Nitroderm TTS 5 (5mg24hr) transdermal patch

Quốc gia: Malaysia

Ngôn ngữ: Tiếng Anh

Nguồn: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Thành phần hoạt chất:

Nitroglycerin, diluted

Sẵn có từ:

SANDOZ PRODUCTS MALAYSIA SDN. BHD.

INN (Tên quốc tế):

Nitroglycerin, diluted

Các đơn vị trong gói:

30 Pieces

Sản xuất bởi:

LTS Lohmann Therapie-Systeme AG

Tờ rơi thông tin

_Consumer Medication Information Leaflet (RiMUP) _
NITRODERM
® TTS TRANSDERMAL
PATCH
Nitroglycerin Transdermal Patch (25 mg, 50 mg)
1
WHAT IS IN THIS LEAFLET
1.
What Nitroderm TTS is used
for
2.
How Nitroderm TTS works
3.
Before you use Nitroderm
TTS
4.
How to use Nitroderm TTS
5.
While you are using
Nitroderm TTS
6.
Side effects
7.
Storage and Disposal of
Nitroderm TTS
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT NITRODERM TTS IS USED
FOR
Nitroderm TTS belongs to a
group of medicines called nitrates
which widen the blood vessels.
This medicine is used to prevent
or reduce the frequency of angina
attacks (chest pain or discomfort).
HOW NITRODERM TTS WORKS
Nitroderm TTS works by
widening the blood vessels, which
makes it easier for the heart to do
its work. It may also be used for
other conditions as determined by
your doctor.
If an angina attack has already
started, you should use a fast-
acting nitrate (sublingual tablets
or spray) instead of Nitroderm
TTS patches.
BEFORE YOU USE NITRODERM TTS
Follow all the doctor’s
instructions carefully. They may
differ from the general
information contained in this
leaflet.
_When you must not use it _

If you are allergic
(hypersensitive) to
nitroglycerin, to any
excipient of Nitroderm TTS,
or to nitrates or nitrites.

If you suffer from a
breakdown of the blood
circulation with very low
blood pressure, such as in
shock.

If you have increased
intracranial pressure (an
increase of pressure in the
brain).

If you suffer from a disease of
the valves of the heart or an
inflammatory disease of the
heart.

If you are currently taking a
medicine to treat erectile
dysfunction from the group of
so-called phosphodiesterase
type 5 inhibitors (e.g.
sildenafil).
If any of these apply to you, tell
your doctor without taking
Nitroderm TTS.
_ _
_PREGNANCY AND BREAST-FEEDING _
There is little experience with the
use of Nitroderm TTS in pregnant
women.
You should tell your doctor if you
are pregnant, or i

Đặc tính sản phẩm

Novartis
Page 1
Malaysian Package Leaflet
15 Nov 2017
Nitroderm TTS®
NITRODERM TTS
 TRANSDERMAL PATCH
Vasodilator used in cardiac diseases
DESCRIPTION AND COMPOSITION
ACTIVE SUBSTANCE
Nitroderm TTS contains Nitroglycerin( 25 mg, or 50 mg) in a
transdermal therapeutic system
(TTS).
LIST OF EXCIPIENTS
Silica, colloidal anhydrous and dimethicone.
PHARMACEUTICAL FORM
Transdermal patch
Flat multilayer system designed to deliver nitroglycerin continuously
through a release
membrane following application to the skin. The release membrane
limits delivery through
hyperpermeable skin. The active substance penetrates the skin and thus
becomes directly
bioavailable to the systemic circulation at relatively constant
concentrations during the
recommended application period. The following three systems are
available:
TABLE 1
NITRODERM TTS PHARMACEUTICAL FORMS
Nitroderm TTS 5
Nitroderm TTS 10
Nitroglycerin content
25 mg
50 mg
Drug-releasing area
10 cm
2
20 cm
2
Imprint (backing side)
CG
CG
DOD
DPD
Colour of the release
liner
off-white to yellowish
The numeric components of the product designations TTS 5 and TTS 10
denote the nominal
amount of nitroglycerin in mg delivered by the system per 24 hours.
The remainder of the nitroglycerin in each system serves as a reserve
and is not delivered in
normal use. After 12 hours, for example, each system has delivered 10%
of its original
content of nitroglycerin. Since nitroglycerin is released from
Nitroderm TTS at a constant rate
per cm

, the dose administered is related to the size of the drug-releasing
area. The nominal
rate of nitroglycerin release in vivo is approximately 20-25
microgram/cm

.h.
The following cross-sectional diagram shows the composition of
Nitroderm TTS.
Novartis
Page 2
Malaysian Package Leaflet
15 Nov 2017
Nitroderm TTS®
DESCRIPTION
Nitroderm TTS 5:
Flat, foil patch, sealed at the edges, with white paste-like filling,
one side with a greyish-
orange backing film with imprint “CG DOD”, the other side with an
off-white protective
liner.
Shape: oblong,