Patient Medication Information: uses, side effects, how to take - Act Telmisartan

ABOUT THIS MEDICATION

What the medication is used for:

To treat high blood pressure

What it does:

ACT 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 ACT TELMISARTAN regularly even if you feel fine.

When it should not be used:

Do not take ACT TELMISARTAN if you:

Are allergic to telmisartan or to any non-
medicianl 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 ACT TELMISARTAN during pregnancy can cause injury and even death to your baby.
Are breastfeeding. It is possible that
ACT TELMISARTAN passes into breast milk.
Are allergic to some sugars (mannitol
intolerant).

What the medicinal ingredient is:

Telmisartan

What the important nonmedicinal ingredients are: Crospovidone, magnesium stearate, mannitol, meglumine, povidone, sodium hydroxide and talc.

If you are on a special diet, or if you are allergic to any substance, ask your doctor or pharmacist whether any of these ingredients may cause a problem for you.

What dosage forms it comes in: Tablets in 40 mg and 80 mg strengths

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions - Pregnancy

ACT TELMISARTAN should not be used during pregnancy. If you discover that you are pregnant while taking ACT TELMISARTAN, stop the medication and please contact your doctor, nurse, or pharmacist as soon as possible.

BEFORE you use ACT 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 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 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 ACT 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, interaction with other drugs is 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 ACT TELMISARTAN:

Blood pressure lowering drugs, including diuretics (“water pills”).
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).

ACT TELMISARTAN Product Monograph Page 29 of 30

PROPER USE OF THIS MEDICATION

Take ACT 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 ACT TELMISARTAN is 80 mg once daily. Your doctor may prescribe 40 mg once daily if you have liver disease.

Overdose:

If you think you have taken too much ACT TELMISARTAN 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:

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.

ACT 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
Symptom / effect		Only if severe	In all cases	Stop taking drug and seek immediate medical help
Very Common	Chest pain		✓
Common	Low Blood Pressure: Dizziness, Fainting, lightheadedness	✓
Common	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		✓

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
Symptom / effect		Only if severe	In all cases
Rare	Liver disorder: Yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite		✓
Rare	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 ACT TELMISARTAN, contact your doctor, nurse or pharmacist.

HOW TO STORE IT

ACT TELMISARTAN tablets should be stored at room temperature (15°C - 30°C). Tablets should not be removed from blisters until immediately prior to administration. Avoid excessive heat and moisture.

Keep out of reach of children and pets.

REPORTING SUSPECTED 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:

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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 MedEffect^™Canada Web site at www.healthcanada.gc.ca/medeffect.