ACH-Candesartan (Accord Healthcare, 8 mg, 16 mg, 32 mg): Uses, Side Effects and Dosage

Serious Warnings and Precautions

ACH-CANDESARTAN should not be used during pregnancy. Taking ACH-CANDESARTAN during pregnancy can cause injury or even death to your baby. If you/your child discover that you/they are pregnant while taking ACH-CANDESARTAN, stop the medication and contact your/their healthcare professional as soon as possible.

What is ACH-CANDESARTAN used for?

ACH-CANDESARTAN is used to treat:

• mild to moderate high blood pressure in children (6 to 17 years of age) and adults. It may be used alone or in combination with diuretics (water pills).

• heart failure in adults. It may be used alone or with medicines called angiotensin-converting enzyme (ACE) inhibitors.

How does ACH-CANDESARTAN work?

ACH-CANDESARTAN is an angiotensin receptor blocker (ARB) that helps relax blood vessels. This makes it easier for your heart to pump blood around your body. You can recognize an ARB because its medicinal ingredient ends in “-SARTAN”.

This medicine does not cure your/your child’s disease. It helps to control it. Therefore, it is important to continue taking ACH-CANDESARTAN regularly even if you/your child feel fine.

What are the ingredients in ACH-CANDESARTAN?

Medicinal ingredient: Candesartan cilexetil

Non-medicinal ingredients: Calcium carboxymethylcellulose, hydroxypropyl cellulose, iron oxide (except 4 mg tablets), lactose monohydrate, magnesium stearate, maize starch and polyethylene glycol.

ACH-CANDESARTAN comes in the following dosage forms:

Tablets: 8 mg, 16 mg and 32 mg.

Do not use ACH-CANDESARTAN if:

• You/your child are allergic to candesartan cilexetil or to any non-medicinal ingredient in ACH-CANDESARTAN.
• You/your child 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 healthcare professional that this has happened to you/your child.
• You/your child are already taking a blood pressure-lowering medicine that contains aliskiren (such as Rasilez) and you/your child have diabetes or kidney disease.
• You/your child are pregnant or intend to become pregnant. Taking ACH-CANDESARTAN during pregnancy can cause injury and even death to your baby.
• You/your child are breastfeeding. It is possible that ACH-CANDESARTAN passes into breast milk.
• Your child is less than 1 year old

• You/your child have one of the following rare hereditary diseases:

  • Galactose intolerance
  • Lapp lactase deficiency
  • Glucose-galactose malabsorption

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

To help avoid side effects and ensure proper use, talk to your/your child’s healthcare professional before you/your child take ACH-CANDESARTAN. Talk about any health conditions or problems you/your child may have, including if you/your child:

• Have experienced an allergic reaction to any drug used to lower blood pressure, including angiotensin converting enzyme (ACE) inhibitors.
• Have or have had heart problems such as heart attack, heart failure and narrowing of an artery or a heart valve.
• Have had a stroke.
• Have heart failure.
• Have diabetes.
• Have kidney or liver problems.
• 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 such as heparin and co-trimoxazole.
• Are on a low-salt diet.
• 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.

Other warnings you should know about:

Use of anesthesia: If you/your child are about to have a surgery or dental procedure with anesthesia, be sure to tell your/your child’s healthcare professional that you/your child are taking ACH-

CANDESARTAN.

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

Monitoring: During your/your child’s treatment with ACH-CANDESARTAN, your/your child’s healthcare professional may monitor:

• Your/your child’s kidney function
• You/your child’s blood pressure
• The amount of electrolytes in your/your child’s blood (such as potassium).

Blood Tests: ACH-CANDESARTAN can cause abnormal blood test results. Your/your child’s healthcare professional will decide when to perform blood tests and will interpret the results.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may also interact with ACH-CANDESARTAN:

• Medicines that increase the potassium in the blood, 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 such as heparin and co-trimoxazole.
• Lithium, used to treat bipolar disease.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, and celecoxib, used to reduce pain and swelling.
• Blood pressure- lowering medicines, including diuretics (“water pills”) or angiotensin converting enzyme (ACE) inhibitors.
• Mineralocorticoid receptor antagonists such as spironolactone and eplerenone, used to treat blood pressure and heart failure.

How to take ACH-CANDESARTAN:

• Take/give ACH-CANDESARTAN exactly as your/your child’s healthcare professional has told you. Check with your/your child’s healthcare professional if you are not sure.
• It is recommended that the dose is taken at about the same time every day. Take/give ACH-CANDESARTAN once a day.
• If you/your child take diuretics (i.e., “water pills”), your/your child’s healthcare professional may ask you/your child to temporarily stop taking them 2 or 3 days before you/your child start your/their treatment with ACH-CANDESARTAN. They may also reduce their dose during your/your child’s treatment. Furthermore, your/your child’s healthcare professional may also prescribe you/your child other medications depending on your/your child’s condition. Follow their instructions carefully.

Usual dose:

Adults and children (6 to 17 years of age):

Your/your child’s healthcare professional will decide on the best dose of ACH-CANDESARTAN for you/your child and how long you/your child will take it. Your/your child’s dose will depend on:

• Other medication you/your child take
• The severity of your/your child’s condition
• The health of your/your child’s kidney and liver
• How you/your child respond to treatment

Your/your child’s healthcare professional will monitor your/your child’s health throughout your/your child’s treatment and may increase or decrease your/their dose as needed.

Overdose:

Missed Dose:

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

What are possible side effects from using ACH-CANDESARTAN?

These are not all the possible side effects you/your child may have when taking ACH-CANDESARTAN. If you/your child experience any side effects not listed here, tell your/your child’s healthcare professional.

Side effects may include:

• dizziness, falls
• drowsiness, difficulty falling asleep or staying asleep (insomnia)
• rash
• diarrhea, vomiting, nausea, constipation
• headache
• back or leg pain, muscle cramps
• cough
• sore throat
• dry mouth
• cold symptoms
• infection in the lungs (pneumonia)
• fainting spells
• confusion
• fatigue, lack of energy
• pain or swelling of the hands, arms, legs or feet

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

Serious side effects and what to do about them

If you/your child have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your/your child’s daily activities, tell your/your child’s healthcare professional.

Reporting Side Effects

Storage:

• 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.
• Do not transfer ACH-CANDESARTAN to any other pill containers. Keep in the original package at room temperature (15°C to 30°C) and in a dry place. Do not keep ACH-CANDESARTAN in the bathroom.

• Do not keep or use ACH-CANDESARTAN after the expiry date indicated on the package.

  • Return any unused medicines, which you know will no longer need, to your pharmacy for disposal.

Keep out of reach and sight of children.

If you want more information about ACH-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/health-canada/services/drugs-health-products/drug- products/drug-product-database.html; the manufacturer’s website www.accordhealth.ca, or by calling Accord Healthcare Inc. at 1-866-296-0354.

3535 boul. St. Charles suite 704

Kirkland, QC, H9H 5B9

Canada

Last Revised: JUN 09, 2025