Buplast 35micrograms/hour transdermal patches

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Buprenorphine

Available from:

Viatris UK Healthcare Ltd

ATC code:

N02AE01

INN (International Name):

Buprenorphine

Dosage:

35microgram/1hour

Pharmaceutical form:

Transdermal patch

Administration route:

Transdermal

Class:

Schedule 3 (CD No Register)

Prescription type:

Caution - AMP level prescribing advised

Product summary:

BNF: 04070200; GTIN: 5016695006987

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BUPLAST 35 MICROGRAMS/H TRANSDERMAL PATCH
BUPLAST 52.5 MICROGRAMS/H TRANSDERMAL PATCH
BUPLAST 70 MICROGRAMS/H TRANSDERMAL PATCH
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 Buplast is and what it is used for
2.
What you need to know before you use Buplast
3.
How to use Buplast
4.
Possible side effects
5.
How to store Buplast
6.
Contents of the pack and other information
1.
WHAT BUPLAST IS AND WHAT IT IS USED FOR
The active substance of Buplast is buprenorphine.
Buplast 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.
Buplast acts through the
skin.
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. Buplast is not suitable for the
treatment of acute (short-lasting) pain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BUPLAST
DO NOT USE BUPLAST
-
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 oxidase (MAO) inhibitors (certain
medicines used to treat
depression or Parkinson’s disease such as moclobemide,selegiline) or
you have t

Summary of Product characteristics

OBJECT 1
BUPLAST 35 MICROGRAMS/H TRANSDERMAL PATCH
Summary of Product Characteristics Updated 13-Jul-2017 | Generics UK
T/A Mylan
1. Name of the medicinal product
Buplast 35 micrograms/h transdermal patch
2. Qualitative and quantitative composition
Each transdermal patch contains 20 mg buprenorphine.
Area containing the active substance: 25 cm
2
Nominal release rate: 35 micrograms of buprenorphine per hour (over a
period of 96 hours).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Transdermal patch
Rectangular beige coloured patch with rounded edges and imprinted with
“Buprenorphin” and “35 μg/h”
in blue colour.
4. Clinical particulars
4.1 Therapeutic indications
Moderate to severe cancer pain and severe pain which does not respond
to non-opioid analgesics.
Buplast is not suitable for the treatment of acute pain.
4.2 Posology and method of administration
Posology
_Patients over 18 years of age_
The dose should be adapted to the condition of the individual patient
(pain intensity, suffering, individual
reaction) and checked at regular intervals. The lowest possible dose
providing adequate pain relief should
be given. Three transdermal patch strengths are available to provide
such adaptive treatment: Buplast 35
micrograms/h, Buplast 52.5 micrograms/h and Buplast 70 micrograms/h.
_Initial dose selection_: patients who have previously not received
any analgesics should start with the
lowest transdermal patch strength (Buplast 35 micrograms/h). Patients
previously given a WHO step-I
analgesic (non-opioid) or a step-II analgesic (weak opioid) should
also begin with Buplast 35
micrograms/h. According to the WHO recommendations, the administration
of a non-opioid analgesic
can be continued, depending on the patient's overall medical
condition.
When switching from a step-III analgesic (strong opioid) to Buplast
and choosing the initial transdermal
patch strength, the nature of the previous medicinal product,
administration and the mean daily dose
should be taken into account in order to