Arcosyl Plus: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

ARCOSYL^® PLUS LD/ ARCOSYL^® PLUS are combinations of two active ingredients, perindopril and indapamide used to treat mild to moderate High Blood Pressure.

What it does:

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

Indapamide is a diuretic often called a “water pill”. It increases urination. This lowers blood pressure. Indapamide affects the kidney’s ability to reabsorb electrolytes.

Each of the active ingredients reduces blood pressure and they work together to control your blood pressure.

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.

This medicine does not cure high blood pressure. It helps to control it. Therefore, it is important to continue taking ARCOSYL^® PLUS LD/ ARCOSYL^® PLUS 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^® PLUS LD/ ARCOSYL^® PLUS if you:

• Are allergic to perindopril arginine or any other ACE inhibitor, or to

  indapamide or any other sulphonamides or to any other non-medicinal ingredients of ARCOSYL® PLUS LD/ ARCOSYL® PLUS

• Previously 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,

• 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 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^® PLUS LD/ ARCOSYL^® PLUS,

  • Are already taking a blood pressure-lowering medicine that contains aliskiren (such as RASILEZ) and you have diabetes or kidney disease,
  • Have trouble urinating,
  • Have severe liver disease or suffer from a condition called hepatic encephalopathy (degenerative disease of the brain),
  • Have a kidney disease,
  • Have low or high blood potassium,

  • Are suspected of having untreated decompensated heart failure

    (severe water retention, difficulty in breathing),

  • Are pregnant or intend to become pregnant. Taking of ARCOSYL^®

    PLUS LD/ ARCOSYL^® PLUS during pregnancy can cause injury and even death to your baby,

  • Are breast feeding. ARCOSYL^® PLUS LD/ ARCOSYL^® PLUS 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^® PLUS LD/ ARCOSYL^® PLUS.

• Are taking drugs to treat heart rhythm disturbances (antiarrythmics)

  that might cause severe cardiac arrhythmias

• Are on dialysis or any other type of blood filtration. Depending on the machine that is used, ARCOSYL^® PLUS LD/ ARCOSYL^® PLUS 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 ingredients are:

Perindopril arginine and indapamide.

What the non-medicinal ingredients are:

Glycerol, Hypromellose, Lactose monohydrate, Macrogol, Magnesium stearate, Maltodextrin, Silica colloidal anhydrous, Sodium starch glycolate, Titanium dioxide.

What dosage forms it comes in:

ARCOSYL^® PLUS LD: film-coated tablets of 2.5 mg perindopril arginine/ 0.625 mg indapamide.

ARCOSYL^® PLUS (5 mg/ 1.25 mg): film-coated tablets of 5 mg perindopril arginine/ 1.25 mg indapamide,

ARCOSYL^® PLUS (10 mg/ 2.5 mg): film-coated tablets of 10 mg perindopril arginine/ 2.5 mg indapamide.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions- Pregnancy

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

BEFORE you use ARCOSYL^® PLUS LD/ ARCOSYL^® PLUS talk to your doctor 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 aortic stenosis (narrowing of the main blood vessel leading from the heart) or hypertrophic cardiomyopathy (cardiac muscle disease) or renal artery stenosis (narrowing of the artery supplying the kidney with blood),
• Have / had a heart attack or a stroke,
• Have diabetes, liver or kidney disease,

• Are taking a medicine that contains aliskiren, such as RASILEZ, used

  to lower high blood pressure. The combination with ARCOSYL^® PLUS LD/ ARCOSYL^® PLUS is not recommended,

• Are taking an angiotensin receptor blocker (ARB). You can recognize

  an ARB because its medicinal ingredient ends in "-SARTAN",

• Are on haemodialysis,

• Have a history of angioedema (swelling around your face, throat or

  tongue),

• Suffer from a collagen disease (skin disease) such as systemic lupus

  erythematosus or scleroderma,

• Have atherosclerosis (hardening of the arteries),

• Suffer from hyperparathyroidism (dysfunctioning of the parathyroid

  gland),

• Suffer from gout,

• Are on a salt restricted diet or use salt substitutes which contain

  potassium, potassium supplements, or a potassium-sparing diuretic (a specific kind of “water pill”),

• Take lithium or potassium-sparing diuretics (spironolactone,

  triamterene) as their use with ARCOSYL^® PLUS LD/ ARCOSYL^® PLUS should be avoided,

• Are dehydrated or have recently suffered from excessive vomiting or

  diarrhoea or sweating,

• Are receiving gold (sodium aurothiomalate) injections,

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

  blood),

• Have any congenital or a family history of heart rhythm problems,
• Are less than 18 years old,
• Are malnourished,
• Are over 65 years old,
• Have any other heart problems,
• Are to undergo anesthesia and/or surgery

• Have abnormally increased levels of a hormone called aldosterone in

  your blood (primary aldosteronism).

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

Athletes should be aware that ARCOSYL^® PLUS LD/ ARCOSYL^® PLUS contains a medicinal ingredient (indapamide) which may give a positive reaction in doping tests.

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

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

• Lithium (used to treat bipolar disorder),
• Agents affecting sympathetic activity,
• Agents causing renin release,
• Blood pressure-lowering drugs, including diuretics (“water pills”), aliskiren-containing products (e.g. RASILEZ), or angiotensin receptor blockers (ARBs),
• 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”),
• Dextran sulphate, special intravenous fluid used to counteract life-threatening low blood pressure.
• Digoxin (a heart medication),
• Medicines to treat diabetes such as insulin, gliptins or metformin,
• Non-steroidal anti-inflammatory drugs (NSAIDS), such as ibuprofen, naproxen, or Celecoxib or high doses of acetylsalicylic acid (more than 3 g/day),
• Drugs used to treat anxiety and schizophrenia (e.g. clozapine, risperidone, pimozide),
• Drugs used to treat depression, in particular serotonin reuptake inhibitors (SSRIs eg. paroxetine, sertraline, citalopram) and tricyclic antidepressants (imipramine),
• Gold for the treatment of rheumatoid arthritis,
• Drugs to treat heart rhythm disturbances (e.g. digoxine, quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, procainamide),
• Allopurinol (for the treatment of gout),
• Oral corticosteroids for treatment of asthma,
• Ciclosporin, tacrolimus or other medications to depress the immune system after organ transplantation,
• Medicines for the treatment of cancer,
• Baclofen, a skeletal muscle relaxant,
• Calcium tablets or other calcium supplements,
• Anaesthetics,
• Iodinated contrast media,
• Stimulant laxatives such as bisacodyl and senna,
• Antifungal medications such as amphotericin B (IV),
• ACTH (e.g. tetracosactide) for treatment of arthritis or inflammatory bowel disease,
• Alcohol, barbiturates (sleeping pills), or narcotics (strong pain medications). They may cause low blood pressure and dizziness when you go from lying or sitting to standing up,
• Antimicrobial medications such as pentamidine,
• Antibiotics such as moxifloxacin, erythromycin IV, gentamycin,
• Trimethoprim (for the treatment of infections),
• Estramustine (used in cancer therapy),

• Neutral endopeptidase (NEP) inhibitors. The combination with

  ARCOSYL^® PLUS LD or ARCOSYL ^® PLUS 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^® PLUS LD/ ARCOSYL^® PLUS exactly as prescribed. It is recommended to take your dose at about the same time every day. Swallow the tablet whole with water.

Usual Adult Dose

The recommended dose of ARCOSYL^® PLUS LD/ ARCOSYL^® PLUS is 1 tablet once daily taken in the morning before a meal. Your doctor may decide to modify the dosage regimen in particular if you suffer from kidney disease renal impairment.

Overdose:

If you think you have taken too much ARCOSYL^® PLUS LD / ARCOSYL^® PLUS, contact your doctor, nurse, pharmacist, hospital emergency department or regional poison control center 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 the dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Side effects may include:

• Dizziness, drowsiness, fatigue, weakness, headache, vertigo, malaise, fall
• Rash, itching
• Gastro-intestinal disorders, stomach or abdominal pain, loss of appetite, nausea, vomiting, constipation, diarrhea
• Taste disturbance
• Dry mouth, dry cough
• Mood swings, sleep disturbances
• Sweating
• Muscle cramps and/or pain, joint pain, pins and needles sensation

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

If you faint, discontinue the drug and contact your doctor.

ARCOSYL^® PLUS LD/ ARCOSYL^® PLUS can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.

*This is known to occur more frequently in black patients.

This is not a complete list of side effects. For any unexpected effects while taking ARCOSYL^® PLUS LD/ ARCOSYL^® PLUS, contact your doctor, nurse or pharmacist.

HOW TO STORE IT

Keep out of reach or 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.

SERVIER CANADA INC.

235, Boulevard Armand Frappier

Laval, Québec

H7V 4A7

Last revised: June 5, 2018