Perindopril Tosilaat/Indapamide ratiopharm 2,5 mg/0,625 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

INDAPAMIDE 0-WATER 0,625 mg/stuk ; PERINDOPRILTOSILAAT 2,5 mg/stuk SAMENSTELLING overeenkomend met ; PERINDOPRIL 1,7 mg/stuk

Beschikbaar vanaf:

Ratiopharm GmbH Graf-Arco-Strasse 3 89079 ULM (DUITSLAND)

ATC-code:

C09BA04

INN (Algemene Internationale Benaming):

INDAPAMIDE 0-WATER 0,625 mg/stuk ; PERINDOPRILTOSILAAT 2,5 mg/stuk SAMENSTELLING overeenkomend met ; PERINDOPRIL 1,7 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

LACTOSE 1-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMWATERSTOFCARBONAAT (E 500 (II)) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; POVIDON K 30 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Perindopril And Diuretics

Product samenvatting:

Hulpstoffen: LACTOSE 1-WATER; MACROGOL 3350; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; MAÏSZETMEEL, GEPREGELATINEERD; NATRIUMWATERSTOFCARBONAAT (E 500 (II)); POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); POVIDON K 30 (E 1201); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2013-08-06

Bijsluiter

Perindopril tosilate/indapamide 2.5 mg/0.625 mg, NL/H/2475/001,
19.01.2023
Approved within IB026, IB028, IA030: shaded in turquoise
Day 20 comments: shaded in yellow
Day 20 second round: shaded in green
rvg 110915 EU PIL IB/033 met NL info-clean versie 3
PACKAGE LEAFLET: INFORMATION FOR THE USER
PERINDOPRIL TOSILAAT/INDAPAMIDE RATIOPHARM 2,5 MG/0,625 MG,
FILMOMHULDE TABLETTEN
perindopril tosilate/indapamide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR 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 signs 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.
WHAT IS IN THIS LEAFLET
:
1.
What [Product name] is and what it is used for
2.
What you need to know before you take [Product name]
3.
How to take [Product name]
4.
Possible side effects
5.
How to store [Product name]
6.
Contents of the pack and other information
1.
WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
WHAT IS [PRODUCT NAME]?
[Product name] 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.
WHAT IS [PRODUCT NAME] USED FOR?
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 Y

Productkenmerken

Perindopril tosilate/indapamide 2.5 mg/0.625 mg, NL/H/2475/001,
19.01.2023
Approved within IB026, IB028, IA030: shaded in turquoise
Day 20 comments: shaded in yellow
Day 20 second round: shaded in green
1
rvg 110915 EU SPC IB/033 met NL info-clean versie 3
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
Perindopril Tosilaat/Indapamide ratiopharm 2,5 mg/0,625 mg,
filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 1.704 mg perindopril corresponding to
2.5 mg perindopril tosilate, converted
_in situ _
to perindopril sodium, and 0.625 mg indapamide.
Excipient with known effect:
Each film-coated tablet contains 74.056 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
White, capsule shaped biconvex film-coated tablet of approx. 4 mm
width and 8 mm length, debossed
breakline on one side and plain on the other side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Essential hypertension.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The usual dose is one [Product name] 2.5mg/0.625mg film-coated tablet
per day as a single dose, preferably
to be taken in the morning and before a meal. If blood pressure is not
controlled after one month of
treatment, the dose can be doubled.
Special populations
_Elderly (see section 4.4) _
Treatment should be started at the normal dose of one [Product name]
2.5mg/0.625mg film-coated tablet per
day.
_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), the maximum dose should
be one tablet of [Product name] 2.5mg/0.625mg per day.
Perindopril tosilate/indapamide 2.5 mg/0.625 mg, NL/H/2475/001,
19.01.2023
Approved within IB026, IB028, IA030: shaded in turquoise
Day 20 comments: shaded in yellow
Da