Bupeaze 35micrograms/hour transdermal patches

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Buprenorphine

Available from:

Dr Reddy's Laboratories (UK) 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: 05036072006461

Patient Information leaflet

WHAT IS IN THIS LEAFLET:
1.
WHAT BUPEAZE IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BUPEAZE
3.
HOW TO USE BUPEAZE
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE BUPEAZE
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT BUPEAZE IS AND WHAT IT IS USED FOR
The active substance of Bupeaze is buprenorphine.
Bupeaze 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.
Bupeaze 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. Bupeaze is not
suitable for the treatment of acute (short-lasting) pain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BUPEAZE
DO NOT USE BUPEAZE
•
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 you
have taken this type of medicine in the last two weeks (see "Other
medicines and Bupeaze")
•
if you suffer from myasthenia gravis (a certain type of severe muscle
weakness)
•
if you suffer from delirium tremens (confusion and trembling caused by
abstinence from alcohol following
habitual excessive drinking or occurring during an episode of heavy
alcohol consumption)
•
if you are pregnant.
Bupeaze must not be used to treat withdrawal symptoms in
drug-dependent persons.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Bupeaze
•
if you have recently drunk a lot of alcohol
•
if you suffer from seizures or convulsions (fits)
•
if your consciousness is disturbed (feeling light-headed or faint) for
an unknown reason
•
if you are in a

Summary of Product characteristics

OBJECT 1
BUPEAZE 35 MICROGRAMS/H TRANSDERMAL PATCHES
Summary of Product Characteristics Updated 21-Nov-2017 | Dr. Reddy's
Laboratories (UK) Ltd
1. Name of the medicinal product
Bupeaze 35 micrograms/h Transdermal Patches
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.
Bupeaze 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). The lowest possible dose providing adequate pain relief
should be given. Three transdermal
patch strengths are available to provide such adaptive treatment:
Bupeaze 35 micrograms/h, Bupeaze 52.5
micrograms/h and Bupeaze 70 micrograms/h.
_Initial dose selection_: patients who have previously not received
any analgesics should start with the
lowest transdermal patch strength (Bupeaze 35 micrograms/h). Patients
previously given a WHO step-I
analgesic (non-opioid) or a step-II analgesic (weak opioid) should
also begin with Bupeaze 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 Bupeaze
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 avoid the recurrence