ARW OLMESARTAN HCTZ 20/12.5 olmesartan medoxomil/hydrochlorothiazide 20/12.5 mg film coated tablets blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
26-09-2020
Summary of Product characteristics
(SPC)
26-09-2020
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
olmesartan medoxomil, Quantity: 20 mg; hydrochlorothiazide, Quantity: 12.5 mg
Available from:
Arrotex Pharmaceuticals Pty Ltd
INN (International Name):
Hydrochlorothiazide,Olmesartan medoxomil
Pharmaceutical form:
Tablet, film coated
Composition:
Excipient Ingredients: hypromellose; purified water; hyprolose; lactose monohydrate; magnesium stearate; microcrystalline cellulose; titanium dioxide; iron oxide yellow; macrogol 4000
Administration route:
Oral
Units in package:
30
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Indicated for the treatment of hypertension.,Treatment should not be initiated with this fixed dose combination.
Product summary:
Visual Identification: 20/12.5 mg film coated tablets are yellow film coated, round, biconvex tablets debossed with 346 on one side and L on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/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 COMBI®
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
OLMERTAN COMBI.
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 COMBI 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 COMBI
TABLETS.
You may need to read it again.
WHAT OLMERTAN
COMBI IS USED FOR
OLMERTAN COMBI 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
COMBI WORKS
OLMERTAN COMBI 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 COMBI
blocks the action of
angiotensin-II and therefore
relaxes your blood vessels. This
helps lower your blood pressure.
OLMERTAN COMBI also
contains a diuretic which reduces
the amount of fluid in the body.
This also helps to lower blood
pressure.
Your doctor may have prescribed
OLMERTAN COMBI for
another reason. Ask your doctor
if you have any questions about
why OLMERTAN COMBI has
been prescribed for you.
OLMERTAN COMBI is not
addictive.
This medicine is available o
Read the complete document
Summary of Product characteristics
1
AUSTRALIAN PRODUCT INFORMATION – OLMERTAN COMBI
(OLMESARTAN MEDOXOMIL/HYDROCHLOROTHIAZIDE) FILM-
COATED TABLETS
1
NAME OF THE MEDICINE
Olmesartan medoxomil/hydrochlorothiazide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
OLMERTAN COMBI contains the active ingredients olmesartan medoxomil
and hydrochlorothiazide
(HCTZ). OLMERTAN COMBI is available for oral use as film-coated
tablets containing 20/12.5 mg,
20/25 mg, 40/12.5 mg, or 40/25 mg olmesartan medoxomil/HCTZ.
Excipient with known effects: sugars as lactose
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
OLMERTAN COMBI 20/12.5 film coated tablets are yellow film coated,
round, biconvex tablets
debossed with ‘346’ on one side and ‘L’ on other side.
OLMERTAN COMBI 20/25 film coated tablets are yellow film coated, oval
shaped, biconvex tablets
debossed with ‘L400’ on one side and plain on other side.
OLMERTAN COMBI 40/12.5 film coated are yellow film coated, oval
shaped, biconvex tablets
debossed with ‘L347’ on one side and plain on other side.
OLMERTAN COMBI 40/25 film coated tablets are yellow film coated, oval
shaped, biconvex tablets
debossed with ‘L348’ on one side and plain on other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Treatment of hypertension.
Treatment should not be initiated with this fixed dose combination.
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
ADULTS
OLMERTAN COMBI is administered once daily, with or without food, in
patients whose blood
pressure is not adequately controlled by olmesartan medoxomil or HCTZ
alone.
OLMERTAN COMBI is registered in combinations of 20/12.5 mg, 20/25 mg,
40/12.5 mg and 40/25
mg.
Dosing should be individualised and dependent on the patient’s
condition. Depending on the blood
pressure response, the dose may be titrated after 4 weeks.
If blood pressure is not adequately controlled on olmesartan medoxomil
alone, HCTZ may be added
with a starting dose of 12.5 mg. Should blood pressure still remain
inadequately controlled either
up-titrati
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