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

Serious Warnings and Precautions

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

What is TEVA-LOSARTAN/HCTZ used for?

TEVA-LOSARTAN/HCTZ is used in adults to lower high blood pressure.

How does TEVA-LOSARTAN/HCTZ work?

TEVA-LOSARTAN/HCTZ contains a combination of 2 drugs, losartan and hydrochlorothiazide:

• losartan is an angiotensin receptor blocker (ARB). It lowers blood pressure.
• hydrochlorothiazide is a diuretic or “water pill” that increases urination. This also helps to lower blood pressure.

This medicine does not cure high blood pressure, it helps to control it. Therefore, it is important to continue taking TEVA-LOSARTAN/HCTZ regularly even if you feel fine.

What are the ingredients in TEVA-LOSARTAN/HCTZ?

Medicinal ingredients: Losartan potassium and hydrochlorothiazide

Non-medicinal ingredients:

TEVA-LOSARTAN/HCTZ Tablets 50 mg / 12.5 mg contain the following non-medicinal ingredients: D&C yellow 10, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and titanium dioxide.

TEVA-LOSARTAN/HCTZ Tablets 100 mg / 12.5 mg and 100 mg / 25 mg contain the following non-medicinal ingredients: iron oxide yellow (E172), lactose monohydrate, macrogol 3350 (polyethylene glycol), magnesium stearate, microcrystalline cellulose, polyvinyl alcohol - part hydrolyzed, pregelatinized starch, talc and titanium dioxide (E171).

Although TEVA-LOSARTAN/HCTZ contain potassium, this amount is too small to replace potassium supplements. If your doctor has prescribed potassium supplements, continue to follow their advice.

TEVA-LOSARTAN/HCTZ comes in the following dosage forms:

Tablets; 50 mg / 12.5 mg, 100 mg / 12.5 mg and 100 mg / 25 mg

Do not use TEVA-LOSARTAN/HCTZ if:

• you are allergic to losartan potassium and hydrochlorothiazide or any of the non-medicinal 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 difficulty urinating or produce no urine.
• you are already taking a blood pressure-lowering medicine that contains aliskiren (such as Rasilez) and you have diabetes or kidney disease.

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

• are allergic to any drug used to lower blood pressure, including angiotensin converting enzyme (ACE) inhibitors, or penicillin.
• are taking an ACE inhibitor.
• have narrowing of an artery or a heart valve.
• have had a heart attack or stroke.
• have recently received or are planning to get allergy shots for bee or wasp stings.
• have heart failure.
• have diabetes, liver or kidney disease.
• 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, a potassium-sparing diuretic (a specific kind of “water pill”), or other drugs that may increase potassium levels (such as trimethoprim-containing products).
• are on a low-salt diet.
• 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 pregnant, planning to become pregnant or think you are pregnant.
• are breastfeeding or plan to breastfeed.
• have had breathing or lung problems (including inflammation or fluid in the lungs) in the past following the use of medication containing hydrochlorothiazide. If you experience any severe shortness of breath or difficulty breathing after taking TEVA-LOSARTAN/HCTZ, stop the medication and seek medical attention immediately.

Other warnings you should know about:

Use of anesthesia: If you are about to have a surgery or dental procedure with anesthesia, be sure to tell your healthcare professional that you are taking TEVA-LOSARTAN/HCTZ.

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

While taking TEVA-LOSARTAN/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 of skin to sun and avoid indoor tanning. Always use sunscreen (SPF 30 or higher) and wear protective clothing when going outside.
• Talk to your healthcare professional 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.

Eye problems: Hydrochlorothiazide in TEVA-LOSARTAN/HCTZ can cause sudden eye disorders:

• Choroidal effusion: an abnormal building of liquid in your eye that may result in vision changes.
• Myopia: sudden nearsightedness or blurred vision.
• Glaucoma: an increased pressure in your eyes, eye pain. Untreated, it may lead to permanent vision loss.

If your vision changes, stop taking TEVA-LOSARTAN/HCTZ and seek immediate medical help. These eye disorders are related and can develop within hours to weeks of starting TEVA-LOSARTAN/HCTZ.

Testing and check-ups: During your treatment with TEVA-LOSARTAN/HCTZ, your healthcare professional may monitor:

• Your kidney function.
• Your blood pressure.
• The amount of electrolytes in your blood (such as potassium, sodium, calcium).
• Your liver function

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

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

The following may also interact with TEVA-LOSARTAN/HCTZ:

• Other medications used to lower blood pressure, such as diuretics (“water pills”).
• Adrenocorticotropic hormone (ACTH) which may be used to treat diseases such as nephrotic syndrome or collagen diseases and in diagnostic tests.
• 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 medications such as cyclophosphamide and methotrexate.
• Antidepressants, in particular selective serotonin reuptake inhibitors (SSRIs), including citalopram, escitalopram, and sertraline.
• Antidiabetic medications such as insulin and oral medicines.
• Bile acid resins used to lower cholesterol such as cholestyramine.
• Calcium or vitamin D supplements.
• Corticosteroids used to treat joint pain and swelling.
• Digoxin, a heart medication.
• Medications that slow down or speed up bowel function, such as atropine, metoclopramide, and domperidone.
• Medications used to treat epilepsy, such as carbamazepine and topiramate.
• Glycyrrhizin (found in liquorice).
• Gout medications, such as allopurinol and probenecid.
• Grapefruit juice (which should be avoided while taking TEVA-LOSARTAN/HCTZ)
• Lithium used to treat bipolar disease.
• Medicines may cause high blood pressure (adrenaline).
• Nonsteroidal anti-inflammatory drugs (NSAIDs), used to reduce pain and swelling. such as ibuprofen, naproxen, acetylsalicylic acid, and celecoxib.
• Skeletal muscle relaxants used to relieve muscle spasms, such as tubocurare.
• Sympathomimetics which may be found in some decongestants, cough/cold, hay fever, sinus medicines.
• Potassium supplements, salt substitutes containing potassium or other drugs that may increase serum potassium (e.g., trimethoprim-containing products)

How to take TEVA-LOSARTAN/HCTZ:

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

• TEVA-LOSARTAN/HCTZ can be taken with or without food, but it should be taken the same way each day. If TEVA-LOSARTAN/HCTZ causes upset stomach, take it with food or milk.

Usual dose:

Your healthcare professional has decided the best dose for you. The usual dose is 1 tablet of TEVA-LOSARTAN/HCTZ once daily.

The maximum dose is 1 tablet of TEVA-LOSARTAN/HCTZ 100 mg/25mg once daily.

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 the dose.

What are possible side effects from using TEVA-LOSARTAN/HCTZ?

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

Side effects may include:

• constipation
• decreased appetite
• diarrhea
• enlargement of the glands in your mouth
• nausea
• upset stomach
• vomiting

• cramping
• seeing more of the colour yellow in your vision
• temporary blurred vision
• fatigue
• fever
• back or leg pain
• joint pain
• muscle cramps
• restlessness
• spasms and pain
• weakness
• dizziness
• headache
• pins and needles in your fingers
• change in taste
• erectile dysfunction/impotence
• reduced libido
• dry cough
• nasal congestion
• upper respiratory infections
• bleeding under the skin
• rash
• red patches on the skin
• hives
• itch
• bruising
• increased sensitivity to the sun
• a feeling of dizziness or lightheadedness due to a sudden drop in blood pressure when standing up quickly

TEVA-LOSARTAN/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

Serious side effects and what to do about them

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, tell your healthcare professional.

Reporting Side Effects

Storage:

• Store TEVA-LOSARTAN/HCTZ 100 mg / 12.5 mg and 100 mg / 25 mg at room temperature (15°C - 25°C). Keep container tightly closed. Protect from light.
• Store the 50 mg / 12.5 mg strength at room temperature (15°C - 30°C). Keep container tightly closed. Protect from light.
• Keep out of reach and sight of children.

If you want more information about TEVA-LOSARTAN/HCTZ:

• 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: June 6, 2023