Details for: TEVA-VALSARTAN
Company: TEVA CANADA LIMITED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02356643 | TEVA-VALSARTAN | VALSARTAN | 40 MG | TABLET | ORAL |
| 02356651 | TEVA-VALSARTAN | VALSARTAN | 80 MG | TABLET | ORAL |
| 02356678 | TEVA-VALSARTAN | VALSARTAN | 160 MG | TABLET | ORAL |
| 02356686 | TEVA-VALSARTAN | VALSARTAN | 320 MG | TABLET | ORAL |
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
High blood pressure (hypertension):
Teva-Valsartan lowers high blood pressure.
Following a heart attack (myocardial infarction):
Teva-Valsartan is used to treat people after a heart attack when an angiotensin-converting enzyme (ACE) inhibitor, considered part of standard therapy for this condition, is not appropriate.
Chronic heart failure:
Teva-Valsartan is used in patients with chronic heart failure, when they are unable to tolerate the standard treatment with medications called ACE inhibitors. There is no evidence that Teva-Valsartan provides added benefit when it is used with ACE inhibitors.
What it does
Teva-Valsartan is an angiotensin receptor blocker (ARB). You can recognize an ARB because its medicinal ingredient ends in “-SARTAN”.
This medicine does not cure your disease. It helps to control it. Therefore, it is important to continue taking Teva-Valsartan regularly even if you feel fine.
When it should not be used
Do not take Teva-Valsartan if you:
- Are allergic to valsartan or to any non-medicinal ingredient in the formulation.
- 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.
- 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 Teva-Valsartan during pregnancy can cause injury and even death to your baby.
- Are breastfeeding. It is possible that Teva-Valsartan passes into breast milk.
What the medicinal ingredient is
Valsartan
What the non-medicinal ingredients are
Teva-Valsartan also contains the following non-medicinal ingredients:
40 mg tablets: colloidal silicon dioxide, croscarmellose sodium, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, purified water, talc, and titanium dioxide.
80 mg tablets : colloidal silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, purified water, talc, and titanium dioxide.
160 mg tablets: colloidal silicon dioxide, croscarmellose sodium, iron oxide yellow, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, purified water, talc, and titanium dioxide.
320 mg tablets: colloidal silicon dioxide, croscarmellose sodium, iron oxide black, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, purified water, talc, and titanium dioxide.
What dosage form it comes in
Teva-Valsartan is available in four tablet strengths containing valsartan 40 mg, 80 mg, 160 mg and 320 mg.
Teva-Valsartan 40 mg is a divisible film-coated tablet. The 20 mg dose may be obtained by dividing a 40 mg tablet in half at the break line.
- Teva-Valsartan tablets, 40 mg are yellow, ovaloid-shaped, slightly convex coated tablets with beveled edges, engraved with “rph” on one side and “V34” on the other side with a deep score and contain 40 mg of valsartan.
- Teva-Valsartan tablets, 80 mg are pale red, round shaped, coated tablets with beveled edges, engraved with “rph” on one side and “V33” on the other side and contains 80 mg of valsartan.
- Teva-Valsartan tablets, 160 mg are grey orange, ovaloid-shaped, coated tablets with beveled edges, engraved with “rph” on one side and “V32” on the other side and contain 160 mg of valsartan.
- Teva-Valsartan tablets, 320 mg are dark grey-violet, ovaloid-shaped, slightly convex coated tablets with beveled edges, engraved with “rph” on one side and “V31” on the other side and contain 320 mg of valsartan.
Warnings and precautions
Serious Warnings and Precautions - Pregnancy
Teva-Valsartan should not be used during pregnancy. If you discover that you are pregnant while taking Teva-Valsartan, stop the medication and contact your doctor, nurse or pharmacist as soon as possible.
BEFORE you use Teva-Valsartan talk to your doctor, nurse or pharmacist if you:
- Have experienced an allergic reaction to any drug, including drugs used to lower blood pressure, such as angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARB).
- Have narrowing of an artery or a heart valve.
- Have had a heart attack or stroke.
- Have heart failure.
- Have diabetes, liver or kidney disease.
- 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” that makes your body keep potassium).
- Are on a low-salt diet.
- Are taking a medicine that contains aliskiren, such as Rasilez, used to lower high blood pressure. The combination with Teva-Valsartan is not recommended.
- Are taking an angiotensin converting enzyme (ACE) inhibitor.
- Are less than 18 years old.
Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to Teva-Valsartan. 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 the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.
The following may interact with Teva-Valsartan:
- Agents increasing serum potassium, such as a salt substitute that contains potassium, potassium supplements, a potassium-sparing diuretic (a specific kind of “water pill”) or other drugs that may increase potassium levels.
- Lithium, a medicine used to treat some types of psychiatric illness such as bipolar disease.
- Nonsteroidal anti-inflammatory drugs (NSAIDs), used to reduce pain and swelling. Examples include ibuprofen, naproxen, and celecoxib.
- Other blood pressure lowering drugs, including diuretics (“water pills”), ACE inhibitors or aliskiren.
- Rifampin an antibiotic
- Cyclosporine a drug used to protect against transplant rejection.
- Ritonavir an antiretroviral drug used to treat HIV/AIDS infection.
Proper use of this medication
Take Teva-Valsartan exactly as prescribed. Swallow Teva-Valsartan tablets with a glass of water. It is recommended to take your dose at about the same time everyday preferably in the morning. You can take Teva-Valsartan with or without food, but it should be taken the same way each day. Do not exceed the recommended dose.
Usual Adult Dose
High blood pressure (hypertension):
Recommended initial dose: 80 mg once a day. Dose should be increased gradually.
Maximum dose: 320 mg a day
Following a heart attack (myocardial infarction):
Recommended starting dose: 20 mg twice a day. Dose can be increased gradually.
Target maintenance dose: 160 mg twice a day
Chronic heart failure:
Recommended starting dose: 40 mg twice a day. Dose should be increased gradually.
Maximum dose: 160 mg twice a day
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 dose.
Side effects and what to do about them
Side effects may include:
- Dizziness, light headedness,
- drowsiness,
- rash,
- diarrhea, vomiting, nausea,
- headache,
- back or leg pain, muscle cramps,
- Muscle pain , muscle weakness,
- Unusual tiredness, weakness,
- Cough,
- Impotence,
- Nose bleed,
- Blistering skin (sign of dermatitis bullous)
If any of these affects you severely, tell your doctor, nurse or pharmacist.
Teva-Valsartan 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 medical help |
|---|---|---|---|
| Common | |||
| Allergic reactions: Skin rash, skin eruption or other effect on the skin or eyes | ✔ | ||
| Increased levels of potassium in the blood: Irregular heartbeats, muscle weakness and generally feeling unwell | ✔ | ||
| Uncommon | |||
| Low blood pressure (hypotension): Dizziness, fainting, light-headedness may occur when you go from lying or sitting to standing up | ✔ | ||
| Angioedema / Allergic reactions: Rash, hives, swelling of the lips, face or neck, tongue or throat accompanied by difficulty in breathing, swallowing or speaking | ✔ | ||
| 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 | ✔ | ||
| Rhabdomyolysis: Muscle pain that you cannot explain, muscle tenderness or weakness, dark brown urine | ✔ | ||
| Abdominal pain | ✔ | ||
| Cardiac failure: Breathlessness, difficulty breathing when lying down, swelling of the feet or legs | ✔ | ||
| Vasculitis: Inflammation of blood vessels purplished-red spots, fever, itching | ✔ | ||
| Decreased platelets: Bruising, unusual bleeding, fatigue and weakness | ✔ | ||
| Anemia: Fatigue, loss of energy, weakness, shortness of breath | ✔ | ||
| Decreased white blood cells: Infections, fatigue, fever, aches, pains, and flu-like symptoms, sore throat or mouth ulcers | ✔ | ||
| Insomnia | ✔ | ||
| Flu like symptoms, joint pain, pharyngitis, inflammation of sinuses, runny or stuffy nose, swollen hands, ankles or feet, upper respiratory tract infection, viral infection | ✔ | ||
| Palpitations: Irregular heartbeats | ✔ | ||
| Unknown | |||
| Change in libido | ✔ | ||
| Blistering skin reactions with symptoms such as rash, red skin, blistering of the lips, eyes or mouth, skin peeling and fever | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking Teva-Valsartan, contact your doctor, nurse or pharmacist.
How to store
Do not take Teva-Valsartan past the expiry date shown on the pack.
Store your Teva-Valsartan tablets in a dry place at room temperature (15°C to 30°C), protect from heat, light and humidity.
Keep this medicine out of the reach and sight of children.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph prepared for health professionals can be found by contacting Teva Canada Limited at:
1-800-268-4127 ext. 1255005 (English);
1-877-777-9117 (French); or
druginfo@tevacanada.com
This leaflet was prepared by:
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada
M1B 2K9
Last revised: October 9, 2015