Perindopril tosilaat/Indapamide DOC 5 mg/1,25 mg, filmomhulde tabletten

Nazione: Paesi Bassi

Lingua: olandese

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

Principio attivo:

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

INN (Nome Internazionale):

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

Forma farmaceutica:

Filmomhulde tablet

Composizione:

LACTOSE 1-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMWATERSTOFCARBONAAT (E 500 (II)) ; POLYVINYLALCOHOL (E 1203) ; POVIDON K 30 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

Via di somministrazione:

Oraal gebruik

Data dell'autorizzazione:

1900-01-01

Foglio illustrativo

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PERINDOPRIL TOSILAAT/INDAPAMIDE DOC 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] 5 mg/1.25 mg is and what it is used for
2.
What you need to know before you take [Product name] 5 mg/1.25 mg
3.
How to take [Product name] 5 mg/1.25 mg
4.
Possible side effects
5.
How to store [Product name] 5 mg/1.25 mg
6.
Contents of the pack and other information
1.
WHAT [PRODUCT NAME] 5 MG/1.25 MG IS AND WHAT IT IS USED FOR
[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.
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 [PRODUCT NAME] 5 MG/1.25 MG
DO NOT TAKE [PRODUCT NAME] 5 MG/1.25 MG
-
if you are allergic to perindopril or any other ACE inhibitor, or to
indapamide or any other
sulfonamide or any of the other ingredients of this medicine (listed
in section 6)

Scheda tecnica

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Perindopril tosilaat/Indapamide DOC 5 mg/1,25 mg, filmomhulde
tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg perindopril tosilate
corresponding to 3.408 mg perindopril,
converted in situ to perindopril sodium, and 1.25 mg indapamide.
Excipient with known effect
:
Each film-coated tablet contains 141 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
White, capsule shaped biconvex film-coated tablet of approximately 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 in adults, Perindopril
tosilaat/Indapamide DOC 5 mg/1.25 mg film-
coated tablet is indicated in patients whose blood pressure is not
adequately controlled on perindopril
alone.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One Perindopril tosilaat/Indapamide DOC 5 mg/1.25 mg 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. Perindopril
tosilaat/Indapamide DOC 5 mg/1.25mg film-coated tablet should be used
when blood pressure is not
adequately controlled on Perindopril tosilaat/Indapamide DOC 2.5
mg/0.625 mg film-coated tablet
(where available). When clinically appropriate, direct change from
monotherapy to Perindopril
tosilaat/Indapamide DOC 5 mg/1.25 mg film-coated tablet 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.
2
In patients with moderate renal impairment (creatinine clearance 30-60
ml/min), it is recommended to
st