Apo-Candesartan Tablets: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

APO-CANDESARTAN TABLETS 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:

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

• Are breastfeeding. It is possible that 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 TABLETS.

What the medicinal ingredient is:

Candesartan cilexetil.

What the nonmedicinal ingredients are:

Carmellose calcium, ferric oxide red (except 4 mg tablets), hydroxypropyl cellulose-L, lactose monohydrate, macrogol 6000, magnesium stearate, and maize starch.

What dosage forms it comes in:

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

WARNINGS AND PRECAUTIONS

Before you use APO-CANDESARTAN TABLETS 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 TABLETS is not recommended.
• Are taking an angiotensin converting enzyme (ACE) inhibitor. You can recognize ACE inhibitors 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 TABLETS. Dizziness, lightheadedness, or fainting can especially occur after the first dose and when the dose is increased.

If you are currently taking APO-CANDESARTAN TABLETS 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 TABLETS:

• 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 TABLETS is individualized.

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

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

Swallow APO-CANDESARTAN TABLETS 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 TABLETS 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:

Missed Dose:

If you miss a dose of APO-CANDESARTAN TABLETS 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 TABLETS 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.

APO-CANDESARTAN TABLETS 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 APO-CANDESARTAN TABLETS, 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.
• APO-CANDESARTAN TABLETS are protected in their package, it is best to keep the tablets in their original package in well-closed containers at a temperature between 15°C- 30°C and in a dry place. Do not keep APO-CANDESARTAN TABLETS 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 APO-CANDESARTAN TABLETS 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.

MORE INFORMATION

• NOTE: For the most current information, the Consumer Information Leaflet plus the full Product Monograph, prepared for health professionals can be found by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html) or by contacting the sponsor, Apotex Inc. at 1-800-667-4708

Apotex Inc., Toronto, Ontario, M9L 1T9

Last revised: September 11, 2023