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Details for: APO-OLMESARTAN/HCTZ

Company: APOTEX INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02453606APO-OLMESARTAN/HCTZOLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE20 MG; 12.5 MGTABLETORAL
02453614APO-OLMESARTAN/HCTZOLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE40 MG; 12.5 MGTABLETORAL
02453622APO-OLMESARTAN/HCTZOLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE40 MG; 25 MGTABLETORAL
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Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

APO-OLMESARTAN/HCTZ lowers high blood pressure.

What it does

APO-OLMESARTAN/HCTZ contains a combination of two drugs, olmesartan medoxomil and hydrochlorothiazide:

  • Olmesartan medoxomil 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 APO-OLMESARTAN/HCTZ regularly even if you feel fine.

When it should not be used

Do not take APO-OLMESARTAN/HCTZ if you:

  • Are allergic to olmesartan medoxomil, hydrochlorothiazide or to any non-medicinal ingredient in the formulation or components of the container.
  • Are allergic to any sulphonamide-derived drugs (sulfa drugs): most of them have a medicinal ingredient that ends in “-MIDE”.
  • 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 olmesartan medoxomil). 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 APO-OLMESARTAN/HCTZ during pregnancy can cause injury and even death to your baby.
  • Are breastfeeding. APO-OLMESARTAN/HCTZ passes into breast milk.
  • Are already taking a blood pressure-lowering medicine that contains aliskiren (such as Rasilez) and you have diabetes or kidney disease.
  • Have one of the following rare hereditary diseases
    • Galactose intolerance
    • Lapp lactase deficiency
    • Glucose-galactose malabsorption

Because lactose is a non-medicinal ingredient in APO-OLMESARTAN/HCTZ.

What the medicinal ingredient is

Olmesartan medoxomil and hydrochlorothiazide

What the non-medicinal ingredients are

Hydroxypropylcellulose, lactose monohydrate, microcrystalline cellulose, low-substituted hydroxypropylcellulose, magnesium stearate, hydroxypropyl methylcellulose, polyethylene glycol, titanium dioxide, talc, iron oxide yellow and iron oxide red.

What dosage form it comes in

Tablets: 20 mg/12.5 mg, 40 mg/12.5 mg and 40 mg/25 mg.

Warnings and precautions

Serious Warnings and Precautions

APO-OLMESARTAN/HCTZ should not be used during pregnancy. If you discover that you are pregnant while taking APO-OLMESARTAN/HCTZ, stop the medication and contact your doctor, nurse or pharmacist as soon as possible.

BEFORE you use APO-OLMESARTAN/HCTZ talk to your doctor, nurse or pharmacist if you:

  • 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.
  • Are allergic to any drug used to lower blood pressure, including angiotensin converting enzyme (ACE) inhibitors, or penicillin.
  • Have narrowing of an artery or a heart valve.
  • Have had a heart attack or stroke.
  • Have heart failure.
  • Have diabetes, liver or kidney disease.
  • Are taking a medicine that contains aliskirin, such as Rasilez, used to lower high blood pressure. The combination with APO-OLMESARTAN/HCTZ is not recommended.
  • Are taking an angiotensin converting enzyme inhibitor (ACEI). You can recognize ACEIs because their medicinal ingredient ends in “-PRIL”.
  • Have lupus or gout.
  • 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”).
  • Are on a low-salt diet.
  • Are less than 18 years old.
  • Are taking any medication including non-prescription or herbal products.
  • You have to undergo any kind of surgery and general anesthesia.

Risk of skin cancer:
APO-OLMESARTAN/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 APO-OLMESARTAN/HCTZ for many years (more than 3) or at a high dose.

While taking APO-OLMESARTAN/HCTZ:

  • 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 out side.
  • 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.

APO-OLMESARTAN/HCTZ can cause severe chronic diarrhea with substantial weight loss (sprue-like enteropathy). It can take months to years for symptoms to develop.

Hydrochlorothiazide in APO-OLMESARTAN/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 APO-OLMESARTAN/HCTZ.

You may become sensitive to the sun while taking APO-OLMESARTAN/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 APO-OLMESARTAN/HCTZ. Dizziness, lightheadedness, or fainting can especially occur after the first dose and when the dose is increased.

Avoid alcoholic beverages until you have discussed their use with your physician. Alcohol consumption may alter your blood pressure.

If APO-OLMESARTAN/HCTZ is taken with medicines to reduce pain and swelling (called Non-steroidal anti-inflammatory drugs (NSAIDs) or with COX-2 inhibitors), you may experience:

  • Decreased kidney function or sudden kidney failure. If you notice a decrease in the amount of urine you produce, generalized swelling, weakness, shortness of breath, or irregular heartbeats, loss of appetite, lethargy, and fatigue, contact your doctor or go to the emergency department of the hospital right away.
  • A decreased ability of APO-OLMESARTAN/HCTZ to lower your blood pressure. This means that APO-OLMESARTAN/HCTZ may not be able to lower your blood pressure as it is expected to do. If this happens, speak with your doctor or pharmacist.
Interactions with this medication

As with most medications, interaction 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 APO-OLMESARTAN/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.
  • 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. When taken in combination with APO-OLMESARTAN/HCTZ, they may cause excessively low blood pressure.
  • Calcium or vitamin D supplements.
  • Corticosteroids used to treat joint pain and swelling.
  • Digoxin, a heart medicine.
  • Drugs that slow down or speed up bowel function, including atropine, metoclopramide and domperidone.
  • 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 for arthritis and to reduce pain and swelling. Examples include ibuprofen, naproxen, and celecoxib.
  • Skeletal muscle relaxants used to relieve muscle spasms, including tubocurare.
  • Pressor amines such as norepinephrine.
  • Sympathomimetics
  • Anesthetics
  • Amantadine
  • Anticholonergic agents
  • Cyclosporine
  • Blood pressure-lowering drugs, including diuretics ("water pills"), aliskiren-containing products (e.g. Rasilez), or angiotensin converting enzyme inhibitors (ACEIs).
Proper use of this medication

Take APO-OLMESARTAN/HCTZ exactly as prescribed. It is recommended to take your dose at about the same time everyday.

Dosage must be individualized. APO-OLMESARTAN/HCTZ is not for initial therapy.

APO-OLMESARTAN/HCTZ may be taken with or without food. If APO-OLMESARTAN/HCTZ causes upset stomach, take it with food or milk.

Usual Adult Dose

One tablet daily.

Overdose

If you think you have taken too much APO-OLMESARTAN/HCTZ contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no 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 dose.

Side effects and what to do about them

Side effects may include:

  • upper respiratory tract infection, cough.
  • 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
  • fatigue, drowsiness, insomnia
  • reduced libido

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

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

Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate medical help
Common
Non-melanoma skin cancer: lump or discoloured patch on the skin that stays after a few weeks and slowly changes. Cancerous lumps are red/pink and firm and sometimes turn into ulcers. Cancerous patches are usually flat and scaly.    
Low Blood Pressure: dizziness, fainting, lightheadedness. May occur when you go from lying or sitting to standing up.    
Decreased or increased levels of potassium in the blood: irregular heartbeats, muscle weakness and generally feeling unwell.    
Chest Pain:    
Edema: Swelling of the hands, ankles or feet.    
Uncommon
Allergic Reaction: rash, hives, swelling of the lips, face, tongue or throat difficulty swallowing or breathing.    
Kidney Disorder: change in frequency of urination, nausea, vomiting, swelling of extremities, fatigue.    
Liver Disorder: yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite.    
Increased blood sugar: frequent urination, thirst, and hunger.    
Electrolyte Imbalance: weakness, drowsiness, muscle pain or cramps, irregular heartbeat.    
Bronchitis: shortness of breath, weakness, high fever, coughing and fatigue.    
Rare
Sudden Kidney Failure (sudden decrease or absence of urine, generalized swelling, weakness, shortness of breath, or irregular heartbeats, loss of appetite, lethargy and fatigue).    
Rhabdomyolysis: muscle pain that you cannot explain, muscle tenderness or weakness, dark brown urine.    
Decreased White Blood Cells: infections, fatigue, fever, aches, pains, and flu-like symptoms.    
Decreased Platelets: bruising, bleeding, fatigue and weakness.    
Very Rare
Toxic Epidermal Necrolysis: severe skin peeling, especially in mouth and eyes.    
Unknown
Eye disorders:
  • Myopia: sudden near sightedness or blurred vision
  • Glaucoma: increased pressure in your eyes, eye pain.
   
Anemia: fatigue, loss of energy, weakness, shortness of breath.    
Inflammation of the Pancreas: abdominal pain that lasts and gets worse when you lie down, nausea, vomiting.    
Palpitations: Irregular heartbeats.    
Sprue-like enteropathy: severe chronic diarrhea with substantial weight loss.    

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

How to store

Store at 15°C - 30°C.

Keep out of reach and sight of children.

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 for information on how to report online, by mail or by fax; or
  • Call toll-free at 1-866-234-2345

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

More information

If you want more information about APO-OLMESARTAN/HCTZ:

  • Talk to your doctor or pharmacist.
  • Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website. Find the Consumer Information on the manufacturer’s website, or by calling 1-800- 667-4708.

This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.

Last revised: February 27, 2020

Date modified: