Zinda-Candesartan: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

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

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

ZINDA-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 ZINDA-CANDESARTAN as directed by your doctor.

What it does:

ZINDA-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 ZINDA-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 ZINDA-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:

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

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

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

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

• If you are pregnant, breast feeding or thinking about becoming pregnant. Taking ZINDA-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 ZINDA-CANDESARTAN, contact your doctor immediately.

It is possible that ZINDA-CANDESARTAN passes into breast milk. You should discuss with your doctor about taking ZINDA-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 ZINDA-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 ZINDA-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 ZINDA-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 ZINDA-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 ZINDA-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 ZINDA-CANDESARTAN on your own.

Usual dose:

Take ZINDA-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 ZINDA-CANDESARTAN is individualized.

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

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

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

Swallow ZINDA-CANDESARTAN with a glass of water.

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

Overdose:

Missed Dose:

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

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

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

HOW TO STORE IT

• It is best to keep ZINDA-CANDESARTAN tablets at normal room temperature (15-30 ºC) and in a dry place. Do not keep ZINDA-CANDESARTAN in the bathroom.
• Keep ZINDA-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 ZINDA-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

MORE INFORMATION

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

www.zindapharma.com/

or by contacting the sponsor, Zinda Pharma Limited, at:

1-888-922-3133 or 514-931-3133.

Zinda Pharma Limited

Montreal, Quebec, H4P 2P5

Last prepared: May 2, 2014