Olmesartan/HCT Sandoz 40/25 olmesartan medoxomil/hydrochlorothiazide 40/25 mg film-coated tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
07-12-2021
Summary of Product characteristics
(SPC)
03-09-2021
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
hydrochlorothiazide, Quantity: 25 mg; olmesartan medoxomil, Quantity: 40 mg
Available from:
Sandoz Pty Ltd
INN (International Name):
Hydrochlorothiazide,Olmesartan medoxomil
Pharmaceutical form:
Tablet, film coated
Composition:
Excipient Ingredients: purified water; lactose monohydrate; magnesium stearate; hyprolose; hypromellose; 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: 40/25 mg film coated tablets are yellow film coated, oval shaped, biconvex tablets debossed with L348 on one side and plain on the 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:
Registered
Authorization date:
2015-02-05
Patient Information leaflet
OLMESARTAN/HCT SANDOZ
®
1
OLMESARTAN/HCT
SANDOZ
®
_Olmesartan medoxomil and hydrochlorothiazide _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Olmesartan/HCT
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/HCT 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/HCT SANDOZ TABLETS.
You may need to read it again.
WHAT OLMESARTAN/HCT
SANDOZ IS USED FOR
Olmesartan/HCT 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/HCT _
_SANDOZ WORKS _
Olmesartan/HCT 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/HCT Sandoz blocks the
action of angiotensin-II and therefore
relaxes your blood vessels. This
helps lower your blood pressure.
Olmesartan/HCT Sandoz 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
Olmesartan/HCT Sandoz for another
reason. Ask your doctor if you have
any questions abo
Read the complete document
Summary of Product characteristics
210901-olmesartan/HCT sandoz-pi
Page 1 of 29
AUSTRALIAN PRODUCT INFORMATION
OLMESARTAN/HCT SANDOZ
®
TABLETS
(OLMESARTAN/HYDROCHLOROTHIAZIDE)
1
NAME OF THE MEDICINE
Olmesartan medoxomil/Hydrochlorothiazide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Olmesartan/HCT Sandoz 20/12.5 mg film coated tablet contains 20
mg of olmesartan
medoxomil and 12.5 mg of hydrochlorothiazide.
Each Olmesartan/HCT Sandoz 20/25 mg film coated tablet contains 20 mg
of olmesartan
medoxomil and 25 mg of hydrochlorothiazide.
Each Olmesartan/HCT Sandoz 40/12.5 mg film coated tablet contains 40
mg of olmesartan
medoxomil and 12.5 mg of hydrochlorothiazide.
Each Olmesartan/HCT Sandoz 40/25 mg film coated tablet contains 40 mg
of olmesartan
medoxomil and 25 mg of hydrochlorothiazide.
_Excipients with known effect:_
Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Olmesartan/HCT Sandoz 20/12.5 film coated tablets - yellow film
coated, round, biconvex
tablets debossed with ‘346’ on one side and ‘L’ on other side.
Olmesartan/HCT Sandoz 20/25 film coated tablets - yellow film coated,
oval shape, biconvex
tablets debossed with ‘L400’ on one side and plain on other side.
Olmesartan/HCT Sandoz 40/12.5 film coated tablets - yellow film
coated, oval shape, biconvex
tablets debossed with ‘L347’ on one side and plain on other side.
Olmesartan/HCT Sandoz 40/25 film coated tablets - yellow film coated,
oval shape, 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.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_ADULTS _
Olmesartan/HCT Sandoz is registered in combinations of 20/12.5 mg,
20/25 mg, 40/12.5 mg
and 40/25 mg.
210901-olmesartan/HCT sandoz-pi
Page 2 of 29
METHOD OF ADMINISTRATION
Olmesartan/HCT Sandoz is administered once daily, with or without
food, in patients whose
blood pressure is not adeq
Read the complete document
