Irbesartan (Ranbaxy Pharmaceuticals Canada): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Your doctor has prescribed IRBESARTAN because you have a condition known as hypertension or high blood pressure. Your doctor may have also prescribed IRBESARTAN if you have high blood pressure and type 2 diabetes mellitus to protect your kidney function.

What it does:

IRBESARTAN belongs to a class of drugs known as angiotensin II AT₁ receptor blockers (ARB) which have been proven to be effective in lowering blood pressure.

IRBESARTAN lowers blood pressure by specifically blocking a natural substance called angiotensin II, which normally narrows your blood vessels.

Treatment with IRBESARTAN allows the blood vessels to relax. 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 IRBESARTAN.

In addition to controlling and lowering your blood pressure, recent studies have shown that irbesartan tablets protects your kidneys by reducing protein in the urine. This in turn slows the progression of your kidney disease.

This medicine does not cure high blood pressure, but does help control it. Therefore, it is important to continue taking IRBESARTAN regularly to keep your blood pressure down 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

  ngredient in the formulation.

• Ever have experienced an allergic reaction and in

  particular with swelling of the face, lips, tongue, throat, or sudden difficulty breathing or swallowing, to any drug in the same class as IRBESARTAN (ARB). Be sure to tell your doctor that this has happened to you.

• Are pregnant or thinking of becoming pregnant.

• Are breastfeeding, you should discuss with your

  physician about taking IRBESARTAN.

  If any of the above apply to you, inform your doctor or pharmacist first and ask for their advice.

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

What the medicinal ingredient is:

Irbesartan, USP.

What the non medicinal ingredients are:

Calcium stearate, lactose monohydrate, microcrystalline cellulose, poloxamer 188, pregelatinized starch, and sodium starch glycolate.

What dosage forms it comes in:

Oval tablets (white to off white); 75 mg, 150 mg, and 300 mg

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

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 or pharmacist if you:

• Have any of these health problems: liver disease, kidney disease or heart disease.
• Have narrowing of a heart valve.
• Have recently suffered from severe diarrhea or excessive vomiting.
• Are on a low-salt diet or use salt substitutes that contain potassium, potassium supplements, potassium-sparing diuretics (a specific kind of “water pills”), or any medicine that may increase your potassium level.
• Are on dialysis.

• Have ever experienced an allergic reaction to any drug to lower blood pressure. Be sure to tell your doctor that this has happened to you. The doctor will decide if IRBESARTAN is right for you.

  Please remember:

  To tell any other doctor, dentist or pharmacist with whom you consult that you are using IRBESARTAN.

• • Dizziness or drowsiness may occasionally occur when taking IRBESARTAN. Therefore, before you perform tasks which may require special attention (driving a car or operating dangerous machinery), wait until you know how you respond to IRBESARTAN.

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

Effects on Pregnancy and Breastfeeding:

Taking IRBESARTAN during pregnancy can cause injury and even death to your baby. This medicine should not be used during pregnancy. If you become pregnant or are planning to become pregnant while taking IRBESARTAN, contact your doctor immediately. It is possible that irbesartan passes into breast milk. Therefore, you should discuss with your doctor about taking IRBESARTAN while breast-feeding.

INTERACTIONS WITH THIS MEDICATION

Before takingIRBESARTAN, tell your doctor or pharmacist about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Drugs that may interact with IRBESARTAN include:

• Other medicines used to lower blood pressure,

  including diuretics (“water pills”).

• Any substance that may increase your potassium

  level, including salt substitutes that contain potassium, potassium supplements, potassium-sparing diuretics (a specific kind of “water pills”).

• Lithium-containing medicines to treat some types of

  depression.

• Nonsteroidal anti-inflammatory drugs (NSAIDs)

  such as aspirin and ibuprofen. NSAIDs are used to reduce pain, fever, and swelling.

• 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 by your doctor. It may be easier to take your dose if you do it at the same time every day.

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

Usual dose:

High Blood Pressure (hypertension) including in patients with Type 2 Diabetes Mellitus: 150 mg once daily. 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:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

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

Along with its intended action, any medication, including IRBESARTAN, may cause side effects. Most patients do not have side effects from taking irbesartan tablets, but if you notice any of the following or any other unusual symptoms tell your pharmacist or your doctor right away:

• Dizziness
• Lightheadedness
• Rash
• Being tired
• Diarrhea

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

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:

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, ON 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 (Irbesartan Tablets USP) at room temperature (15° C - 30° C).

Keep this medication out of the 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 Ranbaxy Pharmaceuticals Canada Inc., at: 1-866-840-1340.

RANBAXY

Ranbaxy Pharmaceuticals Canada Inc.

2680 Matheson Blvd. E., Suite 200

Mississauga, Ontario L4W 0A5

Last revised: November 1, 2013