Perindopril Tosilaat/Indapamide ratiopharm 5 mg/1,25 mg, filmomhulde tabletten

Riik: Holland

keel: hollandi

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

Toimeaine:

INDAPAMIDE 0-WATER 1,25 mg/stuk ; PERINDOPRILTOSILAAT 5 mg/stuk SAMENSTELLING overeenkomend met ; PERINDOPRIL 3,4 mg/stuk

Saadav alates:

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

ATC kood:

C09BA04

INN (Rahvusvaheline Nimetus):

INDAPAMIDE 0-WATER 1,25 mg/stuk ; PERINDOPRILTOSILAAT 5 mg/stuk SAMENSTELLING overeenkomend met ; PERINDOPRIL 3,4 mg/stuk

Ravimvorm:

Filmomhulde tablet

Koostis:

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), 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),

Manustamisviis:

Oraal gebruik

Terapeutiline ala:

Perindopril And Diuretics

Toote kokkuvõte:

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);

Loa andmise kuupäev:

1900-01-01

Infovoldik

Perindopril tosilate/indapamide 5 mg/1.25 mg, NL/H/2475/002,
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 110917 EU PIL IB/033 met NL info-clean versie 3
PACKAGE LEAFLET: INFORMATION FOR THE USER
PERINDOPRIL TOSILAAT/INDAPAMIDE RATIOPHARM 5 MG/1,25 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 YOU TAKE

Toote omadused

Perindopril tosilate/indapamide 5 mg/1.25 mg, NL/H/2475/002,
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 110917 EU SPC IB/033 met NL info-clean versie 3
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
Perindopril Tosilaat/Indapamide ratiopharm 5 mg/1,25 mg, filmomhulde
tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 3.408 mg perindopril corresponding to
5 mg perindopril tosilate, converted
_in situ _
to perindopril sodium, and 1.25 mg indapamide.
Excipient with known effect:
Each film-coated tablet contains 148.112 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. 5 mm
width and 10 mm length, debossed “P”,
“I” and breakline on one side and plain on the other side.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension, [Product name] is indicated in
patients whose blood pressure is not
adequately controlled on perindopril alone.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One [Product name] 5mg/1.25mg 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. [Product name] 5mg/1.25mg
film-coated tablet should be used when blood pressure is not
adequately controlled on
Perindopril/Indapamide 2.5mg/0.625mg film-coated tablet (where
available).When clinically appropriate,
direct change from monotherapy to [Product name] 5mg/1.25mg
film-coated tablet may be considered.
_ _
Special populations
Perindopril tosilate/indapamide 5 mg/1.25 mg, NL/H/2475/002,
19.01.2023
Approved within IB026, IB028, IA030: shaded in turquoise
Day 20 comments: shaded in yellow
Day 20 second round: shaded in green
2
rvg 110917 EU SPC IB/033 met NL info-cle