EPINITRIL 10 mg/24 h transdermal patch

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Glyceryl trinitrate

Available from:

Rottapharm Ltd

ATC code:

C01DA; C01DA02

INN (International Name):

Glyceryl trinitrate

Dosage:

10 milligram(s)/24 hours

Pharmaceutical form:

Transdermal patch

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Organic nitrates; glyceryl trinitrate

Authorization status:

Not marketed

Authorization date:

2000-04-14

Patient Information leaflet

1
IE/H/0104/001-003/II/025
PACKAGE LEAFLET: INFORMATION OF THE USER
EPINITRIL 5 MG/24 H TRANSDERMAL PATCH
EPINITRIL 10 MG/24 H TRANSDERMAL PATCH
EPINITRIL 15 MG/24 H TRANSDERMAL PATCH
_ _
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 Epinitril is and what it is used for
2.
What you need to know before you use Epinitril
3.
How to use Epinitril
4.
Possible side effects
5.
How to store Epinitril
6.
Contents of the pack and other information
1.
WHAT EPINITRIL IS AND WHAT IT IS USED FOR
Epinitril
patches contain the active substance glyceryl trinitrate, a
vasodilator used in cardiac diseases,
which belongs to a group of drugs called organic nitrates.
Epinitril patches are applied to the skin and the active substance
will then pass continuously through
your skin and into your body.
Epinitril is indicated for the prevention of angina attacks either
taken on its own or in combination
with other anti-anginal therapy.
Angina usually occurs as a pain or tightness in the chest although it
may be felt in the neck or arm.
Pain occurs when the heart is not sufficiently oxygenated. Epinitril
is not indicated for the treatment of
acute attacks. You should use your usual sublingual tablet or spray
for treatment of acute attacks.
Epinitril
patches are for external use only.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE EPINITRIL
DO NOT USE_ _EPINITRIL:_ _
-
if you
are allergic (hypersensitive) to glyceryl trinitrate, related organic
nitrates or to any of the
other excipients of Epinitril (listed in

Summary of Product characteristics

Health Products Regulatory Authority
08 February 2023
CRN00CV0R
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
EPINITRIL 10 mg/24 h transdermal patch
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One transdermal patch contains 31.37 mg of glyceryl trinitrate/12.75
cm
2
delivering 10 mg of glyceryl trinitrate in 24 hours (0.4
mg/hour).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Transdermal patch. Each patch is circular, light yellow and
transparent with printed identification code (NR10), covered by a
square both sides aluminised and both sides siliconised protective
liner.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Preventive treatment of angina pectoris either alone or in combination
with other
anti-anginal therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Different strengths of EPINITRILare available.
Treatment is usually initiated with one EPINITRIL 5 mg/24 h applied to
the skin once daily. EPINITRIL5 mg/24 h delivers 0.2
mg/h of glyceryl trinitrate. The dose should be adjusted individually
during the treatment to achieve optimum therapeutic
effect.
The maximum daily dose for EPINITRIL should be 15 mg of glyceryl
trinitrate.
EPINITRIL is administered intermittently, with a daily nitrate-free
interval, in order to avoid the development of nitrate tolerance.
This free interval should correspond for the patient to a period with
no attacks. The timing of administration of concomitant
anti-anginal agents (beta-blockers and/or calcium antagonists) should
be established in order to provide a therapeutic cover
during the nitrate-free interval.
The nitrate-free interval of 8 - 12 hours must be observed.
The development of nitrate tolerance is a well-established event
during the preventive treatment of angina. An adequate
prescription with a nitrate-free interval guarantees the therapeutic
efficacy of nitrates.
Patients experiencing nocturnal angina may benefit from overnight
treatment with a nitrate-free interval during the day. In
these patients, an ad