Țară: Israel
Limbă: engleză
Sursă: Ministry of Health
GLIMEPIRIDE
SANOFI ISRAEL LTD
A10BB12
TABLETS
GLIMEPIRIDE 1 MG
PER OS
Required
SANOFI S.P.A., ITALY
GLIMEPIRIDE
GLIMEPIRIDE
Non-insulin-dependent diabetes melitus ( adult-onset diabetes, type II diabetes), when diet, regular physical exercise, and weight reduction alone cannot maintain therapeutically suitable blood glucose levels.
2020-05-31
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1 Amaryl tabs SPC version 14.1 dated 05.21 based on US SPC approved Dec 2018 1. Name of the medicinal product AMARYL 1mg, 2mg, 3mg, 4mg Glimepiride tablets 2. Therapeutic indications Amaryl is indicated for non-insulin-dependent diabetes melitus (adult-onset diabetes, type II diabetes), when diet, regular physical exercise and weight reduction alone cannot maintain therapeutically suitable blood glucose levels. Limitations of Use AMARYL should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings. 3. DOSAGE AND ADMINISTRATION 3.1 Recommended Dosing AMARYL should be administered with breakfast or the first main meal of the day. The recommended starting dose of AMARYL is 1 mg or 2 mg once daily. Patients at increased risk for hypoglycemia (e.g., the elderly or patients with renal impairment) should be started on 1 mg once daily [see Warnings and Precautions (5.1) and Use in Specific Populations (8.5, 8.6)]. After reaching a daily dose of 2 mg, further dose increases can be made in increments of 1 mg or 2 mg based upon the patient’s glycemic response. Uptitration should not occur more frequently than every 1 to 2 weeks. A conservative titration scheme is recommended for patients at increased risk for hypoglycemia [see Warnings and Precautions (5.1) and Use in Specific Populations (8.5, 8.6)]. The maximum recommended dose is 8 mg once daily. Patients being transferred to AMARYL from longer half-life sulfonylureas (e.g., chlorpropamide) may have overlapping drug effect for 1 to 2 weeks and should be appropriately monitored for hypoglycemia. When colesevelam is coadministered with glimepiride, maximum plasma concentration and total exposure to glimepiride is reduced. Therefore, Amaryl should be administered at least 4 hours prior to colesevelam. 2 4. DOSAGE FORMS AND STRENGTHS AMARYL is formulated as tablets of: 1 mg (pink, oblong tablets, biplanar with score-line on both sides, imprinted on both sides). 2 mg (green, tablets, biplana Citiți documentul complet