Candesartan Cilexetil and Hydrochlorothiazide: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Candesartan Cilexetil and Hydrochlorothiazide lowers high blood pressure.

What it does:

Candesartan Cilexetil and Hydrochlorothiazide 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 Candesartan Cilexetil and Hydrochlorothiazide regularly even if you feel fine.

When it should not be used:

Do not take Candesartan Cilexetil and Hydrochlorothiazide 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 candesartan cilexetil). 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 Candesartan Cilexetil and Hydrochlorothiazide during pregnancy can cause injury and even death to your baby.

  • Are breastfeeding. Candesartan Cilexetil and Hydrochlorothiazide 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 Candesartan Cilexetil and Hydrochlorothiazide.

What the medicinal ingredients are:

Candesartan cilexetil and hydrochlorothiazide.

What the non-medicinal ingredients are:

Lactose anhydrous, maize starch, carmellose calcium, ferric oxide red, ferric oxide yellow, mono and diglycerides, hydroxypropyl cellulose, lactose monohydrate, silica colloidal anhydrous and magnesium stearate.

What dosage forms it comes in:

Tablets in two strengths:

Candesartan Cilexetil and Hydrochlorothiazide (candesartan cilexetil / hydrochlorothiazide): 16 mg / 12.5 mg

Candesartan Cilexetil and Hydrochlorothiazide (candesartan cilexetil / hydrochlorothiazide): 32 mg / 25 mg

WARNINGS AND PRECAUTIONS

Before you use Candesartan Cilexetil and Hydrochlorothiazide 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 Candesartan Cilexetil and Hydrochlorothiazide 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, 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.
• 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.

Risk of skin cancer:

Candesartan Cilexetil and Hydrochlorothiazide contains hydrochlorothiazide. Treatment with hydrochlorothiazide may increase the risk of developing non-melanoma skin cancer. The risk is higher if you have been taking Candesartan Cilexetil and Hydrochlorothiazide for many years (more than 3) or at a high dose.

While taking Candesartan Cilexetil and Hydrochlorothiazide:

• 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.
• Limit your exposure to the sun and to indoor tanning. Always use sunscreen (SPF-30 or higher) and wear protective clothing when going outside.
• Talk to your doctor 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.

Hydrochlorothiazide in Candesartan Cilexetil and Hydrochlorothiazide 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 Candesartan Cilexetil and Hydrochlorothiazide.

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

INTERACTIONS WITH THIS MEDICATION

As with most medicines, interactions with other drugs are possible. Tell your doctor or 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 Candesartan Cilexetil and Hydrochlorothiazide:

• 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 Candesartan Cilexetil and Hydrochlorothiazide, 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

Take Candesartan Cilexetil and Hydrochlorothiazide exactly as prescribed. It is recommended to take your dose at about the same time everyday.

Candesartan Cilexetil and Hydrochlorothiazide can be taken with or without food but it should be taken the same way each day. Swallow Candesartan Cilexetil and Hydrochlorothiazide with a glass of water.

If Candesartan Cilexetil and Hydrochlorothiazide 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 Candesartan Cilexetil and Hydrochlorothiazide to other pill containers. To protect your Candesartan Cilexetil and Hydrochlorothiazide, 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 Candesartan Cilexetil and Hydrochlorothiazide is individualized.

Candesartan Cilexetil and Hydrochlorothiazide is not for initial therapy. You must first be stabilized on the individual components (candesartan cilexetil and hydrochlorothiazide) of Candesartan Cilexetil and Hydrochlorothiazide.

Overdose:

Missed Dose:

If you miss a dose of Candesartan Cilexetil and Hydrochlorothiazide 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 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.

Candesartan Cilexetil and Hydrochlorothiazide can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.

This is not a complete list of side effects. For any unexpected effects while taking Candesartan Cilexetil and Hydrochlorothiazide, contact your doctor, nurse or pharmacist.

HOW TO STORE IT

• Although the Candesartan Cilexetil and Hydrochlorothiazide tablets are protected in their package, it is best to keep the package at controlled room temperature (15°C to 30°C). Do not keep Candesartan Cilexetil and Hydrochlorothiazide 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 Candesartan Cilexetil and Hydrochlorothiazide 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 Side Effects

MORE INFORMATION

This document plus the full product monograph prepared for health professional can be obtained by contacting the distributor Septa Pharmaceuticals Inc. at 1-905-564-5665.

or by email, at: info@septapharmaceuticals.com

Manufacturer:

Jubilant Generics Limited

1-A, Sector -16A, Institutional Area,

Noida -201301, Uttar Pradesh, India

Distributor:

Septa Pharmaceuticals Inc.

7490 Pacific Circle, #1

Mississauga, ON L5T 2A3

Date of Revision: April 7, 2020