Transtec 35 micrograms/h Transdermal Patch

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Buprenorphine

Disponible depuis:

PCO Manufacturing Ltd.

Code ATC:

N02AE; N02AE01

DCI (Dénomination commune internationale):

Buprenorphine

Dosage:

35 Microgram per hour

forme pharmaceutique:

Transdermal patch

Type d'ordonnance:

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

Domaine thérapeutique:

Oripavine derivatives; buprenorphine

Statut de autorisation:

Authorised

Date de l'autorisation:

2014-05-02

Notice patient

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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

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Transtec 35 micrograms/h Transdermal Patch
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One transdermal patch contains 20 mg buprenorphine.
Area containing the active substance: 25 cm²
Nominal release rate: 35 micrograms of buprenorphine per hour (over a
period of 96 hours).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Transdermal Patch
_Product imported from_ Italy:
Skin coloured transdermal patch with rounded corners marked:
Transtec 35µg/h, buprenorphinium 20mg.
4 CLINICAL PARTICULARS
As per PA1032/001/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1032/001/001
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.
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