TRANSIDERM-NITRO 5/24 Unknown Transdermal Patch

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

GLYCERYL TRINITRATE

Available from:

Novartis Pharmaceuticals UK Ltd

ATC code:

C01DA02

INN (International Name):

GLYCERYL TRINITRATE

Dosage:

5/24 Unknown

Pharmaceutical form:

Transdermal Patch

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Organic nitrates

Authorization status:

Authorised

Authorization date:

1995-04-11

Patient Information leaflet

TRANSIDERM-NITRO 5 MILLIGRAMS/24 HOURS, 
TRANSIDERM-NITRO10 MILLIGRAMS/24 HOURS AND 
TRANSIDERM-NITRO15 MILLIGRAMS/24 HOURS TRANSDERMAL PATCH 

(glyceryl trinitrate) 

PATIENT INFORMATION LEAFLET 

READ ALL OF THIS
LEAFLET CAREFULLY BEFORE YOU START USING TRANSIDERM-NITRO 

• 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. Do
not pass it on to others. It may harm them, even
if their symptoms are 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. 

IN THIS LEAFLET 

1. What Transiderm-Nitro is and what it is used for 
2. Before you use Transiderm-Nitro 
3. How to use Transiderm-Nitro 
4. Possible side effects 
5. How to store Transiderm-Nitro 
6. Further information 
7. How to apply the patch 

1.  WHAT TRANSIDERM-NITRO IS AND WHAT IT IS USED FOR

. WHAT TRANSIDERM-NITRO IS AND WHAT IT IS 
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. 

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, 10 and 15 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 m

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Transiderm-Nitro 5milligrams/24 hours Transdermal Patch.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each patch contains glyceryl trinitrate 25 mg.
The average amount of glyceryl trinitrate absorbed per patch in 24
hours is 5 mg.
The surface measurement of the patch is 10 cm
2
.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Transdermal patch.
A flat, foil like patch sealed at the edges with white paste like
filling, one side with a grayish-orange backing film with
imprint ‘CG DOD’, the other side with an off-white protective
liner.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prophylactic treatment of attacks of angina pectoris, as monotherapy
or in combination with other anti-anginal agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
GENERAL RULES
Transiderm-Nitro is not intended for the immediate relief of acute
attacks of angina pectoris; if these occur, rapid-
acting nitrate preparations should be used.
The response to nitrate preparations varies from patient to patient;
the lowest effective dose should be prescribed.
The application site should be changed regularly to prevent local
irritation.
Development of tolerance or attenuation of therapeutic effects
commonly occurs with prolonged or frequent
administration of all long-acting nitrates. A patch-off period of 8-12
hours, usually at night, during each 24 hour
period is recommended to avoid tolerance.
Clinical trials have shown that in most patients, intermittent therapy
is
more effective than continuous administration.
Continuous application of Transiderm-Nitro may be appropriate
for patients in whom long-term clinical responsiveness can be reliably
assessed.
It is recommended that the patch is applied to the lateral chest wall.
If necessary, a suitable area should be shaved free
of hair.
The replacement patch should be applied to a new area of skin.
Allow several days to elapse before applying
a fresh patch to the same area of skin.
If a patch loosens it sho