OLMESARTAN SANDOZ olmesartan medoxomil 10 mg film coated tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

olmesartan medoxomil, Quantity: 10 mg

Available from:

Sandoz Pty Ltd

INN (International Name):

Olmesartan medoxomil

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose monohydrate; magnesium stearate; microcrystalline cellulose; hyprolose; purified water; hypromellose; titanium dioxide; iron oxide yellow; macrogol 4000

Administration route:

Oral

Units in package:

30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

OLMESARTAN SANDOZ is indicated for the treatment of hypertension.

Product summary:

Visual Identification: 10 mg tablet: Yellow film-coated, round, biconvex tablets debossed with 392 one one side, and L on the other side. Blister pack of 30.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2015-02-05

Summary of Product characteristics

200320-Olmesartan Sandoz-pi
Page 1 of 22
AUSTRALIAN PRODUCT INFORMATION
OLMESARTAN SANDOZ (OLMESARTAN MEDOXOMIL) TABLETS
1.
NAME OF THE MEDICINE
Olmesartan medoxomil
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Olmesartan Sandoz contains the active ingredient olmesartan medoxomil.
Olmesartan Sandoz is available for oral use as film-coated tablets
containing 10 mg, 20 mg, or
40 mg olmesartan medoxomil.
_List of excipients with known effect:_
Lactose monohydrate
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
10 MG TABLET:
Yellow film-coated, round, biconvex tablets debossed with 392 one one
side,
and L on the other side.
20 MG TABLET:
Yellow film coated, round, biconvex tablets debossed with 323 on one
side and
L on the other side.
40 MG TABLET:
Yellow film coated, oval shape, biconvex tablets debossed with L324 on
one
side and plain on the other side.
4. CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Olmesartan Sandoz is indicated for the treatment of hypertension.
4.2.
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_ADULTS _
Dosage must be individualised. The optimal recommended starting dose
is 20 mg once daily
when used as monotherapy in patients who are not volume-contracted. If
additional blood
pressure reduction is required, the dose may be increased to a maximum
of 40 mg daily.
In order to assist compliance, it is recommended that olmesartan
medoxomil tablets be taken
at about the same time each day. Twice-daily dosing offers no
advantage over the same total
dose given once daily.
The antihypertensive effect of olmesartan medoxomil is substantially
present within 2 weeks
of initiating therapy and is maximal by about 8 weeks after initiating
therapy. This should be
borne in mind when considering changing the dose regimen for any
patient.
Hydrochlorothiazide therapy should be considered in those patients
requiring additional blood
pressure control beyond 40 mg daily. Olmesartan medoxomil may be
administered with other
antihypertensive agents.
200320-Olmesartan Sandoz