July 22, 2014
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Coversyl Plus

(perindopril - indapamide)

DIN (Drug Identification Number)

02246569 COVERSYL PLUS 1.25/4MG TABLET
02246568 COVERSYL PLUS LD 0.625/2MG TABLET
02321653 COVERSYL PLUS HD 2.5/8MG TABLET

What side effects are possible with Coversyl Plus?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • cold-like symptoms
  • cough (dry, persistent)
  • dizziness
  • headache
  • heartburn
  • nausea
  • taste changes (e.g., metallic taste)
  • vomiting
  • weakness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • joint pain
  • muscle cramps or pain
  • numbness or tingling in hands, feet, or lips
  • signs of liver problems such as yellow eyes or skin, abdominal pain, or itching of skin
  • signs of low blood pressure such as dizziness, lightheadedness, or fainting

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • symptoms of a serious allergic reaction, including angioedema (such as hives; swelling of the face, mouth, hands, or feet; and difficulty breathing)
  • unusual heartbeat (fast or irregular)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.





Are there any other precautions or warnings for Coversyl Plus?

HEALTH CANADA ADVISORY

February 4, 2014

Health Canada has issued new restrictions concerning the use of perindopril. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Allergic reaction: This medication may cause a serious allergic reaction called angioedema, which may be fatal if not treated promptly. If you have difficulty breathing, notice hives or swelling of the face, lips, tongue, or throat, stop taking this medication and get emergency medical help at once.

Other ACE inhibitors should not be taken in the future. People who have had angioedema caused by other substances may be at increased risk of angioedema while receiving this medication.

Blood disorders: In rare cases, a low white blood cell count has been reported by people taking this medication. Your doctor may occasionally monitor your level of white blood cells by performing blood tests. Low white blood cell levels may increase your risk for infection. If you notice any signs of infection (e.g., fever, sore throat), contact your doctor as soon as possible.

Cough: People taking perindopril may develop a dry, persistent cough that usually disappears only after stopping this medication.

Decreased blood pressure: Occasionally, blood pressure drops too low after taking this medication, especially when getting up from a sitting or lying position. This may lead to fainting. It is more common after the first or second dose, when the dose is increased, or when a person is dehydrated. To reduce the risk of dizziness, get up slowly from a lying down or sitting position. If low blood pressure causes you to faint or feel lightheaded, contact your doctor.

Diabetes: Indapamide may make it more difficult for people with diabetes to control their blood sugar. Your doctor will monitor you while you are taking this medication and may need to adjust your doses of antidiabetes medications.

Fluid and electrolyte balance: Your levels of electrolytes, such as potassium, sodium, magnesium, and chloride, may change due to this medication. Your doctor may periodically ask for tests to check that these are in balance. If you experience symptoms of fluid and electrolyte imbalance such as muscle pains or cramps; dry mouth; numb hands, feet, or lips; or racing heartbeat, contact your doctor as soon as possible. Salt substitutes containing potassium should be avoided.

Kidney function: This medication may change the kidney function in certain people. Your doctor will monitor you closely while you are taking this medication. Let your doctor know if you notice any decrease in urine production, or increased swelling of the lower limbs, suggesting accumulation of fluid due to decreased urination.

Liver function: This medication may worsen liver function. If you have liver disease or poor liver function you should be closely monitored by your doctor while taking this medication. If you notice any signs of liver problems (e.g., abdominal pain, itching of skin, yellow eyes or skin, loss of appetite, vomiting), contact your doctor immediately.

Surgery: Tell your doctor and anesthesiologist that you are taking this medication before you undergo any surgical procedures requiring general anesthesia.

Pregnancy: ACE inhibitors such as perindopril have the potential to cause serious problems during pregnancy. This medication should not be used by pregnant women. If you become pregnant while taking this medication, stop taking it immediately and contact your doctor.

Breast-feeding: Perindopril passes into breast milk. It is not known if indapamide passes into breast milk. Do not breast-feed if you are taking this medication.

Children: The safety and effectiveness of using this medication have not been established for children. It is not recommended for children.

What other drugs could interact with Coversyl Plus?

There may be an interaction between perindopril - indapamide and any of the following:

  • alcohol
  • allopurinol
  • antiarrhythmics (e.g., amiodarone, quinidine)
  • antipsychotic medications (e.g., chlorpromazine, pimozide, thioridazine, ziprasidone)
  • barbiturates (e.g., secobarbital, butalbital)
  • beta-blockers (e.g., metoprolol, propranolol)
  • cholestyramine
  • cyclosporine
  • diabetes medications (e.g., insulin, glyburide, metformin)
  • digoxin
  • dronedarone
  • ganglion blockers
  • gentamicin
  • gold salts (e.g., sodium aurothiomalate)
  • lithium
  • narcotic pain relievers (e.g., morphine, codeine)
  • nilotinib
  • nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., ibuprofen, indomethacin, naproxen)
  • other ACE inhibitors (e.g., ramipril, enalapril, captopril)
  • other diuretics (e.g., hydrochlorothiazide, furosemide)
  • quinine
  • rituximab
  • salicylates (e.g., acetylsalicylic acid)
  • substances that increase blood levels of potassium (e.g., potassium supplements, salt replacements containing potassium, spironolactone, triamterene, amiloride)
  • tetrabenazine
  • tricyclic antidepressants (e.g., amitriptyline, imipramine)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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