Patient Medication Information: uses, side effects, how to take - Septa-Telmisartan
ABOUT THIS MEDICATION
What the medication is used for:
- To treat high blood pressure
What it does:
SEPTA-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 SEPTA-TELMISARTAN regularly even if you feel fine.
When it should not be used:
Do not take SEPTA-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
SEPTA-TELMISARTAN during pregnancy can cause injury and even death to your baby.
Are breastfeeding. It is possible that SEPTA-
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 non-medicinal ingredients are:
mannitol, sodium hydroxide, meglumine, povidone, sodium stearyl fumarate, and magnesium stearate.
What dosage forms it comes in:
Tablets: 40 mg and 80 mg.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions - Pregnancy
SEPTA-TELMISARTAN should not be used during pregnancy. If you discover that you are pregnant while taking SEPTA-TELMISARTAN, stop the medication and please contact your doctor, nurse, or pharmacist as soon as possible.
Before you use SEPTA-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 SEPTA-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 SEPTA-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 SEPTA-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 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 SEPTA-TELMISARTAN exactly as prescribed. It is recommended to take your dose at about the same time every day 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 dose:
The recommended dose of SEPTA-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 SEPTA-
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.
SEPTA-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 or pharmacist | Stop taking drug and seek immediate medical help | ||||
| Only if severe | In all cases | |||||
Very Common | Chest pain | √ | ||||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN | ||||||
| AND WHAT TO DO ABOUT THEM | ||||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and seek immediate medical help | ||||
| Only if severe | In all cases | |||||
| Common | Low Blood Pressure: dizziness, fainting, lightheadedness | √ | ||||
| Shortness of breath | √ | |||||
| Un-common | 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) | √ | |||||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN | ||||||
| AND WHAT TO DO ABOUT THEM | ||||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and seek immediate medical help | ||||
| Only if severe | In all cases | |||||
| Unknown | 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 SEPTA-TELMISARTAN, contact your doctor, nurse or pharmacist.
HOW TO STORE IT
SEPTA-TELMISARTAN tablets should be stored at room temperature (15°C -30°C). Tablets should not be removed from blisters or 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 help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
Online at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-
eng.php);
- By calling 1-866-234-2345 (toll-free);
By completing a Consumer Side Effect Reporting Form and sending
it by:
- Fax to 1-866-678-6789 (toll-free), or
Mail to: Canada Vigilance Program
Health Canada, Postal Locator 0701E Ottawa, ON
K1A 0K9
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php).
NOTE: Contact your health professiona if you need information about how to manage your side effects. 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 at:
www.septapharmaceuticals.com or by contacting the sponsor, Septa Pharmaceuticals, Inc. at: 905-564-5665
Please check our website to see if more up-to-date information has been posted.
Septa Pharmaceuticals Inc.
7490 Pacific Circle, Unit # 1
Mississauga, ON
L5T 2A3