PRZ-Olmesartan: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

PRZ-OLMESARTAN is used to lower blood pressure in adults and children above 6 years old.

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 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:

PRZ-OLMESARTAN contains a drug olmesartan medoxomil which acts to inhibit the naturally occurring hormone, angiotensin II in the human body that causes the blood vessels to constrict. As an angiotensin receptor blocker (ARB), PRZ-OLMESARTAN lowers blood pressure by relaxing the blood vessels and as a result blood pressure is lowered. You can recognize 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 PRZ-OLMESARTAN regularly even if you feel fine.

When it should not be used:

Do not take PRZ-OLMESARTAN if you:

• Are allergic to Olmesartan medoxomil 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.

• Are pregnant or intend to become pregnant. If this is the case,

  talk to your doctor as soon as possible. Taking PRZ-OLMESARTAN during pregnancy can cause injury and even death to your baby.

• Are breastfeeding. It is possible that PRZ-OLMESARTAN

  passes into breast milk.

• Are already taking a blood pressure-lowering medicine

  that contains aliskiren (such as Rasilez) and you have diabetes or kidney disease.

  PRZ-OLMESARTAN is not recommended for use in children below the age of 6 years.

What the medicinal ingredient is:

Olmesartan medoxomil

What the nonmedicinal ingredients are: Hypromellose, hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, talc, and titanium dioxide.

What dosage forms it comes in:

Film-Coated Tablets: 20 mg (white, round shaped) and 40 mg (white, oval shaped).

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

PRZ-OLMESARTAN should not be used during pregnancy. If you discover that you are pregnant while taking PRZ-OLMESARTAN, stop the medication and please contact your doctor, nurse, or pharmacist as soon as possible.

BEFORE you use PRZ-OLMESARTAN talk to your doctor or pharmacist if you:

• have experienced an allergic reaction to any drug used to lower blood pressure.
• have narrowing of a heart valve, heart or blood vessel disease.
• have diabetes, liver or kidney disease.
• are on dialysis.
• are dehydrated or suffer from excessive vomiting, diarrhea, or sweating.
• are on a low-salt diet.
• 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 taking a medicine that contains aliskiren, such as Rasilez, used to lower high blood pressure. The combination with PRZ-

  OLMESARTAN is not recommended.

• are taking an angiotensin converting enzyme inhibitor

  (ACEI). You can recognize ACEIs because their medicinal ingredient ends in “-PRIL”.

• are less than 18 years old.

PRZ-OLMESARTAN can cause severe chronic diarrhea with substantial weight loss (sprue-like enteropathy). It can take months to years for symptoms to develop.

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

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 PRZ-OLMESARTAN:

• 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”).

• Blood pressure lowering drugs, including diuretics

  (“water pills”), aliskiren-containing products (e.g. Rasilez), or angiotensin coverting enzyme inhibitors (ACEIs).

• Lithium used to treat bipolar disease.

• Nonsteroidal anti-inflammatory drugs (NSAIDs), used

  to reduce pain and swelling. Examples include ibuprofen, naproxen, and celecoxib (COX-2 Inhibitor).

PROPER USE OF THIS MEDICATION

Usual dose:

For adult patients: 20 mg tablet once daily. It can be increased to 40 mg by your doctor if your blood pressure is not well controlled.

For pediatric patients age 6 to 16 of age:

Children weight between 20 kg to less than 35 kg: 10 mg once daily. If the blood pressure is not well controlled, your doctor can double the dosage to 20 mg once daily.

Children weight 35 kg or more: 20 mg once daily.

If the blood pressure is not well controlled, your doctor can double the dosage to 40 mg once daily.

PRZ-OLMESARTAN may be taken with or without food.

Overdose:

If you think you have taken too much PRZ-OLMESARTAN, contact your healthcare professional, 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

Any medicine may have unintended or undesirable effects, so-called side effects.

Side effects may include:

• dizziness

  • drowsiness, insomnia
  • rash
  • diarrhea, vomiting
  • headache
  • bronchitis
  • back or leg pain, muscle pain and cramps
  • upper respiratory tract infection

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

PRZ-OLMESARTAN 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. For any unexpected effects while taking PRZ-OLMESARTAN, contact your doctor or pharmacist.

Stored at controlled room temperature between 15°C and 30°C in a tight container.

Keep out of sight and reach of children and pets.

If you want more information about PRZ-OLMESARTAN:

• Talk with your healthcare professional

• Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information Section by vising the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the

  manufacturer’s website www.pharmaris.com, or by calling 1-866-913-7955.

  Date of Approval: September 14, 2020

HOW TO STORE IT

REPORTING SIDE EFFECTS

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction

  Reporting (www.canada.ca/en/health-

  canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or

• Calling toll-free at 1-866-234-2345

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION