Ava-Valsartan: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Ava-Valsartan is used to lower blood pressure or to treat people after a heart attack (myocardial infarction) when the use of an angiotensin-converting enzyme (ACE) inhibitor, considered part of standard therapy for this condition, is not appropriate.

Ava-Valsartan is also used in patients with chronic heart failure, when they are unable to tolerate the standard treatment with medications called ACE inhibitors. There is no evidence that Ava-Valsartan provides added benefit when it is used with ACE inhibitors.

High blood pressure increases the workload of the heart and arteries. If this condition continues for a long time, damage to the blood vessels of the brain, heart, and kidneys can occur, and may eventually result in a stroke, heart failure or kidney failure. High blood pressure also increases the risk of heart attacks. Reducing your blood pressure decreases your risk of developing these illnesses.

What it does:

Ava-Valsartan belongs to a class of medicines known as angiotensin II receptor blocker, which help to control high blood pressure or other heart-related problems. Angiotensin II is a natural hormone produced in the body to keep blood pressure at normal levels. One function of angiotensin II is to increase blood pressure, usually when it becomes too low. Ava-Valsartan works by blocking the effect of angiotensin II. As a result, blood pressure is lowered.

When it should not be used:

You should not take Ava-Valsartan if:

• you have ever had an unusual or allergic reaction to valsartan

  or to any other component of this product,

• you are pregnant or plan to become pregnant.

Ava-Valsartan is not recommended for children and adolescents (below the age of 18 years).

What the medicinal ingredient is:

Valsartan

What the important nonmedicinal ingredients are:

Ava-Valsartan also contains the following non-medicinal ingredients:

40 mg tablets: Colloidal silicon dioxide, crospovidone, magnesium stearate, and microcrystalline cellulose, hydroxypropyl methylcellulose, polyethylene glycol, black iron oxide, red iron oxide, yellow iron oxide, and titanium dioxide.

80 mg tablets: Colloidal silicon dioxide, crospovidone, magnesium stearate, and microcrystalline cellulose, hydroxypropyl methylcellulose, polyethylene glycol, black iron oxide, red iron oxide, and titanium dioxide.

160 mg tablets: Colloidal silicon dioxide, crospovidone, magnesium stearate, and microcrystalline cellulose, hydroxypropyl methylcellulose, polyethylene glycol, black iron oxide, red iron oxide, yellow iron oxide, and titanium dioxide.

320 mg tablets: Colloidal silicon dioxide, crospovidone, magnesium stearate, and microcrystalline cellulose, hydroxypropyl methylcellulose, polyethylene glycol, black iron oxide, red iron oxide, yellow iron oxide, and titanium dioxide.

If you are on a special diet, or if you are allergic to any substance, ask your doctor or pharmacist whether any of these ingredients may cause a problem.

What dosage forms it comes in:

Ava-Valsartan is available in four tablet strengths containing valsartan 40 mg, 80 mg, 160 mg and 320 mg.

Ava-Valsartan 40 mg is a divisible film-coated tablet. The 20 mg dose may be obtained by dividing a 40 mg tablet in half at the break line.

• Ava-Valsartan 40 mg tablet is yellow, ovaloid, scored on one side, slightly convex, with bevelled edges, debossed on one side with DO and with NVR on the other side and contains 40 mg of valsartan.
• Ava-Valsartan 80 mg tablet is pale red, round shaped tablets with bevelled edges, debossed with DV on one side and NVR on the other and contains 80 mg of valsartan.
• Ava-Valsartan 160 mg tablet is grey orange, ovaloid shaped tablets with bevelled edges, debossed with DX on one side and NVR on the other and contains 160 mg of valsartan.
• Ava-Valsartan 320 mg tablet is dark grey-violet, ovaloid with bevelled edges, debossed with DXL on one side and NVR on the other and contains 320 mg of valsartan.

WARNINGS AND PRECAUTIONS

Serious warnings and precautions

Ava-Valsartan should not be used during pregnancy. If you discover that you are pregnant while taking Ava-Valsartan, stop the medication and please contact your physician.

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

• you have liver disease
• you have kidney disease or are undergoing dialysis
• you are being treated with diuretics
• you are suffering from excess vomiting or diarrhea
• you have any allergies to this drug or its ingredients or components of the container

You are pregnant, breast-feeding or thinking of becoming pregnant?

Taking Ava-Valsartan during pregnancy can cause injury and even death to your baby. This medicine should not be used during pregnancy. If you are planning to become pregnant while taking Ava-Valsartan, contact immediately your doctor.

It is possible that Ava-Valsartan passes into breast milk. You should discuss with you doctor about taking Ava-Valsartan while breastfeeding

Similar medicines were associated with serious harm to fetuses when they were taken after the first three months of pregnancy. (It is not known if they are harmful during the first three months). It is therefore important to tell your doctor immediately if you think you may have become pregnant, or planning to become pregnant. Your doctor will discuss with you the potential risk of taking Ava-Valsartan during pregnancy.

Although it is not known whether Ava-Valsartan can pass into human breast milk, this does happen in animals. Therefore do not breast-feed during treatment. Tell your doctor if you are breast-feeding, so that other treatment options can be tried.

Like many other medicines used to treat high blood pressure, Ava-Valsartan may rarely cause dizziness and affect your concentration. So before you drive a vehicle, use machinery, or do other things that need concentration, make sure you know how you react to the effects of Ava-Valsartan.

INTERACTIONS WITH THIS MEDICATION

As with other medicines, interactions with other drugs are possible. Therefore, do not take any other medicines unless you have discussed the matter with your physician or your pharmacist.

Drugs that may interact with Ava-Valsartan include:

• medicines used to lower blood pressure, including

  diuretics (water pills),

• potassium-sparing medicines, potassium supplements, or

  salt substitutes containing potassium,

• lithium therapy,

• certain type of pain killers called non-steroidal anti-

  inflammatory medicines (NSAIDs) or Selective Cyclooxygenase-2 Inhibitors (Cox-2 Inhibitors). Your doctor may also check your kidney function.

Before taking Ava-Valsartan make sure your doctor knows about all the medications you are taking, including those not prescribed by your doctor. It may be necessary to change the dose, take other precautions, or perhaps stop one of the medicines. This applies to

both prescription and non-prescription medicines.

PROPER USE OF THIS MEDICATION

If your doctor has prescribed Ava-Valsartan for you following a heart attack, it is important to continue to take it even if you feel well, so that Ava-Valsartan can help to reduce the chance of another heart attack occurring.

Patients who have high blood pressure often do not notice any signs or symptoms of this condition. So even though you are feeling well, your health may be getting worse. This makes it all the more important for you to continue your treatment program and to keep your appointments with your doctor.

Remember that this medicine does not cure your high blood pressure; it only may help to control it. Therefore, if you want to lower your blood pressure and keep it down, you must continue to take Ava-Valsartan as directed.

Usual dose:

It is very important that you take this medicine exactly as your doctor tells you in order to get the best results and reduce the chance of side effects.

High blood pressure (hypertension)

The usual dosage for the treatment of high blood pressure is one 80 mg tablet once a day. In some cases, your doctor may increase the dose to 160 mg and then eventually to 320 mg or prescribe it together with another medicine (e.g., a diuretic).

Following a heart attack (myocardial infarction)

Treatment is generally started as soon as 12 hours following the heart attack, usually at a low dose of 20 mg twice daily in order to minimise side effects including hypotension (low blood pressure). Your doctor may increase this dose gradually over several weeks to a maximum of 160 mg twice daily.

Failing heart (heart failure)

Treatment is generally started at a dose of 40 mg twice daily in order to minimize side effects including low blood pressure. Your doctor may increase this dose gradually over several weeks to a maximum of 160 mg twice daily.

Swallow Ava-Valsartan tablets with a glass of water. You can take Ava-Valsartan with or without food, but it should be taken the same way each day and at the same time.

Overdose:

If you have accidentally taken too many tablets of Ava-Valsartan, seek medical assistance immediately.

For management of a suspected drug overdose, contact your regional Poison Control Centre.

Missed Dose:

Try to take your dose at the same time each day, preferably in the morning. However, if you have forgotten to take your dose during

the day, carry on with the next one at the usual time. Do not take a double dose to make up for the forgotten tablet.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medicines, Ava-Valsartan may cause unwanted reactions, so-called side effects. Most patients do not experience side effects from Ava-Valsartan. Examples of occasional side effects include:

• Dizziness
• Light headedness
• Muscle pain or muscle weakness
• Unusual tiredness and/or weakness
• Headache
• Diarrhea

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

HOW TO STORE IT

Do not take Ava-Valsartan past the expiry date shown on the pack.

Store your Ava-Valsartan tablets in a dry place at room temperature (15 to 30°C).

Always remember

This medicine has been prescribed to you for your current medical problem only. Do not give it to other people.

Keep this medicine out of the reach 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:

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• Report online 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, or

  • Mail to: Canada Vigilance Program Health Canada

    Postal Locator 0701E Ottawa, Ontario

    K1A 0K9

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

Please consult your doctor or pharmacist with any questions or concerns you may have regarding your individual condition.

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 e-mail, at :

medinfo@avanstra.com

Last revised: June 12, 2012