Patient Medication Information: uses, side effects, how to take - Bio-Telmisartan
ABOUT THIS MEDICATION
What the medication is used for:
- To treat high blood pressure
To reduce the risk of non-fatal heart attack or non-fatal
stroke
What it does:
Bio-TELMISARTAN 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 Bio-TELMISARTAN regularly even if you feel fine.
When it should not be used:
Do not take Bio-TELMISARTAN if you:
Are allergic to telmisartan or to any non-medicinal
ingredient in the formulation.
Have experienced an allergic reaction with swelling of
the face, lips, tongue, throat, or sudden difficulty breathing or swallowing to any ARB. Be sure to tell your doctor, nurse, or pharmacist that this happened to you.
Are pregnant or intend to become pregnant. Taking
Bio-TELMISARTAN during pregnancy can cause injury and even death to your baby.
Are breastfeeding. It is possible that Bio-
TELMISARTAN passes into breast milk.
Are allergic to some sugars (fructose and/or mannitol
intolerant).
Are already taking a blood pressure-lowering medicine
that contains aliskiren (such as Rasilez) and you have diabetes or kidney disease.
What the medicinal ingredient is:
Telmisartan
What the nonmedicinal ingredients are:
Magnesium stearate, mannitol, meglumine, povidone and sodium hydroxide.
What dosage forms it comes in:
Tablets: 40 mg and 80 mg
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions-Pregnancy
Bio-TELMISARTAN should not be used during pregnancy. If you discover that you are pregnant while taking Bio-TELMISARTAN, stop the medication and please contact your doctor, nurse, or pharmacist as soon as possible.
Before you use Bio-TELMISARTAN talk to your doctor or pharmacist if you:
- Have experienced an allergic reaction to any drug used to lower blood pressure.
- Have narrowing of a heart valve, diabetes, liver or kidney disease, heart or blood vessel disease.
- Are dehydrated or if you suffer from excessive vomiting, diarrhea, or sweating.
- Are taking a medicine that contains aliskiren, such as Rasilez, used to lower high blood pressure. The combination with Bio-TELMISARTAN is not recommended.
- Are taking an angiotensin-converting-enzyme inhibitor (ACEI).
- 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 on dialysis.
- Are less than 18 years old.
- Have been told by your doctor that you have an intolerance to some sugars.
Before you perform tasks which require special attention (driving a car or operating dangerous machinery), wait until you know how you respond to Bio-
TELMISARTAN. 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 Bio-TELMISARTAN:
Blood pressure lowering drugs, including diuretics
(“water pills”), aliskiren-containing products (e.g. Rasilez), or angiotension-converting-enzyme inhibitors (ACEI).
- Lithium, used to treat mood disorder.
Nonsteroidal anti-inflammatory drugs (NSAIDs)
used to reduce pain and swelling. Examples include
| IMPORTANT: PLEASE READ |
| IMPORTANT: PLEASE READ |
acetylsalicylic acid (ASA), celecoxib, naproxen and ibuprofen.
- Digoxin to treat many heart conditions.
- Warfarin, used to prevent blood clots (blood thinner)
Take Bio-TELMISARTAN exactly as prescribed. It is recommended to take your dose at about the same time everyday with or without food, but it should be taken the same way each day.
Do not stop taking your medication before informing your doctor, nurse, or pharmacist.
Usual adult dose:
The recommended dose of Bio-TELMISARTAN is 80 mg once daily. Your doctor may prescribe 40 mg once daily if you have liver disease.
Overdose:
If you think you, or a person you are caring for, have taken too much Bio-TELMISARTAN contact a healthcare professional, 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:
- back or leg pain, muscle cramps, joint pain, muscle spasms
- headache, anxiety
- diarrhea, constipation, nausea, vomiting, upset stomach, abdominal pain, flatulence
- dry mouth
- rash, eczema, skin eruptions
- drowsiness, insomnia, fatigue
- visual disturbances
- upper respiratory infection
If any of these affects you severely, tell your doctor, nurse or pharmacist.
Bio-TELMISARTAN 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, nurse or pharmacist | Stop taking drug and seek immediate medical help | ||||
| Only if severe | In all cases | |||||
Very Common | Chest pain | √ | ||||
| Common | Low Blood Pressure: dizziness, fainting, lightheadedness | √ | ||||
| Shortness of breath | √ | |||||
| Uncommon | Depression: Low mood, loss of interest in activities, change in appetite and sleep patterns | √ | ||||
Kidney Disorder: Change in frequency of urination, nausea, vomiting, swelling of extremities, fatigue | √ | |||||
| Increased levels of potassium in the blood: Irregular heartbeats, muscle weakness and generally feeling unwell | √ | |||||
Urinary Tract Infections (Cystitis): Frequent or painful urination, feeling unwell | √ | |||||
| Rare | Liver disorder: Yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite | √ | ||||
Low blood sugar: Shaky, irregular heartbeat, sweating, hunger, dizziness (in diabetic patients) | √ | |||||
| Unknown | Allergic Reaction: Rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing (potentially with fatal outcome) | √ | ||||
| Sepsis (blood poisoning): Chills, confusion, fever or low body temperature, shakiness, irregular | √ | |||||
PROPER USE OF THIS MEDICATION
| IMPORTANT: PLEASE READ |
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN | ||||||
| AND WHAT TO DO ABOUT THEM | ||||||
Symptom / effect heartbeat (including fatal outcome) Rhabdomyolysis: Muscle pain that you cannot explain, muscle tenderness or weakness or dark brown urine | Talk with your doctor, nurse or pharmacist | Stop taking drug and seek immediate medical help | ||||
| Only if severe | In all cases | |||||
| √ | ||||||
This is not a complete list of side effects. For any unexpected effects while taking Bio-TELMISARTAN, contact your doctor, nurse or pharmacist.
HOW TO STORE IT
Bio-TELMISARTAN should be stored at room temperature (15°C to 30°C). Avoid excessive heat and moisture.
Keep out of reach and sight of children and pets.
Reporting Side Effects
You can report any suspected side effects 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.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 Bio-TELMISARTAN:
- Talk to your healthcare professional
Find the full Product Monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://www.canada.ca/en/health-
canada/services/drugs-health-products/drug-products/drug-product-database.html); or by contacting the sponsor Biomed Pharma at: 1-888-731-6703 or
info@biomed-pharma.ca.