JANUET XR 501000 MG TABLETS

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

METFORMIN HYDROCHLORIDE; SITAGLIPTIN AS PHOSPHATE SALT

متاح من:

MERCK SHARP & DOHME (ISRAEL - 1996) COMPANY LTD, ISRAEL

ATC رمز:

A10BA02

الشكل الصيدلاني:

TABLETS EXTENDED RELEASE

تركيب:

SITAGLIPTIN AS PHOSPHATE SALT 50 MG; METFORMIN HYDROCHLORIDE 1000 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

MERCK SHARP & DOHME LLC, USA

المجال العلاجي:

METFORMIN

الخصائص العلاجية:

Januet 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 sitagliptin and metformin extended-release is appropriate

تاريخ الترخيص:

2019-01-31

نشرة المعلومات

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS'
REGULATIONS (PREPARATIONS) – 1986
This medicine is marketed upon physician’s prescription only
JANUET
® XR 50 MG/500 MG
EXTENDED-RELEASE TABLETS
Each extended-release tablet contains:
Sitagliptin (as phosphate salt) 50 mg
Metformin hydrochloride (extended release) 500 mg
JANUET
® XR 50 MG/1000 MG
EXTENDED-RELEASE TABLETS
Each extended-release tablet contains:
Sitagliptin (as phosphate salt) 50 mg
Metformin Hydrochloride (extended release) 1000 mg
JANUET
® XR 100 MG/1000 MG
EXTENDED-RELEASE TABLETS
Each extended-release tablet contains:
Sitagliptin (as phosphate salt) 100 mg
Metformin Hydrochloride (extended release) 1000 mg
For a list of inactive ingredients please refer to section 6
“Further information”. See also section 2.7
“Important information about some of the ingredients of the
medicine".
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE.
•
This leaflet contains concise information about JANUET XR. If you have
any 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 ailment is similar
•
This medicine is not intended for administration to children under 18
years of age
1. WHAT JANUET XR IS INTENDED FOR?
1.1 WHAT IS JANUET XR?
THERAPEUTIC GROUP
:
Sitagliptin: DPP-4 enzyme inhibitor. Metformin: biguanide.
1.2 WHAT IS JANUET XR USED FOR?
JANUET XR is a tablet that contains two prescription diabetes
medicines, sitagliptin (JANUVIA
®
) and
extended-release metformin hydrochloride, which lower blood sugar
levels. Sitagliptin, a member of a class
of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4
inhibitors), and metformin, a member of the
biguanide class of medicines, work together to control blood sugar
levels in patients with type 2 diabetes
mellitus, in whom this combination is appropriate.
JANUET XR is designated to lower blood sugar levels in patients with
type 2 diabetes, along with

خصائص المنتج

JANUET
® XR 50 MG/500 MG
EXTENDED-RELEASE TABLETS
Each tablet contains:
Sitagliptin (as phosphate salt) 50 mg
Metformin hydrochloride (extended release) 500 mg
JANUET
® XR 50 MG/1000 MG
EXTENDED-RELEASE TABLETS
Each tablet contains:
Sitagliptin (as phosphate salt) 50 mg
Metformin Hydrochloride (extended release) 1000 mg
JANUET
® XR 100 MG/1000 MG
EXTENDED-RELEASE TABLETS
Each tablet contains:
Sitagliptin (as phosphate salt) 100 mg
Metformin Hydrochloride (extended release) 1000 mg
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/LITER), 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 JANUET XR AND
INSTITUTE GENERAL SUPPORTIVE MEASURES IN A HOSPITAL SETTING. PROMPT
HEMODIALYSIS IS RECOMMENDED
_[SEE WARNINGS AND