Septa-Candesartan: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

SEPTA-CANDESARTAN is used to treat hypertension (high blood pressure).

You may not experience any signs of high blood pressure. It is important to take SEPTA-CANDESARTAN as directed by your doctor. If high blood pressure is not treated, damage may result to vital organs such as the heart or the kidneys. High blood pressure can lead to strokes, heart attacks, heart failure, kidney failure, or blindness.

SEPTA-CANDESARTAN can also be taken for treatment of a heart condition known as heart failure. This is a condition in which your heart does not pump blood around your body as well as it should.

It is important to take SEPTA-CANDESARTAN as directed by your doctor.

What it does:

SEPTA-CANDESARTAN is the brand name for this drug, candesartan cilexetil. It belongs to the group of drugs called “angiotensin II receptor blockers”. 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:

You should not take SEPTA-CANDESARTAN if:

• You are already taking a blood pressure-lowering

  medicine that contains aliskiren (such as Rasilez) and you have diabetes or kidney disease.

• You are allergic to “non-medicinal” substances like food

  products, preservatives, or dyes, which may be present in SEPTA-CANDESARTAN tablets (See What the nonmedicinal ingredients are).

• You have ever had a bad, unusual or allergic reaction to

  candesartan cilexetil.

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): calcium carboxymethylcellulose, corn starch, hydroxypropylcellulose, iron oxide red, lactose monohydrate, magnesium stearate, polyethylene glycol.

What dosage forms it comes in:

SEPTA-CANDESARTAN is available as 16 mg and 32 mg tablets.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

SEPTA-CANDESARTAN should not be used during pregnancy. If you discover that you are pregnant while taking SEPTA-CANDESARTAN, stop the medication and please contact your physician.

Before you start SEPTA-CANDESARTAN, talk to your doctor, nurse or pharmacist:

• If you are pregnant, breast feeding or thinking about becoming pregnant. Taking SEPTA-CANDESARTAN during pregnancy can cause injury and even death to your baby. This medicine should not be used during pregnancy. If you are planning to become pregnant while taking SEPTA-CANDESARTAN, contact your doctor immediately. It is possible that SEPTA-CANDESARTAN passes into breast milk. You should discuss with your doctor about taking SEPTA-CANDESARTAN while breast feeding.

• If you are taking a medicine that contains aliskiren, such as

  Rasilez, used to lower high blood pressure. The combination with SEPTA-CANDESARTAN is not recommended.

• If you are taking an angiotensin converting enzyme inhibitor

  (ACEI). You can recognize ACEIs because their medicinal ingredient ends in “-PRIL”.

• About all health problems you have or have had in the past including any heart, liver or kidney problems.
• If you are taking a diuretic therapy (water pills) or are on salt restrictive diet.
• If you are undergoing dialysis.
• If you are vomiting or have diarrhea.

The treatment of high blood pressure may cause dizziness or weariness in some patients. Make sure you are not affected in this way before driving or operating machinery.

If you are currently taking SEPTA-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

Before taking SEPTA-CANDESARTAN be sure your doctor knows about all medicines you take, including ones you can buy without a prescription. If you visit more than one doctor make sure that each knows about all the medicines you are taking.

Drugs that may interact with SEPTA-CANDESARTAN include:

• Other medicines used to lower blood pressure, including

  diuretics (water pills), aliskiren-containing products (e.g. Rasilez), or angiotensin converting enzyme inhibitors (ACEIs)

• Potassium-sparing diuretics, potassium supplements or

  potassium-containing salt substitutes;

• Lithium therapy;

• Nonsteroidal anti-inflammatory agents (NSAIDs) such as

  aspirin, acetaminophen, and ibuprofen. NSAIDs are used to reduce pain, fever, and swelling.

PROPER USE OF THIS MEDICATION

Remember, you may not notice any signs of high blood pressure. Therefore, it is important to take SEPTA-CANDESARTAN even when you feel well. A constant amount of drug is needed in your body to control your blood pressure. Do not stop taking SEPTA-CANDESARTAN on your own.

Usual dose:

Take SEPTA-CANDESARTAN exactly as your doctor tells you. Do not miss doses or take extra doses, unless your doctor tells you. If you are not clear about the directions, ask your doctor or pharmacist.

The dosage of SEPTA-CANDESARTAN is individualized.

SEPTA-CANDESARTAN is not for use in children under 18 years of age.

Try to take SEPTA-CANDESARTAN with something you do regularly each day; for example, upon waking or at breakfast. This will help you remember each dose.

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

Swallow SEPTA-CANDESARTAN with a glass of water.

SEPTA-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.

Remember to get a new prescription from your doctor or a refill from your pharmacy a few days before all your tablets are taken.

The package protects each tablet. 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 SEPTA-CANDESARTAN to other pill containers. To protect your SEPTA-CANDESARTAN tablets, keep them in the original package.

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 SEPTA-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 SEPTA-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

Along with its effects on controlling blood pressure, SEPTA-CANDESARTAN, like any medication, may cause side effects. These side effects are usually mild and should go away as your body gets used to SEPTA-CANDESARTAN. Talk to your doctor if you suffer from any of these effects or if you get any other unusual or unexpected symptoms.

Common side effects that may occur (in 1% or more of patients but less than 10%):

• Dizziness
• Headache
• Cold symptoms
• Worsening of the kidney function (especially in patients with existing kidney problems or heart failure)
• Abnormally low blood pressure (especially in patients with heart failure)
• High levels of potassium in the blood (especially in patients with heart failure)
• Back pain

Rare side effects that may occur (in between 0.01% and 1% of patients):

• Fainting spells

Very rare side effects that may occur (in less than 0.01% of patients):

• Changes to the way the liver works, including inflammation of the liver

Side effects such as muscle pain, muscle weakness, muscle inflammation and rhabdomyolysis (a muscle-wasting disease), in rare cases leading to kidney failure, have been reported with the use of angiotensin II receptor blockers, the class of drugs to which SEPTA-CANDESARTAN belongs.

Blood samples may be taken occasionally to check whether SEPTA-CANDESARTAN has had any effect on your blood or on your kidneys.

Medicines affect different people in different ways. Just because

side effects have occurred in other patients does not mean you will get them. Discuss how you feel on SEPTA-CANDESARTAN with your doctor and pharmacist. Do not stop taking SEPTA-CANDESARTAN on your own.

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

HOW TO STORE IT

• It is best to keep SEPTA-CANDESARTAN tablets at normal

  room temperature (15-30 ºC) and in a dry place. Do not keep SEPTA-CANDESARTAN in the bathroom.

• Keep SEPTA-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 SEPTA-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 SUSPECTED 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 3 ways:

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• 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, Ontario

    K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™ 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

This document plus the full product monograph, prepared for health professionals can be found at:

www.septapharmaceuticals.com

or by contacting the sponsor, Septa Pharmaceuticals Inc: 905-564-5665

Septa Pharmaceuticals Inc

7490 Pacific Circle, Mississauga

Ontario L5T 2A3

Last revised: October 16, 2015