Patient Medication Information: uses, side effects, how to take - AG-Telmisartan
What is AG-Telmisartan used for?
- To treat high blood pressure in adults
- To reduce the risk of non-fatal heart attack or non-fatal stroke in adults
How does AG-Telmisartan work?
AG-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 AG-Telmisartan regularly even if you feel fine. Do not stop taking your medicine without talking to your healthcare professional.
What are the ingredients in AG-Telmisartan?
Medicinal ingredient: Telmisartan.
Non-medicinal ingredients: mannitol, meglumine, povidone, sodium hydroxide, sodium stearyl fumarate.
AG-Telmisartan comes in the following dosage form:
Tablets: 40 mg and 80 mg.
Do not use AG-Telmisartan if:
- you are allergic to telmisartan or to any non-medicinal ingredient in the formulation.
- you 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.
you are pregnant or intend to become pregnant. Taking AG-Telmisartan during pregnancy can cause injury and even death to your baby.
- you are breastfeeding. It is possible that AG-Telmisartan passes into breast milk.
- you are allergic to some sugars (mannitol intolerant).
- you are already taking a blood pressure-lowering medicine that contains aliskiren and you have diabetes or kidney disease.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take AG-Telmisartan. Talk about any health conditions or problems you may have, including 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 AG-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.
Other warnings you should know about:
Before you perform tasks which require special attention (driving a car or operating dangerous machinery), wait until you know how you respond to AG-Telmisartan. Vertigo, lightheadedness, or fainting can especially occur after the first dose and when the dose is increased.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with AG-Telmisartan:
- Blood pressure lowering drugs, including diuretics (“water pills”), aliskiren-containing products 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.
- Digoxin to treat many heart conditions.
- Warfarin, used to prevent blood clots (blood thinner).
How to take AG-Telmisartan:
Take AG-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 healthcare professional
- AG-Telmisartan tablets are for once-daily oral administration and should be swallowed whole with liquid.
Usual dose:
The recommended dose of AG-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 AG-Telmisartan, contact a healthcare professional, hospital emergency department, or regional poison control center 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.
What are possible side effects from using AG-Telmisartan?
These are not all the possible side effects you may have when taking AG-Telmisartan. If you experience any side effects not listed here, tell your healthcare professional . 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.
AG-Telmisartan can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.
Serious side effects and what to do about them
| Talk to your healthcare professional | Stop taking drug and | ||
| Symptom / effect | Only if severe | In all cases | get 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) | √ | ||
Hyponatraemia (decreased blood sodium): nausea, vomiting, abdominal cramps, agitation, confusion and hallucinations | √ | ||
Decreased Platelets: bruising, bleeding, fatigue and weakness | √ | ||
| 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 | √ |
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
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/adverse-reaction-reporting.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.
Storage:
Blister Pack: AG-Telmisartan tablets are protected from moisture. Tablets should be stored at room temperature, 15°C-30°C (59-86°F). Tablets should not be removed from blisters until immediately prior to administration.
Bottle Pack: Tablets should be stored and dispensed in original bottle at room temperature, 15°C-30°C (59-86°F). Protect from moisture.
Keep out of reach and sight of children and pets.
If you want more information about AG-Telmisartan:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication 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 calling the manufacturer, Angita Pharma Inc. at 450-449-9272.
Angita Pharma Inc.
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada