Patient Medication Information: uses, side effects, how to take - Edarbyclor

Serious warnings and precautions box

EDARBYCLOR should not be used during pregnancy. Taking EDARBYCLOR during pregnancy can cause injury or even death to your baby.
If you discover that you are pregnant while taking EDARBYCLOR, stop the medication and contact your healthcare professional as soon as possible.

What EDARBYCLOR is used for:

EDARBYCLOR is used in adults to lower severe high blood pressure. It can be used as an initial treatment in patients who are likely to need multiple drugs to achieve blood pressure control.

How EDARBYCLOR works:

Azilsartan medoxomil is an angiotensin receptor blocker (ARB). It lowers blood pressure.
Chlorthalidone is a thiazide-like diuretic or “water pill” that increases urination. This also lowers blood pressure.

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

The ingredients in EDARBYCLOR are:

Medicinal ingredients: azilsartan medoxomil and chlorthalidone.

Non-medicinal ingredients: crospovidone, ferric oxide red, fumaric acid, hydroxypropyl cellulose, hypromellose 2910, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol 8000, printing ink grey F1, sodium hydroxide, talc and titanium dioxide

EDARBYCLOR comes in the following dosage forms:

Tablets: 40 mg/12.5 mg, 80 mg/12.5 mg and 40 mg/25 mg

Do not use EDARBYCLOR if:

you are allergic to azilsartan medoxomil, chlorthalidone or to any other ingredients in the formulation.
you are allergic to any sulfonamide-derived drugs (sulfa drugs); most of them have a medicinal ingredient that ends in “-MIDE”.
you have had an allergic reaction (angioedema) to any ARB. Signs of allergic reaction include:
- swelling of the hands, feet, or ankles, face, lips, tongue and throat.
- sudden difficulty breathing or swallowing.

Make sure to tell your doctor, nurse, or pharmacist that this has happened to you before.

you have diabetes or kidney disease and are already taking a blood pressure-lowering medicine that contains aliskiren (such as RASILEZ^®).
you have difficulty urinating or produce no urine.
you have refractory hyponatremia. A condition where sodium levels in the blood are abnormally low.
you are pregnant or intend to become pregnant. Taking EDARBYCLOR during pregnancy can cause injury and even death to your baby.
you are breastfeeding. EDARBYCLOR passes into breast milk.

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

are allergic to any medicine used to lower blood pressure.
are allergic to penicillin.
have a narrow artery or a heart valve.
have heart failure.
have had a heart attack or stroke in the past.
have had a surgery on a nerve (sympathectomy).
have diabetes.
have liver or kidney disease.
have lupus or gout.
are on dialysis.
are dehydrated or suffer from excessive vomiting, diarrhea, or sweating.
are on a low-salt diet.
have asthma.
are taking a medicine that contains aliskiren.
are taking an angiotensin converting enzyme (ACE) inhibitor. You can recognize ACEIs because their medicinal ingredient ends in ‘-PRIL’.

Other warnings you should know about:

EDARBYCLOR can cause serious side effects, including:

Low blood pressure (hypotension): You may feel dizzy or light-headed:
- Particularly in the first few days after you start taking EDARBYCLOR or when your dose is increased.
- When you exercise or when the weather is hot.

You should lie down if this happens. If you faint, talk to your healthcare professional right away.

Allergic reactions (angioedema): Some patients have reported experiencing allergic reactions (angioedema) while taking angiotensin receptor blockers (ARBs) such as EDARBYCLOR. If you experience signs or symptoms of an allergic reaction while taking EDARBYCLOR, stop taking it and tell your healthcare professional right away.
Sudden Eye Disorders: EDARBYCLOR contains chlorthalidone. Treatment with chlorthalidone may increase the risk of developing Sudden Eye Disorders 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: abnormal buildup of liquid in your eye that may result in vision changes.

If your vision changes, stop taking EDARBYCLOR and seek immediate medical help. These eye disorders are related and can develop within hours to weeks of starting EDARBYCLOR. If you have had a penicillin or sulfonamide allergy, you can be at higher risk of developing this. Talk to your healthcare professional immediately if you develop any eye problems while taking EDARBYCLOR.

These eyes disorders are related and can develop within hours to weeks of starting EDARBYCLOR. If your vision changes while taking EDARBYCLOR, tell your healthcare professional right away.

Increased sensitivity to sunlight: You may become sensitive to the sun while taking EDARBYCLOR. Exposure to sunlight should be minimized until you know how you respond.

See the Serious side effects and what to do about them table, below, for more information on these and other serious side effects.

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

Surgery: Tell your healthcare professional you are taking EDARBYCLOR before undergoing any surgeries that require general anesthesia. This includes dental surgery. General anesthesia may cause a sudden fall in blood pressure.

Laboratory tests and monitoring: Your healthcare professional may do blood tests before you take EDARBYCLOR and/or during treatment. This is to make sure your kidneys are working properly.

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 EDARBYCLOR:

Adrenocorticotropic Hormone (ACTH) used to treat West Syndrome
Agents that cause low blood pressure and dizziness when you go from lying or sitting to standing up. These include:
- Alcohol
- Barbiturates (sleeping pills)
- Narcotics (strong pain medications)
Medicines that lower your blood pressure. These include:
- Aliskiren-containing products (e.g., RASILEZ^®)
- Angiotensin converting enzyme (ACE) inhibitors
Medicines that can increase the levels of potassium in your blood. These include:
- potassium-sparing diuretics (a specific kind of “water pill”)
- potassium supplements
- salt substitutes that contain potassium
Amlodipine – used to treat high blood pressure and manage a type of chest pain called angina
Amphotericin B – an antifungal drug
Anticancer drugs, such as cyclophosphamide and methotrexate
Antidepressants, in particular selective serotonin reuptake inhibitors (SSRIs), such as citalopram, escitalopram, and sertraline
Antidiabetic drugs, such as insulin and oral medicines
Bile acid resins – used to lower cholesterol
Calcium or vitamin D supplements
Corticosteroids – used to treat joint pain and swelling
Digitalis – a drug prepared from the dried leaves of foxglove
Digoxin – a heart medication
Medicines that slow down or speed up bowel function, such as atropine, metoclopramide, and domperidone
Medicines used to treat epilepsy, such as carbamazepine and topiramate
Fexofenadine - belongs to a group of medicines called antihistamines
Fluconazole, ketoconazole – used to treat fungal infections
Gout medications, such as allopurinol and probenecid
Lithium – used to treat bipolar disease
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), such as ibuprofen, naproxen, and celecoxib – used to reduce pain and swelling
Skeletal muscle relaxants, such as tubocurare – used to relieve muscle spasms

How to take EDARBYCLOR:

Take EDARBYCLOR exactly as prescribed.
It is recommended to take your dose at about the same time every day.
EDARBYCLOR may be taken with or without food.

Usual dose:

One 40 mg/12.5 mg tablet once a day.
Your healthcare professional may increase your dose if required.

The maximum daily dose of EDARBYCLOR is 40 mg/25 mg a day.

Overdose:

If you think you, or a person you are caring for, have taken too much EDARBYCLOR, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed Dose:

If you have forgotten to take your dose during the day, carry on with the next one at the usual time. Do NOT double the dose.

Possible side effects from using EDARBYCLOR:

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

Side effects 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 the skin
Rash
Red patches on the skin
Drowsiness
Fatigue
Reduced libido
Vertigo
Abdominal discomfort or pain
Impotence (not able to have an erection)
Excessive sweating
Dry mouth

EDARBYCLOR 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

Frequency/Side Effect/Symptom	Talk to your healthcare professional	Stop taking this drug and get immediate medical help
Frequency/Side Effect/Symptom	Talk to your healthcare professional	Stop taking this drug and get immediate medical help
Only if severe	In all cases
Only if severe	In all cases
Common
Hyperkalemia (increased levels of potassium in the blood) or Hypokalemia (decreased levels of potassium in the blood): irregular heartbeats, muscle weakness and generally feeling unwell		√
Hypotension (low blood pressure): dizziness, fainting, light-headedness, blurred vision, nausea, vomiting, fatigue. May occur when you go from lying or sitting to standing up.	√
Uncommon
Allergic reactions (angioedema): difficulty swallowing or breathing; swollen face, hands and feet, genitals, tongue, throat; wheezing; hives or rash; swelling of the digestive tract causing diarrhea, nausea or vomiting			√
Electrolyte Imbalance: weakness, drowsiness, muscle pain or cramps, irregular heartbeat		√
Increased blood sugar: frequent urination, thirst, and hunger	√
Kidney Disorder: change in frequency of urination, nausea, vomiting, swelling of extremities, fatigue		√
Liver Disorder: yellowing of your skin and eyes (jaundice), right upper stomach area pain or swelling, nausea or vomiting, unusual dark urine, unusual tiredness		√
Tachycardia: increased Heart rate		√
Rare
Decreased Platelets: bruising, bleeding, fatigue and weakness		√
Leukopenia (decreased white blood cells): infections, fatigue, fever, aches, pains, and flu-like symptoms		√
Peripheral edema (swelling of the legs or hands caused by fluid retention): swollen or puffy legs or hands, feeling heavy, achy or stiff	√
Rhabdomyolysis (breakdown of damaged muscle): muscle pain that you cannot explain, muscle tenderness or weakness, dark brown urine		√
Very rare
Toxic Epidermal Necrolysis: severe skin peeling, especially in mouth and eyes			√
Unknown
Anemia (decreased number of red blood cells): fatigue, loss of energy, weakness, shortness of breath.		√
Eye disorders: Myopia: sudden near sightedness or blurred vision Glaucoma: increased pressure in your eyes, eye pain Choroidal effusion: blind spots, eye pain, blurred vision			√
Inflammation of the Pancreas: abdominal pain that lasts and gets worse when you lie down, nausea, vomiting		√
Intestinal angioedema (swelling of the intestine): colicky abdominal pain, diarrhea, nausea or vomiting		√

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:

Canada by:
Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
Calling toll-free at 1-866-234-2345.

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

Storage:

Store EDARBYCLOR at 15 to 30°C.
Protect from light and moisture.
Keep tablets in original packaging. Do NOT transfer EDARBYCLOR tablets to a different container.
Keep out of the sight and reach of children.

If you want more information about EDARBYCLOR:

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 Drug Product Database website: (https://www.canada.ca/en/health-canda/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.bauschhealth.ca, or by calling 1-800-361-4261.

Date of Authorization: 2025-10-24

Edarbyclor: Uses, Side Effects and Dosage