Prestarium COMBI Arginine tablets film-coated

Land: Armenien

Sprache: Englisch

Quelle: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Wirkstoff:

perindopril (perindopril arginine), indapamide

Verfügbar ab:

Les Laboratoires Servier Industrie 905

ATC-Code:

C09BA04

INN (Internationale Bezeichnung):

perindopril (perindopril arginine), indapamide

Dosierung:

5mg+ 1,25mg

Darreichungsform:

tablets film-coated

Einheiten im Paket:

(30) in plastic container

Verschreibungstyp:

Prescription

Berechtigungsstatus:

Registered

Berechtigungsdatum:

2017-11-30

Gebrauchsinformation

CIS_PIL_PRESTARIUM COMBI Arginine_02.2015
1/7
LEAFLET: INFORMATION FOR THE USER
PRESTARIUM
® COMBI ARGININE
perindopril arginine/indapamide
film-coated tablets
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOT YOU.
-
Keep this leaflet. You may need to read it again.
-
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 sings of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
IN THIS LEAFLET:
1.
What PRESTARIUM COMBI Arginine is and what it is used for
2.
what you need to know before you take PRESTARIUM COMBI Arginine
3.
How to take PRESTARIUM COMBI Arginine
4.
Possible side effects
5.
How to store PRESTARIUM COMBI Arginine
6.
Contents of the pack and other information
1.
WHAT PRESTARIUM COMBI ARGININE IS AND WHAT IT IS USED FOR
PRESTARIUM COMBI Arginine is a combination of two active ingredients,
perindopril and indapamide. It
is an anti-hypertensive and is used in the treatment of high blood
pressure (hypertension) in adults.
Perindopril belongs to a class of medicines called ACE inhibitors.
These work by widening the blood
vessels, which makes it easier for your heart to pump blood through
them. Indapamide is a diuretic.
Diuretics increase the amount of urine produced by the kidneys.
However, indapamide is different from
other diuretics, as it only causes a slight increase in the amount of
urine produced. Each of the active
ingredients reduces blood pressure and they work together to control
your blood pressure.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PRESTARIUM COMBI ARGININE
DO NOT TAKE PRESTARIUM COMBI ARGININE
-
if you are allergic to perindopril or any other ACE inhibitor, or to
indapamide or any other
sulphonamides or any of the other ingredients of this medicine (listed
in section 6),

Fachinformation

SPC_Prestarium Combi arginine_06.2017
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
PRESTARIUM
®
COMBI Arginine 5mg/1.25mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 3.395mg perindopril corresponding to
5mg perindopril arginine and 1.25mg
indapamide.
Excipient with know effect: 71.33mg lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White, rod-shaped film-coated tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension in adults, PRESTARIUM COMBI
Arginine is indicated in patients
whose blood pressure is not adequately controlled on perindopril
alone.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One PRESTARIUM COMBI Arginine film-coated tablet per day as a single
dose, preferably to be taken in
the morning, and before a meal.
When possible individual dose titration with the components is
recommended. PRESTARIUM COMBI
arginine film-coated tablet should be used when blood pressure is not
adequately controlled on NOLIPREL
arginine film-coated tablet (when available). When clinically
appropriate, direct change from monotherapy
to PRESTARIUM COMBI Arginine may be considered.
Special populations
_ _
_Elderly (see section 4.4) _
Treatment should be initiated after considering blood pressure
response and renal function.
_Renal impairment (see section 4.4) _
In severe renal impairment (creatinine clearance below 30 ml/min),
treatment is contraindicated.
In patients with moderate renal impairment (creatinine clearance 30-60
ml/min), it is recommended to start
treatment with the adequate dosage of the free combination.
In patients with creatinine clearance greater than or equal to 60
ml/min, no dose modification is required.
Usual medical follow-up will include frequent monitoring of creatinine
and potassium.
2
_Hepatic impairment (see sections 4.3, 4.4 and 5.2) _
In severe hepatic impairment, treatment is contraindicated.
In patients with mod