NRA-Candesartan HCTZ: Uses, Side Effects and Dosage

Serious Warnings and Precautions

• NRA-CANDESARTAN HCTZ should not be used during pregnancy. Taking NRA-

  CANDESARTAN HCTZ during pregnancy can cause injury or even death to your baby. If you discover that you are pregnant while taking NRA-CANDESARTAN HCTZ, stop the medication and contact your healthcare professional as soon as possible.

What is NRA-CANDESARTAN HCTZ used for?

• NRA-CANDESARTAN HCTZ is used in adults to lower high blood pressure.

How does NRA-CANDESARTAN HCTZ work?

Candesartan Cilexetil and Hydrochlorothiazide Tablet is a combination of 2 drugs, candesartan cilexetil and hydrochlorothiazide:

• Candesartan is an angiotensin receptor blocker (ARB). It lowers blood pressure.
• Hydrochlorothiazide is a diuretic or “water pill” that increases urination. This also helps to lower blood pressure.

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

What are the ingredients in NRA-CANDESARTAN HCTZ?

Medicinal ingredients: candesartan cilexetil and hydrochlorothiazide

Non-medicinal ingredients: Carboxymethyl cellulose calcium, corn starch, hydroxypropyl cellulose, iron oxide red (16 mg / 12.5 mg and 32 mg / 25 mg), iron oxide yellow (32 mg / 12.5 mg), Lactose monohydrate, magnesium stearate and polyethylene glycol

NRA-CANDESARTAN HCTZ comes in the following dosage forms: Candesartan cilexetil / hydrochlorothiazide tablets: 16 mg / 12.5 mg, 32 mg / 12.5 mg and 32 mg / 25 mg

Do not use NRA-CANDESARTAN HCTZ if:

• You are allergic to candesartan cilexetil, hydrochlorothiazide or to any non-medicinal ingredient in the formulation.
• You have severe liver disease.
• You have severe kidney disease.
• You are allergic to any sulfonamide-derived drugs (sulfa drugs); most of them have a medicinal ingredient that ends in “-MIDE”.
• You have diabetes or kidney disease and are already taking a blood pressure-lowering medicine that contains aliskiren.
• You 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 candesartan cilexetil). Be sure to tell your healthcare professional that this has happened to you.
• You have difficulty urinating or produce no urine.
• You are pregnant or intend to become pregnant. Taking NRA-CANDESARTAN HCTZ during pregnancy can cause injury and even death to your baby.
• You are breastfeeding. NRA-CANDESARTAN HCTZ passes into breast milk.
• You have gout.

• You have one of the following rare hereditary diseases, because NRA-CANDESARTAN

  HCTZ contains lactose:

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

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

• Are allergic to any drug used to lower blood pressure, including angiotensin converting enzyme (ACE) inhibitors, or penicillin.
• Have a liver or kidney disorder.
• 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, a potassium- sparing diuretic (a specific kind of “water pill”) or other drugs that may increase potassium levels such as heparin, co-trimoxazole.
• Are on a low-salt diet.
• Have had a heart attack or stroke.
• Have had skin cancer or have a family history of skin cancer.
• Have a greater chance of developing skin cancer because you have light-coloured skin, get sunburned easily, or are taking drugs to suppress your immune system.

Other warnings you should know about:

Use of anesthesia: If you are about to have a surgery or dental procedure with anesthesia, be sure to tell your healthcare professional that you are taking NRA-CANDESARTAN HCTZ.

Risk of skin cancer: NRA-CANDESARTAN HCTZ contains hydrochlorothiazide. Treatment with hydrochlorothiazide may increase the risk of developing non-melanoma skin cancer. The risk is higher if you have been taking NRA-CANDESARTAN HCTZ for many years (more than

1. 3) or at a high dose. While taking NRA-CANDESARTAN HCTZ:
2. • Make sure to regularly check your skin for any new lesions. Check areas that are most exposed to the sun, such as the face, ears, hands, shoulders, upper chest and back.
3. • Limit your exposure to the sun and to indoor tanning. Always use sunscreen (SPF -30 or higher) and wear protective clothing when going outside.
4. • Talk to your healthcare professional immediately if you get more sensitive to the sun or UV light or if you develop an unexpected skin lesion (such as a lump, bump, sore, or patch) during the treatment.

Sudden eye disorders: Treatment with hydrochlorothiazide in NRA-CANDESARTAN HCTZ can cause sudden eye problems such as:

• Myopia: sudden nearsightedness or blurred vision.
• Glaucoma: an increased pressure in your eyes, eye pain. Untreated, it may lead to permanent vision loss.
• Choroidal effusion: an abnormal building of liquid in your eye that may result in vision changes.

These eye disorders are related and can develop within hours to weeks of starting NRA-CANDESARTAN HCTZ. If you earlier have had a penicillin or sulfonamide allergy, you can be at higher risk of developing this. If you experience the above symptoms, stop taking NRA-CANDESARTAN HCTZ and seek immediate medical help.

Monitoring: During your treatment with NRA-CANDESARTAN HCTZ, your healthcare professional may monitor:

• Your kidney function.
• Your blood pressure.
• The amount of electrolytes in your blood (such as potassium).

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

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

The following may interact with NRA-CANDESARTAN HCTZ:

Serious Drug Interactions

• Aliskiren-containing drugs if you have diabetes or kidney disease.
• Adrenocorticotropic hormone (ACTH), which may be used to treat diseases such as nephrotic syndrome or collagen diseases and in diagnostic tests.
• 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 used to treat the flu and reduce symptoms of Parkinson’s Disease.
• Amphotericin B, an antifungal drug.
• Drugs used to treat cancer such as cyclophosphamide and methotrexate.
• Antidepressants, in particular selective serotonin reuptake inhibitors (SSRIs) such as citalopram, escitalopram and sertraline.
• Drugs used to treat diabetes such as insulin and oral medicines.
• Bile acid resins used to lower cholesterol such as cholestyramine.

• Other blood pressure lowering drugs such as:

  • Diuretics (“water pills”).
  • Guanethidine.
  • Diazoxide.
  • Methyldopa.
  • Beta-blockers, such as atenolol, metoprolol, propranolol.
  • Vasodilators.
  • Calcium channel blockers, such as felodipine and amlodipine.
  • Angiotensin converting enzyme inhibitors (ACEIs) .
  • Angiotensin receptor blockers (ARBs), such as valsartan and losartan.
  • Direct renin inhibitors.
• Calcium or vitamin D supplements.
• Corticosteroids used to treat joint pain and swelling.
• Cyclosporine used to treat autoimmune diseases.
• Digoxin, a heart medication.
• Drugs that slow down or speed up bowel function such as atropine, biperiden, domperidone and metoclopramide.
• Drugs used to treat epilepsy such as carbamazepine and topiramate.
• Gout medications such as allopurinol, probenecid, uricosurics and xanthine oxidase inhibitors.
• Lithium used to treat bipolar disease.
• Nonsteroidal anti-inflammatory drugs (NSAIDs), used to reduce pain and swelling such as ibuprofen, naproxen, acetylsalicylic acid and celecoxib.
• Drugs that can increase blood potassium levels such as heparin, co -trimoxazole, potassium supplements or potassium-containing salt substitutes.
• Pressor amines such as norepinephrine.
• Skeletal muscle relaxants used to relieve muscle spasms such as tubocurarine.

How to take NRA-CANDESARTAN HCTZ:

• Take NRA-CANDESARTAN HCTZ exactly as prescribed.
• It is recommended to take your dose at about the same time everyday.

• NRA-CANDESARTAN HCTZ can be taken with or without food but it should be taken the same way each day. If a Candesartan Cilexetil and Hydrochlorothiazide Tablet causes upset stomach, take it with food or milk.

• Swallow NRA-CANDESARTAN HCTZ whole, with water as (if) needed. Do not split, crush or chew the tablet.

• Do not transfer NRA-CANDESARTAN HCTZ to other pill containers. To protect your

  NRA-CANDESARTAN HCTZ, 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 dose:

Your healthcare professional has decided the best dose for you. The recommended dose is 1 tablet once daily.

Overdose:

If you think you, or a person you are caring for, have taken too much NRA-CANDESARTAN HCTZ, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

Missed Dose:

If you miss a dose of NRA-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 take a double dose.

What are possible side effects from using NRA-CANDESARTAN HCTZ?

These are not all the possible side effects you may have when taking NRA-CANDESARTAN HCTZ. If you experience any side effects not listed here, tell your healthcare professional.

• back or leg pain, muscle cramps, spasms and pain, weakness, restlessness
• cold or flu-like symptoms
• dizziness, pins and needles in your fingers, headache
• urinary tract infections
• constipation, diarrhea, nausea, vomiting, decreased appetite, upset stomach, enlargement of the glands in your mouth
• cough
• bleeding under skin, rash, red patches on the skin, itching
• drowsiness, insomnia
• low sex drive
• nose bleeds

NRA-CANDESARTAN HCTZ can cause abnormal blood test results. Your healthcare professional will decide when to perform blood tests and will interpret the results.

Serious side effects and what to do about them

Serious side effects and what to do about them

Serious side effects and what to do about them

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

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting

  (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect- canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or

• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about howto manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

• Keep in the original package at room temperature (15°C to 30°C) and in a dry place. Do not keep NRA-CANDESARTAN HCTZ in the bathroom.
• Do not keep or use NRA-CANDESARTAN HCTZ after the expiry date indicated on the package. Return any unused medicines, which you know you will no longer need, to your pharmacy for disposal.

Keep out of reach and sight of children.

If you want more information about NRA-CANDESARTAN HCTZ:

• 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) or by calling Nora Pharma Inc at 1-888-270-9874.

Nora Pharma Inc.

1565 Lionel-Boulet Blvd.

Varennes, Quebec

J3X 1P7

Last revised: SEP 21, 2022