OLMESARTAN ARW olmesartan medoxomil 20 mg film coated tablets blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
15-06-2020
Summary of Product characteristics
(SPC)
15-06-2020
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
olmesartan medoxomil, Quantity: 20 mg
Available from:
Arrotex Pharmaceuticals Pty Ltd
INN (International Name):
Olmesartan medoxomil
Pharmaceutical form:
Tablet, film coated
Composition:
Excipient Ingredients: microcrystalline cellulose; lactose monohydrate; purified water; magnesium stearate; hyprolose; hypromellose; titanium dioxide; iron oxide yellow; macrogol 4000
Administration route:
Oral
Units in package:
30
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Olmertan is indicated for the treatment of hypertension.
Product summary:
Visual Identification: 20 mg tablet: Yellow film-coated, round, biconvex tablets debossed with 323 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
Patient Information leaflet
1
OLMERTAN
OLMESARTAN MEDOXOMIL
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about OLMERTAN.
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
OLMERTAN 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
OLMERTAN TABLETS.
You may need to read it again.
WHAT OLMERTAN IS USED
FOR
OLMERTAN 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 OLMERTAN WORKS
OLMERTAN 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.
OLMERTAN blocks the action of
angiotensin-II and therefore relaxes
your blood vessels. This helps
lower your blood pressure.
Your doctor may have
prescribed
OLMERTAN
for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY
OLMERTAN HAS BEEN
PRESCRIBED FOR YOU.
OLMERTAN is not addictive.
This medicine is available only
with a doctor's prescription.
BEFORE YOU TAKE
OLMERTAN
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE OLMERTAN IF:
•
YOU HAVE SERIOUS PROBLEMS
WITH YOUR KIDNEYS
•
YOU HAVE SERIOUS PROBLEMS
WITH YOUR LIVER
•
YOU HAVE DIABET
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Summary of Product characteristics
1
AUSTRALIAN PRODUCT INFORMATION – OLMERTAN (OLMESARTAN
MEDOXOMIL) FILM COATED TABLETS
1
NAME OF THE MEDICINE
Olmesartan medoxomil
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
OLMERTAN is available for oral use as film-coated tablets containing
10 mg, 20 mg, or 40 mg
olmesartan medoxomil.
Excipient with known effects: lactose
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 shaped, bioconvex tablets
debossed with L324 on one side
and plain on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
OLMERTAN is indicated for the treatment of hypertension.
4.2
D
OSE AND METHOD OF ADMINISTRATION
ADULTS
Dosage must be individualised. The optimal recommended starting dose
of OLMERTAN 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 of OLMERTAN may be
increased to a maximum of 40
mg daily.
2
OLMERTAN may be administered with or without food. In order to assist
compliance, it is
recommended that OLMERTAN 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.
Hydrochlorothiazde therapy should be considered in those patients
requiring additional blood
pressure control beyond 40 mg daily. OLMERTAN may be administered with
other antihypertensive
agents.
SPECIAL POPULATIONS
ELDERLY
No dosage adjustment is necessary.
If up-titration to the maximum dose of 40 mg daily is required, bl
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