Details for: TELMISARTAN
Company: SIVEM PHARMACEUTICALS ULC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02390345 | TELMISARTAN | TELMISARTAN | 40 MG | TABLET | ORAL |
| 02390353 | TELMISARTAN | TELMISARTAN | 80 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
- 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 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 has happened to you.
- Patients who 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 allergic to some sugars (fructose and/or sorbitol 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 non-medicinal ingredients are
Hydroxypropyl methylcellulose, magnesium stearate, mannitol, meglumine, povidone, sodium hydroxide and sorbitol.
What dosage form it comes in
Tablets in 40 mg and 80 mg strengths
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 physician as possible.
Before you use TELMISARTAN tablets 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 TELMISARTAN is not recommended.
- 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 may 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 (e.g. Rasilez), or angiotensin-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.
- Diogoxin 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 tablets 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 emergency 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 | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking TELMISARTAN tablets, contact your doctor, nurse or pharmacist.
How to store
For Bottles: Store between 15ºC and 30ºC. Keep container tightly closed. Protect from moisture.
For Blisters: Store between 15ºC and 30ºC. Protect from moisture.
Tablets should not be removed from blisters until immediately prior to administration.
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 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 the sponsor, Sivem Pharmaceuticals ULC. at:
1-855-788-3153
This leaflet was prepared by Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent
Quebec, H4R 2P7
Last revised: June 16, 2014