Perindopril tert-butylamine/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 3,338 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 3,338 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 MG/0.625 MG TABLETS
PERINDOPRIL /INDAPAMIDE STADA 4 MG/1.25 MG TABLETS
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 Perindopril/Indapamide is and what it is used for
2. What you need to know before you take Perindopril/Indapamide
3. How to take Perindopril/Indapamide
4. Possible side effects
5. How to store Perindopril/Indapamide
6. Contents of the pack and other information
1. WHAT PERINDOPRIL/INDAPAMIDE IS AND WHAT IT IS USED FOR
WHAT IS PERINDOPRIL/INDAPAMIDE ?
Perindopril/Indapamide 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).
WHAT IS PERINDOPRIL/INDAPAMIDE 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 PERINDOPRIL/INDAPAMIDE
DO NOT TAKE PERINDOPRIL/INDAPAMIDE
•
if you are allergic to perindopril or any other ACE inhibitor, or to
indapamide or any othe

Productkenmerken

1
Each tablet contains 4 mg perindopril tert-butylamine salt, equivalent
to 3.338 mg perindopril
and 1.25 mg indapamide
Excipient with known effects
58.47 mg of lactose monohydrate
Each tablet contains 2 mg perindopril tert-butylamine salt, equivalent
to 1.669 mg perindopril
and 0.625 mg indapamide.
Excipient with known effects
58.47 mg of lactose monohydrate
Treatment of essential hypertension, Perindopril/Indapamide 4 mg/1.25
mg is indicated in
patients whose blood pressure is not adequately controlled on
perindopril alone.
Essential hypertension.
Posology
The usual dose is one Perindopril/Indapamide 2 mg/0.625 mg 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
Perindopril/Indapamide 2 mg/0.625 mg
tablet per day.
Renal impairment (see section 4.4)
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Perindopril tert-butylamine/Indapamide STADA 2/0,625 mg, tabletten
Perindopril tert-butylamine/Indapamide STADA 4/1,25 mg, tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet
White, rod shaped tablets having ‘PI’ debossed on one side and
plain on the other.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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.
2
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 Perindopril/Indapamide 2 mg/0.625 mg per
day.
In patients with creatinine clearance greater than or equal to 60
ml/min, no dose modification
i