BuTrans 20micrograms/hour transdermal patches

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Buprenorphine

Available from:

Napp Pharmaceuticals Ltd

ATC code:

N02AE01

INN (International Name):

Buprenorphine

Dosage:

20microgram/1hour

Pharmaceutical form:

Transdermal patch

Administration route:

Transdermal

Class:

Schedule 3 (CD No Register)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070200; GTIN: 5012854036178

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
_BUTRANS_
_®_
_ _5 MICROGRAM/HOUR TRANSDERMAL PATCHES
_BUTRANS_
_®_
_ _10 MICROGRAM/HOUR TRANSDERMAL PATCHES
_BUTRANS_
_®_
_ _20 MICROGRAM/HOUR TRANSDERMAL PATCHES
Buprenorphine
•
THESE PATCHES CONTAIN A STRONG PAIN KILLER
•
ENSURE THAT OLD PATCHES ARE REMOVED BEFORE APPLYING A NEW ONE
•
PATCHES MUST NOT BE CUT
•
DO NOT EXPOSE THE PATCHES TO A HEAT SOURCE (SUCH AS A HOT WATER
BOTTLE)
•
DO NOT SOAK IN A HOT BATH OR TAKE A HOT SHOWER WHILST WEARING A PATCH
•
IF YOU DEVELOP A FEVER TELL YOUR DOCTOR IMMEDIATELY
•
FOLLOW THE DOSAGE INSTRUCTIONS CAREFULLY AND ONLY CHANGE YOUR PATCH ON
THE SAME DAY
AND AT THE SAME TIME 7 DAYS LATER
•
IF YOUR BREATHING BECOMES SHALLOW AND WEAK TAKE THE PATCH OFF AND SEEK
MEDICAL HELP
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
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.
Content 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 t

Summary of Product characteristics

OBJECT 1
BUTRANS 5UG/H TRANSDERMAL PATCH
Summary of Product Characteristics Updated 18-Apr-2017 | Napp
Pharmaceuticals Limited
1. Name of the medicinal product
_BUTRANS _5 microgram/hour, transdermal patch
BuTrans 10 microgram/hour transdermal patch
BuTrans 20 microgram/hour transdermal patch
2. Qualitative and quantitative composition
Each transdermal patch contains 5 mg of buprenorphine in a 6.25 cm
2
area releasing a nominal 5
micrograms of buprenorphine per hour over a period of 7 days.
Each transdermal patch contains 10 mg of buprenorphine in a 12.5 cm2
area releasing a nominal 10
micrograms of buprenorphine per hour over a period of 7 days.
Each transdermal patch contains 20 mg of buprenorphine in a 25 cm2
area releasing a nominal 20
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.
Square patch marked: _BUTRANS_ 5 μg/h
Beige coloured patch with rounded corners
Rectangular patch marked BuTrans 10 ug/h
Beige coloured patch with rounded corners
Square patch marked: BuTrans 20 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.
The dose of _BUTRANS_ may be t