SYNJARDYXR(empagliflozin and metformin hydrochloride extended-release) tablets(三十四)
efield, CT 06877 USA
Marketed by:
Boehringer Ingelheim Pharmaceuticals, Inc.
Ridgefield, CT 06877 USA
and
Eli Lilly and Company
Indianapolis, IN 46285 USA
Licensed from:
Boehringer Ingelheim International GmbH, Ingelheim, Germany
Boehringer Ingelheim Pharmaceuticals, Inc. either owns or uses the Synjardy® and EMPA-REG OUTCOME® trademarks under license.
The other trademarks referenced are owned by third parties not affiliated with Boehringer Ingelheim Pharmaceuticals, Inc.
Copyright © 2016 Boehringer Ingelheim International GmbH
ALL RIGHTS RESERVED
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This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: December 2016
MEDICATION GUIDE
SYNJARDY® XR (sin-JAR-dee XR)
(empagliflozin and metformin hydrochloride extended-release)
Tablets
What is the most important information I should know about SYNJARDY XR?
Serious side effects can happen in people taking SYNJARDY XR, including:
Lactic Acidosis. Metformin, one of the medicines in SYNJARDY XR 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:
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
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 XR if you:
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
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 XR for a while if you have any of these things.
SYNJARDY XR can have other serious side effects. See “What are the possible side effects of SYNJARDY XR?”
What is SYNJARDY XR?
SYNJARDY XR is a prescription medicine that contains 2 prescription diabetes medicines, empagliflozin and metformin. SYNJARDY XR 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 XR is not for pe |
