AVSARTAN HCT 150/12.5 irbesartan 150 mg and hydrochlorothiazide 12.5 mg tablets blister pack

Country: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

hydrochlorothiazide, Quantity: 12.5 mg; irbesartan, Quantity: 150 mg

Fáanlegur frá:

Arrotex Pharmaceuticals Pty Ltd

INN (Alþjóðlegt nafn):

Hydrochlorothiazide,Irbesartan

Lyfjaform:

Tablet, film coated

Samsetning:

Excipient Ingredients: povidone; hypromellose; colloidal anhydrous silica; mannitol; polysorbate 80; sodium starch glycollate type B; magnesium stearate; titanium dioxide; iron oxide yellow; iron oxide red; Carnauba Wax; macrogol 3350

Stjórnsýsluleið:

Oral

Einingar í pakka:

30 (3x10 in carton)

Gerð lyfseðils:

(S4) Prescription Only Medicine

Ábendingar:

Indicated for the treatment of hypertension. Treatment should not be initiated with this fixed-dose combination.

Vörulýsing:

Visual Identification: Peach coloured, capsule shaped, biconvex, film-coated tablets, approx. 14 mm long and 7 mm wide, debossed with 'IH' on one face and plain on other face.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Leyfisstaða:

Licence status A

Leyfisdagur:

2017-03-14

Upplýsingar fylgiseðill

AVSARTAN HCT
150/12.5 MG, 300/12.5 MG, 300/25 MG TABLETS
_Irbesartan and Hydrochlorothiazide _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Read this leaflet carefully
before taking Avsartan
HCT. This leaflet answers
some common questions
about Avsartan HCT. It
does not contain all the
available information. It
does not take the place of
talking to your doctor or
pharmacist. Do not throw
this leaflet away. You may
need to refer to it again
later.
ALWAYS FOLLOW THE
INSTRUCTIONS THAT YOUR
DOCTOR AND PHARMACIST
GIVE YOU ABOUT AVSARTAN
HCT. IF YOU HAVE ANY
CONCERNS ABOUT TAKING
AVSARTAN HCT, ASK YOUR
DOCTOR OR PHARMACIST.
WHAT IS AVSARTAN HCT
Avsartan HCT is a trade
name (manufacturer's
name). Avsartan HCT
tablets contain two
medicines, irbesartan and
hydrochlorothiazide. Both
these medicines are in the
tablets your doctor has
prescribed for you.
_WHAT AVSARTAN HCT IS _
_USED FOR _
_ _
Avsartan HCT lowers high
blood pressure, which
doctors call hypertension.
Your doctor measured
your blood pressure and
found it to be too high.
Everyone has blood
pressure. This pressure
helps get your blood all
around your body. Your
blood pressure may be
different at different times
of the day, depending on
how busy or worried you
are. You have hypertension
(high blood pressure)
which means your blood
pressure stays high, even
when you are calm and
relaxed.
There are usually no
symptoms of high blood
pressure. The only way of
knowing that you have
hypertension is to have
your blood pressure
checked on a regular basis.
High blood pressure, if not
treated, can damage blood
vessels in several organs
such as the heart, the
kidneys, the brain and the
eyes. This may lead to
heart attacks, heart or
kidney failure, strokes, or
blindness. There are
usually no symptoms of
high blood pressure before
damage occurs, so your
doctor needs to measure
your blood pressure to see
if it is too high.
High blood pressure can be
treated and controlled with
medicines such as
Avsartan HCT. Your
doctor may also have
recommended that you
adjust your l

Vara einkenni

1
AUSTRALIAN PRODUCT INFORMATION AVSARTAN HCT (IRBESARTAN/HYDROCHLOROTHIAZIDE) TABLETS
1
NAME OF THE MEDICINE
Irbesartan/hydrochlorothiazide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Avsartan HCT 150/12.5mg Film-coated Tablets:
Film-coated tablets containing 150mg of irbesartan and 12.5mg of
hydrochlorothiazide.
Avsartan HCT 300/12.5 mg Film-coated Tablets:
Film-coated tablets containing 300mg of irbesartan and 12.5mg of
hydrochlorothiazide.
Avsartan HCT 300/25 mg Film-coated Tablets:
Film-coated tablets containing 300mg of irbesartan and 25mg of
hydrochlorothiazide.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Avsartan HCT 150/12.5mg tablets are Peach coloured, capsule shaped,
biconvex, film-coated
tablets, approximately 14 mm long and 7 mm wide, debossed with
‘IH’ on one face and plain
on other face.
Avsartan HCT 300/12.5mg tablets are Peach coloured, capsule shaped,
biconvex, film-coated
tablets, approximately 18 mm long and 9 mm wide debossed with
‘IH2’ on one face and plain
on other face.
Avsartan HCT 300/25mg tablets are Brick red coloured, capsule shaped,
biconvex, film-coated
tablets, approximately 18 mm long and 9 mm wide, debossed with
‘IH1’ on one face and plain
on other face.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Avsartan HCT is indicated for the treatment of hypertension. Treatment
should not be
initiated with this fixed-dose combination.
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
Avsartan HCT should not be initiated as first-line therapy. The daily
dose can be administered
with or without food.
REPLACEMENT THERAPY
The combination may be substituted for the titrated components at the
same dose level.
DOSE TITRATION BY CLINICAL EFFECT
When clinically appropriate, direct change from monotherapy to the
fixed combinations may
be considered:
•
Avsartan HCT 150/12.5mg may be administered to patients whose blood
pressure is not
adequately controlled with hydrochlorothiazide or irbesartan 150 mg
alone.
•
Avsartan HCT 300/12.5 mg may b