NTP-Candesartan: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

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

You may not experience any signs of high blood pressure. It is important to take NTP-

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.

NTP-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 NTP-CANDESARTAN as directed by your doctor.

What it does:

NTP-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 NTP-CANDESARTAN if:

• You are allergic to “non-medicinal” substances

  like food products, preservatives, or dyes, which may be present in NTP-CANDESARTAN tablets (See What the important 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 nonmedicinal 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: carmellose calcium, microcrystalline cellulose, lactose monohydrate, magnesium stearate, pregelatinized starch, poloxamer 188, povidone, red iron oxide.

What dosage forms it comes in:

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

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

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

Before you start NTP-CANDESARTAN be sure you have told your doctor:

• If you are pregnant, breast feeding or thinking about becoming pregnant.

  Taking NTP-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 NTP-CANDESARTAN, contact your doctor immediately. It is possible that NTP-CANDESARTAN passes into breast milk. You should discuss with your doctor about taking NTP-CANDESARTAN while breast feeding.

• 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 NTP-CANDESARTAN and are going to have an operation, be sure to tell your doctor or dentist

27 about your medication before you are given an anaesthetic.

INTERACTIONS WITH THIS MEDICATION

Before taking NTP-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 NTP-CANDESARTAN include:

• Other medicines used to lower blood pressure,

  including diuretics (water pills);

• Potassium-sparing diuretics, potassium

  supplements or potassium-containing salt substitutes;

• Lithium therapy.

PROPER USE OF THIS MEDICATION

Remember, you may not notice any signs of high blood pressure. Therefore, it is important to take NTP-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 NTP-CANDESARTAN on your own.

Usual Dose:

Take NTP-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 NTP-CANDESARTAN is individualized.

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

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

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

Swallow NTP-CANDESARTAN with a glass of water.

NTP-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 NTP-CANDESARTAN to other pill containers. To protect your NTP-CANDESARTAN tablets, keep them in the original package.

Overdose:

If you take more NTP-CANDESARTAN than you should, contact a doctor, the Regional Poison Control centre or pharmacist immediately.

Missed Dose:

If you miss a dose of NTP-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 NTP-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, NTP-CANDESARTAN, like any medication, may cause side effects. These side effects are usually mild and should go away as your body gets used to NTP-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

  28 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 NTP-CANDESARTAN belongs.

Blood samples may be taken occasionally to check whether NTP-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 NTP-CANDESARTAN with your doctor and pharmacist. Do not stop taking NTP-CANDESARTAN on your own.

*If you think you have these side effects, it is important that you seek medical advice from your doctor immediately. This is not a complete list of side effects. For any unexpected effects while taking NTP-CANDESARTAN, contact your doctor or pharmacist.

HOW TO STORE IT

• Although the NTP-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 NTP-CANDESARTAN in the bathroom.
• Keep NTP-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 NTP-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:

• 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 0701D Ottawa, ON 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.

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MORE INFORMATION

All drugs can have both helpful and harmful effects. Both depend on the person and his or her health condition. This leaflet alerts you to some of the times you should call your doctor. Other situations which cannot be predicted may arise. Nothing in this leaflet should stop you from calling your doctor or pharmacist with any questions or concerns you have about NTP-CANDESARTAN.

This document plus the full product monograph, prepared for health professionals can be found by contacting Teva Canada Ltd. at: 1-800-268-4127 ext. 5005 (English Canada)

or druginfo@tevacanada.com

or 1-877-777-9117 (French Canada)

Teva Canada Ltd.

30 Novopharm Court

Toronto, Ontario

M1B 2K9

Last revised: July 12, 2013