JANUET 50 MG500 MG

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

METFORMIN HYDROCHLORIDE; SITAGLIPTIN AS MONOHYDRATE PHOSPHATE

Tilgængelig fra:

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

ATC-kode:

A10BA02

Lægemiddelform:

TABLETS

Sammensætning:

SITAGLIPTIN AS MONOHYDRATE PHOSPHATE 50 MG; METFORMIN HYDROCHLORIDE 500 MG

Indgivelsesvej:

PER OS

Recept type:

Required

Fremstillet af:

MERCK SHARP & DOHME LLC, USA

Terapeutisk gruppe:

METFORMIN

Terapeutisk område:

METFORMIN

Terapeutiske indikationer:

Januet is indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus. Important limitations of use:Januet should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.Januet has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using Januet.

Autorisation dato:

2023-11-30

Indlægsseddel

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS'
REGULATIONS (PREPARATIONS) – 1986
This medicine is marketed upon physician’s prescription only
JANUET
®
50 MG/500 MG
TABLETS
Each tablet contains:
Sitagliptin (as monohydrate phosphate) 50 mg
Metformin Hydrochloride 500 mg
JANUET
®
50 MG/850 MG
TABLETS
Each tablet contains:
Sitagliptin (as monohydrate phosphate) 50 mg
Metformin Hydrochloride 850 mg
JANUET
®
50 MG/1000 MG
TABLETS
Each tablet contains:
Sitagliptin (as monohydrate phosphate) 50 mg
Metformin Hydrochloride 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. 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 IS INTENDED FOR?
1.1 WHAT IS JANUET?
THERAPEUTIC GROUP:
Sitagliptin: DPP-4 enzyme inhibitor. Metformin: biguanide.
1.2 WHAT IS JANUET USED FOR?
JANUET is a tablet that contains 2 prescription medicines, sitagliptin
phosphate (JANUVIA
®
) and
metformin, which lower blood sugar. 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, along with a recommended diet and exercise program is intended
to lower blood sugar in patients
with type 2 diabetes.
2. BEFORE USING JANUET
2.1 DO NOT USE JANUET IF YOU:
2.2 SPECIAL WARNINGS REGARDING USE OF JANUET
BEFORE STARTING TREATMENT WITH JANUET, TELL YOUR DOCTOR ABOUT ALL OF
YOUR MEDI

Produktets egenskaber

JANUET
® 50 MG/500 MG
TABLETS
Each tablet contains:
Sitagliptin (as monohydrate phosphate) 50 mg
Metformin Hydrochloride 500 mg
JANUET
®
50 MG/850 MG
TABLETS
Each tablet contains:
Sitagliptin (as monohydrate phosphate) 50 mg
Metformin Hydrochloride 850 mg
JANUET
®
50 MG/1000 MG
TABLETS
Each tablet contains:
Sitagliptin (as monohydrate phosphate) 50 mg
Metformin Hydrochloride 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 ANHYDRAE 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 AND
INSTITUTE
GENERAL
SUPPORTIVE
MEASURES
IN
A
HOSPITAL
SETTING.
PROMPT
HEMODIALYSIS
IS
RECOMMENDED _[SEE WARNINGS AND PRECAUTIONS (5.1)]_.
1
INDICATIONS AND USAGE
JANUET is indicated as an adjunct to diet and exercise to impr