ABISART HCTZ 300/25 irbesartan 300 mg + hydrochlorothiazide 25 mg tablet blister pack

Држава: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

hydrochlorothiazide, Quantity: 25 mg; irbesartan, Quantity: 300 mg

Доступно од:

Sun Pharma ANZ Pty Ltd

Фармацеутски облик:

Tablet, film coated

Састав:

Excipient Ingredients: microcrystalline cellulose; colloidal anhydrous silica; hypromellose; lactose monohydrate; croscarmellose sodium; magnesium stearate; titanium dioxide; purified talc; iron oxide red; macrogol 4000; iron oxide black; macrogol 400

Пут администрације:

Oral

Јединице у пакету:

30, 90

Тип рецептора:

(S4) Prescription Only Medicine

Терапеутске индикације:

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

Резиме производа:

Visual Identification: Pink to red, film-coated, oval-shaped tablets debossed with 'IH 2' on one side and plain on the other.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Статус ауторизације:

Registered

Датум одобрења:

2018-11-06

Информативни летак

ABISART HCTZ
1
ABISART HCTZ
_contains the active ingredient irbesartan/hydrochlorothiazide _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ABISART HCTZ.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking ABISART HCTZ
against the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT ABISART HCTZ
IS USED FOR
ABISART HCTZ is used to treat
hypertension (i.e. high blood
pressure). ABISART HCTZ is a
trade name (manufacturer's name).
ABISART HCTZ tablets contain two
medicines, irbesartan and
hydrochlorothiazide.
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 you r 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 ABISART HCTZ.
One of the active ingredients in
ABISART HCTZ is irbesartan which
belongs to a class of medicines called
angiotensin-II receptor antagonists.
Angiotensin II is a substance
produced

Карактеристике производа

PRODUCT INFORMATION
ABISART HCTZ 150/12.5, 300/12.5
& 300/25
_Irbesartan Hydrochlorothiazide _
1.
NAME OF THE MEDICINE
Irbesartan and hydrochlorothiazide
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ABISART HCTZ is an oral antihypertensive agent combining a nonpeptide
angiotensin II receptor (AT
1 subtype) antagonist, irbesartan, and a thiazide diuretic,
hydrochlorothiazide. The active ingredients in
ABISART HCTZ 150/12.5, 300/12.5 & 300/25 (herein referred to as
ABISART HCTZ) tablets are
irbesartan and hydrochlorothiazide. Irbesartan is a white to off-white
crystalline powder. It is a relatively
non-polar compound with a partition coefficient (octanol-water) of
10.1 at a pH of 7.4. Irbesartan is
slightly
soluble
in
alcohol
and
methylene
chloride,
and
practically
insoluble
in
water.
Hydrochlorothiazide is a white crystalline powder. It is slightly
soluble in water but freely soluble in
sodium hydroxide solution.
ABISART HCTZ 150/12.5 contains the active ingredients 150 mg of
irbesartan and 12.5 mg of
hydrochlorothiazide, ABISART HCTZ 300/12.5 contains 300 mg of
irbesartan and 12.5 mg of
hydrochlorothiazide, and ABISART HCTZ 300/25 contains 300 mg of
irbesartan and 25 mg of
hydrochlorothiazide.
Excipient with known effect:
Each tablet of ABISART HCTZ 150/12.5 mg, 300/25 mg and 300/12.5 mg
contains 42.50 mg, 85.00 mg
and 97.50 mg of lactose monohydrate respectively. Patients with rare
hereditary problems of galactose
intolerance, the Lapp lactase deficiency or glucose-galactose
malabsorption should not take this
medicine.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
ABISART
HCTZ
150/12.5
tablets
contain
the
active
ingredients
irbesartan
150
mg
and
hydrochlorothiazide 12.5 mg and are pink to red, film-coated,
oval-shaped and debossed with ‘IH1” on
one side and plain on the other.
ABISART
HCTZ
300/12.5
tablets
contain
the
active
ingredients
irbesartan
300
mg
and
hydrochlorothiazide 12.5 mg and are yellow, film-coated, oval-shaped
and debossed with ‘IH3” on one
sid