Panitaz 20micrograms/hour transdermal patches

Country: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Buprenorphine

Доступно од:

Dr Reddy's Laboratories (UK) Ltd

АТЦ код:

N02AE01

INN (Међународно име):

Buprenorphine

Дозирање:

20microgram/1hour

Фармацеутски облик:

Transdermal patch

Пут администрације:

Transdermal

Класа:

Schedule 3 (CD No Register)

Тип рецептора:

Valid as a prescribable product

Резиме производа:

BNF: 04070200; GTIN: 05036072006492

Информативни летак

WHAT IS IN THIS LEAFLET:
1.
WHAT PANITAZ IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE PANITAZ
3.
HOW TO USE PANITAZ
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE PANITAZ
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT PANITAZ IS AND WHAT IT IS USED FOR
Panitaz patches 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.
Panitaz patches should not be used to relieve acute pain.
Panitaz patches act through the skin. After application, buprenorphine
passes through the skin into the blood.
Each patch lasts for seven days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE PANITAZ
DO NOT USE PANITAZ:
•
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, moclobamide 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.
Panitaz MUST NOT be used to treat symptoms associated with DRUG
WITHDRAWAL.
WARNINGS AND PRECAUTIONS
Talk to your doctor before using Panitaz:
•
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 LIGHT-HEADED or FAINT
•
if you have severe LIVER PROBLEMS
•
if you have ever been ADDICTED TO DRUGS
•
if you have a HIGH TEMPERATU

Карактеристике производа

OBJECT 1
PANITAZ 20 MICROGRAMS/H TRANSDERMAL PATCHES
Summary of Product Characteristics Updated 08-Aug-2016 | Dr. Reddy's
Laboratories (UK) Ltd
1. Name of the medicinal product
Panitaz 20 micrograms/h Transdermal Patches
2. Qualitative and quantitative composition
Each transdermal patch contains 20 mg buprenorphine.
Area containing active substance: 25 cm
2
.
Nominal release rate: 20 micrograms 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 with rounded edges, a beige coloured web backing
layer imprinted with
“Buprenorphin“ and “20 μg/h “ in blue colour, a transparent
adhesive matrix laminated with a central
placed transparent matrix and a transparent release liner with a cut
to facilitate the application.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of non-malignant pain of moderate intensity when an opioid
is necessary for obtaining
adequate analgesia.
Panitaz is not suitable for the treatment of acute pain.
4.2 Posology and method of administration
Posology
Panitaz should be administered every 7
th
day.
_Patients aged 18 years and over:_
The lowest Panitaz dose (Panitaz 5 micrograms/h 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 and titration with Panitaz, patients should use the
usual recommended doses of short-
acting supplemental analgesics (see section 4.5) as needed until
analgesic efficacy with Panitaz is
attained.
The dose should not be increased before 3 days, when the maximum
effect of a given dose is established.
Subsequent dosage 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 patch