Sandoz Lisinopril HCT: Uses, Side Effects and Dosage

Serious Warnings and Precautions

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

What is Sandoz Lisinopril HCT used for?

Sandoz Lisinopril HCT is used in adults to lower high blood pressure.

How does Sandoz Lisinopril HCT work?

Sandoz Lisinopril HCT is a combination of 2 drugs, lisinopril and hydrochlorothiazide:

• Lisinopril is an angiotensin converting enzyme (ACE) inhibitor. 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 Sandoz Lisinopril HCT regularly even if you feel fine.

What are the ingredients in Sandoz Lisinopril HCT?

Medicinal ingredients: lisinopril and hydrochlorothiazide.

Non-medicinal ingredients: calcium hydrogen phosphate dihydrate, croscarmellose sodium, magnesium stearate, maize starch and mannitol.

The 10 mg/12.5 mg and 20 mg/25 mg tablets also contain ferric oxide

Sandoz Lisinopril HCT comes in the following dosage forms:

Lisinopril and hydrochlorothiazide tablets: 10 mg / 12.5 mg, 20 / 12.5 mg, and 20 mg / 25 mg.

Do not use Sandoz Lisinopril HCT if:

• You are allergic to lisinopril, hydrochlorothiazide, or to any non -medicinal ingredient 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 a family history of angioedema (allergic reaction) or have ever had angioedema to any ACE inhibitor. Be sure to tell your healthcare professional that this has happened to you.

• You are already taking a blood pressure-lowering medicine that contains aliskiren and you have one of the following conditions:

  • diabetes.
  • kidney disease.
  • high potassium levels.
  • heart failure combined with low blood pressure.

• You are taking an angiotensin receptor blocker (ARB), another medicine to treat your high blood pressure, or another ACE inhibitor and have one of the following conditions:

  • diabetes with end organ damage.
  • kidney disease.
  • high potassium levels.
  • heart failure combined with low blood pressure.

You can recognize ARBs because their medicinal ingredient ends in “-SARTAN”.

• You are taking sacubitril/valsartan due to the increased risk of serious allergic reaction, which causes swelling of the face or throat (angioedema) when taken with Sandoz Lisinopril HCT.
• You have difficulty urinating or produce no urine.
• You are pregnant or intend to become pregnant. Taking Sandoz Lisinopril HCT during pregnancy can cause injury and even death to your baby.
• You are breastfeeding. Sandoz Lisinopril HCT passes into breast milk.

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

• Have experienced an allergic reaction to any drug used to lower blood pressure or penicillin.
• Have recently received or are planning to get allergy shots for bee or wasp stings.
• Have a history of allergic reactions or asthma.
• Have narrowing of an artery or a heart valve.
• Have had a heart attack or stroke.
• Have heart failure.
• Have a liver or kidney disorder.
• Have diabetes, liver, heart or kidney disease.
• Have lupus or gout.
• 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 taking an angiotensin receptor blocker (ARB).
• Are on a low-salt diet.
• Are on dialysis.
• Are receiving gold (sodium aurothiomalate) injections.
• Are on LDL Apheresis (a treatment to lower the LDL cholesterol in the blood).
• 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.
• If you experienced breathing or lung problems (including inflammation or fluid in the lungs) following hydrochlorothiazide intake in the past. If you develop any severe shortness of breath or difficulty breathing after taking Sandoz Lisinopril HCT, seek medical attention immediately.

Other warnings you should know about:

Use of anesthesia: If you are going to have a surgery or dental procedure with anesthesia, be sure to tell your healthcare professional that you are taking Sandoz Lisinopril HCT.

Risk of skin cancer: Sandoz Lisinopril 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 Sandoz Lisinopril HCT for many years (more than 3) or at a high dose. While taking Sandoz Lisinopril HCT:

• 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.

Sudden eye disorders: Treatment with hydrochlorothiazide in Sandoz Lisinopril HCT can cause sudden eye problems 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: an abnormal buildup of liquid in your eye that may result in vision changes.

These eye disorders are related and can develop within hours to weeks of starting Sandoz Lisinopril HCT. If you earlier have had a penicillin or sulfonamide allergy, you can be at higher risk of developing this. If you experience the above symptoms, stop taking Sandoz Lisinopril HCT and seek immediate medical help.

Monitoring: During your treatment with Sandoz Lisinopril HCT, your healthcare professional may monitor:

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

Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to Sandoz Lisinopril HCT. 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 interact with Sandoz Lisinopril HCT:

• 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.
• Amantadine used to treat the flu and reduce symptoms of Parkinson’s disease.
• Amphotericin B, an antifungal drug.
• Antacids.
• Drugs used to treat cancer such as cyclophosphamide, methotrexate, temsirolimus and everolimus.
• Antidepressants, in particular selective serotonin reuptake inhibitors (SSRIs) such as citalopram, escitalopram, and sertraline.
• Drugs to treat diabetes such as insulin and oral medications (such as sulphonylureas).
• Bile acid resins used to lower cholesterol such as cholestyramine.

• Other blood pressure-lowering drugs such as:

  • Diuretics (“water pills”).
  • Guanethidine.
  • Diazoxide.
  • Methyldopa.
  • Beta-blockers such as atenolol, metoprolol, propranolol.
  • Vasodilators.
  • Calcium channel blockers such as felodipine, amlodipine, nifedipine.
  • Angiotensin converting enzyme inhibitors (ACEIs).
  • Angiotensin II receptor blockers (ARBs) such as candesartan, valsartan, losartan.
  • Direct renin inhibitors.
• Calcium or vitamin D supplements.
• Capsaicin, an ingredient in some creams used to relieve arthritis pain.
• Corticosteroids used to treat joint pain and swelling.
• Cyclosporine used to treat autoimmune diseases.
• Digoxin, a heart medication.
• Dipeptidyl peptidase IV (DPP-IV) inhibitors (e.g. alogliptin, linagliptin, saxagliptin, and sitagliptin.
• Drugs that slow down or speed up bowel function such as atropine, biperiden, domperidone and metoclopramide.
• Drugs used to treat epilepsy such as carbamazepine and topiramate.
• Gold (sodium aurothiomalate), used to treat autoimmune conditions such as rheumatoid arthritis and psoriatic arthritis.
• Gout medications such as allopurinol, probenecid, uricosurics and xanthine oxidase inhibitors.
• A type of drug called a “neutral endopeptidase inhibitor”.
• Lithium, a medicine to treat bipolar disease.
• Drugs that can cause low blood potassium levels (hypokalemia) such as laxatives, corticosteroids (such as prednisone) and Salicylic acid derivatives.
• Nonsteroidal anti-inflammatory drugs (NSAIDs), used to reduce pain and swelling such as include ibuprofen, naproxen and celecoxib.
• Drugs that can increase blood potassium levels such as potassium supplements or potassium containing salt substitutes.
• Rituximab used to treat cancer, transplant rejection, and some autoimmune diseases.
• Mammalian target of rapamycin (mTOR) inhibitors such as sirolimus, a drug used to prevent organ rejection after a transplant.
• Skeletal muscle relaxants used to relieve muscle spasms such as tubocurarine.
• Tetracycline antibiotics.
• Tissue plasminogen activator (TPA) that is used to dissolve blood clots that have formed in blood vessels.
• Pressor amines such as norepinephrine.

How to take Sandoz Lisinopril HCT

• Take Sandoz Lisinopril HCT exactly as prescribed.
• It is recommended to take your dose at about the same time everyday.
• Swallow Sandoz Lisinopril HCT whole, with water. Do NOT crush, split or chew the tablet.

• Sandoz Lisinopril HCT can be taken with or without food. If Sandoz Lisinopril HCT causes upset stomach, take it with food or milk.

Usual dose:

Your healthcare professional has decided the best dose for you. Take your dose once daily, exactly as your healthcare professional has told you to.

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 take a double dose.

What are possible side effects from using Sandoz Lisinopril HCT?

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

• dizziness
• headache
• cough
• drowsiness, fatigue, weakness
• diarrhea, nausea, vomiting, indigestion
• cold or flu-like symptoms
• muscle pain or cramps
• pins and needles in hands or feet
• rash
• impotence, low sex drive
• rash
• abdominal pain, upset stomach, decreased appetite, constipation
• muscle pain or cramps

Sandoz Lisinopril HCT 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

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:

• Keep in the original package at room temperature (15°C to 30°C), tightly closed and protected from light.
• Return any unused medicines, which you know you will no longer need, to your pharmacy for disposal.
• Keep out of reach and sight of children.

If you want more information about Sandoz Lisinopril 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/drugn-products/drug-product-database.html or the manufacturer’s website www.sandoz.ca or by calling 1-800-361-3062.

Last Revised: MAY 26, 2024