Consumer Information for: TELMISARTAN
Consumer Information
Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
What the medication is used for
- To treat high blood pressure
What it does
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 Telmisartan
regularly even if you feel fine.
When it should not be used
Do not take Telmisartan if you:
- Are lactose intolerant.
- 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 Telmisartan during pregnancy can cause injury and even death to your baby.
- Are breastfeeding. It is possible that Telmisartan passes into breast milk.
- Are already taking a blood pressure-lowering medicine that contains aliskiren and you have diabetes or kidney disease.
What the medicinal ingredient is
Telmisartan
What the non-medicinal ingredients are
Crospovidone, lactose anhydrous, lactose monohydrate, magnesium stearate, meglumine, povidone and sodium hydroxide.
What dosage form it comes in
Tablets containing telmisartan: 40 mg and 80 mg
Warnings and precautions
Serious Warnings and Precautions – Pregnancy
Telmisartan should not be used during pregnancy. If you discover that you are pregnant while taking Telmisartan, stop the medication and please contact your doctor, nurse, or pharmacist as soon as possible.
Before you use 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, used to lower high blood pressure. The combination with Telmisartan is not recommended.
- If you have lactose intolerance
- 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.
Before you perform tasks which require special attention (driving a car or operating dangerous machinery), wait until you know how you respond to 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 Telmisartan:
- Blood pressure lowering drugs, including diuretics (“water pills”), aliskiren-containing products, 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 acetylsalicylic acid (ASA), celecoxib, naproxen and ibuprofen.
- Digoxin to treat many heart conditions.
- Warfarin, used to prevent blood clots (blood thinner).
Proper use of this medication
Take 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 Telmisartan is 80 mg once daily. Your doctor may prescribe 40 mg once daily if you have liver disease.
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:
- 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.
Telmisartan 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 |
|---|---|---|---|
| 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 heartbeat (including fatal outcome) | ✔ | ||
| Rhabdomyolysis: Muscle pain that you cannot explain, muscle tenderness or weakness or dark brown urine | ✔ | ||
How to store
Telmisartan tablets should be stored at room temperature (15 -
30°C). Tablets should not be removed from blisters and bottles
until immediately prior to administration. Avoid excessive heat
and moisture.
Keep out of reach and sight of children and pets.
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 3 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 obtained by contacting the
sponsor, Pharmascience Inc., at: 1-888-550-6060,
This leaflet was prepared by:
Pharmascience Inc.
Montréal, Québec
H4P 2T4
www.pharmascience.com
Last preparation: October 27, 2014.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| AMIODARONE | 02385465 | SIVEM PHARMACEUTICALS ULC | AMIODARONE HYDROCHLORIDE 200 MG |