Perindopril/Indapamide STADA 4/1,25 mg, tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

INDAPAMIDE 0-WATER 1,25 mg/stuk ; PERINDOPRIL-TERT-BUTYLAMINE 4 mg/stuk SAMENSTELLING overeenkomend met ; PERINDOPRIL 3,34 mg/stuk

Beschikbaar vanaf:

Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)

ATC-code:

C09BA04

INN (Algemene Internationale Benaming):

INDAPAMIDE 0-WATER 1,25 mg/stuk ; PERINDOPRIL-TERT-BUTYLAMINE 4 mg/stuk SAMENSTELLING overeenkomend met ; PERINDOPRIL 3,34 mg/stuk

farmaceutische vorm:

Tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE, HYDROFOOB, CELLULOSE, MICROKRISTALLIJN (E 460) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE, HYDROFOOB,

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Perindopril And Diuretics

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); SILICIUMDIOXIDE, HYDROFOOB;

Autorisatie datum:

1900-01-01

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PERINDOPRIL/INDAPAMIDE STADA 2/0.625 MG, TABLETTEN
PERINDOPRIL/INDAPAMIDE STADA 4/1.25 MG, TABLETTEN
Perindopril tert-butylamine / 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 of the 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 is and what it is used for
2. What you need to know before you take
3. How to take
4. Possible side effects
5. How to store
6. Contents of the pack and other information
1. WHAT PERINDOPRIL/INDAPAMIDEIS AND WHAT IT IS USED FOR
WHAT IS ?
Perindopril/Indapamideis 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).
WHAT IS PERINDOPRIL/INDAPAMIDEUSED 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
DO NOT TAKE
•
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 sec

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Perindopril/Indapamide STADA 2/0.625 mg, tabletten
Perindopril/Indapamide STADA 4/1.25 mg, tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2 mg/0.625 mg Tablets
Each tablet contains 2 mg perindopril tert-butylamine salt, equivalent
to 1.669 mg perindopril
and 0.625 mg indapamide.
Excipient with known effect
Each tablet contains 58.47 mg of lactose monohydrate
4 mg/1.25 mg Tablets
Each tablet contains 4 mg perindopril tert-butylamine salt, equivalent
to 3.338 mg perindopril
and 1.25 mg indapamide
Excipient with known effect
Each tablet contains 58.47 mg of lactose monohydrate
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet
White, rod shaped tablets having ‘P’ and ‘I’ engraved on
either side of score line on one side
and score line on the other side.
The tablet can be divided into equal doses.
White, rod shaped tablets having ‘PI’ debossed on one side and
plain on the other.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension
Treatment of essential hypertension for patients whose blood pressure
is not adequately
controlled on perindopril alone.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: Oral use
It is recommended that one Perindopril/Indapamide 2 mg/0.625 mg is
taken daily, preferably
in the morning before a meal. The dose should be adjusted according to
the patient profile and
blood pressure response. If blood pressure is not adequately
controlled the dose may be
increased to one Perindopril/Indapamide 4 mg/1.25 mg daily.
When
clinically
appropriate,
direct
change
from
monotherapy
with
perindopril
to
Perindopril/Indapamide may be considered. Individual dose titration
with the components may
be required.
2
_ _
_SPECIAL POPULATIONS _
Elderly population (see section 4.4)
Treatment should be initiated at a dose of 2 mg/0.625 mg daily with
consideration of the blood
pressure response and renal function.
Renal impairment (see sections 4.3 and 4.4)
In severe renal fa