Amprilan HL tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

ramipril, hydrochlorothiazide

Available from:

KRKA d.d.

ATC code:

C09BA05

INN (International Name):

ramipril, hydrochlorothiazide

Dosage:

2,5mg+ 12,5mg

Pharmaceutical form:

tablets

Units in package:

(30/3x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2019-07-18

Patient Information leaflet

Ramipril
+ Hydrochlorothiazide
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Summary of Product characteristics

SPC,
Labelin
1.3.1
SUMMARY OF PRODUCT
CHARACTERISTICS
1.
NAME OF THE MEDICINAL
PRODUCT
Amprilan
HL tablets
2.5 mg/12.5
mg
2.
QUALITATIVE
AND QUANTITATIVE
COMPOSITION
Amprilan
HL tablets
2.5 mgl12.5
mg:
Each tablet
contains
ramipril2.5
mg and
hydrochlorothiazide
12.5 mg
3.
PHARMACEUTICAL
FORM
Tablet.
Flat,
capsule
shape
tablete,
white
to off-
white,
scored
on one side and marked
with
12.5 on the
other
side.
4.
CLINICAL
PARTICULARS
4.1
Therapeutic
indications
Essential
hypel1ension
that
cannot
be adequately
controlled
with ramipril
alone
(or
hydrochlorothiazide
alone).
4.2
Posology and method
of administration
Administration
of
the fixed combination
ramipril/hydrochlorothiazide
is only recommended
after
individual
titration
of
the doses
with the single
components.
The
dose
may be increased
at
intervals
of
at
least
3 weeks.
The
usual
maintenance
dose
is
I tablet
Amprilan
HL (2.5 mg
ramipril
and
12.5 mg hydrochlorothiazide)
in the morning.
The
maximal
dose
is 2 tablets
Amprilan
HL (5 mg ramipril
and 25 mg hydrochlorothiazide).
_Prior diuretic therapy_
The diuretic
therapy
should
be stopped
or
the dose
reduced,
two to three
days
prior
to the
start
of a
treatment
with ramipril/hydrochlorothiazide.
to prevent
the development
of
symptomatic
hypotension.
Renal
function
should
be assessed
before
starting
the treatment.
_PalienlS with impaired renal junction:_
In patients
with a creatinine
clearance
greater
than 0.5
_mIls_
or
serum creatinine
265 j.lmollL
(3 mg/I
00 ml)
can be assigned
regular
dose.
_impaired hepalicjul1clion:_
In patients
with mild to moderate
impairment
of
hepatic
function
the dose
of
ramipril
should
be
titrated
before
changing
to ramipril/hydrochlorothiazide
tablets.
Ramipril/hydrochlorothiazide
tablets
should
not
be used
for
patients
with severely
impaired
hepatic
function
andlor
cholestasis
(see
also section
4.3).
_Children and adolescents_
«18
_years ajage):_
I
SmPCPIL125274
2
16.01.2019
-
Updated:
16.01.2019
I
Page
1
of
11
SPC,
Labelin
1.3.1
The
safety and efficacy
oframipril/hydrochlorothiazide
tab