AMARYL 2 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

GLIMEPIRIDE

Available from:

SANOFI ISRAEL LTD

ATC code:

A10BB12

Pharmaceutical form:

TABLETS

Composition:

GLIMEPIRIDE 2 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

SANOFI S.P.A., ITALY

Therapeutic group:

GLIMEPIRIDE

Therapeutic area:

GLIMEPIRIDE

Therapeutic indications:

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.

Authorization date:

2020-05-31

Patient Information leaflet

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Summary of Product characteristics

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