Taro-Valsartan: Uses, Side Effects and Dosage

Serious Warnings and Precautions

• Pregnancy: Angiotensin receptor blockers (ARBs), such as TARO-VALSARTAN, can cause harm or even death to your unborn baby. Therefore, TARO-VALSARTAN should not be taken during pregnancy. If you become pregnant or think you are pregnant, stop taking TARO-VALSARTAN right away and tell your healthcare professional.

What is TARO-VALSARTAN used for?

TARO-VALSARTAN is used in adults:

• to treat mild to moderate high blood pressure. It may be given alone or in combination with diuretics (i.e., water pills).
• to reduce the risk of death after a heart attack when an angiotensin-converting enzyme (ACE) inhibitor, considered part of standard therapy for this condition, is not appropriate. TARO-VALSARTAN is given to patients who are in a stable condition but have signs or symptoms of heart problems.
• with chronic heart failure when they are unable to tolerate the standard treatment with medicines called ACE inhibitors.

How does TARO-VALSARTAN work?

TARO-VALSARTAN is an angiotensin receptor blocker (ARB) that helps relax blood vessels. This makes it easier for your heart to pump blood around your body. This helps to lower your blood pressure.

What are the ingredients in TARO-VALSARTAN?

Medicinal ingredient: Valsartan

Non-medicinal ingredients: crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, silica colloidal anhydrous, talc and titanium dioxide.

Additionally, the 40 mg tablet contains iron oxide yellow; the 80 mg tablet contains iron oxide black and iron oxide red; and the 160 mg tablet contains iron oxide red and iron oxide yellow.

TARO-VALSARTAN comes in the following dosage forms:

Tablets: 40 mg, 80 mg, and 160 mg.

Do not use TARO-VALSARTAN if:

• you are allergic to valsartan or to any other ingredients in TARO-VALSARTAN.
• you are pregnant or planning to become pregnant.
• you are breastfeeding or planning to breastfeed.
• you are taking medicines that contain aliskiren (such as RASILEZ®) that help lower blood pressure and you have diabetes or kidney disease.

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

• are taking other medicines, including:

  • medicines used to lower high blood pressure such as angiotensin-converting enzyme (ACE) inhibitors, diuretics (“water pills”) and medicines containing aliskiren;
  • medicines that increase the level of potassium in the blood such as a salt substitute that contains potassium, potassium supplements, potassium-sparing diuretic (a type of “water pill”) heparin (used to treat and prevent blood clots), etc.

• ever had an allergic reaction, which may involve swelling of the hands, feet, or ankles, face, lips, tongue, throat, or sudden difficulty breathing or swallowing (angioedema), when taking other medicines, including:

  • medicines used to treat high blood pressure such as ACE inhibitors and angiotensin receptor blockers (ARBs).
• have or have had heart problems (e.g., heart attack, heart failure, narrowing of an artery or a heart valve).
• have had problems that affect the blood flow and blood vessels in the brain (e.g., stroke).
• have diabetes.
• have kidney problems.
• are undergoing dialysis (a procedure to remove waste products and excess fluid from the blood when the kidneys stop working properly).
• are dehydrated or suffer from excessive vomiting, diarrhea, or sweating.
• are on a low-salt diet.
• have liver problems.

Other warnings you should know about:

TARO-VALSARTAN can cause the following:

• Angioedema (swelling of tissue under the skin): Treatment with TARO-VALSARTAN can cause angioedema. This can be life-threatening. Your healthcare professional will monitor your health for signs of angioedema. If you notice swelling on your body or have difficulty swallowing or breathing, stop taking TARO-VALSARTAN and tell your healthcare professional right away.

• Hypotension (low blood pressure): Treatment with TARO-VALSARTAN can cause hypotension, in some cases even after the first dose. Patients who have heart failure or are taking TARO-VALSARTAN after a heart attack are at a higher risk of experiencing low blood pressure. Your healthcare professional may monitor your health and adjust your dose as

  • dehydrated, are vomiting, or have diarrhea.
• Kidney problems: Treatment TARO-VALSARTAN can cause kidney problems resulting in decreased urine, progressive azotemia (high levels of nitrogen in the blood), kidney failure or even death. Your healthcare professional will closely monitor your kidneys before and during your treatment. They may decide to reduce or stop your treatment.

See the Serious side effects and what to do about them table, below, for more information on these and other serious side effects.

Driving and using machines: TARO-VALSARTAN can decrease your blood pressure causing light-headedness, dizziness, and fainting. These can occur more often after your first dose, and when your dose is increased. Before you drive or do tasks that require special attention, wait until you know how you respond to TARO-VALSARTAN.

Check-ups and testing: You may have regular visits with your healthcare professional, before, during and after your treatment. These tests may be used to monitor your health such as your kidney function, and blood pressure.

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 TARO-VALSARTAN:

• other medicines used to lower high blood pressure such as ACE inhibitors, and ARBs.
• medicines known as diuretics (“water pill”) such as potassium-sparing diuretic and potassium-retaining diuretics (e.g., spironolactone, triamterene, or amiloride).
• medicines that increase the potassium in the blood such as a salt substitute that contains potassium, potassium supplements, and a potassium-sparing diuretic (a type of “water pill”).
• medicines used to treat and prevent blood clots such as heparin.
• non-steroidal anti-inflammatory drugs (NSAIDs), that are used to reduce pain and swelling such as ibuprofen, naproxen, celecoxib, indomethacin, and acetylsalicylic acid (aspirin).
• medicines used to treat bacterial infections such as trimethoprim-sulfamethoxazole and rifampin.
• medicines used to treat bipolar disorder such as lithum.
• medicines used to treat heart conditions such as digoxin.
• medicines used to suppress the immune system such as cyclosporine.
• medicines used to treat HIV/AIDS such as ritonavir.

How to take TARO-VALSARTAN:

• Your healthcare professional will decide the dose and length of TARO-VALSARTAN for you. They may start with a low dose and slowly adjust the dose as needed. Take TARO-VALSARTAN exactly as prescribed by your healthcare professional.

• TARO-VALSARTAN can be taken with or without food, but it should be taken the same way each day.

• It is recommended that you take your dose at about the same time everyday. If you take TARO-VALSARTAN once a day, it should preferably be taken in the morning.
• Your healthcare professional will monitor your health throughout your treatment and may interrupt, reduce or stop your dose.
• If you take diuretics (i.e., “water pills”), your healthcare professional may ask you to temporarily stop taking them 2 or 3 days before you start your treatment with TARO-VALSARTAN. They may also reduce their dose during your treatment. Furthermore, your healthcare professional may also prescribe you other medications depending on your condition. Follow their instructions carefully.

Usual Dose:

To treat high blood pressure:

• The recommended initial dose is 80 mg once a day.
• Your dose may be adjusted as needed.
• The maximum daily dose is 320 mg.

To reduce the risk of death after a heart attack:

• The recommended starting dose is 20 mg twice a day.
• Your dose may be gradually increased to a target maintenance dose of 160 mg twice a day, as tolerated.

To treat chronic heart failure:

• The recommended starting dose is 40 mg twice a day.
• Your dose may be increased every two weeks to the highest dose you can tolerate.
• The maximum recommended dose is 160 mg twice a day.

Overdose:

Signs of an overdose with TARO-VALSARTAN may include:

• low blood pressure, which can lead to shock (rapid breathing, pale skin, cold and sweaty skin).
• decreased consciousness.
• a rapid or slow heart rate.

If you think you, or a person you are caring for, have taken too much TARO-VALSARTAN , contact a 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, skip the missed dose and take your next dose at the usual time. Do not double the doses.

What are possible side effects from using TARO-VALSARTAN?

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

Side effects may include:

• dizziness, difficulty in maintaining your balance while standing, fainting
• diarrhea, nausea, vomiting, indigestion
• chest pain, respiratory tract infection, runny or stuffy nose, cough, throat pain, fever, chills, body aches
• pain or swelling of the hands, arms, legs or feet
• itchy skin
• fatigue, lack of energy
• impotence, decreased sexual desire
• drowsiness, problems with sleeping
• headache
• back pain
• muscle pain or aches, weakness or inflammation
• joint pain
• nosebleed
• changes in taste

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

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

Storage:

• Store at room temperature (store at 15 - 30° C) Protect from moisture and heat.
• Do not take TARO-VALSARTAN past the expiry date shown on the pack.
• Keep out of the reach and sight of children.

If you want more information about TARO-VALSARTAN:

• 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), or by calling 1-866-840-1340.

Sun Pharma Canada Inc.

Brampton, ON L6T 1C1

Last revised: January 16, 2024

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