacist with any questions or concerns you have about Ava-Ramipril.

INTERACTIONS WITH THIS MEDICATION

Some drugs may have a negative effect on ramipril, or ramipril may have a negative effect on other drugs. If you are currently taking any other medications, whether on prescription or otherwise, inform your doctor or pharmacist. This is especially important if you are taking diuretics (water pills) or any other medication to reduce blood pressure which may add to the blood pressure lowering effect of ramipril.

Drugs that may interact with ramipril include also agents increasing serum potassium: such as potassium supplements. Salt substitutes or medicines which contain potassium. These should be used with caution.

PROPER USE OF THIS MEDICATION

Usual Dose:

It is important to take Ava-Ramipril at the same time every day as prescribed by your doctor.

High Blood Pressure: The recommended initial dosage of Ava-Ramipril is 2.5 mg once daily. Your doctor will determine the appropriate dosage.

For patients taking diuretics or with impaired kidney function: The recommended initial dosage of ramipril is 1.25 mg daily.

Missed Dose:

If you forgot to take your Ava-Ramipril tablet, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Along with its intended action, any medication, including ramipril, may cause side effects. After you have started taking ramipril, it is important that you tell your doctor at once about any unexplained symptom you might experience. Examples of this are unexplained fever, rash, itching, any sign of infection, viral-like symptoms, flu-like symptoms, coughing, sore throat, abdominal

pain, loss of appetite, sad mood, jaundice, dizziness, fatigue, or nausea. These side effects may disappear once your system becomes used to the medication. If they persist, discuss this with your doctor. Your medication might have to be reduced or changed.

Dizziness or lightheadedness may occur after the first dose of this medicine. Make sure you know how you react to this medicine before you drive, operate machinery, or do anything requiring you to be alert. If fainting occurs after using ramipril, discontinue use and consult your doctor.

If you are suffering from excessive sweating, vomiting or diarrhea, this may cause you to lose too much water and lead to problems with low blood pressure. See your doctor.

Angioedema is characterized by swollen mouth, lips, tongue, eyes, extremities, throat or difficulty in swallowing or breathing. Intestinal angioedema may also occur and is characterized by abdominal pain (with or without nausea or vomiting). If you notice swelling or feel pain in these areas, inform your doctor immediately. You should also inform your doctor if you have an unexplained fever, rash or itching.

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

HOW TO STORE IT

Store in original container between 15 and 30°C, protect from light and moisture and do not store beyond the date indicated on the container.

Keep out of reach of children.

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:

Toll-free telephone: 1 866-234-2345

Toll-free fax: 1 866-678-6789

By email: cadrmp@hc-sc.gc.ca

By regular mail:

National AR Centre

Marketed Health Products Safety and Effectiveness Information Division

Marketed Health Products Directorate

Tunney’s Pasture, AL 0701C

Ottawa ON K1A 0K9

NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.

MORE INFORMATION

This document, plus the full product monograph prepared for health professionals, can be obtained by contacting the sponsor, Avanstra Inc., at: 1-855-708-3678

or

by written request at:

10761-25th NE, Suite 110, Building B,

Calgary, Alberta, Canada

T2C 3C2

or by e-mail at :

medinfo@avanstra.com

February 2011