Palexia

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TAPENTADOL

Available from:

Grunenthal GmbH Zieglerstrasse 6, 52078 Aachen, Germany

ATC code:

N02AX06

INN (International Name):

TAPENTADOL 100 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

TAPENTADOL 100 mg

Prescription type:

POM

Therapeutic area:

ANALGESICS

Authorization status:

Withdrawn

Authorization date:

2011-01-18

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PALEXIA 50 MG FILM-COATED TABLETS
PALEXIA 75 MG FILM-COATED TABLETS
PALEXIA 100 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 tumors,
2

suffer from a liver or kidney dise

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
PALEXIA 50 mg film-coated tablets
PALEXIA 75 mg film-coated tablets
PALEXIA 100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg tapentadol (as hydrochloride).
Each film-coated tablet contains 75 mg tapentadol (as hydrochloride).
Each film-coated tablet contains 100 mg tapentadol (as hydrochloride).
Excipient(s) with known effect:
PALEXIA 50 mg contains 24.74 mg lactose.
PALEXIA 75 mg contains 37.11 mg lactose.
PALEXIA 100 mg contains 49.48 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
[50 mg]: White round shaped film-coated tablets of 7 mm diameter,
marked with Grünenthal logo on one
side and “H6” on the other side.
[75 mg]: Pale yellow round shaped film-coated tablets of 8 mm
diameter, marked with Grünenthal logo on
one side and “H7” on the other side.
[100 mg]: Pale pink round shaped film-coated tablets of 9 mm diameter,
marked with Grünenthal logo on
one side and “H8” 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 ph