Pro-Irbesartan: Uses, Side Effects and Dosage

Serious warnings and precautions

What PRO-IRBESARTAN is used for:

• PRO-IRBESARTAN is used in adults to lower high blood pressure. It can be used alone or together with a thiazide diuretic (a “water pill”)
• If you have high blood pressure, type 2 diabetes and kidney disease, PRO-IRBESARTAN may help to protect kidney function

How PRO-IRBESARTAN works:

PRO-IRBESARTAN is an angiotensin receptor blocker (ARB).

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

The ingredients in PRO-IRBESARTAN are:

Medicinal ingredient(s): Irbesartan

Non-medicinal ingredients: Colloidal Silicon Dioxide, Copovidone, Croscarmellose Sodium, Lactose Monohydrate and Magnesium Stearate.

PRO-IRBESARTAN comes in the following dosage form(s):

Tablets; 75 mg, 150 mg and 300 mg of irbesartan.

Do not use PRO-IRBESARTAN if :

• you are allergic to irbesartan or to any non-medicinal ingredient in the formulation.
• you 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 healthcare professional that this has happened to you.

• you have diabetes or kidney disease and are already taking:

  • a blood pressure-lowering medicine that contains aliskiren (such as RASILEZ^®*); or
  • an angiotensin converting enzyme (ACE) inhibitor. You can recognize ACE inhibitors because their medicinal ingredient ends in ‘-PRIL’.

• you are pregnant or intend to become pregnant. Taking PRO-IRBESARTAN during pregnancy can cause injury and even death to your baby.

• you are breastfeeding. It is possible that irbesartan passes into breast milk.

• you have one of the following rare hereditary diseases:

  • Galactose intolerance
  • Lapp lactase deficiency; or
  • Glucose-galactose malabsorption

because lactose is a non-medicinal ingredient in PRO-IRBESARTAN.

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

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take PRO-IRBESARTAN. Talk about any health conditions or problems you may have, including 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 liver or kidney disease.
• have diabetes. PRO-IRBESARTAN may cause low blood sugar levels.
• have psoriasis or a history of psoriasis.
• 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 PRO-IRBESARTAN is not recommended.
• are taking an angiotensin converting enzyme (ACE) inhibitor. The combination with PRO-IRBESARTAN is not recommended.
• are taking a medicine that contains lithium. The combination with PRO-IRBESARTAN is not recommended.

Other warnings you should know about:

Before surgery and general anesthesia (even at the dentist’s office), tell the doctor or dentist that you are taking PRO-IRBESARTAN, as there may be a sudden fall in blood pressure associated with general anesthesia.

Allergic reactions: Allergic reactions (swelling of areas of tissue under the skin, sometimes affecting the face and throat, hives and severe allergic reactions) have been reported. Stop taking PRO-IRBESARTAN and get immediate medical help if you experience any symptoms of an allergic reaction.

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

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements, or alternative medicines.

The following may interact with PRO-IRBESARTAN:

• 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.
• Medicines used to lower blood sugar levels, including insulin and oral medicines, such as repaglinide.

How to take PRO-IRBESARTAN:

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

• PRO-IRBESARTAN may be taken with or without food.

Usual dose:

Recommended Initial Dose: 150 mg once a day.

Your healthcare professional can increase the dosage to 300 mg once daily if required.

Overdose

Missed dose:

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

Possible side effects from using PRO-IRBESARTAN?

These are not all the possible side affects you may have when taking PRO-IRBESARTAN. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• dizziness;
• drowsiness, insomnia, being tired;
• rash;
• diarrhea, vomiting;
• abdominal pain;
• nausea; • headache;
• back or leg pain, muscle cramps;
• lightheadedness;
• ringing in the ears.

PRO-IRBESARTAN can cause abnormal blood test results. Your healthcare professional will decide when to perform blood tests and will interpret the results.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

Store PRO-IRBESARTAN tablets at room temperature (15°C to 30°C).

Keep out of reach and sight of children.

If you want more information about PRO-IRBESARTAN:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html or by contacting Pro Doc Ltée at 1-800-361-8559, www.prodoc.qc.ca or medinfo@prodoc.qc.ca.

*RASILEZ^® is a trademark of Novartis AG, Switzerland and not a trademark of Pro Doc Ltd. Novartis is not affiliated with and does not endorse Pro Doc Ltd or its products.