Sandoz Olmesartan HCTZ: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Sandoz Olmesartan HCTZ lowers high blood pressure.

What it does:

Sandoz 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 Sandoz Olmesartan HCTZ regularly even if you feel fine.

When it should not be used:

Do not take Sandoz 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 Sandoz Olmesartan HCTZ during pregnancy can cause injury and even death to your baby.

• Are breastfeeding. Sandoz 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 Sandoz Olmesartan HCTZ.

What the medicinal ingredients are:

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 forms 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 –Pregnancy

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

BEFORE you use Sandoz 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 Sandoz 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:

Sandoz 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 Sandoz Olmesartan HCTZ for many years (more than 3) or at a high dose.

While taking Sandoz 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 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.

Sandoz 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 Sandoz 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 Sandoz Olmesartan HCTZ.

You may become sensitive to the sun while taking Sandoz 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 Sandoz 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 Sandoz 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 Sandoz Olmesartan HCTZ to lower your blood pressure. This means that Sandoz 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 Sandoz 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 Sandoz 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 Sandoz Olmesartan HCTZ exactly as prescribed. It is recommended to take your dose at about the same time everyday.

Dosage must be individualized. Sandoz Olmesartan HCTZ is not for initial therapy.

Sandoz Olmesartan HCTZ may be taken with or without food. If Sandoz 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 Sandoz 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.

Sandoz Olmesartan HCTZ 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 Sandoz Olmesartan HCTZ, contact your doctor or pharmacist.

HOW TO STORE IT

Store at 15°C - 30°C.

Keep out of reach and sight of children.

REPORTING SIDE EFFECTS

MORE INFORMATION

If you want more information about Sandoz Olmesartan HCTZ:

• Talk to your healthcare professional
• Find the full Product Monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html), the manufacturer’s website (www.sandoz.ca), or by calling the manufacturer, Sandoz Canada Inc., at 1-800-361-3062.
• or by written request at:

110 Rue de Lauzon

Boucherville Québec

J4B 1E6

or by e-mail at:

medinfo@sandoz.com

Last revised: January 17, 2020