GLIMEPIRIDE B&B 4mg glimepiride tablet 4mg blister pack

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

glimepiride, Quantity: 4 mg

Disponível em:

Micro Labs Pty Ltd

DCI (Denominação Comum Internacional):

Glimepiride

Forma farmacêutica:

Tablet, uncoated

Composição:

Excipient Ingredients: microcrystalline cellulose; povidone; magnesium stearate; sodium lauryl sulfate; lactose monohydrate; sodium starch glycollate type A; indigo carmine aluminium lake

Via de administração:

Oral

Unidades em pacote:

blister pack of 30's [15's X 2] in Monocarton

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

Indicated as an adjunct to diet, exercise and weight loss, to lower the blood glucose in patients with non-insulin-dependent (type 2) diabetes mellitus.

Resumo do produto:

Visual Identification: Light blue coloured capsule shaped uncoated tablet with embossing GM & 4 with score line on one side and score line on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Status de autorização:

Licence status A

Data de autorização:

2016-08-03

Características técnicas

1
AUSTRALIAN
PRODUCT INFORMATION- GLIMEPIRIDE B&B TABLETS (GLIMEPIRIDE)
1
NAME OF THE MEDICINE
Glimepiride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Glimepiride B&B tablets contain 1 mg, 2 mg, 3 mg or 4 mg of
glimepiride.
Excipient with known effect:
Contains sugars as lactose monohydrate
For a full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Glimepiride B&B tablets
•
1.0 mg: Pink coloured capsule shaped tablet with embossing “GM” &
“1” with score line
on one side and score line on the other side.
•
2.0 mg: Pale green coloured capsule shaped tablet with embossing
“GM” & “2” with
score line on one side and score line on the other side.
•
3.0 mg: Pale yellow coloured capsule shaped tablet with embossing
“GM” & “3” with
score line on one side and score line on the other side.
•
4.0 mg: Light blue coloured capsule shaped uncoated tablet with
embossing “GM” & “4”
with score line on one side and score line on the other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Glimepiride B&B is indicated as an adjunct to diet, exercise and
weight loss, to
lower the blood glucose in patients with non-insulin-dependent (type
2) diabetes
mellitus.
4.2 DOSE AND METHOD OF ADMINISTRATION
In the management of type 2 diabetes mellitus, administration of an
oral antidiabetic
agent is not a substitute for appropriate dietary control.
2
In initiating treatment for type 2 diabetes mellitus, diet should be
emphasised as the
primary form of treatment. Caloric restriction and weight loss are
essential in the
obese
diabetic
patient.
Proper
dietary
management
alone
may
be
effective
in
controlling the blood glucose and symptoms of hyperglycaemia. The
importance of
regular physical activity should also be stressed, and cardiovascular
risk factors
should be identified and corrective measures taken where possible.
If this treatment program fails to reduce symptoms and/or blood
glucose, the use of
an oral sulfonylurea should be considered. Use of Glimepiride B&B must