Details for: AURO-VALSARTAN
Company: AURO PHARMA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02414201 | AURO-VALSARTAN | VALSARTAN | 40 MG | TABLET | ORAL |
| 02414228 | AURO-VALSARTAN | VALSARTAN | 80 MG | TABLET | ORAL |
| 02414236 | AURO-VALSARTAN | VALSARTAN | 160 MG | TABLET | ORAL |
| 02414244 | AURO-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):
AURO-VALSARTAN lowers high blood pressure.
Following a heart attack (myocardial infarction):
AURO-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:
AURO-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 AUROVALSARTAN
provides added benefit when it is
used with ACE inhibitors.
What it does
AURO-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 AURO-VALSARTAN regularly even if you feel fine.
When it should not be used
Do not take AURO-VALSARTAN if you:
- Are allergic to valsartan or to any nonmedicinal 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 AURO-VALSARTAN during pregnancy can cause injury and even death to your baby.
- Are breastfeeding. It is possible that AUROVALSARTAN passes into breast milk.
What the medicinal ingredient is
Valsartan
What the non-medicinal ingredients are
Core Tablet contains: Cellulose microcrystalline,
lactose monohydrate, crospovidone, silica colloidal
anhydrous, hypromellose, sodium lauryl sulfate, talc,
and magnesium Stearate.
Film coat contains:
40 mg, 80 mg & 160 mg: Hypromellose, titanium
dioxide, polyethylene glycol, iron oxide red and iron
oxide yellow.
320 mg: Hypromellose, titanium dioxide,
polyethylene glycol, iron oxide red, iron oxide yellow
and iron oxide black.
What dosage form it comes in
Film-coated tablets, 40 mg (yellow), 80 mg (red), 160 mg (grey orange), 320 mg (grey-violet).
Warnings and precautions
Serious Warnings and Precautions– Pregnancy
AURO-VALSARTAN should not be used during pregnancy. If you discover that you are pregnant while taking AURO-VALSARTAN, stop the medication and contact your doctor, nurse or pharmacist as soon as possible.
BEFORE you use AURO-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 AUROVALSARTAN is not recommended.
- Are taking an angiotensin converting enzyme (ACE) inhibitor.
- Are less than 18 years old,
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 AUROVALSARTAN:
- 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 a antiretroviral drug used to treat HIV/AIDS infection
Proper use of this medication
Take AURO-VALSARTAN exactly as prescribed. Swallow AURO-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 AURO- 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)
AURO-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 talk with your doctor or pharmacist |
|---|---|---|---|
| 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, lightheadedness 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, shortnesss 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 AUROVALSARTAN, contact your doctor, nurse or pharmacist.
How to store
Do not use AURO-VALSARTAN past the expiry
date shown on the pack.
Store at room temperature (15°C to 30°C).
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 at:
http:// www.auropharma.ca
or by contacting the sponsor, Auro Pharma Inc., at:
1-855-648-6681
This leaflet was prepared by
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.
Date of Revision: August 21, 2015