PALEXIA SR 50 Milligram Tablet Prolonged Release

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

TAPENTADOL HYDROCHLORIDE

Prieinama:

Grünenthal Ltd

ATC kodas:

N02AX06

INN (Tarptautinis Pavadinimas):

TAPENTADOL HYDROCHLORIDE

Dozė:

50 Milligram

Vaisto forma:

Tablet Prolonged Release

Recepto tipas:

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

Gydymo sritis:

Other opioids

Autorizacija statusas:

Authorised

Leidimo data:

2010-12-21

Pakuotės lapelis

Material No.
CMO Mat. No.
Class. No.
Customer Mat. No.
Laetus Code
Colors &
Collating Marks
93024028
–
50/030/23
–
93020345
229
GI PALEXIA PR IRL
07.12.2017 V2 | DMA
Previous Mat. No.
Product Name
Date/Version
8 pt
Font Size
Dimension
185 X 297 MM
Grain Direction
297 MM
BLACK ................. 2
PANT 123 ............. 35
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
The full name of your medicine is ‘PALEXIA SR 50 mg/100 mg/150
mg/200 mg/250 mg
prolonged-release tablets’. It is referred to as ‘PALEXIA SR’ in
the rest of this leaflet.
The active ingredient of PALEXIA SR is tapentadol.
PALEXIA SR belongs to the class of opioids and is used in adults to
treat severe
long term pain, when your doctor recommends the use of a strong
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 no bowel movement as shown by severe constipation and
bloating
which may be accompanied

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Palexia SR 50 mg prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 50 mg tapentadol (as
hydrochloride).
Excipient(s) with known effect:
Palexia SR 50 mg contains 3.026 mg lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet
White film-coated oblong shaped tablets (6.5 mm x 15 mm) marked with
Grünenthal logo on one side and “H1” 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 has shown that a titration regimen in
increments of 50 mg tapentadol as prolonged-
release tablet twice daily every 3