Krajina: Izrael
Jazyk: angličtina
Zdroj: Ministry of Health
METFORMIN HYDROCHLORIDE; SITAGLIPTIN AS PHOSPHATE SALT
MERCK SHARP & DOHME (ISRAEL - 1996) COMPANY LTD, ISRAEL
A10BA02
TABLETS EXTENDED RELEASE
SITAGLIPTIN AS PHOSPHATE SALT 100 MG; METFORMIN HYDROCHLORIDE 1000 MG
PER OS
Required
MERCK SHARP & DOHME LLC, USA
METFORMIN
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
2019-01-31
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 Prečítajte si celý dokument
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 Prečítajte si celý dokument