Perindopril tosilate/Indapamide 10 mg/2.5 mg film-coated tablets

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Perindopril tosilate; Indapamide

Boleh didapati daripada:

Teva B.V.

Kod ATC:

C09BA; C09BA04

INN (Nama Antarabangsa):

Perindopril tosilate; Indapamide

Dos:

10mg/2.5 milligram(s)

Borang farmaseutikal:

Film-coated tablet

Jenis preskripsi:

Product subject to prescription which may be renewed (B)

Kawasan terapeutik:

ACE inhibitors and diuretics; perindopril and diuretics

Status kebenaran:

Marketed

Tarikh kebenaran:

2017-01-13

Risalah maklumat

ZINC Ref:
EAS4392F LEA
PERINDOPRIL
TOSI
L
AT
E
/
I
N
DA
P
A
M
ID
E TEVA 10
M
G
/
2.5
M
G FC TAB IE DEB
Version:
3
05 APRIL 2022
UK & Ireland Artwork Department
Length: 825 MM
Width: 130 MM
Depth: -
Colours Used:
PANTONE®
GREEN C
BLACK
T
EMPLAT
E
P
ERINDOPRIL
TOSILATE/INDAPAMIDE
TEVA
10 MG/2.5 MG FILM-COAT
ED
TABLETS
perindopril
tosilate/indapamide
PACKAGE LEAFLET:
INFOR
MATION FOR THE
PATIENT
READ ALL OF THIS LEAFLET
CAR
EFULLY
BEFORE YOU START TAKING USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
- Keep this leaflet. You may need
to
read
it
ag
ain.
- If you have any
further questions,
ask your
doctor
or
pharmacist.
- This medicine has been
prescribed
for you only. Do not pass
it
on
to
others. It may harm them, even
if
their signs of illness are the
same
as
your
s.
- If you get any side effects, talk
to
your
doctor
or
pharmacist.
This
includes
any
possible
side
ef
fects
not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET
1. What
P
erindopril
tosilate/
Indapamide
Teva is and what
it is
used
for
2. What you need to know
before
you take
P
erindopril
tosilate/
Indapamide
T
eva
3. How to take
P
erindopril
tosilate/
Indapamide
T
eva
4. Possible side
ef
fects
5. How to store
P
erindopril
tosilate/
Indapamide
T
eva
6.
Contents
of the pack and
other
information
1
WHAT PERINDOPRIL
T
OSILAT
E/
INDAPAMIDE TEVA IS
AND
WHAT IT IS USED
FOR
valsartan),
used to
treat
long-term
heart
failure.
-
if
you are of black
origin since
you may have a
higher
risk
of
angioedema
and this
medicine
may be less
effective
in
lowering
your
blood pressure
than
in
non-black patients,
-
if
you are a
haemodialysis patient
dialysed with
high-flux membranes.
-
if
you
experience
a decrease
in
vision
or eye pain. These could
be
symptoms
of
fluid accumulation
in the
vascular
layer of the
eye
(choroidal effusion)
or
an
increase of
pressure
in your
eye
and can happen
within
hours
to
weeks of taking
P
erindopril
tosilate/Indapamide
Teva. This
can
lead to
permanent vision
loss,
if
not
treated.
If you earlier
have
had a
p

Ciri produk

Health Products Regulatory Authority
26 July 2022
CRN00CNM9
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Perindopril tosilate/Indapamide 10 mg/2.5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Perindopril tosilate/Indapamide Teva Each film-coated tablet contains
10 mg perindopril tosilate corresponding to 6.816 mg
perindopril, converted in situ to perindopril sodium, and 2.5 mg
indapamide.
Excipient with known effect:
Each film-coated tablet contains 296.224 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White, round and biconvex film-coated tablet of approx. 10 mm
diameter, plain on both sides.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Perindopril tosilate/Indapamide Teva is indicated as substitution
therapy for treatment of essential hypertension, in patients
already controlled with perindopril and indapamide given concurrently
at the same dose level.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One Perindopril tosilate/Indapamide Teva 10 mg/2.5 mg film-coated
tablet per day as a single dose, preferably to be taken in
the morning and before a meal.
Special populations
_Elderly (see section 4.4)_
In elderly, the plasma creatinine must be adjusted in relation to age,
weight and gender. Elderly patients can be treated if renal
function is normal and after considering blood pressure response.
_ _
_Renal impairment (see section 4.4)_
In severe and moderate renal impairment (creatinine clearance below 60
ml/min), treatment is contraindicated.
Usual medical follow-up will include frequent monitoring of creatinine
and potassium.
_ _
_Hepatic impairment (see sections 4.3, 4.4 and 5.2)_
In severe hepatic impairment, treatment is contraindicated.
In patients with moderate hepatic impairment, no dose modification is
required.
_ _
_Paediatric population_
The safety and efficacy of Perindopril tosilate/Indapamide Teva in
children and adolescents have not yet been established. No
data are a