Amprilan HD tablets

Nazione: Armenia

Lingua: inglese

Fonte: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Principio attivo:

ramipril, hydrochlorothiazide

Commercializzato da:

KRKA d.d.

Codice ATC:

C09BA05

INN (Nome Internazionale):

ramipril, hydrochlorothiazide

Dosaggio:

5mg+ 25mg

Forma farmaceutica:

tablets

Confezione:

(30/3x10/) in blister

Tipo di ricetta:

Prescription

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2019-07-18

Foglio illustrativo

1.3.
I
Ramipril
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drochlorothiazide
SPC,
Labeling
and Packa
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Leggi il documento completo

Scheda tecnica

1.3.1
SPC,
Labelin
and Package
Leaflet
SUMMARY OF PRODUCT
CHARACTERISTICS
1.
NAME OF THE MEDICINAL
PRODUCT
Amprilan
HD tablets
5
_mgl25_
Il1g
2.
QUALITATIVE
AND QUANTITATIVE
COMPOSITION
Amprilan
HD tablets
5 Il1g/25 Il1g: Each tablet
contains
ramipril
5 mg and hydrochlorothiazide
25 mg
3.
PHARMACEUTICAL
FORM
Tablet.
Flat,
capsule
shape
tablets,
white
to off-white
coloured,
size 5 x 10 mm,
with beveled
edges
and
marked
2
and
5
on one side,
separated
with line;
scored
on side.
4.
CLINICAL
PARTICULARS
4.1
Therapeutic
indications
Essential
hypertension
that
cannot
be adequately
controlled
with ramipril
alone
(or
hydrochlorothiazide
alone).
4.2
Posology and method
of administration
Administration
of
the fixed combination
ramiprillhydrochlorothiazide
is only recommended
after
individual
titration
of
tile doses
with the single
components.
The
dose may be increased
at
intervals
of at
least
3 weeks.
The
usual
maintenance
dose
is
_112_
tablet
Ampri
Ian HD (2.5 mg
ramipril
and
12.5 111ghydrochlorothiazide)
in the morning.
The maximal
dose
is
I
tablets
Amprilan
HD (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.
_Patients with impaired renal jimetion:_
[n patients
with a creatinine
clearance
greater
than 0.5 mils
or
serum creatinine
265
_Il_
_m_
_oi_
_/_
_L_
(3
_mg/iOO_
ml)
can be assigned
regular
dose.
_Impaired hepatic junefion:_
In patients
with mild to moderate
impairment
of hepatic
function
the dose oframipril
should
be
titrated
before
changing
to ramiprillhydrochlorothiazide
tablets.
Ramiprillbydrochlorothiazide
tablets
should
not
be used for
patients
with severely
impaired
hepatic
function
and/or
cholestasis
(see
also section
4.3).
_Children and adolescents_
«
18
_years of age):_
1 SmPCPIL 120261
3
130.10.2018
-
Updated:
16.01.2019