Buprenorphin - 1 A Pharma Transdermal Patch 35mcg/hr

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

BUPRENORPHINE

Available from:

1 A Pharma GmbH Keltenring 1+3, 82041 Oberhaching, Germany

ATC code:

N02AE01

INN (International Name):

BUPRENORPHINE 35 µg

Pharmaceutical form:

TRANSDERMAL PATCH

Composition:

BUPRENORPHINE 35 µg

Prescription type:

POM

Therapeutic area:

ANALGESICS

Authorization status:

Withdrawn

Authorization date:

2016-08-22

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Buprenorphin - 1 A Pharma 35 microgram/hour transdermal patch
Buprenorphin - 1 A Pharma 52.5 microgram/hour, transdermal patch
Buprenorphin - 1 A Pharma 70 microgram/hour transdermal patch
buprenorphine
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 Buprenorphin - 1 A Pharma is and what it is used for
2.
What you need to know before you use Buprenorphin - 1 A Pharma
3.
How to use Buprenorphin - 1 A Pharma
4.
Possible side effects
5.
How to store Buprenorphin - 1 A Pharma
6.
Contents of the pack and other information
1.
WHAT BUPRENORPHIN - 1 A PHARMA IS AND WHAT IT IS USED for
Buprenorphin - 1 A Pharma contains the active substance buprenorphine
which is a strong painkiller
and belongs to a group of medicines called opioids. It acts on
specific nerve cells in the spinal cord
and in the brain.
Buprenorphin - 1 A Pharma is used to treat

MODERATE TO SEVERE CANCER PAIN and SEVERE PAIN that has not responded
to other types of
painkillers.
This medicine is not suitable for treating short-lasting pain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BUPRENORPHIN - 1 A PHARMA
DO NOT USE BUPRENORPHIN - 1 A PHARMA IF YOU:

are ALLERGIC to buprenorphine or any of the other ingredients of this
medicine (listed in section 6)

are DEPENDENT ON OPIOIDS
Buprenorphin - 1 A Pharma must not be used to treat withdrawal
symptoms of addicted persons.

have serious BREATHING PROBLEMS

are being treated or have been treated during the last 2 weeks with
medicines

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Buprenorphin - 1 A Pharma 35 microgram/hour, transdermal patch
Buprenorphin - 1 A Pharma 52.5 microgram/hour, transdermal patch
Buprenorphin - 1 A Pharma 70 microgram/hour, transdermal patch
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Buprenorphin - 1 A Pharma 35 microgram/hour, transdermal patch:
Each transdermal patch contains 20 mg of buprenorphine in a patch size
of 25 cm
2
releasing 35
micrograms of buprenorphine per hour.
Buprenorphin - 1 A Pharma 52.5 microgram/hour transdermal patch:
Each transdermal patch contains 30 mg of buprenorphine in a patch size
of 37.5 cm2 releasing 52.5
micrograms of buprenorphine per hour.
Buprenorphin - 1 A Pharma 70 microgram/hour transdermal patch:
Each transdermal patch contains 40 mg of buprenorphine in a patch size
of 50 cm2 releasing 70
micrograms of buprenorphine per hour.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Transdermal patch.
The product is composed of a drug containing transdermal patch
integrated with an oversized pale
yellowish-brown cover patch without any active substance. The shape of
the transdermal patch is
rectangular with rounded edges. The transdermal patch contains the
following imprint:
Buprenorphinum 35 µg/h
Buprenorphinum 52.5 µg/h
Buprenorphinum 70 µg/h
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Moderate to severe cancer pain and severe pain which does not respond
to non-opioid analgesics.
Buprenorphin - 1 A Pharma 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: Buprenorphin - 1 A
Pharma 35 microgram/hour, Buprenorphin - 1 A Pharma 52.5
microgram/hour and Buprenorphin - 1
A Pharma 70