OLMESARTAN SANDOZ olmesartan medoxomil 40 mg film coated tablets blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
olmesartan medoxomil, Quantity: 40 mg
Available from:
Sandoz Pty Ltd
INN (International Name):
Olmesartan medoxomil
Pharmaceutical form:
Tablet, film coated
Composition:
Excipient Ingredients: hypromellose; microcrystalline cellulose; lactose monohydrate; hyprolose; purified water; magnesium stearate; 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: 40 mg tablet: Yellow film-coated, oval shaped, biconvex tablets debossed with L324 on one side, and plain 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
Patient Information leaflet
OLMESARTAN SANDOZ
1
OLMESARTAN SANDOZ
_Olmesartan medoxomil _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Olmesartan Sandoz.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Olmesartan
Sandoz against the benefits he/she
expects it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
OLMESARTAN SANDOZ TABLETS.
You may need to read it again.
WHAT OLMESARTAN
SANDOZ IS USED FOR
Olmesartan Sandoz is used to treat
high blood pressure which is
sometimes called hypertension.
Everyone has blood pressure. This
pressure helps push blood all around
your body. Your blood pressure
changes at different times of the day,
depending on how busy or worried
you are. You have hypertension (high
blood pressure) when your blood
pressure stays higher than is needed,
even when you are calm and relaxed.
There are usually no symptoms of
hypertension. The only way of
knowing that you have hypertension
is to have your blood pressure
checked on a regular basis. If high
blood pressure is not treated it can
lead to serious health problems,
including stroke, heart disease and
kidney failure.
_HOW OLMESARTAN SANDOZ _
_WORKS _
Olmesartan Sandoz belongs to a
group of medicines known as
angiotensin-II receptor antagonists.
Angiotensin-II is a substance
produced in the body which causes
blood vessels to tighten. Olmesartan
Sandoz blocks the action of
angiotensin-II and therefore relaxes
your blood vessels. This helps lower
your blood pressure.
Your doctor may have prescribed
Olmesartan Sandoz for another
reason. Ask your doctor if you have
any questions about why Olmesartan
Sandoz has been prescribed for you.
Olmesartan Sandoz is not addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
OLMESARTAN SANDOZ
_WHEN YOU MUST NOT TAKE
Read the complete document
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
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