Patient Medication Information: uses, side effects, how to take - M-Valsartan (Mantra Pharma, 40 mg, 80 mg)
What the medication is used for:
High blood pressure (hypertension):
M-VALSARTAN lowers high blood pressure.
Following a heart attack (myocardial infarction):
M-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:
M-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 M-VALSARTAN provides added benefit when it is used with ACE inhibitors.
What it does:
M-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 M- VALSARTAN regularly even if you feel fine.
When it should not be used:
Do not take M-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 M-
VALSARTAN during pregnancy can cause injury and even death to your baby.
Are breastfeeding. It is possible that valsartan passes into
breast milk.
What the medicinal ingredient is:
Valsartan
What the nonmedicinal ingredients are:
M-VALSARTAN also contains the following non-medicinal ingredients: crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, silica colloidal anhydrous, talc and titanium dioxide.
Additionally, the 40 mg contains iron oxide yellow; the 80 mg iron oxide black and iron oxide red; and the 160 mg iron oxide red and iron oxide yellow.
What dosage forms it comes in:
Tablets: 40 mg, 80 mg, and 160 mg.
Serious Warnings and Precautions - Pregnancy M-VALSARTAN should not be used during pregnancy. If you discover that you are pregnant while taking M-VALSARTAN, stop the medication and contact your doctor, nurse, or pharmacist as soon as possible.
BEFORE you use M-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 M-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 M-VALSARTAN. Dizziness, lightheadedness, or fainting can especially occur after the first dose and when the dose is increased.
ABOUT THIS MEDICATION
WARNINGS AND PRECAUTIONS
| IMPORTANT:PLEASE READ |
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 M-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 a antiretroviral drug used to treat HIV/AIDS
infection
PROPER USE OF THIS MEDICATION
Take M-VALSARTAN exactly as prescribed. Swallow M-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 M- 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:
If you think you have taken too much M-VALSARTAN contact your doctor, nurse, pharmacist, 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, 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.
M-VALSARTAN can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and seek immediate medical help | ||
| Only if severe | In all cases | |||
| 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 | √ | |||
| IMPORTANT:PLEASE READ |
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and seek immediate medical help | ||
| Only if severe | In all cases | |||
| 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 | √ | |||
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and seek immediate medical help | ||
| Only if severe | In all cases | |||
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 M-VALSARTAN, contact your doctor, nurse or pharmacist.
| IMPORTANT:PLEASE READ |
HOW TO STORE IT
Do not use M-VALSARTAN past the expiry date shown on the pack.
Protect from moisture and heat (store at 15 - 30° C).
Keep this medicine out of the reach and sight of children.
Reporting Side Effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report :
- Online at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php);
By calling 1-866-234-2345 (toll-free); • By completing a Consumer Side Effect Reporting
Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
Mail to: Canada Vigilance Program
Health Canada, Postal Locator 0701E Ottawa, ON
K1A 0K9
Postage paid labels, and the Consumer Side Effect Reporting Form are available at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php).
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
Please consult your doctor or pharmacist with any questions or concerns you may have regarding your individual condition.
This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Mantra Pharma Inc. at: 1-877-726-2707.
Mantra Pharma Inc.
4605-B boul. Lapinière, Suite 250
Brossard (Quebec), J4Z 3T5