|What is the
most important information I should know about SYNJARDY?
Serious side effects can happen in people taking SYNJARDY, including:
Lactic Acidosis. Metformin, one of the medicines in SYNJARDY
can cause a rare but serious condition called lactic acidosis (a build-up
of lactic acid in the blood) that can cause death. Lactic acidosis
is a medical emergency and must be treated in a hospital.
Call your doctor right away if you have any of the following
symptoms, which could be signs of lactic acidosis:
Most people who have had lactic acidosis with metformin have
other things that, combined with metformin, led to the lactic acidosis.
Tell your doctor if you have any of the following, because you have
a higher chance for getting lactic acidosis with SYNJARDY if you:
- you feel cold in your hands or feet
- you feel dizzy or lightheaded
- you have a slow or irregular heartbeat
- you feel very weak or tired
- you have unusual (not normal) muscle pain
- you have trouble breathing
- you feel sleepy or drowsy
- you have stomach pains, nausea or vomiting
The best way to keep from having a problem with lactic acidosis
from metformin is to tell your doctor if you have any of the problems
in the list above. Your doctor may decide to stop your SYNJARDY for
a while if you have any of these things.
- have moderate to severe kidney problems or your kidneys
are affected by certain x-ray tests that use injectable dye.
- have liver problems
- drink alcohol very often, or drink a lot of alcohol in the
short-term (“binge” drinking)
- get dehydrated (lose a large amount of body fluids). This
can happen if you are sick with a fever, vomiting, or diarrhea. Dehydration
can also happen when you sweat a lot with activity or exercise and
do not drink enough fluids.
- have surgery
- have a heart attack, severe infection, or stroke
SYNJARDY can have
other serious side effects. See “What are the possible side
effects of SYNJARDY?”
|What is SYNJARDY?
- SYNJARDY is a prescription medicine that contains 2 prescription
diabetes medicines, empagliflozin and metformin. SYNJARDY can be used:
- along with diet and exercise to improve blood sugar in adults
with type 2 diabetes,
- in adults with type 2 diabetes who have known cardiovascular
disease when both empagliflozin and metformin is appropriate and empagliflozin
is needed to reduce the risk of cardiovascular death.
- SYNJARDY is not for people with type 1 diabetes.
- SYNJARDY is not for people with diabetic ketoacidosis (increased
ketones in the blood or urine).
- It is not known if SYNJARDY is safe and effective in children
under 18 years of age.
not take SYNJARDY?
Do not take SYNJARDY if
- have moderate to severe kidney problems or are on dialysis
- have a condition called metabolic acidosis or diabetic ketoacidosis
(increased ketones in the blood or urine)
- are allergic to empagliflozin, metformin, or any of the
ingredients in SYNJARDY. See the end of this Medication Guide for
a list of ingredients in SYNJARDY.
I tell my doctor before using SYNJARDY?
taking SYNJARDY, tell your healthcare provider about all of your medical
conditions, including if you:
Tell your healthcare provider about all the medicines you
take, including prescription or over-the-counter medicines, vitamins,
or herbal supplements.
- have moderate to severe kidney problems
- have liver problems
- have a history of urinary tract infection or problems with
- have heart problems, including congestive heart failure
- are going to have surgery
- are eating less due to illness, surgery, or a change in your
- have or have had problems with your pancreas, including
pancreatitis or surgery on your pancreas
- drink alcohol very often, or drink a lot of alcohol in the
short term (“binge” drinking)
- are going to get an injection of dye or contrast agents
for an x-ray procedure. SYNJARDY may need to be stopped for a short
time. Talk to your doctor about when you should stop SYNJARDY and
when you should start SYNJARDY again.
is the most important information I should know about SYNJARDY?”
- have type 1 diabetes. SYNJARDY should not be used to treat
people with type 1 diabetes.
- have any other medical conditions
- are pregnant or plan to become pregnant. SYNJARDY may harm
your unborn baby. If you become pregnant while taking SYNJARDY, tell
your doctor as soon as possible. Talk with your doctor about the best
way to control your blood sugar while you are pregnant.
- are a premenopausal woman (before the “change of life”),
who does not have periods regularly or at all. Talk to your doctor
about birth control choices while taking SYNJARDY if you are not planning
to become pregnant since SYNJARDY may increase your chance of becoming
pregnant. Tell your doctor right away if you become pregnant while
- are breastfeeding or plan to breastfeed. SYNJARDY may pass
into your breast milk and may harm your baby. Talk with your doctor
about the best way to feed your baby if you are taking SYNJARDY. Do
not breastfeed while taking SYNJARDY.
I take SYNJARDY?
- Take SYNJARDY exactly as your doctor tells you to take it.
- Take SYNJARDY by mouth 2 times each day with meals. Taking
SYNJARDY with meals may lower your chance of having an upset stomach.
- Your doctor will tell you how much SYNJARDY to take and
when to take it.
- Your doctor may change your dose if needed.
- 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 SYNJARDY at the same time. Talk with your doctor if you have
questions about a missed dose.
- Your doctor may tell you to take SYNJARDY along with other
diabetes medicines. Low blood sugar can happen more often when SYNJARDY
is taken with certain other diabetes medicines. See “What are
the possible side effects of SYNJARDY?”
- If you take too much SYNJARDY, call your doctor 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.
- When taking SYNJARDY, you may have sugar in your urine,
which will show up on a urine test.
- Stay on your prescribed diet and exercise program while
- Talk to your doctor about how to prevent, recognize and
manage low blood sugar (hypoglycemia), high blood sugar (hyperglycemia),
and complications of diabetes.
- Your doctor will check your diabetes with regular blood
tests, including your blood sugar levels and your hemoglobin A1C.
- Your doctor will do blood tests to check how well your kidneys
are working before and during your treatment with SYNJARDY.
- Your doctor may do certain blood tests before you start
SYNJARDY and during treatment.
I avoid while taking SYNJARDY?
Avoid drinking alcohol
very often, or drinking a lot of alcohol in a short period of time
(“binge” drinking). It can increase your chances of getting serious
|What are the possible
side effects of SYNJARDY?
SYNJARDY may cause
serious side effects, including:
- See “What is the most important information I should
know about SYNJARDY?”
Dehydration. SYNJARDY can cause some people
to have dehydration (the loss of body water and salt). Dehydration
may cause you to feel dizzy, faint, light-headed, or weak, especially
when you stand up (orthostatic hypotension).
You may be
at higher risk of dehydration if you:
- have low blood pressure
- have kidney problems
- are 65 years of age or older
- are on low sodium (salt) diet
- take medicines to lower your blood pressure, including diuretics
Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis has happened in people who have type 1 diabetes
or type 2 diabetes, during treatment with empagliflozin, one
of the medicines in SYNJARDY. Ketoacidosis is a serious condition,
which may need to be treated in a hospital. Ketoacidosis may lead
to death. Ketoacidosis can happen with SYNJARDY even if your
blood sugar is less than 250 mg/dL. Stop taking SYNJARDY and call
your doctor right away if you get any of the following symptoms:
- stomach-area (abdominal) pain
- trouble breathing
If you get any of these symptoms during
treatment with SYNJARDY, if possible, check for ketones in your urine,
even if your blood sugar is less than 250 mg/dL.
Kidney problems. Sudden kidney injury has happened
to people taking SYNJARDY. Talk to your doctor right away if you:
- reduce the amount of food or liquid you drink for example,
if you are sick or cannot eat or
- start to lose liquids from your body for example, from vomiting,
diarrhea or being in the sun too long
Serious urinary tract infections. Serious urinary
tract infections that may lead to hospitalization have happened in
people who are taking empagliflozin, one of the medicines in SYNJARDY.
Tell your doctor if you have any signs or symptoms of a urinary tract
infection such as a burning feeling when passing urine, a need to
urinate often, the need to urinate right away, pain in the lower part
of your stomach (pelvis), or blood in the urine. Sometimes people
also may have a fever, back pain, nausea or vomiting.
Low blood sugar (hypoglycemia). If you take
SYNJARDY 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 SYNJARDY. Signs and symptoms of low blood
sugar may include:
- fast heartbeat
- shaking or feeling jittery
A rare but serious bacterial infection that causes
damage to the tissue under the skin (necrotizing fasciitis) in the
area between and around the anus and genitals (perineum). Necrotizing fasciitis of the perineum has happened in women and men
who take empagliflozin, one of the medicines in SYNJARDY. Necrotizing
fasciitis of the perineum may lead to hospitalization, may require
multiple surgeries, and may lead to death. Seek medical attention
immediately if you have a fever or you are feeling very weak, tired
or uncomfortable (malaise), and you develop any of the following symptoms
in the area between and around your anus and genitals:
- redness of skin (erythema)
The most common side effects of SYNJARDY include
stuffy or runny nose and sore throat.
Vaginal yeast infection. Women who take SYNJARDY
may get vaginal yeast infections. Symptoms of a vaginal yeast infection
include vaginal odor, white or yellowish vaginal discharge (discharge
may be lumpy or look like cottage cheese), or vaginal itching.
Yeast infection of the penis (balanitis).
Men who take SYNJARDY may get a yeast infection of the skin around
the penis. Certain men who are not circumcised may have swelling of
the penis that makes it difficult to pull back the skin around the
tip of the penis. Other symptoms of yeast infection of the penis include
redness, itching, or swelling of the penis, rash of the penis, foul
smelling discharge from the penis, or pain in the skin around the
Talk to your doctor about what to do if you
get symptoms of a yeast infection of the vagina or penis. Your
doctor may suggest you use an over-the-counter antifungal medicine.
Talk to your doctor right away if you use an over-the-counter antifungal
medication and your symptoms do not go away.
Allergic (hypersensitivity) reactions. Serious
allergic reactions have happened in people who are taking empagliflozin,
one of the medicines in SYNJARDY. Symptoms may include:
- swelling of your face, lips, throat and other areas of your
- difficulty with swallowing or breathing.
- raised, red areas on your skin (hives)
If you have any of these symptoms, stop taking
SYNJARDY and call your doctor right away or go to the nearest hospital
Low vitamin B12 (vitamin B12 deficiency). Using metformin for long periods
of time may cause a decrease in the amount of vitamin B12 in your blood, especially if you have had low vitamin
B12 blood levels before. Your doctor may do
blood tests to check your vitamin B12 levels.
Increased fats in your blood (cholesterol)
These are not all
the possible side effects of SYNJARDY. For more information, ask your
doctor or pharmacist.
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 SYNJARDY?
Store SYNJARDY at room temperature 68°F to 77°F (20°C
General information about the safe
and effective use of SYNJARDY.
Medicines are sometimes
prescribed for purposes other than those listed in a Medication Guide.
Do not use SYNJARDY for a condition for which it was not prescribed.
Do not give SYNJARDY to other people, even if they have the same symptoms
that you have. It may harm them.
This Medication Guide
summarizes the most important information about SYNJARDY. If you would
like more information, talk with your doctor. You can ask your pharmacist
or healthcare provider for information about SYNJARDY that is written
for health professionals.
What are the ingredients in SYNJARDY?
Active Ingredients: empagliflozin and metformin hydrochloride
Ingredients: copovidone, corn starch, colloidal silicon dioxide,
magnesium stearate. In addition, the film coating contains the following
inactive ingredients: hypromellose, titanium dioxide, talc, and polyethylene
glycol 400. 5 mg/500 mg and 5 mg/1000 mg tablets also contain yellow
ferric oxide;12.5 mg/500 mg and 12.5 mg/1000 mg tablets also contain
red ferric oxide and black ferrosoferric oxide
Distributed by: Boehringer Ingelheim Pharmaceuticals,
Inc.; Ridgefield, CT 06877 USA
Boehringer Ingelheim Pharmaceuticals, Inc.; Ridgefield, CT 06877 USA
and Eli Lilly and Company, Indianapolis, IN 46285 USA
from: Boehringer Ingelheim International GmbH, Ingelheim, Germany
Boehringer Ingelheim Pharmaceuticals,
Inc. either owns or uses the Synjardy® and EMPA-REG OUTCOME® trademarks under
license.Copyright © 2018 Boehringer Ingelheim International
The other trademarks referenced are owned by third
parties not affiliated with Boehringer Ingelheim Pharmaceuticals,
ALL RIGHTS RESERVED
For more information
about SYNJARDY including current prescribing information and Medication
Guide, go to www.synjardy.com, scan the adjacent
code, or call
Boehringer Ingelheim Pharmaceuticals, Inc.
at 1-800-542-6257 or (TTY) 1-800-459-9906.