KOMBIGLYZE XR 2.5 MG1000 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN

Available from:

ASTRAZENECA (ISRAEL) LTD

ATC code:

A10BA02

Pharmaceutical form:

FILM COATED TABLETS - EXTENDED RELEASE

Composition:

SAXAGLIPTIN 2.5 MG; METFORMIN HYDROCHLORIDE 1000 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

ASTRA ZENECA PHARMACEUTICALS LP, USA

Therapeutic area:

METFORMIN

Therapeutic indications:

KOMBIGLYZE XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate.

Authorization date:

2019-03-31

Patient Information leaflet

PATIENT PACKAGE LEAFLET IN ACCORDANCE WITH
THE PHARMACISTS’ REGULATIONS (PREPARATIONS) –1986
This medicine is dispensed with a doctor's prescription only
KOMBIGLYZE® XR 5 MG/1000 MG
EXTENDED-RELEASE TABLETS
COMPOSITION:
Each tablet contains:
5 mg saxagliptin
1000 mg metformin hydrochloride
KOMBIGLYZE® XR 2.5 MG/1000 MG
EXTENDED-RELEASE TABLETS
COMPOSITION:
Each tablet contains:
2.5 mg saxagliptin
1000 mg metformin hydrochloride
For inactive ingredients please see section 6 – “Further
Information”.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
Keep this leaflet; you may need it again. 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 you. Do not pass it on to
others. It may harm them, even if
it seems to you that their medical condition is similar.
THIS MEDICINE IS NOT INTENDED FOR CHILDREN AND ADOLESCENTS UNDER THE
AGE OF 18 YEARS.
VERY IMPORTANT INFORMATION TO KNOW BEFORE USING KOMBIGLYZE XR:
LACTIC ACIDOSIS AND PANCREATITIS – please see section 2 below,
“Special warnings regarding use
of this medicine”.
1.
WHAT IS THE MEDICINE INTENDED FOR?
Kombiglyze XR is intended to balance blood sugar levels in adult
patients (from 18 years and
above) with type 2 diabetes in combination with diet and exercise.
2.
BEFORE USING THE MEDICINE
X DO NOT USE THE MEDICINE IF:
•
you have type 1 diabetes
•
you have severe decreased renal function (your doctor will define your
renal disfunction level)
•
you have kidney function problems
•
you are sensitive to the active ingredients: metformin hydrochloride
or saxagliptin or to any of
the other ingredients of Kombiglyze XR (see section 6 “Further
Information”). Signs of a severe
allergic reaction (hypersensitivity) to Kombiglyze XR can include:
•
swelling of the face, lips, throat and other areas on the skin
•
difficulty breathing or swallowing
•
raised red marks on the skin (hives)
•
skin rash, itching, flakin

Summary of Product characteristics

THE CONTENT OF THIS LEAFLET WAS APPROVED BY THE MINISTRY OF HEALTH IN
JULY 2015 AND UPDATED
ACCORDING TO THE GUIDELINES OF THE MINISTRY OF HEALTH IN AUG 2019
KOMBIGLYZE XR (SAXAGLIPTIN AND METFORMIN HCL EXTENDED-RELEASE) TABLETS
2.5MG/1000MG
KOMBIGLYZE XR (SAXAGLIPTIN AND METFORMIN HCL EXTENDED-RELEASE) TABLETS
5MG/1000MG
1.
INDICATIONS AND USAGE
KOMBIGLYZE XR is indicated as an adjunct to diet and exercise to
improve glycemic control in adults
with type 2 diabetes mellitus when treatment with both saxagliptin and
metformin is appropriate. [See
_Clinical Studies (14)_
.]
1.1 LIMITATIONS OF USE
KOMBIGLYZE XR should not be used for the treatment of type 1 diabetes
mellitus or diabetic
ketoacidosis.
KOMBIGLYZE XR has not been studied in patients with a history of
pancreatitis. It is unknown whether
patients with a history of pancreatitis are at an increased risk for
the development of pancreatitis while
using KOMBIGLYZE XR. [See
_Warnings and Precautions (5.2)_
.
2.
DOSAGE AND ADMINISTRATION
2.1.
ADULTS WITH NORMAL RENAL FUNCTION (GLOMERULAR FILTRATION RATE [EGFR]
≥ 90
ML/MIN)
The dosage of KOMBIGLYZE XR should be individualized on the basis of
the patient’s current
regimen, effectiveness, and tolerability. KOMBIGLYZE XR should
generally be administered once daily
with the evening meal, with gradual dose titration to reduce the
gastrointestinal side effects associated
with metformin. The following dosage forms are available:
•
KOMBIGLYZE XR (saxagliptin and metformin HCl extended-release) tablets
5 mg/1000 mg
•
KOMBIGLYZE XR (saxagliptin and metformin HCl extended-release) tablets
2.5 mg/1000 mg
WARNING: LACTIC ACIDOSIS
•
POST-MARKETING 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