Transtec 70 micrograms/h Transdermal Patch

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Buprenorphine

Available from:

PCO Manufacturing Ltd.

ATC code:

N02AE; N02AE01

INN (International Name):

Buprenorphine

Dosage:

70 Microgram per hour

Pharmaceutical form:

Transdermal patch

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Oripavine derivatives; buprenorphine

Authorization status:

Authorised

Authorization date:

2014-05-02

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
TRANSTEC
® 35 MICROGRAMS/H TRANSDERMAL PATCH
TRANSTEC
® 52.5 MICROGRAMS/H TRANSDERMAL PATCH
TRANSTEC
® 70 MICROGRAMS/H TRANSDERMAL PATCH
Buprenorphine
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 Transtec is and what it is used for
2.
What you need to know before you use Transtec
3.
How to use Transtec
4.
Possible side effects
5.
How to store Transtec
6.
Contents of the pack and other information
1.
WHAT TRANSTEC IS AND WHAT IT IS USED FOR
Transtec is an analgesic (a pain-relieving medicine) intended to
relieve moderate to severe
cancer pain and severe pain that has not responded to other types of
painkillers. Transtec acts
through the skin. When the transdermal patch is applied to the skin,
the active substance
buprenorphine passes through the skin into the blood. Buprenorphine is
an opioid (strong pain
reliever), which reduces pain by acting on the central nervous system
(specific nerve cells in
the spinal cord and in the brain). The effect of the transdermal patch
lasts for up to four days.
Transtec is not suitable for the treatment of acute (short-lasting)
pain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE TRANSTEC
DO NOT USE TRANSTEC,
–
if you are allergic to buprenorphine or any of the other ingredients
of this medicine (listed in
section 6);
–
if you are dependent on strong pain relievers (opioids);
–
if you suffer from a disease in which you have or may have great
difficulty breathing
–
if you are taking monoamine oxi

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Transtec 70 micrograms/h Transdermal Patch
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One transdermal patch contains 40 mg buprenorphine.
Area containing the active substance: 50 cm²
Nominal release rate: 70 micrograms of buprenorphine per hour (over a
period of 96 hours).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Transdermal Patch
_Product imported from_ Italy:
Skin coloured patch with rounded corners marked:
Transtec 70µg/h, buprenorphinium 40mg
4 CLINICAL PARTICULARS
As per PA1032/001/003
5 PHARMACOLOGICAL PROPERTIES
As per PA1032/001/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Adhesive matrix (containing buprenorphine):_ [(Z)-octadec-9-en-1-yl]
oleate, povidone K90, 4-oxopentanic acid, poly
[acrylic
acid-co-butylacrylate-co-(2-ethylhexyl)acrylate-co-vinylacetate]
(5:15:75:5), cross-linked
_Adhesive matrix (without buprenorphine):_ poly[acrylic
acid-co-butylacrylate-co-(2-ethylhexyl)acrylate-co-vinylacetate]
(5:15:75:5), not cross-linked
_Separating foil between the adhesive matrices with and without
buprenorphine:_ poly(ethyleneterephthalate) – foil
_Backing layer:_ poly(ethyleneterephthalate) – tissue
_Release liner (on the front covering the adhesive matrix containing
buprenorphine):_ poly(ethyleneterephthalate) – foil,
siliconised, coated on one side with aluminium.
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the container and outer package of the product on
the market in the country of origin.
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