Irbesartan (Actavis Pharma): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

• IRBESARTAN lowers high blood pressure

• If you have high blood pressure, type 2 diabetes and

  kidney disease, IRBESARTAN may help to protect kidney function.

What it does:

IRBESARTAN is an angiotensin receptor blocker (ARB). You can recognise an ARB because its medicinal ingredient ends in “-SARTAN”.

This medicine does not cure your disease. It helps to control it. Therefore, it is important to continue taking IRBESARTAN regularly even if you feel fine.

When it should not be used:

Do not take IRBESARTAN if you:

• Are allergic to irbesartan or to any non-medicinal

  ingredient in the formulation.

• 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 ARB. Be sure to tell your doctor, nurse, or pharmacist that this has happened to you.

• Have diabetes or kidney disease and are already taking:

  • A blood pressure-lowering medicine that contains aliskiren (such as Rasilez)

  • An angiotensin converting enzyme (ACE)

    inhibitor. You can recognize ACE inhibitors because their medicinal ingredient ends in ‘-PRIL’.

• Are pregnant or intend to become pregnant. Taking

  IRBESARTAN during pregnancy can cause injury and even death to your baby.

• Are breastfeeding. It is possible that IRBESARTAN

  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 IRBESARTAN.

    IRBESARTAN is not recommended for use in children and adolescents (under the age of 18 years).

What the medicinal ingredient is:

Irbesartan.

What the nonmedicinal ingredients are:

Each tablet contains the following non-medicinal ingredients: crospovidone, hydroxypropyl cellulose, lactose monohydrate, microcrystalline cellulose, sodium stearyl fumarate and talc. In addition, the tablet film coating contains: polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide

What dosage forms it comes in:

IRBESARTAN tablets are formulated for oral administration and are available as 75 mg, 150 mg and 300 mg tablets.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions - Pregnancy IRBESARTAN should not be used during pregnancy. If you discover that you are pregnant while taking IRBESARTAN, stop the medication and contact your physician as soon as possible.

BEFORE you use IRBESARTAN talk to your doctor, nurse or pharmacist if you:

• Have experienced an allergic reaction to any drug used to lower blood pressure, including angiotensin converting enzyme (ACE) inhibitors.
• Have narrowing of an artery or a heart valve.
• Have had a heart attack or stroke.
• Have heart failure.
• Have diabetes, liver or kidney disease.
• Are on dialysis.
• Are dehydrated or suffer from excessive vomiting, diarrhea, or sweating.
• Are taking a salt substitute that contains potassium, potassium supplements, or a potassium-sparing diuretic (a specific kind of “water pill” that makes your body keep potassium).
• 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 IRBESARTAN is not recommended.

• Are taking an angiotensin converting enzyme (ACE)

  inhibitor. The combination with IRBESARTAN is not recommended.

• Are less than 18 years old.

Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to IRBESARTAN. Dizziness, lightheadedness, or fainting can especially occur after the first dose and when the dose is increased.

Please remember:

If you are to undergo any surgery or receive anaesthetics, you should make sure your doctor knows that you are taking IRBESARTAN.

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 IRBESARTAN include:

• 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”).

• Lithium used to treat bipolar disease.

• Nonsteroidal anti-inflammatory drugs (NSAIDs), used

  to reduce pain and swelling. Examples include ibuprofen, naproxen, and celecoxib.

• Blood pressure-lowering drugs, including diuretics

  (“water pills”), aliskiren-containing products (e.g. RASILEZ®), or angiotensin converting enzyme (ACE) inhibitors.

• Certain medications tend to increase your blood

  pressure, for example, preparations for appetite control, asthma, colds, coughs, hay fever and sinus problems.

PROPER USE OF THIS MEDICATION

Take IRBESARTAN exactly as prescribed. It is recommended to take your dose at about the same time every day.

Do not stop taking your medication without having first informed your doctor.

Usual Adult Dose:

High Blood Pressure (hypertension) including in patients with Type 2 Diabetes Mellitus:

Recommended Initial Dose: 150 mg once a day.

Your doctor can increase the dosage to 300 mg once daily when required.

IRBESARTAN may be taken with or without food.

Remember that your doctor has prescribed this medicine only for you. Never give it to anyone else.

Overdose:

If you think you have taken too much ACT IRBESRTAN contact your doctor, nurse, pharmacist, hospital emergency department or regional Poison control Centre immediately, even if there are no symptoms.

Missed Dose:

If you have forgotten to take your dose during the day, carry on with the next one at the usual time. Do not double dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Side effects may include:

• Dizziness
• Drowsiness, insomnia, being tired
• Rash
• Diarrhea, vomiting
• Headache
• Back or leg pain, muscle cramps
• Lightheadedness

If any of these affects you severely, tell your doctor, nurse or pharmacist.

IRBESARTAN can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.

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

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.

HOW TO STORE IT

Store IRBESARTAN Tablets at room temperature (15-30°C). Protect from light.

Keep out of reach and sight of children.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Actavis Pharma Company, at: 1-866-254-6111

Last revised: November 6, 2014