Teva-Candesartan/HCTZ (Teva Canada, 32 mg / 25 mg): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

ABOUT THIS MEDICATION

What the medication is used for:

TEVA-CANDESARTAN/HCTZ lowers high blood pressure.

What it does:

TEVA-CANDESARTAN/HCTZ contains a combination of 2 drugs, candesartan cilexetil and hydrochlorothiazide.

• Candesartan is an angiotensin receptor blocker (ARB). You can recognize an ARB because its medicinal ingredient ends in ‘-SARTAN’. It lowers blood pressure.
• Hydrochlorothiazide is a diuretic or ‘water pill’ that increases urination. This lowers blood pressure.

This medicine does not cure high blood pressure. It helps to control it. Therefore it is important to continue taking TEVA-CANDESARTAN/HCTZ regularly even if you feel fine.

When it should not be used:

Do not take TEVA-CANDESARTAN/HCTZ if you:

• Are allergic to candesartan cilexetil, hydrochlorothiazide or to any non-medicinal ingredient in the formulation.
• Have severe liver disease.
• Have severe kidney disease.
• Are allergic to any sulphonamide-derived drugs (sulfa drugs); most of them have a medicinal ingredient that ends in ‘-MIDE’.
• Are already taking a blood pressure-lowering medicine that contains aliskiren (such as Rasilez) and you have diabetes or kidney disease.

• 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 (any drug in the same class as TEVA-CANDESARTAN/HCTZ). Be sure to tell your doctor, nurse or pharmacist that this has happened to you.

  • Have difficulty urinating or produce no urine.

  • Are pregnant or intend to become pregnant. Taking TEVA-CANDESARTAN/HCTZ during pregnancy can cause injury and even death to your baby.

  • Are breastfeeding. TEVA-CANDESARTAN/HCTZ passes into breast milk.
  • Are less than 1 year old.
  • Have gout.

  • Have one of the following rare hereditary diseases:

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

because lactose is a non-medicinal ingredient in TEVA-CANDESARTAN/HCTZ.

What the medicinal ingredients are:

Candesartan cilexetil and hydrochlorothiazide

What the non-medicinal ingredients are:

Carmellose calcium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer 188, povidone, pregelatinized starch, red iron oxide (16 mg/12.5 mg tablets).

What dosage forms it comes in:

TEVA-CANDESARTAN/HCTZ is available as tablets: 16 mg / 12.5 mg and 32 mg / 12.5 mg.

WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS

Before you use TEVA-CANDESARTAN/HCTZ talk to your doctor, nurse or pharmacist if you:

• Are allergic to any drug used to lower blood pressure, including angiotensin converting enzyme (ACE) inhibitors, or penicillin.
• Have a liver disorder.
• Have a kidney disorder.
• Are taking a medicine that contains aliskiren, such as Rasilez, used to lower high blood pressure. The combination with TEVA-CANDESARTAN/HCTZ is not recommended.
• Are taking an angiotensin converting enzyme inhibitor (ACEI). You can recognize ACEIs because their medicinal ingredient ends in ‘-PRIL’.
• Have narrowing of an artery or a heart valve.
• Have heart failure.

• Have diabetes, liver, heart or kidney disease.
• Have lupus.
• 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’) or other drugs that may increase potassium levels (e.g. heparin, co-trimoxazole).
• Are on a low salt diet.
• Are less than 18 years old.
• Are having any kind of surgery or dental procedure with anesthesia.
• Have had a heart attack or stroke.

Hydrochlorothiazide in TEVA-CANDESARTAN/HCTZ can cause Sudden Eye Disorders:

• Myopia: sudden nearsightedness or blurred vision.
• Glaucoma: an increased pressure in your eyes, eye pain. Untreated, it may lead to permanent vision loss.

These eye disorders are related and can develop within hours to weeks of starting TEVA-CANDESARTAN/HCTZ.

You may become sensitive to the sun while taking TEVA-CANDESARTAN/HCTZ. Exposure to sunlight should be minimized until you know how you respond.

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

INTERACTIONS WITH THIS MEDICATION

ONS 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 TEVA-CANDESARTAN/HCTZ:

• Adrenocorticotropic hormone (ACTH) used to treat West Syndrome.
• Alcohol, barbiturates (sleeping pills), or narcotics (strong pain medications). They may cause low blood pressure and dizziness when you go from lying or sitting to standing up.
• Amantadine
• Amphotericin B, an antifungal drug.

• Anticancer drugs including cyclophosphamide and methotrexate.

  • Antidepressants, in particular selective serotonin reuptake inhibitors (SSRIs), including citalopram, escitalopram and sertraline.
  • Antidiabetic drugs, including insulin and oral medicines.
  • Bile acid resins used to lower cholesterol.
  • Other blood pressure lowering drugs, including diuretics (water pills), aliskiren-containing products (e.g. Rasilez), or angiotensin converting enzyme inhibitors (ACEIs). When taken in combination with TEVA-CANDESARTAN/HCTZ, they may cause excessively low blood pressure.
  • Calcium or vitamin D supplements
  • Corticosteroids used to treat joint pain and swelling.
  • Cyclosporine
  • Digoxin, a heart medication.
  • Drugs that slow down or speed up bowel function including atropine, biperiden, domperidone and metoclopramide.
  • Drugs used to treat epilepsy, including carbamazepine and topiramate.
  • Gout medications including allopurinol and probenecid.
  • Lithium used to treat bipolar disease.
  • Nonsteroidal anti-inflammatory drugs (NSAIDs), used to reduce pain and swelling. Examples include ibuprofen, naproxen and celecoxib
  • Pressor amines such as norepinephrine
  • Skeletal muscle relaxants used to relieve muscle spasms, including tubocurarine.

PROPER USE OF THIS MEDICATION

PROPER USE OF THIS MEDICATION

Take TEVA-CANDESARTAN/HCTZ exactly as prescribed. It is recommended to take your dose at about the same time every day.

TEVA-CANDESARTAN/HCTZ may be taken with or without food, but it should be taken the same way each day. Swallow TEVA-CANDESARTAN/HCTZ with a glass of water.

If TEVA-CANDESARTAN/HCTZ causes upset stomach, take it with food or milk.

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

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

Usual Adult Dose:

Usual maintenance dose is 1 tablet daily.

The dosage of TEVA-CANDESARTAN/HCTZ is individualized.

TEVA-CANDESARTAN/HCTZ is not for initial therapy. You must first be stabilized on the individual components (candesartan cilexetil and hydrochlorothiazide) of TEVA-CANDESARTAN/HCTZ.

Overdose:

Missed Dose:

If you miss a dose of TEVA-CANDESARTAN/HCTZ 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. Do not double dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

SIDE EFFECTS AND WHAT TO DO ABOUT T

Side effects may include:

• Back or leg pain, muscle cramps, spasms and pain, weakness, restlessness
• Dizziness, pins and needles in your fingers, headache
• Constipation, diarrhea, nausea, vomiting, decreased appetite, upset stomach, enlargement of the glands in your mouth
• Bleeding under skin, rash, red patches on the skin, itching
• Drowsiness, insomnia
• Reduced libido
• Throat infections
• Cough

If any of these affects you severely, tell your doctor, nurse or pharmacist.

TEVA-CANDESARTAN/HCTZ can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.

RIOUS SIDE EFFECTS, HOW OFTEN THEY

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

HOW TO STORE IT

• Although the TEVA-CANDESARTAN/HCTZ tablets are protected in their package, it is best to keep the package at normal room temperature (15°C to 30°C) and in a dry place. Do not keep TEVA-CANDESARTAN/HCTZ 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 TEVA-CANDESARTAN/HCTZ 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, 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.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting Teva Canada Limited

at: 1-800-268-4127 ext. 1255005 (English)

or druginfo@tevacanada.com

or 1-877-777-9117 (French)

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

Canada, M1B 2K9

Last revised: July 25, 2016