Palexia SR 50 mg prolonged-release tablets

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Tapentadol

थमां उपलब्ध:

PCO Manufacturing Ltd.

ए.टी.सी कोड:

N02AX06

INN (इंटरनेशनल नाम):

Tapentadol

डोज़:

50 milligram(s)

फार्मास्यूटिकल फॉर्म:

Prolonged-release tablet

चिकित्सीय क्षेत्र:

tapentadol

प्राधिकरण की तारीख:

2020-12-11

सूचना पत्रक

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PACKAGE LEAFLET: INFORMATION FOR THE USER
PALEXIA
® SR 50 MG, 100 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 disturbed consciousness
up to
coma,
•
have had a head injury or brain tumor
•
suffer from liver or kidney problems (see ‘

उत्पाद विशेषताएं

Health Products Regulatory Authority
11 December 2020
CRN00C0R0
Page 1 of 2
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 lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet
_Product imported from Czech republic_
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
As per PA2242/012/004
5 PHARMACOLOGICAL PROPERTIES
As per PA2242/012/004
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Tablet core:
Hypromellose 2208/100000
Microcrystalline cellulose
Colloidal anhydrous silica oxide
Magnesium stearate
Tablet coat:
Hypromellose 2910/06
Lactose monohydrate
Talc
Macrogol 6000
Propylene glycol
Titanium dioxide (E171)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the blister and outer package of the product on the market
in the country of origin.
Health Products Regulatory Authority
11 December 2020
CRN00C0R0
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage
conditions.
6.5 NATURE AND CONTENTS OF CONTAINER
PVC/PVDC aluminium/paper/PET perforated unit-dose blisters
Packs with 60x1 prolonged-release tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/458/002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 11
th
December 2020
10 DATE OF REVISION OF THE TEXT