Perindopril Tosilaat Teva 5 mg, filmomhulde tabletten

Land: Nederländerna

Språk: nederländska

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

Aktiva substanser:

PERINDOPRILTOSILAAT SAMENSTELLING overeenkomend met ; PERINDOPRIL

Tillgänglig från:

Teva Nederland B.V. Swensweg 5 2031 GA HAARLEM

ATC-kod:

C09AA04

INN (International namn):

PERINDOPRILTOSILAAT COMPOSITION corresponding to ; PERINDOPRIL

Läkemedelsform:

Filmomhulde tablet

Sammansättning:

BRILJANTBLAUW FCF ALUMINIUMLAK (E133) ; CHINOLINEGEEL ALUMINIUMLAK (E 104) ; IJZEROXIDE GEEL (E 172) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; 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),

Administreringssätt:

Oraal gebruik

Terapiområde:

Perindopril

Produktsammanfattning:

Hulpstoffen: BRILJANTBLAUW FCF ALUMINIUMLAK (E133); CHINOLINEGEEL ALUMINIUMLAK (E 104); IJZEROXIDE GEEL (E 172); INDIGOKARMIJN ALUMINIUMLAK (E 132); 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);

Tillstånd datum:

2013-06-12

Bipacksedel

Perindopril tosilate, film-coated tablets, NL/H/2473/001-003,
07.03.2019
Changes due CMDh:without shading
Changes due to Excipients Guideline and QRD: shaded in turquoise
1
BIJSLUITER: INFORMATIE VOOR DE GEBRUIKER
PERINDOPRIL TOSILAAT TEVA 2,5 MG, FILMOMHULDE TABLETTEN
PERINDOPRIL TOSILAAT TEVA 5 MG, FILMOMHULDE TABLETTEN
PERINDOPRIL TOSILAAT TEVA 10 MG, FILMOMHULDE TABLETTEN
perindopril tosilate
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 Perindopril Tosilate is and what it is used for
2.
What you need to know before you take Perindopril Tosilate
3.
How to take Perindopril Tosilate
4.
Possible side effects
5.
How to store Perindopril Tosilate
6.
Contents of the pack and other information
1.
WHAT PERINDOPRIL TOSILATE IS AND WHAT IT IS USED FOR
Perindopril Tosilate is an angiotensin converting enzyme (ACE)
inhibitor. These work by
widening the blood vessels, which makes it easier for your heart to
pump blood through them.
Perindopril Tosilate is used:
-
to treat _high blood pressure_ (hypertension),
-
[2.5 mg and 5 mg strengths]to treat _heart failure_ (a condition where
the heart is unable to pump
enough blood to meet the body’s needs),
-
to reduce the risk of cardiac events, such as heart attack, in
patients with _stable coronary _
_artery disease_ (a condition where the blood supply to the heart is
reduced or blocked) and
who have already had a heart attack and/or an operation to improve the
blood supply to the
heart by widening the vessels that supply it.
2.
WHAT YOU NEED TO KNOW BEFORE

Produktens egenskaper

Perindopril tosilate, film-coated tablets, NL/H/2473/001-003,
07.03.2019
Changes due CMDh:without shading
Changes due to Excipents Guideline and QRD: shaded in turquoise
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
Perindopril Tosilaat Teva 2,5 mg, filmomhulde tabletten
Perindopril Tosilaat Teva 5 mg, filmomhulde tabletten
Perindopril Tosilaat Teva 10 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Perindopril tosilate
2.5 mg
Each film-coated tablet contains 1.704 mg perindopril corresponding to
2.5 mg perindopril
tosilate converted _in situ_ to perindopril sodium.
Excipient with known effect:
Each film-coated tablet contains 35.981 mg lactose monohydrate.
5 mg
Each film-coated tablet contains 3.408 mg perindopril corresponding to
5 mg perindopril
tosilate converted _in situ_ to perindopril sodium.
Excipient with known effect:
Each film-coated tablet contains 71.962 mg lactose monohydrate.
10 mg
Each film-coated tablet contains 6.816 mg perindopril corresponding to
10 mg perindopril
tosilate converted _in situ_ to perindopril sodium.
Excipient with known effect:
Each film-coated tablet contains 143.924 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
2.5 mg
White, round, biconvex, film-coated tablet of approx. 5 mm diameter,
debossed “T” on one side
and plain on the other.
5 mg
Light green, capsule shape, biconvex film-coated tablet of approx. 4
mm width and 8 mm
length, debossed “T” on one side, plain on the other side with
breaklines on both edges. The
tablet can be divided into equal doses.
10 mg
Green, round, biconvex, film-coated tablet of approx. 8 mm diameter,
debossed “10” on one
side and “T” on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
2
Hypertension:
Treatment of hypertension.
[2.5 mg and 5 mg strengths]
Heart failure:
Treatment of symptomatic heart failure.
Stable coronary artery disease:
Reduction of risk of cardiac events in patients with a history of
myoc