TRADJENTA® (TRAD gen ta)
this Medication Guide carefully before you start taking TRADJENTA
and each time you get a refill. There may be new information. This
information does not take the place of talking to your doctor about
your medical condition or your treatment. If you have any questions
about TRADJENTA, ask your doctor or pharmacist.
What is the most important information I should
know about TRADJENTA?
Serious side effects can happen to people taking TRADJENTA, including inflammation of the pancreas (pancreatitis) which may be
severe and lead to death.
medical problems make you more likely to get pancreatitis.
Before you start taking
your doctor if you have ever had:
- inflammation of your pancreas (pancreatitis)
- stones in your gallbladder (gallstones)
- a history of alcoholism
- high blood triglyceride levels
- Stop taking TRADJENTA and call your
doctor right away if you have pain in your stomach area (abdomen)
that is severe and will not go away. The pain may be felt going from
your abdomen through to your back. The pain may happen with or without
vomiting. These may be symptoms of pancreatitis.
What is TRADJENTA?
- TRADJENTA is a prescription medicine used along with diet
and exercise to lower blood sugar in adults with type 2 diabetes.
- TRADJENTA is not for people with type 1 diabetes.
- TRADJENTA is not for people with diabetic ketoacidosis (increased
ketones in the blood or urine).
- If you have had pancreatitis in the past, it is not known
if you have a higher chance of getting pancreatitis while you take
It is not known if TRADJENTA is safe
and effective in children under 18 years of age.
Who should not take TRADJENTA?
Do not take TRADJENTA
- are allergic to linagliptin or any of the ingredients in
TRADJENTA. See the end of this Medication Guide for a complete list
of ingredients in TRADJENTA.
Symptoms of a serious
allergic reaction to TRADJENTA may include:
- skin rash, itching, flaking or peeling
- raised red patches on your skin (hives)
- swelling of your face, lips, tongue and throat that may
cause difficulty in breathing or swallowing
- difficulty with swallowing or breathing
If you have any of
these symptoms, stop taking TRADJENTA and contact your doctor or go
to the nearest hospital emergency room right away.
What should I tell my doctor before
Before you take TRADJENTA, tell your doctor
- have or have had inflammation of your pancreas (pancreatitis).
- have any other medical conditions
- are pregnant or plan to become pregnant. It is not known
if TRADJENTA will harm your unborn baby. If you are pregnant, talk
with your doctor about the best way to control your blood sugar while
you are pregnant.
- are breastfeeding or plan to breastfeed. It is not known
if TRADJENTA passes into your breast milk. Talk with your doctor about
the best way to feed your baby if you take TRADJENTA.
Tell your doctor about
all the medicines you take, including prescription
and non-prescription medicines, vitamins, and herbal supplements.
TRADJENTA may affect the way other medicines work,
and other medicines may affect how TRADJENTA works.
Especially tell your doctor if you take
Ask your doctor or pharmacist for a list of these medicines
if you are not sure if your medicine is one that is listed above.
- other medicines that can lower your blood sugar
- rifampin (Rifadin®, Rimactane®, Rifater®, Rifamate®)*, an
antibiotic that is used to treat tuberculosis
Know the medicines you take. Keep a list of them and
show it to your doctor and pharmacist when you get a new medicine.
How should I take
- Take 1 tablet 1 time each day with or without food.
- Your doctor will tell you when to take TRADJENTA.
- Talk with your doctor if you do not understand how to take
- If you miss a dose, take it as soon as you remember. If
you do not remember until it is time for your next dose, skip the
missed dose and go back to your regular schedule. Do not take two
doses of TRADJENTA at the same time.
- Your doctor may tell you to take TRADJENTA along with other
diabetes medicines. Low blood sugar can happen more often when TRADJENTA
is taken with certain other diabetes medicines. See “What are
the possible side effects of TRADJENTA?”
- If you take too much TRADJENTA, call your doctor or Poison
Control Center at 1-800-222-1222 or go to the nearest hospital emergency
room right away.
- When your body is under some types of stress, such as fever,
trauma (such as a car accident), infection, or surgery, the amount
of diabetes medicine that you need may change. Tell your doctor right
away if you have any of these conditions and follow your doctor's
- Check your blood sugar as your doctor tells you to.
- Stay on your prescribed diet and exercise program while
- Your doctor will check your diabetes with regular blood
tests, including your blood sugar levels and your hemoglobin A1C.
What are the possible
side effects of TRADJENTA?
TRADJENTA may cause serious side effects,
- See “What is the most important information I should
know about TRADJENTA?”
low blood sugar (hypoglycemia). If you take TRADJENTA with another medicine that can cause
low blood sugar, such as a sulfonylurea or insulin, your risk of getting
low blood sugar is higher. The dose of your sulfonylurea medicine
or insulin may need to be lowered while you take TRADJENTA. Signs
and symptoms of low blood sugar may include:
- fast heart beat
- feeling jittery
Allergic (hypersensitivity) reactions. Serious
allergic reactions can happen after your first dose or up to 3 months
after starting TRADJENTA. Symptoms may include:
- swelling of your face, lips, throat, and other areas on
- difficulty with swallowing or breathing
- raised, red areas on your skin (hives)
- skin rash, itching, flaking, or peeling
have these symptoms, stop taking TRADJENTA and call your doctor or
go to the nearest hospital emergency room right away.
The most common side effects of TRADJENTA
- stuffy or runny nose and sore throat
These are not all the possible side
effects of TRADJENTA. For more information, ask your doctor or pharmacist.
Tell your doctor if you have any side effect
that bothers you or that does not go away.
Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088.
How should I store TRADJENTA?
- Store TRADJENTA between 68°F and 77°F (20°C and 25°C).
Keep TRADJENTA and
all medicines out of the reach of children.
General information about
the safe and effective use of TRADJENTA.
Medicines are sometimes prescribed for
purposes other than those listed in Medication Guides. Do not use
TRADJENTA for a condition for which it was not prescribed. Do not
give TRADJENTA to other people, even if they have the same symptoms
you have. It may harm them.
Medication Guide summarizes the most important information about TRADJENTA.
If you would like more information, talk with your doctor. You can
ask your pharmacist or doctor for information about TRADJENTA that
is written for health professionals.
For more information, go to www.TRADJENTA.com or call Boehringer
Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257, or (TTY) 1-800-459-9906.
What are the ingredients
Active Ingredient: linagliptin
Inactive Ingredients: mannitol, pregelatinized starch, corn starch,
copovidone, and magnesium stearate. The film coating contains the
following inactive ingredients: hypromellose, titanium dioxide, talc,
polyethylene glycol, and red ferric oxide.
What is type 2 diabetes?
Type 2 diabetes is a
condition in which your body does not make enough insulin, and/or
the insulin that your body produces does not work as well as it should.
Your body can also make too much sugar. When this happens, sugar (glucose)
builds up in the blood. This can lead to serious medical problems.
The main goal of treating diabetes is to
lower your blood sugar to a normal level. High blood sugar can be
lowered by diet and exercise, and by certain medicines when necessary.
Talk to your doctor about how to prevent,
recognize, and take care of low blood sugar (hypoglycemia), high blood
sugar (hyperglycemia), and other problems you have because of your
This Medication Guide
has been approved by the U. S. Food and Drug Administration.
Ingelheim Pharmaceuticals, Inc.
Ridgefield, CT 06877
Ingelheim Pharmaceuticals, Inc.
Ridgefield, CT 06877 USA
Eli Lilly and Company
IN 46285 USA
Boehringer Ingelheim International GmbH
*The brands listed are trademarks
of their respective owners and are not trademarks of Boehringer Ingelheim
Pharmaceuticals, Inc. The makers of these brands are not affiliated
with and do not endorse Boehringer Ingelheim Pharmaceuticals, Inc.,
or its products.
2014 Boehringer Ingelheim International GmbH
Boehringer Ingelheim Pharmaceuticals, Inc.