Tranzileve 10 microgram/hour Transdermal Patch

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Buprenorphine

Available from:

Alissa Healthcare Research Limited

ATC code:

N02AE; N02AE01

INN (International Name):

Buprenorphine

Dosage:

10 Microgram per hour

Pharmaceutical form:

Transdermal patch

Prescription type:

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

Therapeutic area:

Oripavine derivatives; buprenorphine

Authorization status:

Authorised

Authorization date:

2017-07-14

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRANZILEVE
® 5 MICROGRAM/HOUR TRANSDERMAL PATCH
TRANZILEVE
® 10 MICROGRAM/HOUR TRANSDERMAL PATCH
TRANZILEVE
® 20 MICROGRAM/HOUR TRANSDERMAL PATCH
BUPRENORPHINE
WHAT IS IN THIS LEAFLET
1.
What Tranzileve
®
is and what it is used for
2.
What you need to know before you use Tranzileve
®
3.
How to use Tranzileve
®
4.
Possible side effects
5.
How to store Tranzileve
®
6.
Contents of the pack and other information
1. WHAT TRANZILEVE
® IS AND WHAT IT IS USED FOR
Tranzileve
®
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.
Tranzileve
®
should not be used to relieve acute pain.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE TRANZILEVE
®
DO NOT USE TRANZILEVE
®
:
• 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 from withdrawal symptoms such as
agitation, anxiety, shaking or
sweating upon stopping taking alcohol.
Tranzileve
®
must not be used to treat symptoms associated with drug withdrawal.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Tranzileve
®
:
• if you suffer from seizures, fits or convulsions;
• if you have a severe headache or feel sick due to a head injury or
increased pressure in your skull
(for instance due to brain disease). This is because the patches may
make symptoms worse or
hide the extent of a head injury;
• if you are feeling

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tranzileve 10 microgram/hour Transdermal Patch
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each transdermal
patch contains 10 mg of buprenorphine in a 12.5 cm² area releasing a
nominal
10 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 beige coloured patch with rounded edges and imprinted with
“Buprenorphin” and “10 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.
Tranzileve is not suitable for the treatment of acute pain.
Tranzileve is indicated in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Patients aged 18 years and over:_
The lowest
Tranzileve dose (Tranzileve 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 Tranzileve, short-acting
supplemental analgesics may be required (see section 4.5)
as needed until analgesic efficacy with Tranzileve is attained.
The dose of Tranzileve 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 (