BuTrans 5 micrograms/hour transdermal patch

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Buprenorphine

Mevcut itibaren:

Imbat Limited

ATC kodu:

N02AE; N02AE01

INN (International Adı):

Buprenorphine

Doz:

5 Microgram per hour

Farmasötik formu:

Transdermal patch

Reçete türü:

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

Terapötik alanı:

Oripavine derivatives; buprenorphine

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2013-03-15

Bilgilendirme broşürü

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
BUTRANS
_®_
_ _5 MICROGRAMS/HOUR
TRANSDERMAL PATCH (buprenorphine)
Your medicine is available using the name BuTrans 5 micrograms/
hour
Transdermal Patch but will be
referred to as BuTrans patches throughout this leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
•
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 become serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
WHAT BUTRANS_ _PATCHES ARE AND WHAT THEY ARE USED FOR
2.
BEFORE YOU USE BUTRANS_ _PATCHES
3.
HOW TO USE BUTRANS_ _PATCHES
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE BUTRANS_ _PATCHES
6.
FURTHER 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.
BEFORE YOU USE BUTRANS PATCHES
DO NOT USE BUTRANS_ _PATCHES:
•
if you are allergic (hypersensitive) to buprenorphine or any of the
other ingredients of BuTrans
patches;
•
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
tranylcypromide, phenelzine, isocarboxazid, moclobamide and
linezolid), or you have taken this
type of medicine in the last two weeks;
•
if you suffer from myasthenia gravis (a

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
BuTrans 5 micrograms/hour transdermal patch
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
5 µg/h transdermal patch contains: 5 mg buprenorphine
Area containing active substance: 6.25 cm
2
.
Nominal release rate:
5 micrograms of buprenorphine per hour (over a period of 7 days).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Transdermal patch.
_Product imported from: UK_
Square, beige coloured patch with rounded corners marked: BuTrans
®
5 mg 5 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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
BuTrans should be administered every 7th day.
_Patients aged 18 years and over:_
The lowest BuTrans dose (BuTrans 5 µg/h 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 and titration with BuTrans, patients should use the
usual recommended doses of short-acting
supplemental analgesics_ (see section 4.5)_ as needed until analgesic
efficacy with BuTrans is attained.
The dose should not be increased before 3 days, when the maximum
effect of a given dose is established.
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
applied at the same time, regardless of the patch strength.
A new patch should not be applied to the same skin site for
the subsequent 3-4 weeks_ (see section 5.2)._
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