Nitro-Dur 0.2mg/hour transdermal patches

Country: United Kingdom

Bahasa: Inggeris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Glyceryl trinitrate

Boleh didapati daripada:

Organon Pharma (UK) Ltd

Kod ATC:

C01DA02

INN (Nama Antarabangsa):

Glyceryl trinitrate

Dos:

5mg/24hour

Borang farmaseutikal:

Transdermal patch

Laluan pentadbiran:

Transdermal

Kelas:

No Controlled Drug Status

Jenis preskripsi:

Valid as a prescribable product

Ringkasan produk:

BNF: 02060100; GTIN: 5012376019253

Risalah maklumat

PACKAGE LEAFLET: INFORMATION FOR THE USER
NITRO-DUR® 0.2 MG/H, 0.4 MG/H, 0.6 MG/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 Nitro-Dur is and what it is used for
2. What you need to know before you use Nitro-Dur
3. How to use Nitro-Dur
4. Possible side effects
5. How to store Nitro-Dur
6. Contents of this pack and other information
1. WHAT NITRO-DUR IS AND WHAT IT IS USED FOR
Nitro-Dur is an adhesive patch containing Glyceryl Trinitrate (GTN).
This is one of a group of
medicines called nitrate vasodilators which are used to treat the
symptoms of angina (chest pain).
Vasodilators are drugs that cause widening of the blood vessels and
therefore an increase in blood
flow. The GTN is contained in the adhesive and when the patch is in
contact with the skin the GTN
passes slowly and steadily from the patch through the skin and into
the bloodstream.
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 to
do. Nitro-Dur is used to prevent symptoms of angina; it is not for
treatment of an acute attack. You
should use your usual tablets or spray under the tongue for treatment
of acute attacks.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE NITRO-DUR
DO NOT USE NITRO-DUR IF YOU
:
-
are allergic to GTN or any of the other ingredients of Nitro-Dur.
-
have had a head injury or a condition which could cause an increase in
pressure

Ciri produk

OBJECT 1
NITRO-DUR 0.2MG/H TRANSDERMAL PATCH
Summary of Product Characteristics Updated 01-Aug-2017 | Merck Sharp &
Dohme Limited
1. Name of the medicinal product
Nitro-Dur® 0.2mg/h; 0.4mg/h and 0.6mg/h Transdermal Patch
2. Qualitative and quantitative composition
Glyceryl trinitrate 37.4 % w/w
For excipients, see 6.1.
3. Pharmaceutical form
Transdermal Patch
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
_Adults, including elderly patients:_
The recommended initial dose is one 0.2mg/h Nitro-Dur patch daily. In
some patients dose titration to
higher or lower doses may be necessary to achieve optimum therapeutic
effect.
Maximum dose: 15 mg in 24 hours.
Nitro-Dur is suitable for continuous or intermittent use. Patients
already receiving continuous 24-hour
nitrate therapy without signs of nitrate tolerance may continue on
this regimen provided clinical response
is maintained. Attenuation of effect has however occurred in some
patients being treated with sustained
release nitrate preparations. In such patients intermittent therapy
may be more appropriate. Under these
circumstances Nitro-Dur is applied daily for a period of approximately
12 hours.
The patch is then removed to provide a nitrate-free interval of 12
hours which may be varied between 8-
12 hours to suit individual patients (see section 4.4).
Patients experiencing nocturnal angina may benefit from overnight
treatment with a nitrate-free interval
during the day. In this patient group additional anti-anginal therapy
may be needed during the day.
Patients with severe angina may need additional anti-anginal therapy
during nitrate-free intervals.
Nitro-Dur Transdermal patches may be applied to any convenient skin
area; the recommended site is the
chest or outer upper arm. Application sites should be rotated and
suitable areas may be shaved if
necessary. Nitro-Dur patches should not be applied to the distal part
of th