INDOPRIL COMBI 4/1.25 perindopril erbumine 4mg and indapamide hemihydrate1.25mg tablet blister pack

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

perindopril erbumine, Quantity: 4 mg; indapamide hemihydrate, Quantity: 1.25 mg (Equivalent: indapamide, Qty 1.22 mg)

Prieinama:

Arrotex Pharmaceuticals Pty Ltd

INN (Tarptautinis Pavadinimas):

indapamide hemihydrate,Perindopril erbumine

Vaisto forma:

Tablet

Sudėtis:

Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; hydrophobic colloidal silica anhydrous; magnesium stearate

Vartojimo būdas:

Oral

Vienetai pakuotėje:

30 tablets

Recepto tipas:

(S4) Prescription Only Medicine

Terapinės indikacijos:

Treatment of hypertension. Treatment should not be initiated with this combination.

Produkto santrauka:

Visual Identification: White to off-white, capsule shaped uncoated tablets, plain on both sides; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Autorizacija statusas:

Licence status A

Leidimo data:

2009-07-01

Pakuotės lapelis

INDOPRIL COMBI- Consumer Medicine Information
Page 1 of 5
INDOPRIL COMBI 4/1.25 MG TABLETS
_perindopril erbumine and indapamide hemihydrate. _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
Indopril Combi 4/1.25 mg
tablets. It does not contain
all the available information
about this medicine.
Reading this leaflet 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 Indopril Combi
4/1.25 mg tablets against
the expected benefits for
you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS
MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it
again.
WHAT INDOPRIL
COMBI 4/1.25 MG
TABLETS ARE
Indopril Combi 4/1.25 mg
tablets. The medicine
contains the active
ingredients perindopril
erbumine and indapamide
hemihydrate. Perindopril
belongs to a group of
medicines called
angiotensin converting
enzyme (ACE) inhibitors.
Indapamide belongs to a
group of medicines called
chlorosulphamoyl diuretics.
WHAT INDOPRIL
COMBI 4/1.25 MG
TABLETS ARE USED FOR
Indopril Combi 4/1.25 mg
tablets are available only
with a doctor's
prescription.
There is no evidence that
Indopril Combi 4/1.25 mg
tablets are addictive.
WHY INDOPRIL COMBI
4/1.25 MG TABLETS 4/1.25
MG IS USED FOR HIGH
BLOOD PRESSURE
Everyone has blood
pressure. This pressure
helps to circulate blood
all around the body. Your
blood pressure may be
different at different times
of the day, depending on
how busy or stressed you
are.
You have high blood
pressure (also known as
hypertension) when your
blood pressure stays
higher than is needed,
even when you are calm
and relaxed.
If high blood pressure is
not treated it can lead to
serious health problems.
You may feel fine and
have no symptoms, but
eventually it can cause
stroke, heart disease and
kidney failure.
Indopril Combi 4/1.25 mg
tablets help to lower your
blood pressure.
ASK YOUR DOCTOR IF YOU
HAVE ANY QUESTIONS
ABOUT WHY INDOP

Prekės savybės

INDOPRIL COMBI- Product Information
Page 1 of 21
PRODUCT INFORMATION
INDOPRIL COMBI 4/1.25
NAME OF THE MEDICINE
Indopril Combi 4 /1.25 containing perindopril erbumine 4mg and
indapamide
hemihydrate 1.25mg
DESCRIPTION
PERINDOPRIL ERBUMINE
It is described chemically as tert-butylammonium (_2S, 3aS,
7aS_)-1-(_N-[(S_)-1-ethoxycarbonyl
butyl]-L-alanyl) perhydroindole-2-carboxylate. Perindopril is a
dipeptide monoacid monoester
with a perhydroindole group and no sulphydryl radical. Perindopril
erbumine is a white
powder, readily soluble in purified water, ethanol and chloroform.
Perindopril erbumine has
five asymmetric centres. The drug is synthesised stereoselectively so
that it is a single
enantiomer (all _S _stereochemistry).
Molecular formula: C
19
H
32
N
2
O
5
, C
4
H
11
N
Molecular Weight: 441.6
CAS: 107133-36-8
Perindopril erbumine: Chemical structure.
INDAPAMIDE HEMIHYDRATE
Indapamide hemihydrate is 4-chloro-_N_-(2
methyl-1-indolinyl)-3-sulphamoyl benzamide
hemihydrate.
Empirical formula: C
16
H
16
ClN
3
O
3
S, ½ H
2
O
Molecular Weight: 365. 84
CAS: 26807-65-8
Indapamide hemihydrate is white crystalline lipophilic powder, soluble
in methanol, ethanol,
acetic acid and ethyl acetate, very slightly soluble in ether,
chloroform and benzene and
INDOPRIL COMBI- Product Information
Page 2 of 21
practically insoluble in water.
Chemical structure of anhydrous indapamide:
EXCIPIENTS
Lactose, microcrystalline cellulose, hydrophobic colloidal anhydrous
silica, magnesium
stearate.
PHARMACOLOGY
MECHANISM OF ACTION
Indopril Combi 4 /1.25 tablets are a combination of perindopril
erbumine, an angiotensin
converting enzyme (ACE) inhibitor, and indapamide, a chlorosulphamoyl
diuretic, in which the
doses of the ACE inhibitor and diuretic components are up to two times
lower than the usual
dose used for monotherapy. Its pharmacological properties are derived
from each of its
components, in addition to those due to the synergistic action of the
two products when
combined on vascular endothelium and the target-organs of
hypertension