Consumer Information for: APO-CANDESARTAN

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

APO-CANDESARTAN is used to :

  • High Blood Pressure in Adults
  • High Blood Pressure in Children (6 to 17 years of age)
  • Heart Failure in Adults
What it does

APO-CANDESARTAN is an angiotensin receptor blocker (ARB). 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 APO-CANDESARTAN regularly even if you feel fine.

Its main action is to relax the arteries, letting the blood flow more freely, thereby lowering the blood pressure.

When it should not be used

Do not take APO-CANDESARTAN if you:

  • Are allergic to candesartan cilexetil 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 already taking a blood pressure-lowering medicine that contains aliskiren (such as Rasilez) and you have diabetes or kidney disease.
  • Are pregnant or intend to become pregnant. Taking APO-CANDESARTAN during pregnancy can cause injury and even death to your baby.
  • Are breastfeeding. It is possible that APO-CANDESARTAN passes into breast milk.
  • Are less than 1 year old
  • Have one of the following rare hereditary diseases:
    • Galactose intolerance
    • Lapp lactase deficiency
    • Glucose-galactose malabsorption

Because lactose is a non-medicinal ingredient in APO-CANDESARTAN.

What the medicinal ingredient is

Candesartan cilexetil.

What the non-medicinal ingredients are

Most medicines contain more ingredients than just the active drug. These ingredients are needed to keep medicines in a form that you can swallow. Check with your doctor if you think you might be allergic to any of the following items (listed in alphabetical order): Carboxymethyl cellulose calcium, Euroxide red iron oxide (except 4 mg tablets), Hydroxypropyl cellulose, Lactose Monohydrate, Magnesium stearate Maize starch, and Triacetin.

What dosage form it comes in

APO-CANDESARTAN is available as 4 mg, 8 mg, 16 mg and 32 mg tablets.

Warnings and precautions

Serious Warnings and Precautions

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

Before you use APO-CANDESARTAN talk to your doctor, nurse or pharmacist if you:

  • Have experienced an allergic reaction to any drug used to lower blood pressure, including angiotensin converting enzyme (ACE) inhibitors.
  • Have narrowing of an artery or a heart valve.
  • Have had a heart attack or stroke.
  • Have heart failure.
  • Have diabetes, heart, 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” that makes your body keep potassium) or other drugs that may increase potassium levels (e.g., heparin, co-trimoxazole).
  • Are on a low-salt diet.
  • Are taking a medicine that contains aliskiren, such as Rasilez, used to lower high blood pressure. The combination with APO-CANDESARTAN is not recommended.
  • Are taking an angiotensin converting enzyme inhibitor (ACEI). You can recognize ACEIs because their medicinal ingredient ends in ‘-PRIL’.
  • Are taking an ACE-inhibitor together with a medicine which belongs to the class of medicines known as mineralocorticoid receptor antagonists (for example, spironolactone, eplerenone). These medicines are for the treatment of heart failure.

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

If you are currently taking APO-CANDESARTAN and are going to have an operation, be sure to tell your doctor or dentist about your medication before you are given an anaesthetic.

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 APO-CANDESARTAN:

  • Agents increasing serum potassium, such as a salt substitute that contains potassium, potassium supplements, potassium-sparing diuretic (a specific kind of “water pill”, or other drugs that may increase potassium levels (e.g., heparin, co-trimoxazole).
  • Lithium used to treat bipolar disease.
  • Nonsteroidal anti-inflammatory drugs (NSAIDs), used to reduce pain and swelling. Examples include ibuprofen, naproxen, and celecoxib.
  • Blood pressure-lowering drugs, including diuretics (water pills), aliskiren-containing products (e.g. Rasilez) or angiotensin converting enzyme (ACE) inhibitors.
  • Mineralocorticoid receptor antagonists (for example, spironolactone, eplerenone) and ACE inhibitors used in Heart failure.
Proper use of this medication

The dosage of APO-CANDESARTAN is individualized.

Take APO-CANDESARTAN exactly as prescribed. It is recommended to take your dose at about the same time everyday.

APO-CANDESARTAN is taken once a day. Even if your doctor has prescribed 2 tablets a day, both should be taken at the same time, unless otherwise indicated.

APO-CANDESARTAN may be taken with food or on an empty stomach but it should be taken consistently the same way each day. Swallow APO-CANDESARTAN with a glass of water.

Usual Dose

Lower doses may be required based on the other medications you take and the presence of other disease conditions.

High Blood Pressure in Adults:
Recommended Initial Dose: 16 mg once a day.
Total Daily Dose: 8 mg to 32 mg once a day.

High Blood Pressure in Children (6 to 17 years of age):

  • For children who weigh less than 50 kg:
    Recommended Starting Dose: 4 mg once a day.
    Maximum Dose: 8 mg once a day
  • For children who weigh 50 kg or more:
    Recommended Starting Dose: 8 mg once a day.
    Maximum Dose: 16 mg once a day

APO-CANDESARTAN must not be given to children under 1 year of age due to the potential risk to the developing kidneys.

Heart Failure in Adults:
Usual Recommended Initial Dose: 4 mg once a day.
If tolerated by the patient, this dose is gradually doubled (approximately every 2 weeks) until the target dose is reached.
Target Dose: 32 mg once a day.

Overdose

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

If you miss a dose of APO-CANDESARTAN and remember within 12 hours, you should take your usual dose as soon as possible. Then go back to your regular schedule. But if it is more than 12 hours when you remember, do not take the missed dose. Just take the next dose on time.

Never take a double dose of APO-CANDESARTAN to make up for missed tablets. If you are still unsure, check with your doctor or pharmacist to see what you should do.

Side effects and what to do about them

Side effects may include:

  • Dizziness, falls
  • drowsiness, insomnia
  • rash
  • diarrhea, vomiting
  • headache
  • back or leg pain, muscle cramps
  • cough
  • sore throat
  • dry mouth
  • cold symptoms
  • pneumonia
  • fainting spells
  • confusion

Side effects in adults and children are similar, but may occur more more often in children.

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

APO-CANDESARTAN can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor, nurse, or pharmacist only if severe Talk with your doctor, nurse, or pharmacist in all cases Stop taking drug and seek immediate medical help
Common
Low Blood Pressure: dizziness, fainting, lightheadedness ✔    
Fast, Slow or Irregular Heart Beat ✔    
Increased levels of potassium in the blood: irregular heartbeats, muscle weakness and generally feeling unwell   ✔  
Uncommon
Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing     ✔
Kidney Disorder: change in frequency of urination, nausea, vomiting, swelling of extremities, fatigue   ✔  
Hematuria (blood in urine)   ✔  
Liver Disorder: yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite   ✔  
Shortness of breath, difficulty breathing (Dyspnea, Pulmonary edema) ✔    
Rare
Rhabdomyolysis : muscle pain that you cannot explain, muscle tenderness or weakness, dark brown urine   ✔  
Very rare
Decreased Platelets: bruising, bleeding, fatigue and weakness   ✔  
Unknown
Inflammation of the Pancreas: abdominal pain that lasts and gets worse when you lie down, nausea and vomiting   ✔  
Chest Pain   ✔  
Stroke (cerebrovascula r accident): face or arm weakness, abnormal speech and blurred vision, loss of consciousness   ✔  

This is not a complete list of side effects. For any unexpected effects while taking APO-CANDESARTAN, contact your doctor, nurse or pharmacist.

How to store
  • Although the APO-CANDESARTAN tablets are protected in their package, it is best to keep the package at normal room temperature and in a dry place. Do not keep APO-CANDESARTAN in the bathroom.
  • Keep APO-CANDESARTAN out of sight and out of reach of children. Never take medicine in front of small children as they will want to copy you.
  • Do not keep or use APO-CANDESARTAN after the expiry date indicated on the package. Unused medicines which you know you will no longer need should be carefully discarded. You may wish to seek advice from your pharmacist.
Reporting side effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to:
      Canada Vigilance Program
      Health Canada
      Postal Locator 0701E
      Ottawa ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More information

If you want more information about APO-CANDESARTAN:

  • Talk to your healthcare professional
  • Find the full product monograph that is prepared for healthcare professionals and includes this patient medication information by visiting the Health Canada website (https://www.canada.ca/en/healthcanada/services/drugs-health-products/drugproducts/drug-product-database.html); the manufacturer’s website http://www.apotex.ca/products, or by calling 1- 800-667-4708.

This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.

Last revised: January 29, 2019

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