BuTrans 10 micrograms/hour transdermal patch

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Buprenorphine

Beszerezhető a:

Mundipharma Pharmaceuticals Limited

ATC-kód:

N02AE; N02AE01

INN (nemzetközi neve):

Buprenorphine

Adagolás:

10 milligram(s)

Gyógyszerészeti forma:

Transdermal patch

Recept típusa:

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

Terápiás terület:

Oripavine derivatives; buprenorphine

Engedélyezési státusz:

Marketed

Engedély dátuma:

2005-06-24

Betegtájékoztató

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
_BUTRANS_
® 5 microgram/hour transdermal patches
_BUTRANS_
® 10 microgram/hour transdermal patches
_BUTRANS_
® 15 microgram/hour transdermal patches
_BUTRANS_
® 20 microgram/hour transdermal patches
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, pharmacist or
nurse.
•
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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What
_BUTRANS_
patches are and what they are used for
2.
What you need to know before you use
_BUTRANS_
patches
3.
How to use
_BUTRANS_
patches
4.
Possible side effects
5.
How to store
_BUTRANS_
patches
6.
Contents of the pack and other information
1.
WHAT _BUTRANS_ PATCHES ARE AND WHAT THEY ARE USED FOR
_BUTRANS_
patches contain the active ingredient buprenorphine which belongs to a
group of medicines called
strong analgesics or ‘painkillers’. They have been prescribed for
you by your doctor to relieve moderate,
long-lasting pain that requires the use of a strong painkiller.
_BUTRANS_
patches should not be used to relieve acute pain.
_BUTRANS _
patches act through the skin. After application, buprenorphine passes
through the skin into the
blood. Each patch lasts for seven days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE _BUTRANS_ PATCHES
DO NOT USE _BUTRANS_
PATCHES
:
•
if you are allergic to buprenorphine or any of the other ingredients
of this medicine (listed in section 6);
_ _
•
if you have breathing problems;
_ _
•
if you are addicted to drugs;
•
if you are taking a type of medicine known as a monoamine oxidase
inhibitor (examples include
tranylcypromine, phen

Termékjellemzők

Health Products Regulatory Authority
26 April 2023
CRN00D06Q
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
BuTrans 10 micrograms/hour transdermal patch
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each _BUTRANS_ 10 micrograms/hour transdermal patch contains 10 mg of
buprenorphine in a 12.5 cm
2
area releasing a nominal
10 micrograms of buprenorphine per hour over a period of 7 days.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Transdermal patch.
Beige coloured patch with rounded corners.
_BUTRANS_ 10 micrograms/hour transdermal patch is a rectangular patch
marked _BUTRANS_ 10 μg/h
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of non-malignant pain of moderate intensity when an opioid
is necessary for obtaining adequate analgesia
_BUTRANS _is not suitable for the treatment of acute pain.
_BUTRANS_ is indicated in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_BUTRANS_ should be administered every 7th day.
_Patients aged 18 years and over_
The lowest _BUTRANS_ dose (_BUTRANS_ 5 microgram/hour transdermal
patch) should be used as the initial dose. Consideration
should be given to the previous opioid history of the patient (see
section 4.5) as well as to the current general condition and
medical status of the patient.
_ _
_Titration_
During initiation of treatment with _BUTRANS_, short‑acting
supplemental analgesics may be required (see section 4.5) as needed
until analgesic efficacy with _BUTRANS_ is attained.
During the titration process, the dose may be adjusted every 3-days
(72 hours). Thereafter, the 7-day dosing interval should be
maintained. Subsequent dosage increases may then be titrated based on
the need for supplemental pain relief and the
patient's analgesic response to the patch.
To increase the dose, a larger patch should replace the patch that is
currently being worn, or a combination of patches should
be applied in different places to achieve the desired dose. It is
recommended that no more than two patches are a