Tradjenta - Consumer Medicine Information
|Manufacture:||Boehringer Ingelheim Pharmaceuticals, Inc.|
|Condition:||Diabetes, Type 2|
|Class:||Dipeptidyl peptidase 4 inhibitors|
|Ingredients:||linagliptin, mannitol, pregelatinised starch, maize starch, copovidone, magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide, talc, macrogol, iron oxide red|
About this medication
What the medication is used for
TRAJENTA, along with diet and exercise to improve control of blood sugar in adults with type 2 diabetes, is used:
- alone in patients who cannot take metformin, or
- in combination with metformin, or
- in combination with a sulfonylurea, or
- in combination with metformin and a sulfonylurea
What it does
TRAJENTA is a member of a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors). TRAJENTA helps to improve the levels of insulin when blood sugar level is high, especially after a meal. TRAJENTA also helps to decrease the amount of sugar made by the body.
When it should not be used
You should not take TRAJENTA if:
- you are allergic (hypersensitive) to linagliptin or any of the non-medicinal ingredients listed below.
- you have type 1 diabetes (your body does not produce any insulin) or diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss, nausea or vomiting).
What the medicinal ingredient is
What the important non-medicinal ingredients are
TRAJENTA tablets contain the following non-medicinal ingredients: mannitol, pregelatinised starch, maize starch, copovidone, magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide, talc, macrogol, iron oxide red.
What dosage forms it comes in
TRAJENTA is supplied as tablets containing 5 mg linagliptin. The tablets are round, light red in colour and have the marking “D5”on one side.
Warnings and precautions
BEFORE you use TRAJENTA talk to your doctor or pharmacist if:
- you are taking insulin because TRAJENTA is not approved for use with insulin;
- you are taking an anti-diabetic medicine known as ‘sulfonylurea’, your doctor may want to reduce your dose of sulfonylurea when you take it together with TRAJENTA in order to avoid low blood sugar;
- you have had allergic reactions to any other medicines that you take to control the amount of sugar in your blood;
- you are pregnant or planning to become pregnant;
- you are breast-feeding or plan to breast-feed;
- you have or have had pancreas problems such as inflammation of the pancreas (pancreatitis);
- you have congestive heart failure or any heart problems;
- you have any skin problems;
- you have liver problems.
TRAJENTA is not recommended for children and adolescents under 18 years.
Interactions with this medication
Talk to your doctor or pharmacist about all the medicines you take. This includes prescription and non-prescription medicines, and herbal supplements.
Proper use of this medication
The adult dose is one 5 mg tablet, once daily, taken with or without food.
|In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.|
- If you forget to take a dose of TRAJENTA, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose.
- Do not take a double dose to make up for a forgotten dose. Never take two doses on the same day.
Side effects and what to do about them
Like all medicines, TRAJENTA can cause side effects. Side effects with TRAJENTA include:
- Low blood sugar (hypoglycemia) when taken with a sulfonylurea. You should stop taking TRAJENTA and see your doctor immediately if you experience symptoms of low blood sugar such as trembling, sweating, anxiety, blurred vision, tingling lips, paleness, mood change, vagueness or confusion.
- Inflamed nose or throat (nasopharyngitis)
- High blood triglyceride
- Severe allergic reaction (hypersensitivity)
- Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema)
- Hives or nettle rash (urticaria)
- Inflammation of pancreas (pancreatitis)
- Mouth ulceration
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
This is not a complete list of side effects. For any unexpected effects while taking TRAJENTA, contact your doctor or pharmacist.
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 call your doctor or pharmacist|
|Only if severe||In all cases|
|Very Common||Hypoglycemia(when used witha sulfonylurea)||√||√|
|Uncommon||Allergic reactions including such symptoms as hives, and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing (angioedema, urticaria), and wheezing and shortness of breath (bronchial hyperreactivity)||√||√|
|Rare||Pancreatitis: symptoms of pancreatitis (prolonged severe abdominal pain which may be accompanied by vomiting)||√||√|
How to store it
Store at room temperature (15 - 30°C).
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:
- 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
Postal Locator 0701E
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Forms and the adverse reaction reporting guidelines are available on the MedEffect™ 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.
This document plus the full product monograph, prepared for health professionals can be found at: http://www.boehringer-ingelheim.ca or by contacting the sponsor, Boehringer Ingelheim (Canada) Ltd., at: 1-800-263-5103, ext. 84633 (Medical Information).
Please check our website to see if more up-to-date information has been posted.