Transiderm-Nitro 5 transdermal patches

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Glyceryl trinitrate

Available from:

Novartis Pharmaceuticals UK Ltd

ATC code:

C01DA02

INN (International Name):

Glyceryl trinitrate

Dosage:

5mg/24hour

Pharmaceutical form:

Transdermal patch

Administration route:

Transdermal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02060100; GTIN: 5010678550009

Patient Information leaflet

TRANSIDERM-NITRO® 5 AND 10
(GLYCERYL TRINITRATE)
PATIENT INFORMATION LEAFLET
WHAT YOU NEED TO KNOW ABOUT TRANSIDERM-NITRO® 5 AND 10
Your doctor has decided that you need this medicine to help treat your
condition.
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TO USE THE
PATCHES. IT CONTAINS IMPORTANT
INFORMATION. Keep the leaflet in a safe place because you may want to
read it again.
If you have any other questions, or if there is something you don’t
understand, please ask
your doctor or pharmacist.
This medicine has been prescribed for you. Never give it to someone
else. It may not be the
right medicine for them even if their symptoms seem to be the same as
yours.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
This product will be referred to as Transiderm-Nitro in this leaflet.
IN THIS LEAFLET:
1.
What Transiderm-Nitro patches are and what they are used for
2.
Things to consider before you start to use Transiderm-Nitro patches
3.
How to use Transiderm-Nitro
4.
Possible side effects
5.
How to store Transiderm-Nitro
6.
Further information
1.
WHAT TRANSIDERM-NITRO PATCHES ARE AND WHAT THEY ARE USED FOR
Transiderm-Nitro is a patch which you stick on your skin. The patch
contains a supply of
glyceryl trinitrate which is released from the patch and absorbed
through the skin and into
the blood vessels. This is called a transdermal patch. See diagram of
patch below.
Glyceryl trinitrate, the active ingredient in the patches is one of a
group of medicines called
vasodilators. These cause blood vessels to relax, increasing the
supply of blood and oxygen
to the heart and reducing the amount of work the heart has to do.
Transiderm-Nitro 5 and 10 are used

to prevent angina attacks. Angina means a painful tightness in the
chest. This is a
good description of a typical attack, although the pain may also be
felt in the arm or
neck. The pain really comes from the heart muscle and is a sign that
part of the
muscle is not g

Summary of Product characteristics

OBJECT 1
TRANSIDERM-NITRO 5
Summary of Product Characteristics Updated 28-Jul-2015 | Novartis
Pharmaceuticals UK Ltd
1. Name of the medicinal product
Transiderm Nitro
®
5.
Transiderm Nitro
®
10.
2. Qualitative and quantitative composition
Transiderm Nitro 5:
Nitroglycerin on lactose 250mg equivalent to nitroglycerin 25mg.
Transiderm Nitro
10:
Nitroglycerin on lactose 500mg equivalent to nitroglycerin 50mg.
For excipients see section 6.1.
3. Pharmaceutical form
Transdermal patch.
4. Clinical particulars
4.1 Therapeutic indications
Prophylactic treatment of attacks of angina pectoris, as monotherapy
or in combination with other anti-
anginal agents.
TRANSIDERM NITRO 5 ONLY: Prophylactic treatment of phlebitis and
extravasation secondary to venous
cannulation for intravenous fluid and drug administration when the
duration of treatment is expected to
last for 2 days or longer.
4.2 Posology and method of administration
For dermal administration
_Adults:_
Angina: Treatment should be initiated with one Transiderm Nitro 5
patch daily. If a higher dosage is
required a Transiderm Nitro 10 patch may be substituted. The dosage
may be increased to a maximum of
two Transiderm Nitro 10 patches daily in resistant cases. Transiderm
Nitro may be given either
continuously, or intermittently with a patch off period of 8-12 hours,
usually at night, during each 24 hour
period. Development of tolerance or attenuation of therapeutic effect
commonly occurs with prolonged or
frequent administration of all long-acting nitrates. Recent evidence
suggests that intermittent therapy with
Transiderm Nitro may reduce the incidence of tolerance.
Prior to the use of intermittent therapy, the clinical benefits to the
patients should be weighed against the
risks of angina in the patch-free interval. In patients considered to
be at risk, concomitant anti-anginal
therapy should be implemented (see “Precautions“).
It is recommended that the patch is applied to the lateral chest wall.
The replacement patch should be
applied to a new area of skin. All