Palexia 50 mg film-coated tablets

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Tapentadol

Dostupné s:

Grunenthal Pharma Ltd

ATC kód:

N02AX; N02AX06

INN (Mezinárodní Name):

Tapentadol

Dávkování:

50 milligram(s)

Léková forma:

Film-coated tablet

Druh předpisu:

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

Terapeutické oblasti:

Other opioids; tapentadol

Stav Autorizace:

Marketed

Datum autorizace:

2010-12-21

Informace pro uživatele

Page 1 of 7
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PALEXIA 50 MG FILM-COATED 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 is and what it is used for
2.
What you need to know before you take PALEXIA
3.
How to take PALEXIA
4.
Possible side effects
5.
How to store PALEXIA
6.
Contents of the pack and other information
1.
WHAT PALEXIA IS AND WHAT IT IS USED FOR
Tapentadol - the active substance in PALEXIA - is a strong painkiller
which belongs to the class of opioids.
PALEXIA is used for the treatment of moderate to severe acute pain in
adults that can only be adequately
managed with an opioid painkiller.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PALEXIA
DO NOT TAKE PALEXIA
•
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”)
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking PALEXIA 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 tumours,
•
suffer from a liver or kidney disease (see “How to take PALEXIA”),
•
suffer from

Charakteristika produktu

Health Products Regulatory Authority
28 February 2024
CRN00DWLS
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Palexia 50 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 58.24 mg tapentadol hydrochloride
equivalent to 50 mg tapentadol.
Excipient(s) with known effect:
PALEXIA 50 mg contains 24.74 mg lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet)
White round shaped film-coated tablets of 7 mm diameter, marked with
Grünenthal logo on one side and “H6” on the other
side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
PALEXIA is indicated for the relief of moderate to severe acute pain
in adults, which can be adequately managed only with
opioid analgesics.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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.
Patients should start treatment with single doses of 50 mg tapentadol
as film-coated tablet administered every 4 to 6 hours.
Higher starting doses may be necessary depending on the pain intensity
and the patient’s previous history of analgesic
requirements.
On the first day of dosing, an additional dose may be taken as soon as
one hour after the initial dose, if pain control is not
achieved. The dose should then be titrated individually to a level
that provides adequate analgesia and minimises undesirable
effects under the close supervision of the prescribing physician.
Total daily doses greater than 700 mg tapentadol on the first day of
treatment and maintenance daily doses greater than 600
mg tapentadol have not been studied and are therefore not recommended.
_Duration of treatment_
The film-coated tablets are intended for acute pain situations. If
longer term treatment is anticipated or becomes necessary
and effective pain relief in the absence of intolerable adverse events
was achieved with PALEXIA, the