Details for: VALSARTAN HCT
Company: SIVEM PHARMACEUTICALS ULC
DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
---|---|---|---|---|---|
02384736 | VALSARTAN HCT | VALSARTAN; HYDROCHLOROTHIAZIDE | 80 MG; 12.5 MG | TABLET | ORAL |
02384744 | VALSARTAN HCT | VALSARTAN; HYDROCHLOROTHIAZIDE | 160 MG; 12.5 MG | TABLET | ORAL |
02384752 | VALSARTAN HCT | VALSARTAN; HYDROCHLOROTHIAZIDE | 160 MG; 25 MG | TABLET | ORAL |
02384760 | VALSARTAN HCT | VALSARTAN; HYDROCHLOROTHIAZIDE | 320 MG; 12.5 MG | TABLET | ORAL |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
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 ingredient is
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 form 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:
- 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.
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 breastfeeding. 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.
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.
Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and seek immediate help |
---|---|---|---|
Common | |||
Allergic reactions: Skin rash, skin eruption or other effect on the skin or eyes | ✔ | ||
Low Blood
Pressure:
dizziness,
fainting,
lightheadedness May occur when you go from lying or sitting to standing up. |
✔ | ||
Decreased or increased levels of potassium in the blood: irregular heartbeats, muscle weakness and generally feeling unwell | ✔ | ||
Non-melanoma skin cancer: lump or discoloured patch on the skin that stays after a few weeks and slowly changes. Cancerous lumps are red/pink and firm and sometimes turn into ulcers. Cancerous patches are usually flat and scaly. | ✔ | ||
Uncommon | |||
Kidney Disorder: change in frequency of urination, nausea, vomiting, swelling of extremities, fatigue | ✔ | ||
Liver Disorder: yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite | ✔ | ||
Increased blood sugar: frequent urination, thirst, and hunger | ✔ | ||
Electrolyte Imbalance: weakness, drowsiness, muscle pain or cramps, irregular heartbeat | ✔ | ||
Abdominal pain | ✔ | ||
Rare | |||
Rhabdomyolysis: muscle pain that you cannot explain, muscle tenderness or weakness, dark brown urine | ✔ | ||
Decreased White Blood Cells: infections, fatigue, fever, aches, pains, and flu-like symptoms | ✔ | ||
Decreased Platelets: bruising, bleeding, fatigue and weakness | ✔ | ||
Very rare | |||
Toxic Epidermal Necrolysis: severe skin peeling, especially in mouth and eyes | ✔ | ||
Unknown | |||
Eye disorders: - Myopia: sudden near sightedness or blurred vision - Glaucoma: increased pressure in your eyes, eye pain |
✔ | ||
Anemia: fatigue, loss of energy, weakness, shortness of breath. | ✔ | ||
Inflammation of the Pancreas: abdominal pain that lasts and gets worse when you lie down, nausea, vomiting | ✔ | ||
Blistering skin reactions with symptoms such as rash, red skin, blistering of the lips, eyes or mouth, skin peeling and fever | ✔ | ||
Rare or very rare | |||
Possible signs of a blood disorder (symptoms like sore throat, fever, or chills) | ✔ | ||
Jaundice: Yellow eyes or skin | ✔ | ||
Irregular heart beat | ✔ | ||
Necrotizing vasculitis; (Inflammation of vessels with or without pain) | ✔ | ||
Tiredness, confusion, muscle twitching, convulsions (possible symptoms of hypernatremia) | ✔ | ||
Respiratory problems including pneumonitis and pulmonary edema | ✔ | ||
Bone marrow failure, aplastic anemia: (Weakness, bruising and frequent infections) | ✔ |
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
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/healthcanada/services/drugs-health-products/medeffectcanada/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
This leaflet was prepared by:
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent, Quebec, Canada
H4R 2P7
Last revised: August 19, 2019