Teva-Olmesartan / HCTZ: Uses, Side Effects and Dosage

What is ACT OLMESARTAN HCT used for?

ACT OLMESARTAN HCT is used to lower blood pressure in adults.

How does ACT OLMESARTAN HCT work?

ACT OLMESARTAN HCT contains a combination of two drugs, olmesartan medoxomil and hydrochlorothiazide:

• Olmesartan medoxomil is an angiotensin receptor blocker (ARB). It acts to prevent the hormone in your body that causes the blood vessels to constrict. It lowers blood pressure by relaxing the blood vessels.
• Hydrochlorothiazide is a diuretic or “water pill”. This lowers blood pressure by increasing urination.

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

What are the ingredients in ACT OLMESARTAN HCT?

Medicinal ingredients: Olmesartan medoxomil and hydrochlorothiazide

Non-medicinal ingredients: hydroxypropylcellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, , polyethylene glycol, titanium dioxide, triacetin, red iron oxide, sunset yellow FCF aluminum lake (20 mg/12.5 mg and 40 mg/12.5 mg only), and yellow iron oxide.

ACT OLMESARTAN HCT comes in the following dosage forms:

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

Do not use ACT OLMESARTAN HCT if you:

• Are allergic to olmesartan medoxomil, hydrochlorothiazide or to any of the other ingredients of ACT OLMESARTAN HCT
• 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 with swelling of the hands, feet, or ankles, face, lips, tongue, throat, or sudden difficulty breathing or swallowing to any ARB (Angiotensin Receptor Blocker). You can recognize an ARB because its medicinal ingredient ends in “-SARTAN”. Be sure to tell your doctor, nurse, or pharmacist that this has happened to you.
• Have problems passing urine or produce no urine.

• Are pregnant or intend to become pregnant. Taking ACT OLMESARTAN HCT during pregnancy

  • can cause harm and even death to your baby.
• Are breastfeeding. It is possible that ACT OLMESARTAN HCT passes into breast milk.
• Have diabetes or kidney disease and are already taking medicine that contains aliskiren (such as Rasilez), which is used to lower high blood pressure.

• Have one of the following rare hereditary diseases

  • 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 ACT OLMESARTAN HCT. Talk about any health conditions or problems you may have, including if you:

• Have a greater chance of developing skin cancer because you:

  • had skin cancer or have a family history of skin cancer.
  • have light-coloured skin
  • sunburn easily
  • take drugs to suppress your immune system
• Are allergic to any drug used to lower blood pressure, including angiotensin converting enzyme (ACE) inhibitors
• Are allergic to the penicillin (antibiotic drug)

• Have a narrow artery or a heart valve.
• Had a heart attack or have heart or blood vessel disease
• Had a stroke or have a condition that affects the blood supply to the brain.
• Have liver or kidney disease
• Have blocked bile ducts
• Are taking a medicine that contains aliskirin, such as Rasilez, used to lower high blood pressure. The combination with ACT OLMESARTAN HCT is not recommended.
• Are taking an angiotensin converting enzyme inhibitor (ACE inhibitors). You can recognize ACE inhibitors because their medicinal ingredient ends in “-PRIL”.
• Have lupus or gout.

• Have diabetes
• 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.
• Have asthma
• Are taking any medication including non-prescription or herbal products.

You have to undergo any kind of surgery and general anesthesia.

Other warnings you should know about:

ACT OLMESARTAN HCT can:

• cause severe chronic diarrhea with substantial weight loss (sprue-like enteropathy). It can take months to years for symptoms to develop.
• lower the levels of sodium, chloride and potassium in the blood.

Pregnancy

ACT OLMESARTAN HCT can cause harm to your unborn baby. Taking ACT OLMESARTAN HCT during pregnancy can:

• prevent the normal growth of your baby’s kidneys and skull if you take the drug during the second and third trimester. Your doctor may recommend an ultrasound.
• cause your baby’s eyes and skin to turn yellow after birth.
• lower the level of platelets in your baby’s blood.

Risk of skin cancer:

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

While taking ACT OLMESARTAN HCT:

• Make sure to regularly check your skin for any new lesions (such as a lump, bump, sore, or patch). Check areas that are most exposed to the sun, such as the face, ears, hands, shoulders, upper chest and back. Talk to your doctor immediately if you develop new skin lesions
• Limit your exposure to the sun and to indoor tanning.
• Always use sunscreen (SPF-30 or higher)
• Protect your skin when going outside by covering your skin with clothing and a hat.
• You may become sensitive to the sun. Talk to your doctor immediately if you get more sensitive to the sun or UV light.

Hydrochlorothiazide in ACT OLMESARTAN HCT can cause Sudden Eye Disorders. These disorders can develop within hours to weeks of starting ACT OLMESARTAN HCT.

• Sudden Myopia (nearsightedness): objects further away appear blurry.
• Sudden Glaucoma: blurred vision increased pressure in your eyes, and eye pain. It may lead to permanent vision loss if left untreated.

Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to ACT OLMESARTAN HCT. Dizziness, lightheadedness, or fainting can occur when you take the drug for after the first time and when your dosage is increased.

Avoid drinking alcohol until you have discussed this with your doctor. Drinking alcohol may lower your blood pressure and may cause you to feel sudden dizziness when you stand up.

If you take ACT OLMESARTAN HCT with medicines that reduce pain and swelling (Non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors), you may experience:

• A decline in kidney function or sudden kidney failure. Contact your doctor and go to the emergency department immediately 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
• A decrease in the ability of ACT OLMESARTAN HCT to lower your blood pressure. This means that ACT OLMESARTAN HCT may not be able to lower your blood pressure as it is expected to do. If this happens, speak with your doctor or pharmacist.

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

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 ACT OLMESARTAN HCT:

• Adrenocorticotropic hormone (ACTH) used to treat West Syndrome
• Agents increasing serum potassium, such as a salt substitute that contains potassium, potassium supplements, or a potassium-sparing diuretic (a specific kind of “water pill”)
• Alcohol, barbiturates (sleeping pills), or narcotics (strong pain medications).
• Amantadine

• Amphotericin B, an antifungal drug.
• Anesthetics
• Anticancer drugs, including cyclophosphamide and methotrexate.
• Anticholinergic agents
• 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.
• Blood pressure-lowering drugs, including diuretics (“water pills”), aliskiren-containing products (e.g. Rasilez), or angiotensin converting enzyme inhibitors ACE inhibitors.
• Calcium or vitamin D supplements.
• Corticosteroids used to treat joint pain and swelling.
• Cyclosporine
• 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 (COX-2 Inhibitor).
• Skeletal muscle relaxants used to relieve muscle spasms, including tubocurare.
• Pressor amines such as norepinephrine.
• Sympathomimetics

How to take ACT OLMESARTAN HCT

• Take ACT OLMESARTAN HCT exactly as prescribed. Do NOT take more of it than prescribed.
• It is recommended to take your dose at about the same time every day.
• ACT OLMESARTAN HCT is not for initial treatment.

• ACT OLMESARTAN HCT may be taken with or without food.

Usual dose:

Take one tablet daily. More than one tablet daily is not recommended.

Overdose:

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.

What are possible side effects from using ACT OLMESARTAN HCT

These are not all the possible side effects you may feel when taking ACT OLMESARTAN HCT. If you experience any side effects not listed here, contact your doctor.

Side effects may include:

• Back pain
• Decreased appetite
• Dizziness, headache
• Fatigue
• Gastrointestinal problems:
• Constipation
• Diarrhea
• Nausea
• Upset stomach
• Vomiting
• Joint pain
• Muscle cramps, spasms and pain
• Rash, red itchy patches on the skin
• Restlessness and weakness
• Upper respiratory tract infection
• congested and runny nose
• cough
• sore throat

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

ACT OLMESARTAN HCT 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

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

Reporting Side Effects

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

Storage:

Store at 15-30°C.

Keep out of reach and sight of children.

If you want more information about ACT OLMESARTAN HCT:

• 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); the manufacturer’s website http://www.tevacanada.com; or by calling 1-800-268-4127 ext. 3; or email druginfo@tevacanada.com.

Last Revised: December 2, 2021