Bio-Candesartan: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Bio-CANDESARTAN is used to treat:

• High Blood Pressure in Adults

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

• Heart Failure in Adults

What it does:

Bio-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 Bio-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 Bio-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 Bio-

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

• Are breastfeeding. It is possible that Bio-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 Bio-CANDESARTAN

What the medicinal ingredient is:

Candesartan cilexetil

What the important nonmedicinal ingredients are: carboxymethylcellulose calcium, cornstarch, hydroxypropyl cellulose, iron oxide red, lactose monohydrate, magnesium stearate and polyethylene glycol.

What dosage forms it comes in:

Tablets: 4 mg, 8 mg, 16 mg and 32 mg tablets.

WARNINGS AND PRECAUTIONS

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

BEFORE you use Bio-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 Bio-CANDESARTAN is not recommended.

• Are taking an angiotensin converting enzyme (ACE)

  inhibitor. You can recognize ACEIs because their medicinal ingredients ends in ‘-PRIL’

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

If you are currently taking Bio-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 Bio-CANDESARTAN:

• 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”) 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 Bio-CANDESARTAN is individualized.

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

Bio-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.

Bio-CANDESARTAN may be taken with food or on an empty stomach but it should be taken consistently the same way each day.

Swallow Bio-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

Bio-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 Bio-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 Bio-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 often in children.

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

Bio-CANDESARTAN 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 Bio-CANDESARTAN, contact your doctor, nurse or pharmacist.

HOW TO STORE IT

• When you first open the package, if you find any damage to the plastic seal or foil which exposes the tablet, ask your pharmacist to check the package.

• Bio-CANDESARTAN tablets are protected in their

  package, it is best to keep the tablets in their original package at normal room temperature and in a dry place. Do not keep Bio-CANDESARTAN in the bathroom.

• Keep out of sight and reach of children. Never take

  medicine in front of small children as they will want to copy you.

• Do not keep or use Bio-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.

• Remember to get a new prescription from your doctor or

  a refill from your pharmacy a few days before all your tablets are taken.

• Store between 15°C and 30°C.

Reporting Side Effects

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report:

• Online at MedEffect (http://hc-sc.gc.ca/dhp-

  mps/medeff/index-eng.php);

• By calling 1-866-234-2345 (toll-free);

• By completing a Consumer Side Effect

  Reporting Form and sending it by:

  • Fax to 1-866-678-6789 (toll-free), or

  • Mail to: Canada Vigilance Program

    Health Canada, Postal Locator 0701E Ottawa, ON

    K1A 0K9

    Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.

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 obtained by contacting Biomed Pharma.

Biomed Pharma

100-5950, Ch. de la Côte de Liesse

Mont-Royal, QC, H4T 1E2

Phone# (514) 731-2003; Fax: (514) 731-2004

Date of Revision: June 15, 2016