Perindopril tosilaat/Indapamide DOC 10 mg/2,5 mg, filmomhulde tabletten

Nazione: Paesi Bassi

Lingua: olandese

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

Principio attivo:

INDAPAMIDE 0-WATER 2,5 mg/stuk ; PERINDOPRILTOSILAAT 10 mg/stuk SAMENSTELLING overeenkomend met ; PERINDOPRIL 6,8 mg/stuk

INN (Nome Internazionale):

INDAPAMIDE 0-WATER 2,5 mg/stuk ; PERINDOPRILTOSILAAT 10 mg/stuk SAMENSTELLING overeenkomend met ; PERINDOPRIL 6,8 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 10 MG/2,5 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] 10 mg/2.5 mg is and what it is used for
2.
What you need to know before you take [Product name] 10 mg/2.5 mg
3.
How to take [Product name] 10 mg/2.5 mg
4.
Possible side effects
5.
How to store [Product name] 10 mg/2.5 mg
6.
Contents of the pack and other information
1.
WHAT [PRODUCT NAME] 10 MG/2.5 MG IS AND WHAT IT IS USED FOR
[Product name] 10 mg/2.5 mg 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.
[Product name] 10 mg/2.5 mg is prescribed for patients already
receiving perindopril 10 mg and indapamide
2.5 mg from separate tablets, these patients may instead receive one
tablet of [Product name] 10 mg/2.5 mg
which contains both ingredients.
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 BEF

Scheda tecnica

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Perindopril tosilaat/Indapamide DOC 10 mg/2,5 mg, filmomhulde
tabletten.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg perindopril tosilate
corresponding to 6.816 mg perindopril,
converted in situ to perindopril sodium, and 2.5 mg indapamide.
Excipient with known effect:
Each film-coated tablet contains 281 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White, round and biconvex film-coated tablet of approximately 10 mm
diameter, plain on both sides.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Perindopril tosilaat/Indapamide DOC 10 mg/2.5 mg is indicated as
substitution therapy for treatment of
essential hypertension, in patients already controlled with
perindopril and indapamide given concurrently
at the same dose level.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One Perindopril tosilaat/Indapamide DOC 10 mg/2.5 mg film-coated
tablet per day as a single dose,
preferably to be taken in the morning and before a meal.
Special populations
_Elderly (see section 4.4) _
In elderly, the plasma creatinine must be adjusted in relation to age,
weight and gender. Elderly patients
can be treated if renal function is normal and after considering blood
pressure response.
_ _
_Renal impairment (see section 4.4) _
In severe and moderate renal impairment (creatinine clearance below 60
ml/min), treatment is
contraindicated.
Usual medical follow-up will include frequent monitoring of creatinine
and potassium.
_ _
_Hepatic impairment (see sections 4.3, 4.4 and 5.2) _
In severe hepatic impairment, treatment is contraindicated.
In patients with moderate hepatic impairment, no dose modification is
required.
_ _
_Paediatric population _
2
The safety and efficacy of Perindopril tosilaat/Indapamide DOC 10
mg/2.5 mg in children and adolescents
have not yet been established. No data are available. Perindopril
tosilaat/Indapamide DOC 10 mg/2.5 mg
should not be use