Arcosyl (Servier Canada, 2.5 mg, 5 mg, 10 mg): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Your doctor can prescribe ARCOSYL^® to:

• treat mild to moderate High Blood Pressure.

• treat mild to moderate Congestive Heart Failure along

  with other medications.

• Reduce Cardiovascular Risk in patients with high blood

  pressure and/or those who have suffered a heart attack and have stable coronary artery disease.

What it does:

ARCOSYL^® is an angiotensin converting enzyme (ACE) inhibitor. You can recognize ACE inhibitors because their medicinal ingredient ends in ‘-PRIL’.

This medicine does not cure your disease. It is important to continue taking ARCOSYL^® regularly even if you feel fine. Do not stop taking your medicine without the advice of your doctor.

When it should not be used:

Do not take ARCOSYL^® if you:

• Are allergic to perindopril arginine 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 ACE inhibitor or without a known cause. Be sure to tell your doctor, nurse, or pharmacist that this has happened to you.

• Are taking a drug containing the combination of sacubitril/

  valsartan, due to the increased risk of serious allergic reaction which causes swelling of the face or throat (angioedema) when taken with ARCOSYL^®

• Are already taking a blood pressure-lowering medicine that

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

• Have been diagnosed with hereditary angioedema: an increased

  risk of getting an allergic reaction that is passed down through families. This can be triggered by different factors, such as surgery, flu, or dental procedures.

  • Are pregnant or intend to become pregnant. Taking

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

  • Are breastfeeding. ARCOSYL® passes into breast milk.

  • Are lactose intolerant or have one of the following rare hereditary diseases:

    • Galactose intolerance
    • Lapp lactase deficiency

    • Glucose-galactose malabsorption Because lactose is a non-medicinal ingredient in ARCOSYL^®

      .

  • Are on dialysis or any other type of blood filtration. Depending on the machine that is used, ARCOSYL^® may not be suitable for you.
  • Have kidney problems where the blood supply to your kidneys is significantly reduced (renal artery stenosis).

What the medicinal ingredient is:

Perindopril arginine

What the non-medicinal ingredients are:

ARCOSYL^® tablets: glycerol, hydrophobic colloidal silica, hypromellose, lactose monohydrate, macrogol 6000, magnesium stearate, maltodextrin, sodium starch glycolate (type A), titanium dioxide. The 5mg and 10mg tablets also contain chlorophyllin (E141ii) as a colorant.

ARCOSYL^® orodispersible tablets:

acesulfame potassium, aspartame, lactose monohydrate, magnesium stearate, maize starch, silica colloidal anhydrous.

What dosage forms it comes in:

• film-coated tablets of 2.5 mg, 5 mg or 10 mg,
• orodispersible tablets of 5 mg or 10 mg.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions - Pregnancy ARCOSYL^® should not be used during pregnancy. If you discover that you are pregnant while taking ARCOSYL^®, stop the medication and contact your doctor, nurse, or pharmacist as soon as possible.

BEFORE you use ARCOSYL^® talk to your doctor, nurse or pharmacist if you:

• Are allergic to any drug used to lower blood pressure.
• Have recently received or are planning to get allergy shots for bee or wasp stings.
• Have narrowing of an artery or a heart valve.
• Have/had a heart attack or a stroke.

• Are taking a medicine that contains aliskiren, such as

  RASILEZ, used to lower high blood pressure. The combination with ARCOSYL^® is not recommended.

• Are taking an angiotensin receptor blocker (ARB). You can recognize an ARB because its medicinal ingredient ends in "-SARTAN".
• 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”).

• Are on a low-salt diet.
• Are receiving gold (sodium aurothiomalate) injections.
• Are less than 18 years old.

• Are on LDL Apheresis (a treatment to lower the LDL

  cholesterol in the blood).

• Have systemic lupus erythematosus (SLE),

• Have a skin condition known as scleroderma or “hard skin”

  (thickening of the skin).

• Have abnormally increased levels of a hormone called aldosterone in

  your blood (primary aldosteronism).

Because ARCOSYL^® orodispersible tablets contain aspartame, it can be harmful to the people suffering from phenylketonuria (a rare, hereditary disorder of the metabolism).

You may become sensitive to the sun while taking ARCOSYL^®. Exposure to sunlight should be minimized until you know how you respond.

If you are going to have surgery and will be given an anesthetic, be sure to tell your doctor or dentist that you are taking ARCOSYL^®.

Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to ARCOSYL^®. 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 ARCOSYL^®:

• 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”).

• Allopurinol used to treat gout.

• Anti-diabetic drugs, including insulin, gliptins and oral

  medicines.

• Baclofen (a skeletal muscle relaxant).

• Blood pressure-lowering drugs, including diuretics (“water

  pills”), aliskiren-containing products (e.g. RASILEZ), or angiotensin receptor blockers (ARBs).

  • Other blood pressure lowering drugs, including diuretics

    (“water pills”). When taken in combination with ARCOSYL® they may cause excessively low blood pressure.

  • Vasodilators including nitrates (products that make the blood vessels become wider).
  • Estramustine (used in cancer therapy).
  • Lithium used to treat bipolar disorder.
  • Nonsteroidal anti-inflammatory drugs (NSAIDs), used to reduce pain and swelling. Examples include aspirin, ibuprofen, naproxen, and celecoxib.
  • Digoxin, a heart medication.
  • Procainamide, used to treat irregular heartbeats.
  • Dextran sulphate, special intravenous fluid used to counteract life-threatening low blood pressure.
  • Gentamicin, an antibiotic.
  • Tricyclic antidepressants,
  • Anaesthetics,
  • Medications for mental disorders,
  • Treatment for bee and wasp allergies,
  • Gold salts for the treatment of rheumatoid arthritis,
  • Trimethoprim (for the treatment of infections).
  • Tacrolimus (for the treatment of auto-immune disorders or following transplant surgery).
  • Neutral endopeptidase (NEP) inhibitors. The combination with ARCOSYL^® is not recommended.
  • Sirolimus, everolimus, temsirolimus and other drugs belonging to the class of mTOR inhibitors (used to avoid rejection of transplanted organs).

PROPER USE OF THIS MEDICATION

Take ARCOSYL^® exactly as prescribed.

Tablets should be swallowed whole with a glass of water in the morning. It is recommended to take your dose before a meal. Orodispersible tablets should be placed on the tongue for disintegration and swallow with saliva or disperse the tablet in a glass of water and drink the resulting suspension.

Only the 5 mg tablet may be broken.

Usual Adult Dose:

Dosage must be individualised and adjusted for the elderly and patients with kidney disease.

High Blood Pressure

For patients who are not taking diuretics (water pills) Usual initial dose: 5 mg once a day

Usual maintenance dose: 5 mg to 10 mg once a day.

Your doctor will monitor your blood pressure. If you are having high blood pressure in the hours before you take your dose, a twice a day schedule may be required.

For patients who are taking diuretics (water pills)

Your doctor may stop the diuretic for 2 to 3 days while you are given the initial doses of ARCOSYL^®. The doctor will decide the best ARCOSYL^® dosage for you to take. They may start with 2.5 mg once a day.

In elderly patients, the starting dose should be 2.5 mg once a day. If necessary, your doctor may increase the dose to 5 mg daily and then to 10 mg in one or two divided doses depending on your kidney function.

Heart Failure

Usual initial dose: 2.5 mg once a day, the dose may be increased to 5 mg once a day.

In the elderly, the usual dose is used.

Reduce Cardiovascular Risk

Usual initial dose: 5 mg once a day for 2 weeks.

Usual maintenance dose: 10 mg once a day.

In elderly patients, the initial dose should be 2.5 mg once a day for the first week, followed by 5 mg once a day the second week and 10 mg once a day thereafter if tolerated as the usual maintenance dose. The doctor should make adjustments at intervals of at least 2 to 4 weeks.

Overdose:

If you think you have taken too much ARCOSYL^® 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, fatigue, weakness,

• Cough (often described as dry and irritating, usually is worse

  at night or when lying down), upper respiratory infection,

• Rash,
• Headache, ringing in the ears,
• Abdominal pain, nausea, disturbed digestion, diarrhea,
• Back pain,

• Loss of taste or metallic taste in your mouth.

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

  ARCOSYL^® 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 ARCOSYL^®, contact your doctor, nurse or pharmacist.

HOW TO STORE IT

Keep out of reach and sight of children.

Store at room temperature (15°C-30°C).

Do not use after the expiry date stated on the carton or bottle.

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 (https://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

This document plus the full product monograph, prepared for health professionals can be found at www.servier.ca. or by contacting the sponsor, Servier Canada Inc., at: 1-800-363-6093.

235, Boulevard Armand Frappier

Laval, Québec

H7V 4A7

Last revised: June 5, 2018