Reletrans 15 micrograms/hour Transdermal Patches

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Buprenorphine

थमां उपलब्ध:

Rowex Ltd

ए.टी.सी कोड:

N02AE; N02AE01

INN (इंटरनेशनल नाम):

Buprenorphine

डोज़:

15 Microgram per hour

फार्मास्यूटिकल फॉर्म:

Transdermal patch

प्रिस्क्रिप्शन प्रकार:

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

चिकित्सीय क्षेत्र:

Oripavine derivatives; buprenorphine

प्राधिकरण का दर्जा:

Marketed

प्राधिकरण की तारीख:

2016-02-05

सूचना पत्रक

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
RELETRANS 5 MICROGRAMS/HOUR TRANSDERMAL PATCHES
RELETRANS 10 MICROGRAMS/HOUR TRANSDERMAL PATCHES
RELETRANS 15 MICROGRAMS/HOUR TRANSDERMAL PATCHES
RELETRANS 20 MICROGRAMS/HOUR TRANSDERMAL PATCHES
buprenorphine
For use in adults
_ _
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 Reletrans is and what it is used for
2.
What you need to know before you use Reletrans
3.
How to use Reletrans
4.
Possible side effects
5.
How to store Reletrans
6.
Contents of the pack and other information
1.
WHAT RELETRANS IS AND WHAT IT IS USED FOR
Reletrans transdermal patches contain the active substance
buprenorphine which belongs to a group of
medicines called strong analgesics or ‘painkillers’.
Reletrans is used in adults to relieve moderate, long-lasting pain
that requires the use of a strong
painkiller.
Reletrans should not be used to relieve acute pain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE RELETRANS
_ _
DO NOT USE RELETRANS IF YOU

are allergic to buprenorphine or any of the other ingredients of this
medicine (listed in section 6)

have breathing problems

are addicted to drugs

are taking a type of medicine known as a monoamine oxidase (MAO)
inhibitor (examples include
tranylcypromine, phenelzine, isocarboxazid, moclobemide and
linezolid), or you have taken this
type of medicine in the last two weeks

suffer from myasthenia gravis (a condition in which the muscles become
weak)

have previously suffered from withdrawal sy

उत्पाद विशेषताएं

Health Products Regulatory Authority
07 September 2021
CRN00CG0K
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Reletrans 15 micrograms/hour Transdermal Patches
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each transdermal patch contains 15 mg of buprenorphine per 18.75 cm
2
, releasing 15 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 15 microgram/h’
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of non-malignant pain of moderate intensity when an opioid
is necessary for obtaining adequate analgesia.
Reletransis not suitable for the treatment of acute pain.
Reletransis indicated in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Reletrans should be administered every 7th day.
_ _
_Patients aged 18 years and over_
The lowest Reletrans dose Reletrans 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.
Reletrans should not be used at higher doses than recommended.
_Titration_
During initiation of treatment with Reletrans, short-acting
supplemental analgesics may be required (see section 4.5) as needed
until analgesic efficacy with Reletrans is attained.
The dose of Reletrans 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 transdermal patch.
To increase the dose, a patch with a higher strength should repl