CARDIOPLAST

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

NITROGLYCERIN (GLYCERYL TRINITRATE)

Commercializzato da:

McDermott Laboratories Ltd t/a Gerard Laboratories

Codice ATC:

C01DA02

INN (Nome Internazionale):

NITROGLYCERIN (GLYCERYL TRINITRATE)

Dosaggio:

0.2

Forma farmaceutica:

Transdermal Patch

Tipo di ricetta:

Product subject to prescription which may be renewed (B)

Area terapeutica:

glyceryl trinitrate

Stato dell'autorizzazione:

Not Marketed

Data dell'autorizzazione:

2013-07-19

Foglio illustrativo

PACKAGE LEAFLET
PAGE 14 OF 21
PACKAGE LEAFLET: INFORMATION FOR THE USER
Cardioplast 0.2 mg/h transdermal patches
Cardioplast 0.4 mg/h transdermal patches
Cardioplast 0.6 mg/h transdermal patches
Glyceryl trinitrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Cardioplast is and what it is used for
2.
What you need to know before you use Cardioplast
3.
How to use Cardioplast
4.
Possible side effects
5.
How to store Cardioplast
6.
Contents of the pack and other information
The full name of your product is Cardioplast 0.2 mg/h transdermal
patch, Cardioplast 0.4 mg/h
transdermal patch or Cardioplast 0.6 mg/h transdermal patch, however,
throughout the leaflet it will be
referred to as Cardioplast.
1.
WHAT CARDIOPLAST IS AND WHAT IT IS USED FOR
Cardioplast is an adhesive patch that delivers a medicine called
glyceryl trinitrate.
Glyceryl trinitrate is contained in the adhesive and when the patch is
in contact with the skin the
glyceryl trinitrate passes slowly and steadily from the patch through
the skin and into the bloodstream.
Glyceryl trinitrate belongs to a group of medicines called nitrate
vasodilators which are used to treat
the symptoms of angina (chest pain). Vasodilators work by widening of
the blood vessels and
therefore an increase in blood flow, letting more blood and oxygen
reach the heart.
Angina usually occurs as a pain or tightness in the chest although it
may be felt in the neck or arm.
The pain occurs when the heart muscle does not receive the oxygen it
needs to do the work it has

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cardioplast 0.2mg/h transdermal patches
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Glyceryl trinitrate
Each Cardioplast 0.2mg/h transdermal patch contains 20.7 mg of
glyceryl trinitrate in a patch size of 7.4 cm
2
, releasing
0.2 mg of glyceryl trinitrate per hour (4.8 mg/24 h).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Transdermal Patch
A translucent rectangular patch with rounded corners, marked with
“Glyceryl trinitrate” and the release rate. The
following is printed on each patch:
“Glyceryl trinitrate 0.2 mg/h (5mg/24 h)”
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For prophylaxis of angina pectoris either alone or in combination with
other anti-anginal therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adults including elderly patients:
Cardioplast transdermal patch it is not indicated for the immediate
treatment of an acute anginal attacks. If anginal
attacks occur, rapid-acting nitrate preparations (like spray) should
be used.
In order to avoid an attenuation of effect, in patients being treated
with sustained release nitrate preparations,
intermittent therapy is recommended.
The recommended initial dose is one Cardioplast 0.2 mg/h equivalent to
5 mg/24 h patch applied to the skin once daily
for a period of approximately 12 hours. The patch is then removed to
provide a nitrate-free interval of at least 8 hours
which may be increased up to 12 hours to suit individual patients (a
daily patch-off period of 8-12 hours).
In case of insufficient efficacy, the posology can be progressively
increased to one Cardioplast 0.4 mg/h equivalent to
10 mg/24 h patch once daily, and if necessary to a maximum of one
Cardioplast 0.6 mg/h equivalent to 15 mg/24 h
patch daily.
Maximum dose is one Cardioplast 0.6 mg/h patch in each 24 hour period
(15mg/24 h).
The nitrate-free interval should correspond to a time period when
patient does not usually experience crises, and should
be covered by another anti-angi