Valsartan HCT (Sivem Pharmaceuticals, 320 mg / 25 mg): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

VALSARTAN HCT lowers high blood pressure.

High blood pressure increases the workload of the heart and arteries. If this condition continues for a long time, damage to the blood vessels of the brain, heart, and kidneys can occur, and may eventually result in a stroke, heart failure or kidney failure. High blood pressure also increases the risk of heart attacks. Reducing your blood pressure decreases your risk of developing these illnesses.

What it does:

VALSARTAN HCT contains a combination of 2 drugs, valsartan and hydrochlorothiazide:

• Valsartan is an angiotensin receptor blocker (ARB). You can

  recognize an ARB because its medicinal ingredient ends in “- SARTAN”. It lowers blood pressure. VALSARTAN HCT does this by specifically blocking angiotensin II. Angiotensin II is a natural hormone produced in the body to keep blood pressure at normal levels. One function of angiotensin II is to increase blood pressure, usually when it becomes too low. Valsartan works by blocking the effect of angiotensin II. As a result, blood pressure is lowered.

• Hydrochlorothiazide is a diuretic or “water pill” that

  increases urination. This lowers blood pressure.

Together valsartan and hydrochlorothiazide lower blood pressure.

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

If you have any questions about how VALSARTAN HCT works or why this medicine has been prescribed for you, ask your doctor.

When it should not be used:

Do not take VALSARTAN HCT if you:

• Are allergic to valsartan, hydrochlorothiazide or to any

  non- medicinal ingredient in the formulation.

• Are allergic to any sulfonamide-derived drugs (sulfa

  drugs); most of them have a medicinal ingredient that ends in “- MIDE”. Ask your physician or pharmacist if you are not sure what sulfonamide-derived drugs are.

• Have experienced an allergic reaction (angioedema) with

  swelling of the hands, feet, or ankles, face, lips, tongue,

  throat, or sudden difficulty breathing or swallowing to any ARB. Be sure to tell your doctor, nurse, or pharmacist that this has happened to you.

  • Have difficulty urinating or produce no urine.
  • Suffer from severe liver disease with destruction of the small bile ducts within the liver (biliary cirrhosis) leading to the build up bile in the liver (cholestasis).

  • Are taking a medicine that contains aliskiren (such as

    RASILEZ) and you have diabetes or kidney disease.

  • Are pregnant or intend to become pregnant. Taking

    VALSARTAN HCT during pregnancy can cause injury and even death to your baby.

  • Are breastfeeding. VALSARTAN HCT passes into breast milk.
  • Have serious kidney disease.
  • Have a too low level of potassium or sodium or if you have a too high level of calcium in your blood despite treatment.
  • Have uric acid crystals in the joints (gout).
  • Are under 18 years old.

If either of these apply to you, tell your doctor without taking VALSARTAN HCT.

What the medicinal ingredients are:

Valsartan and hydrochlorothiazide

What the non-medicinal ingredients are:

VALSARTAN HCT tablets: Colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide.

In addition, the tablets also contain:

VALSARTAN HCT 80/12.5 mg: Red and yellow iron oxide VALSARTAN HCT 160/12.5 mg: Red iron oxide VALSARTAN HCT 160/25 mg: Red, yellow and black iron oxide

VALSARTAN HCT 320/12.5 mg: Red and black iron oxide VALSARTAN HCT 320/25 mg: Yellow iron oxide

If you are on a special diet, or if you are allergic to any substance, ask your doctor or pharmacist whether any of these ingredients may cause a problem.

What dosage forms it comes in:

Film-coated tablets, 80/12.5 mg (light orange), 160/12.5 mg (dark red), 160/25 mg (brown orange), 320/12.5 mg (pink), and 320/25 mg (yellow).

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions - Pregnancy VALSARTAN HCT should not be used during pregnancy. If you discover that you are pregnant while taking VALSARTAN HCT, stop the medication and contact your doctor, nurse, or pharmacist as soon as possible.

BEFORE you use VALSARTAN HCT talk to your doctor, nurse, or pharmacist if you:

• Are allergic to any drug used to lower blood pressure,

  including angiotensin converting enzyme (ACE) inhibitors, or penicillin.

• Have narrowing of an artery or a heart valve.
• 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, or a potassium-sparing diuretic (a specific kind of “water pill”).

• Are on a low-salt diet.
• Are less than 18 years old.

• Suffer from severe liver disease with destruction of the small

  bile ducts within the liver (biliary cirrhosis) leading to the builds up bile in the liver (cholestasis);

• Ever had swelling mainly of the face and throat while

  taking other drugs (including an ACE-inhibitor). If you get those symptoms, stop taking VALSARTAN HCT and contact your doctor straight away. You should never take VALSARTAN HCT again.

• Have low levels of potassium in your blood (with or without

  symptoms such as muscle weakness, muscle spasms, abnormal heart rhythm).

• Have low levels of sodium in your blood (with or without

  symptoms such as tiredness, confusion, muscle twitching, convulsions).

• Have high levels of calcium in your blood (with or without

  symptoms such as nausea, vomiting, constipation, stomach pain, frequent urination, thirst, muscle weakness and twitching).

• Have high levels of uric acid in the blood.
• Are suffering from allergy or asthma
• Have high levels of cholesterol or triglycerides in your blood.

• Are suffering from vomiting or diarrhea, or taking high

  doses of a diuretic (water pill).

• Are taking a medicine that contains aliskiren, such

  RASILEZ, used to lower high blood pressure. The combination with VALSARTAN HCT is not recommended.

• Are taking an angiotensin converting enzyme (ACE)

  inhibitor.

• 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.

Risk of skin cancer:

• VALSARTAN 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 VALSARTAN HCT for many years (more than 3) or at a high dose.

  • While taking VALSARTAN HCT:

    o 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.

    o Limit your exposure to the sun and to indoor tanning.

    Always use sunscreen (SPF-30 or higher) and wear protective clothing when going outside.

    o 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.

Hydrochlorothiazide in VALSARTAN HCT can cause Sudden Eye Disorders:

• Myopia: sudden nearsightedness or blurred vision.

• Glaucoma: an increased pressure in your eyes, eye pain.

  Untreated, it may lead to permanent vision loss.

These eye disorders are related and can develop within hours to weeks of starting VALSARTAN HCT.

You may become sensitive to the sun while taking VALSARTAN HCT. Exposure to sunlight should be minimized until you know how you respond.

You should have regular blood tests before and during treatment with VALSARTAN HCT. These will monitor the amount of electrolytes (such as potassium, sodium, calcium or magnesium) in your blood and may also monitor your kidney function

You are pregnant, breast-feeding or thinking of becoming pregnant?

Taking VALSARTAN HCT during pregnancy can cause injury and even death to your baby. This medicine should not be used during pregnancy. If you are planning to become pregnant while taking VALSARTAN HCT, contact immediately your doctor.

It is also advisable not to take VALSARTAN HCT during breast- feeding. The diuretic component of VALSARTAN HCT passes into the breast milk and may also reduce your milk supply. If you are breast-feeding, avoid using VALSARTAN HCT unless recommended by your doctor.

Similar medicines were associated with serious harm to fetuses when they were taken during pregnancy. It is therefore important to tell your doctor immediately if you think you may have become pregnant, or planning to become pregnant. Your doctor will discuss with you the potential risk of taking VALSARTAN HCT during pregnancy.

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

INTERACTIONS WITH THIS MEDICATION

As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.

Certain medicines tend to increase your blood pressure, for example, non-prescription preparations for appetite control, asthma, colds, coughs, hay fever and sinus problems.

Before surgery and general anesthesia (even at the dentist’s office), tell the physician or dentist that you are taking VALSARTAN HCT, as there may be a sudden drop in blood pressure associated with general anesthesia.

The following may interact with VALSARTAN HCT:

• 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 drugs, including cyclophosphamide

  and methotrexate.

• 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.

• Other blood pressure lowering drugs, including

  ACE inhibitors or aliskiren.

• Calcium or vitamin D supplements.
• Corticosteroids used to treat joint pain and swelling.
• Digoxin, a heart medication, or other digitalis glycosides.

• 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, antipsychotics, medicines used to treat

  some psychological conditions such as bipolar disease.

• Nonsteroidal anti-inflammatory drugs (NSAIDs), used

  to reduce pain and swelling. Examples include ibuprofen, naproxen, and celecoxib.

• Skeletal muscle relaxants used to relieve muscle

  spasms, including tubocurare.

• Other diuretics (water pills),

• Pressor amines such as epinephrine (substances that

  raise blood pressure),

• Potassium-sparing agents

• Potassium supplement, salt substitutes containing potassium

  or other drugs that may increase potassium levels. Your doctor may monitor the levels of potassium in your blood periodically,

• Some antibiotics (rifamycin group), a drug used to protect

  against transplant rejection (cyclosporine) or an antiretroviral drug used to treat HIV/AIDS infection (ritonavir). These drugs may increase the effect of VALSARTAN HCT.

  • Amantadine (medicine to treat Parkinson's disease and also used to treat or prevent certain illnesses caused by viruses),
  • Anticholinergic agents (medicines used to treat a variety of disorders such as gastrointestinal cramps, urinary bladder spasm, asthma, motion sickness, muscular spasms, Parkinson's disease and as an aid to anaesthesia)
  • Cortisone-like medicines, carbenoxolone (a medicine used to treat ulceration and inflammation), antibiotics such as penicillin G, antiarrhythmics (medicines used to treat heart problems),
  • Cyclosporine (a medicine used in transplantation and in autoimmune disorders)
  • Warfarin (medicine to prevent blood clot)
  • Diazoxide (medicine to increase blood glucose level)

Taking carbamazepine with hydrochlorothiazide (a medicinal ingredient in VALSARTAN HCT) may cause a low sodium level in the blood. Symptoms of low sodium level in the blood may include: nausea, vomiting, headache, muscular cramps or weakness, and general uneasiness. As it worsens, confusion, decreased consciousness, convulsions (fits), or coma may occur. Tell your doctor if this happens to you.

Sedatives, tranquilizers, narcotics, alcohol and analgesics may increase the blood-pressure lowering effect of VALSARTAN HCT, so tell your physician or pharmacist if you are taking any of these.

PROPER USE OF THIS MEDICATION

Take VALSARTAN HCT exactly as prescribed. It is recommended to take your dose at about the same time everyday.

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

Patients who have high blood pressure often do not notice any signs or symptoms of this condition. So even though you are feeling well, your health may be getting worse. This makes it all the more important for you to continue your treatment program and to keep your appointments with your doctor.

If you have any questions about how long to take VALSARTAN HCT, talk to your doctor or your pharmacist.

Usual Adult dose:

Take VALSARTAN HCT as directed. Dosage must be individualized. VALSARTAN HCT is not for initial therapy. Once you are stabilized on both individual components of VALSARTAN HCT the usual dosage is one 80 mg/12.5mg tablet once a day. In some cases, your doctor may prescribe a higher dose (e.g., the 160mg/12.5mg, 160 mg/25 mg, 320mg/12.5mg or the 320mg/25mg tablet).

Overdose:

If you experience severe dizziness and/or fainting, contact your doctor immediately so that medical attention may be given promptly.

If you think you have taken too much VALSARTAN HCT contact your doctor, nurse, pharmacist, hospital emergency department or regional Poison control Centre immediately, even if there are no symptoms.

Missed Dose:

Try to take your dose at the same time each day, preferably in the morning. If you have forgotten to take your dose during the day, carry on with the next one at the usual time. Do not double doses.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Side effects may include:

• back or leg pain, muscle cramps, spasms and pain, weakness, restlessness
• dizziness, pins and needles in your fingers, headache
• constipation, diarrhea, nausea, vomiting, decreased appetite, upset stomach, enlargement of the glands in your mouth
• bleeding under the skin, rash, red patches on the skin
• drowsiness, insomnia
• reduced libido
• joint pain
• cough
• fatigue (unusual tiredness or weakness, sometimes sign of potassium loss)
• upper respiratory tract infection
• blistering skin (sign of dermatitis bullous)

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

• VALSARTAN HCT can cause abnormal blood test results.

  Your doctor will decide when to perform blood tests and will interpret the results.

This is not a complete list of side effects. For any unexpected effects while taking VALSARTAN HCT, contact your doctor, nurse, or pharmacist.

HOW TO STORE IT

Store your VALSARTAN HCT tablets in a dry place at room temperature (15-30°C).

Do not take VALSARTAN HCT past the expiry date shown on the pack.

Always remember

This medicine has been prescribed to you for your current medical problem only. Do not give it to other people.

It is very important that you take this medicine exactly as your doctor tells you in order to get the best results and reduce the chance of side effects.

Keep out of reach and sight of children.

Reporting Side Effects

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

• Visiting the Web page on Adverse Reaction Reporting

  (https://www.canada.ca/en/health-

  canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or

• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

If you want more information about Sandoz Valsartan 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; the manufacturer’s website www.sivem.ca , or by calling: 1-855-788-3153

Sivem Pharmaceuticals ULC

4705 Dobrin Street

Saint-Laurent, Quebec, Canada

H4R 2P7

Last revised: August 19, 2019