PRENOPATCH 5 Microgram per hour Transdermal Patch

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BUPRENORPHINE

Available from:

Alfred E Tiefenbacher (GmbH & Co. KG)

ATC code:

N02AE01

INN (International Name):

BUPRENORPHINE

Dosage:

5 Microgram per hour

Pharmaceutical form:

Transdermal Patch

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Oripavine derivatives

Authorization status:

Transfer Pending

Authorization date:

2017-07-14

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
[] 5 MICROGRAM/HOUR TRANSDERMAL PATCH
[] 10 MICROGRAM/HOUR TRANSDERMAL PATCH
[] 20 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 [] is and what it is used for
2.
What you need to know before you use []
3.
How to use []
4.
Possible side effects
5.
How to store []
6.
Contents of the pack and other information
1.
WHAT [] IS AND WHAT IT IS USED FOR
[] 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.
[] should not be used to relieve acute pain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE []
DO NOT USE []:
-
if you are allergic to buprenorphine or any of the other ingredients
of this medicine (listed in
section 6);
-
if you have breathing problems;
-
if you are addicted to drugs;
-
if you are taking a type of medicine known as a monoamine oxidase
inhibitor (examples
include tranylcypromide, phenelzine, isocarboxazid, moclobemide and
linezolid), or you have
taken this type of medicine in the last two weeks;
-
if you suffer from myasthenia gravis (a condition in which the muscles
become weak);
-
if you have previously suffered

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Prenopatch 5 microgram/hour transdermal patch
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each transdermal patch contains 5 mg of buprenorphine in a 6.25 cm²
area releasing a nominal 5 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
Rectangular patch beige coloured with rounded edges and imprinted with
“Buprenorphin” and “5 µg/h” in blue colour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of non-malignant pain of moderate intensity when an opioid
is necessary for obtaining adequate analgesia.
Prenopatch is not suitable for the treatment of acute pain.
Prenopatch is indicated in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Patients aged 18 years and over:_
The lowest Prenopatch dose (Prenopatch 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 Prenopatch, short-acting
supplemental analgesics may be required (see section 4.5)
as needed until analgesic efficacy with Prenopatch is attained.
The dose of Prenopatch may be titrated upwards as indicated after 3
days, when the maximum effect of a given dose is
established. Subsequent dose increases may then be titrated based on
the need for supplemental pain relief and the
patient's analgesic response to the patch.
To increase the dose, a larger patch should replace the patch that is
currently being worn, or a combination of patches
should be applied in different places to achieve the desired dose. It
is recommended that no more than two patches are
applied at the same time, up to a maximum total dose of 40
microgram/hour buprenorphine. A new patch should not be
applied to the same skin site for the subsequent 3-4 weeks (see