Percarnil 4 mg Tablets

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Perindopril tert-butylamine

Mevcut itibaren:

Accord Healthcare Ireland Ltd.

ATC kodu:

C09AA; C09AA04

INN (International Adı):

Perindopril tert-butylamine

Doz:

4 milligram(s)

Farmasötik formu:

Tablet

Reçete türü:

Product subject to prescription which may be renewed (B)

Terapötik alanı:

ACE inhibitors, plain; perindopril

Yetkilendirme durumu:

Marketed

Yetkilendirme tarihi:

2008-12-12

Bilgilendirme broşürü

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PERCARNIL 4 MG TABLETS
PERCARNIL 8 MG TABLETS
perindopril tert-butylamine
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 Percarnil is and what is it used for
2.
What you need to know before you take Percarnil
3.
How to take Percarnil
4.
Possible side effects
5.
How to store Percarnil
6.
Contents of the pack and other information
1.
WHAT PERCARNIL IS AND WHAT IT IS USED FOR
Percarnil contains the active substance perindopril tert-butylamine
which belongs to a group of medicines
called ACE inhibitors. These work by widening the blood vessels. This
makes it easier for your heart to pump
blood through the body.
Percarnil 4 mg Tablets are used to:
•
treat high blood pressure (hypertension)
•
treat heart failure (a condition where the heart is unable to pump
enough blood to meet the body’s
needs)
•
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.
Percarnil 8 mg Tablets are used to:
•
treat high blood pressure (hypertension)
•
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 su

Ürün özellikleri

HealthProductsRegulatoryAuthority
31May2019
CRN008Z7N
Page1of16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Percarnil4mgTablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Eachtabletcontains:
4mgperindopriltert-butylaminesalt,equivalentto3.338mgperindopril
Excipient with known effect:
Eachtabletcontains62.78mgoflactosemonohydrate
Forthefulllistofexcipients,seesection6.1.
3 PHARMACEUTICAL FORM
Tablet
White,oblongtablet,withabreak-lineonbothsides,‘PP’engravedononesideand‘4’ontheother.
Thetabletcanbedividedintoequaldoses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension:
Treatmentofhypertension
Heart failure:
Treatmentofsymptomaticheartfailure
Stable coronary artery disease
Reductionofriskofcardiaceventsinpatientswithahistoryofmyocardialinfarctionand/orrevascularisation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Thedoseshouldbeindividualisedaccordingtothepatientprofile(seesection4.4)andbloodpressureresponse.
_Hypertension_
Percarnilmaybeusedinmonotherapyorincombinationwithotherclassesofantihypertensivetherapy(seesections4.3,4.4,
4.5and5.1).
Therecommendedstartingdoseis4mggivenoncedailyinthemorning.
Patientswithastronglyactivatedrenin-angiotensin-aldosteronesystem(inparticular,renovascularhypertension,saltand/or
volumedepletion,cardiacdecompensationorseverehypertension)mayexperienceanexcessivedropinbloodpressure
followingtheinitialdose.Astartingdoseof2mgisrecommendedinsuchpatientsandtheinitiationoftreatmentshouldtake