Losartan (Sivem Pharmaceuticals): Uses, Side Effects and Dosage

Serious Warnings and Precautions

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

What is LOSARTAN used for?

LOSARTAN is used in adults to:

• lower high blood pressure.
• provide kidney protection by delaying the worsening of kidney disease in type 2 diabetic patients with protein in the urine (proteinuria) and high blood pressure.

LOSARTAN is used in children (6 to16 years of age) to:

• lower high blood pressure.

How does LOSARTAN work?

LOSARTAN is an angiotensin receptor blocker (ARB). It lowers blood pressure. This medicine does not cure high blood pressure. It helps to control it. Therefore, it is important to continue taking LOSARTAN regularly even if you feel fine.

What are the ingredients in LOSARTAN?

Medicinal ingredients: Losartan potassium.

Non-medicinal ingredients: colloidal anhydrous silica, hydroxypropyl cellulose, hypromellose, lactose monohydrate, macrogol 400, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc and colouring agents (titanium dioxide).

LOSARTAN 25 mg, 50 mg and 100 mg tablets contain the following amounts of potassium: 2.12 mg (<1 mmol), 4.24 mg (<1 mmol), and 8.48 mg (<1 mmol) respectively.

Although LOSARTAN tablets contain potassium, this amount is too small to replace potassium supplements. If your physician has prescribed potassium supplements, continue to follow their advice.

LOSARTAN comes in the following dosage forms:

Tablets: 25 mg, 50 mg and 100 mg.

Do not use LOSARTAN if:

• you are allergic to losartan potassium or any of the nonmedicinal ingredients in LOSARTAN.
• 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 LOSARTAN. Talk about any health conditions or problems you may have, including if you:

• Have had an allergic reaction to any drug used to lower blood pressure, including angiotensin converting enzymes (ACE) inhibitors.
• Are taking an ACE inhibitor.
• have narrowing of an artery or a heart valve.
• have had a heart attack or stroke.
• are taking a salt substitute that contains potassium, potassium supplements, a potassium-sparing diuretic (a specific kind of ‘‘water pill’’ that makes your body keep potassium), or other drugs that may increase potassium levels (such as trimethroprim-containing products)
• are on a low salt diet.
• are on dialysis.
• are dehydrated or suffer from excessive vomiting, diarrhea or sweating.
• Have difficulty urinating or produce no urine.
• have heart failure.
• have diabetes, liver or kidney disease.
• Are pregnant, planning to become pregnant or think you are pregnant
• Are breastfeeding or plan to breastfeed

Other warnings you should know about:

Sun exposure: You may become sensitive to the sun while taking LOSARTAN. Exposure to sunlight should be minimized until you know how you respond.

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 LOSARTAN, as there may be a sudden fall in blood pressure.

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

• Your kidney function
• Your blood pressure
• The amount of potassium in your blood
• Your liver function

Driving and using machines: Before doing tasks which require special attention, wait until you know how you respond to LOSARTAN. 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 LOSARTAN:

• Other medications used to lower blood pressure such as diuretics
• Digoxin, a heart medication.
• Lithium used to treat bipolar disease.
• Nonsteroidal anti-inflammatory drugs (NSAIDs), used to reduce pain and swelling. Examples include ibuprofen, naproxen, and celecoxib.
• Warfarin used to thin the blood and prevent blood clots.
• Antibiotics used to treat bacterial infections, such as Rifampin and erythromycin.
• Fluconazole, used to treat fungal infections.
• Phenobarbital, used to treat epilepsy.
• Cimetidine, used to treat heartburn and stomach ulcers.
• Agents increasing serum potassium, such as potassium supplements, salt substitutes containing potassium, a potassium-sparing diuretic (a specific kind of ‘‘water pill’’) or other drugs that may increase serum potassium (e.g., trimethoprim-containing products).
• Grapefruit juice (which should be avoided while taking LOSARTAN).

How to take LOSARTAN:

• Take LOSARTAN exactly as prescribed.
• It is recommended to take your dose at about the same time every day.

• LOSARTAN may be taken with or without food, but it should be taken the same way each day.

Usual dose:

High blood pressure:

Adults:

• The usual starting dose is 50 mg once daily. The usual dose range is 50 to 100 mg once daily.

Children (6 to 16 years of age) who can swallow tablets:

• For patients who weigh between 20 kg and less than 50 kg, the recommended dose is 25 mg once daily. The dose can be increased by your healthcare professional to a maximum of 50 mg once daily.
• For patients who weigh 50 kg or more, the starting dose is 50 mg once daily. The dose can be increased by your healthcare professional to a maximum of 100 mg once daily.

Type 2 diabetes patients with protein in the urine and high blood pressure:

Adults:

• The usual starting dose is 50 mg once daily. Your healthcare professional may increase the dose to 100 mg 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 LOSARTAN?

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

Side effects may include:

• diarrhea
• vomiting
• fatigue
• back or leg pain
• muscle cramps
• change in taste
• dizziness
• headache
• rash

LOSARTAN 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, tell your healthcare professional.

Storage:

Bottles: Store LOSARTAN between 15 and 30°C. Keep container tightly closed. Protect from light.

Blisters: Store LOSARTAN between 15 and 30°C.

Keep out of the reach and sight of children.

If you want more information about LOSARTAN:

• 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; Sivem Pharmaceuticals ULC web site www.sivem.ca or by calling Sivem Pharmaceuticals ULC at 1 855-788-3153

or by written request at:

Sivem Pharmaceuticals ULC

4705 Dobrin Street

Saint-Laurent, Québec, Canada

Reporting Side Effects

H4R 2P7

Last revised: APR 25, 2024