Butec 10micrograms/hour transdermal patches

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Buprenorphine

Available from:

Qdem Pharmaceuticals Ltd

ATC code:

N02AE01

INN (International Name):

Buprenorphine

Dosage:

10microgram/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: 05060307920253

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
_BUTEC_
_®_
_ _5 MICROGRAM/HOUR TRANSDERMAL PATCHES
_BUTEC_
_®_
_ _10 MICROGRAM/HOUR TRANSDERMAL PATCHES
_BUTEC_
_®_
_ _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 or 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
_BUTEC_
patches are and what they are used for
2.
What you need to know before you use
_BUTEC_
patches
3.
How to use
_BUTEC_
patches
4.
Possible side effects
5.
How to store
_BUTEC_
patches
6.
Content of the pack and other information
1.
WHAT _BUTEC_
PATCHES
ARE AND WHAT THEY ARE USED FOR
_BUTEC_
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.
_BUTEC_
patches should not be used to relieve acute pain.
_BUTEC_
patches act through the skin. After appli

Summary of Product characteristics

OBJECT 1
BUTEC 5, 10 AND 20 MICROGRAM/HOUR TRANSDERMAL
PATCH
Summary of Product Characteristics Updated 18-Oct-2016 | Qdem
Pharmaceuticals Limited
1. Name of the medicinal product
_BUTEC _5, 10 and 20 microgram/hour transdermal patch
2. Qualitative and quantitative composition
5 microgram/hour 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.
10 microgram/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.
20 microgram/hour transdermal patch contains:
Each transdermal patch contains 20 mg of buprenorphine in a 25 cm
2
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.
5 microgram/hour patch
Beige coloured patch with rounded corners.
Square patch marked: _BUTEC_ 5 μg/h
10 microgram/hour patch
Beige coloured patch with rounded corners.
Rectangular patch marked: _BUTEC_ 10 μg/h
20 microgram/hour patch
Beige coloured patch with rounded corners.
Square patch marked: _BUTEC_ 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
_BUTEC _is not suitable for the treatment of acute pain.
_BUTEC _is indicated in adults.
4.2 Posology and method of administration
Posology
_BUTEC _should be administered every 7th day.
_Patients aged 18 years and over_:
The lowest _BUTEC_ dose (_BUTEC_ 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 _BUTEC_, short-acting supplemental
analgesics may be required (see
section 4.5) as needed until