XIGDUO XR 5 MG1000 MG

Land: Israël

Taal: Engels

Bron: Ministry of Health

Werkstoffen:

DAPAGLIFLOZIN PROPANEDIOL; METFORMIN HYDROCHLORIDE

Beschikbaar vanaf:

ASTRAZENECA (ISRAEL) LTD

ATC-code:

A10BD15

farmaceutische vorm:

TABLETS EXTENDED RELEASE

Samenstelling:

METFORMIN HYDROCHLORIDE 1005.04 MG; DAPAGLIFLOZIN PROPANEDIOL 6.150 MG

Toedieningsweg:

PER OS

Prescription-type:

Required

Geproduceerd door:

BRISTOL-MYERS SQUIBB MANUFACTURING COMPANY, PUERTO RICO

Therapeutisch gebied:

METFORMIN AND DAPAGLIFLOZIN

therapeutische indicaties:

XIGDUO XR (dapagliflozin and metformin HCl extended-release) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate.שינוי משטר מינון 2/4/2019Patients with Renal Impairment

Autorisatie datum:

2017-11-09

Bijsluiter

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
XIGDUO
® XR 5 MG/500 MG
EXTENDED-RELEASE TABLETS
COMPOSITION:
Each tablet contains:
Dapagliflozin 5 mg
Metformin hydrochloride 500 mg
XIGDUO
® XR 5 MG/1000 MG
EXTENDED-RELEASE TABLETS
COMPOSITION:
Each tablet contains:
Dapagliflozin 5 mg
Metformin hydrochloride 1000 mg
XIGDUO
® XR 10 MG/500 MG
EXTENDED-RELEASE TABLETS
COMPOSITION:
Each tablet contains:
Dapagliflozin 10 mg
Metformin hydrochloride 500 mg
XIGDUO
® XR 10 MG/1000 MG
EXTENDED-RELEASE TABLETS
COMPOSITION:
Each tablet contains:
Dapagliflozin 10 mg
Metformin hydrochloride 1000 mg
For inactive ingredients, please see section 6 – “Further
Information”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
Keep this leaflet, as you may need to read it later.
This leaflet contains concise information about the medicine. If you
have further questions,
refer to the doctor or pharmacist.
This medicine has been prescribed for the treatment of your ailment.
Do not pass it on to
others. It may harm them even if it seems to you that their ailment is
similar.
•
Xigduo XR may cause serious side effects, including lactic acidosis -
please see section
2 “Special warnings regarding use of Xigduo XR”.
•
Xigduo XR is not intended for type 1 diabetes patients.
•
Xigduo XR is not intended for patients with diabetic ketoacidosis
(increased ketones in
blood or urine).
•
Xigduo XR is not intended for children and adolescents under 18 years
of age.
1. WHAT IS THE MEDICINE INTENDED FOR?
Xigduo XR is given to treat type 2 diabetes in adults (18 years of age
and over), in
combination with diet and exercise
. Xigduo XR is intended to improve control of blood
sugar levels, when treatment with dapagliflozin or metformin alone
have not brought
to controlled blood sugar levels.
THERAPEUTIC GROUP:
Dapagliflozin – inhibitor of the SGLT2 sugar carrier in the kidney,
which inhibits reuptake of
gl

Productkenmerken

XIGDUO XR (DAPAGLIFLOZIN AND METFORMIN HCL EXTENDED-RELEASE) TABLETS,
FOR ORAL USE
XIGDUO XR 5MG/500MG EXTENDED RELEASE TABLETS
XIGDUO XR 5MG/1000MG EXTENDED RELEASE TABLETS
XIGDUO XR 10MG/500MG EXTENDED RELEASE TABLETS
XIGDUO XR 10MG/1000MG EXTENDED RELEASE TABLETS
WARNING: LACTIC ACIDOSIS
•
Postmarketing cases of metformin-associated lactic acidosis have
resulted in death, hypothermia,
hypotension, and resistant bradyarrhythmias. The onset of
metformin-associated lactic acidosis is often
subtle, accompanied only by nonspecific symptoms such as malaise,
myalgias, respiratory distress,
somnolence, and abdominal pain. Metformin-associated lactic acidosis
was characterized by elevated
blood lactate levels (>5 mmol/L), anion gap acidosis (without evidence
of ketonuria or ketonemia), an
increased lactate/pyruvate ratio; and metformin plasma levels
generally >5 mcg/mL [see Warnings and
Precautions (5.1)].
• Risk factors for metformin-associated lactic acidosis include
renal impairment, concomitant use of
certain drugs (e.g., carbonic anhydrase inhibitors such as
topiramate), age 65 years old or greater, having
a radiological study with contrast, surgery and other procedures,
hypoxic states (e.g., acute congestive
heart failure), excessive alcohol intake, and hepatic impairment.
• Steps to reduce the risk of and manage metformin-associated lactic
acidosis in these high risk groups
are provided in the full prescribing information [see Dosage and
Administration (2.2), Contraindications
(4), Warnings and Precautions (5.1), Drug Interactions (7), and Use in
Specific Populations (8.6, 8.7)].
• If metformin-associated lactic acidosis is suspected, immediately
discontinue XIGDUO XR and
institute general supportive measures in a hospital setting. Prompt
hemodialysis is recommended [see
Warnings and Precautions (5.1)].
. 1. THERAPEUTIC INDICATIONS
XIGDUO XR (dapagliflozin and metformin HCl extended-release) is
indicated as an adjunct to diet and
exercise to improve glycemic control in adults with type 2 diabetes
mellitu