Mylan-Perindopril Erbumine: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Your doctor can prescribe Mylan-Perindopril Erbumine Mylan-Perindopril Erbumine 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:

Mylan-Perindopril Erbumine 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 Mylan-Perindopril Erbumine 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 Mylan-Perindopril Erbumine if:

• Are allergic to perindopril erbumine 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 Mylan-Perindopril Erbumine.

• 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

    Mylan-Perindopril Erbumine during pregnancy can cause injury and even death to your baby.

  • Are breastfeeding. Mylan-Perindopril Erbumine 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 Mylan-Perindopril Erbumine.

  • Are on dialysis or any other type of blood filtration.

    Depending on the machine that is used, Mylan-Perindopril Erbumine 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 erbumine.

What the non-medicinal ingredients are:

cellulose microcrystalline, lactose anhydrous, magnesium stearate, silica hydrophobic colloidal anhydrous, sodium hydrogen carbonate, spectracol copper chlorophylline lake as a colorant.

What dosage forms it comes in:

tablets of 2 mg, 4 mg or 8 mg.

WARNINGS AND PRECAUTIONS

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

BEFORE you use Mylan-Perindopril Erbumine 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 perindopril erbumine is not recommended.

• Are taking an angiotensin receptor blocker (ARB).

  You can recognize an ARB because its medicinal ingredient ends “-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).

You may become sensitive to the sun while taking Mylan-Perindopril Erbumine. 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 Mylan-Perindopril Erbumine.

Driving and using machines: Before you perform tasks which may require special attention, wait until you know how yourespond to Mylan-Perindopril Erbumine. 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 Mylan-Perindopril Erbumine:

• 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.

• Antidiabetic 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).

• 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.

  • Other blood pressure lowering drugs, including diuretics

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

  • Vasodilators including nitrates (products that make the blood vessels become wider).
  • 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 Mylan-Perindopril Erbumine 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 Mylan-Perindopril Erbumine 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. Only the 4mg 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: 4 mg once a day.

Usual maintenance dose: 4 mg to 8 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 Mylan-Perindopril Erbumine. The doctor will decide the best Mylan-Perindopril Erbumine dosage for you to take. They may start with 2 mg once a day.

In elderly patients, the starting dose should be 2 mg once a day. If necessary, your doctor may increase the dose to 4 mg daily

and then to 8 mg in one or two divided doses depending on your kidney function.

Heart Failure

Usual initial dose: 2 mg once a day.

In most cases, the dose may be increased to 4 mg once a day. In the elderly, the usual dose is used.

Reduce Cardiovascular Risk

Usual initial dose: 4 mg once a day for 2 weeks.

Usual maintenance dose: 8 mg once a day.

In elderly patients, the initial dose should be 2 mg once a day for the first week, followed by 4 mg once a day the second week and 8 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:

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.

Mylan-Perindopril Erbumine 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 Mylan-Perindopril Erbumine, contact your doctor, nurse, or pharmacist.

HOW TO STORE IT

Keep out of reach and sight of children.

This medicinal product should be stored at controlled room temperature (15-30°C).

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

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.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 can be found at: www.mylan.ca.

The full Product Monograph prepared for health professionals can be obtained by contacting the sponsor, Mylan Pharmaceuticals ULC at: 1-800-575-1379

Revised on: February 28, 2018

Mylan Pharmaceuticals ULC

Etobicoke, ON M8Z 2S6

1-800-575-1379

www.mylan.ca