Palexia SR 100 mg prolonged-release tablets

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

Tapentadol

Доступна с:

Grunenthal Pharma Ltd

код АТС:

N02AX; N02AX06

ИНН (Международная Имя):

Tapentadol

дозировка:

100 milligram(s)

Фармацевтическая форма:

Prolonged-release tablet

Тип рецепта:

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

Терапевтические области:

Other opioids; tapentadol

Статус Авторизация:

Marketed

Дата Авторизация:

2010-12-21

тонкая брошюра

Common-leaflet ie/uk v6.0 PRAC Label safety change RFI including UK
Drug Driving warning
December 2022
Page 1 of 8
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PALEXIA SR 50 MG, 100 MG, 150 MG, 200 MG AND 250 MG PROLONGED-RELEASE
TABLETS
Tapentadol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 PALEXIA SR is and what it is used for
2.
What you need to know before you take PALEXIA SR
3.
How to take PALEXIA SR
4.
Possible side effects
5.
How to store PALEXIA SR
6.
Contents of the pack and other information
1.
WHAT PALEXIA SR IS AND WHAT IT IS USED FOR
Tapentadol - the active substance in PALEXIA SR is a strong painkiller
which belongs to the class of
opioids. PALEXIA SR is used for the treatment of severe chronic pain
in adults that can only be adequately
managed with an opioid painkiller.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PALEXIA SR
DO NOT TAKE PALEXIA SR:
•
If you are allergic to tapentadol or any of the other ingredients of
this medicine (listed in section 6)
•
If you have asthma or if your breathing is dangerously slow or shallow
(respiratory depression,
hypercapnia)
•
If you have paralysis of the gut
•
If you have acute poisoning with alcohol, sleeping pills, pain
relievers or other psychotropic
medicines (medicines that affect mood and emotions) (see “Other
medicines and PALEXIA SR”)
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking PALEXIA SR if you:
•
have slow or shallow breathing,
•
suffer from increased pressure in the brain or dis

Характеристики продукта

Health Products Regulatory Authority
23 February 2023
CRN00D7H6
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Palexia SR 100 mg prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 116.48 mg tapentadol
hydrochloride equivalent to 100 mg tapentadol.
Excipient(s) with known effect:
PALEXIA SR 100 mg contains 3.026 mg lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet
Pale yellow film-coated oblong shaped tablets (6.5 mm x 15 mm) marked
with Grünenthal logo on one side and “H2” on the
other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Palexia SR is indicated for the management of severe chronic pain in
adults, which can be adequately managed only with
opioid analgesics.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosing regimen should be individualised according to the severity
of pain being treated, the previous treatment
experience and the ability to monitor the patient.
PALEXIA SR should be taken twice daily, approximately every 12 hours.
_Initiation of therapy_
_Initiation of therapy in patients currently not taking opioid
analgesics_
Patients should start treatment with single doses of 50 mg tapentadol
as prolonged-release tablet administered twice daily.
_Initiation of therapy in patients currently taking opioid analgesics_
When switching from opioids to PALEXIA SR and choosing the initial
dose, the nature of the previous medicinal product,
administration and the mean daily dose should be taken into account.
This may require higher initial doses of PALEXIA SR for
patients currently taking opioids compared to those not having taken
opioids before initiating therapy with PALEXIA SR.
_Titration and maintenance_
After initiation of therapy the dose should be titrated individually
to a level that provides adequate analgesia and minimises
undesirable effects under the close supervision of the prescribing
physician.
Experience from clinical trials