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The product information leaflet is Part III of a three-part “Product Monograph” published when AVALIDE was approved for sale in Canada and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about AVALIDE. Please read this leaflet carefully before you start to take your medicine, even if you have just refilled your prescription. Contact your doctor or pharmacist if you have any questions about the drug. Remember that your doctor has prescribed this medicine only for you. Never give it to anyone else.

About this medication

What the medication is used for:

AVALIDE is used to treat hypertension (high blood pressure).

What it does:

The irbesartan ingredient of AVALIDE lowers blood pressure by specifically blocking a naturally occurring substance called angiotensin II, which normally narrows your blood vessels. The irbesartan ingredient of AVALIDE allows the blood vessels to relax. The hydrochlorothiazide ingredient of AVALIDE works by making your kidneys pass more water and salt. Together irbesartan and hydrochlorothiazide lower high blood pressure. Although your doctor will be able to tell you that the medicine is working by measuring your blood pressure, you will probably feel no different while you are taking AVALIDE.

If your blood pressure remains too high after an adequate trial period, your doctor may decide to increase the dose of either irbesartan or hydrochlorothiazide.

When it should not be used:

Do not take AVALIDE:

• If you are allergic to any of its ingredients or to sulfonamide. (See What the nonmedicinal ingredients are).
• If you have difficulty in producing urine

If you are not sure whether you should start taking AVALIDE, contact your doctor or your pharmacist.

• Pregnancy and Breast-feeding: It is not recommended that you use AVALIDE while you are pregnant or breast-feeding. If you are pregnant or planning to become pregnant while taking AVALIDE, talk to your doctor as soon as possible.

Children:

AVALIDE should not be given to children.

What the medicinal ingredient is:

Each tablet of AVALIDE contains irbesartan and hydrochlorothiazide.

What the nonmedicinal ingredients are:

AVALIDE 150/12.5 mg tablets contain the following nonmedicinal ingredients: croscarmellose sodium, ferric oxide red and ferric oxide yellow, lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, silicon dioxide.

AVALIDE 300/12.5 mg tablets contain the following nonmedicinal ingredients: croscarmellose sodium, ferric oxide red and ferric oxide yellow. lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, silicon dioxide.

The 300/25 mg strength contains black iron oxides, carnauba wax, croscarmellose sodium, ferric oxide red, and ferric oxide yellow, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, silicon dioxide, titanium dioxide.

What dosage forms it comes in:

AVALIDE tablets are available in three different strengths. Tablets which contain 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide come in the form of peach coloured, oval, biconvex tablets with a heart shape stamped on one side and the digits 2775 on the other side.

The next strength contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide. These come in a similar form and colour, with a heart shape stamped on one side and the digits 2776 on the other side.

The highest strength tablets contain 300 mg of irbesartan and 25 mg of hydrochlorothiazide. These tablets come in the form of pink coloured, film-coated, biconvex, oval tablets, with a heart shape stamped on one side and the digits 2788 on the other.

Warnings & Precautions

BEFORE you use AVALIDE talk to your doctor or pharmacist about any medical problems you have or have had, and about any allergies. Tell your doctor if you have recently suffered from excess vomiting or diarrhea.

• It is particularly important to tell your doctor if you have liver or kidney disease, gout, diabetes, lupus erythematosus, or if you are being treated with other diuretics (water pills). In these cases, your doctor may need to adjust the dose of your medications.
• Before surgery and general anesthesia (even at the dentist’s office), tell the doctor or dentist that you are taking AVALIDE, as there may be a sudden fall in blood pressure associated with general anesthesia.
• You are pregnant, breast-feeding or thinking of becoming pregnant? Taking AVALIDE during pregnancy can cause injury and even death to your baby. This medication should not be used during pregnancy. If you are planning to become pregnant while taking AVALIDE, contact immediately your doctor.

It is possible that AVALIDE passes into breast milk. You should discuss with your doctor about taking AVALIDE while breast-feeding.

Wait until you know how you respond to your medication before performing tasks that require special attention (for example, driving an automobile or operating dangerous machinery).

Interactions with this medication

You should have informed your doctor of any medicines you are taking. These include medicines obtained without prescription.

The diuretic agent, hydrochlorothiazide, contained in AVALIDE may interact with other medicines.

Preparations containing lithium should not be taken with AVALIDE without close supervision by your doctor.

Special precautionary measures (e.g., blood tests) may be appropriate if you take potassium supplements, potassium-containing salt substitutes or potassium sparing medicines, other diuretics (water pills), warfarin, digoxin, antidiabetic drugs, alcohol, barbiturates, narcotics, pressor amines, skeletal muscle relaxants, cholestyramine and colestipol resins.

If calcium or a calcium sparing drug (e.g., vitamin D therapy) is prescribed, serum calcium levels should be monitored and calcium dosage adjusted accordingly.

It is important for your doctor to know if you are taking other medicines to reduce your blood pressure, or if you are taking steroids, or anti-inflammatory medicines used in arthritis.

Proper use of this medication

Usual dose:

Take AVALIDE every day exactly as your doctor has instructed.

It is important to continue taking AVALIDE for as long as your doctor prescribes it in order to maintain control of your blood pressure.

AVALIDE may be taken with or without food, however it should be taken consistently with respect to food intake.

Overdose:

For management of a suspected drug overdose, or in case of an actual overdose, contact your Regional Poison Centre or your doctor immediately, so that medical attention may be given promptly.

Missed Dose:

Try to take AVALIDE daily as prescribed. However, if you miss a dose, do not take an extra dose. Just resume your normal schedule.

Side effects and what to do about them

Along with its intended action, any medication, including AVALIDE, may cause side effects. In most patients, AVALIDE is well tolerated. Side effects may include:

• Headache
• Dizziness
• Fatigue
• Muscle pain

Side effects such as myalgia (muscle pain), myasthenia (muscle weakness), myositis (muscle inflammation) and rhabdomyolysis (a muscle wasting disease), in rare cases leading to kidney failure, have been reported with the use of angiotensin II receptor blockers, the class of drugs to which a component of AVALIDE belongs. You should contact your physician promptly if you experience muscle pain that you cannot explain, muscle tenderness or weakness, generalised weakness, or when you notice dark/brown urine.

Your physician or pharmacist has a more complete list. Tell your physician or pharmacist promptly about these or any other unusual symptoms.

Serious side effects, how often they happen & what to do about them

This is not a complete list of side effects. If you have any unexpected effects while taking AVALIDE, contact your doctor or pharmacist.

How to store it

Store AVALIDE tablets at room temperature (15 to 30ºC).
Keep this medication out of the reach of children.

More information

This document plus the full product monograph, prepared for health professionals can be found at www.bmscanada.ca or obtained by contacting the sponsor, Bristol-Myers Squibb Canada, at 1-866-463-6267.

This leaflet was prepared by Bristol-Myers Squibb Canada.

sanofi-aventis Canada Inc.,
Laval, Quebec, Canada H7L 4A8

Bristol-Myers Squibb Canada
Montreal, Quebec H4S 0A4

Last revised: 29 December 2008