Palexia Retard

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 200 mg

Pharmaceutical form:

PROLONGED-RELEASE TABLET

Composition:

TAPENTADOL 200 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Withdrawn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 RETARD 50 MG PROLONGED-RELEASE TABLETS
PALEXIA RETARD 100 MG PROLONGED-RELEASE TABLETS
PALEXIA RETARD 150 MG PROLONGED-RELEASE TABLETS
PALEXIA RETARD 200 MG PROLONGED-RELEASE TABLETS
PALEXIA RETARD 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 Retard is and what it is used for
2.
What you need to know before you take PALEXIA Retard
3.
How to take PALEXIA Retard
4.
Possible side effects
5.
How to store PALEXIA Retard
6.
Contents of the pack and other information
1.
WHAT PALEXIA RETARD IS AND WHAT IT IS USED FOR
Tapentadol - the active substance in PALEXIA Retard - is a strong
painkiller which belongs to the class of
opioids. PALEXIA Retard 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 RETARD
DO NOT TAKE PALEXIA RETARD:

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
Retard”)
WARNINGS AND PRECAUTIONS
2
Talk to your doctor or pharmacist before taking PALEXIA Retard if yo

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
PALEXIA Retard 25 mg prolonged-release tablets
PALEXIA Retard 50 mg prolonged-release tablets
PALEXIA Retard 100 mg prolonged-release tablets
PALEXIA Retard 150 mg prolonged-release tablets
PALEXIA Retard 200 mg prolonged-release tablets
PALEXIA Retard 250 mg prolonged-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 25 mg tapentadol (as
hydrochloride).
Each prolonged-release tablet contains 50 mg tapentadol (as
hydrochloride).
Each prolonged-release tablet contains 100 mg tapentadol (as
hydrochloride).
Each prolonged-release tablet contains 150 mg tapentadol (as
hydrochloride).
Each prolonged-release tablet contains 200 mg tapentadol (as
hydrochloride).
Each prolonged-release tablet contains 250 mg tapentadol (as
hydrochloride).
Excipient(s) with known effect:
PALEXIA Retard 25 mg contains 1.330 mg lactose.
PALEXIA Retard 50 mg contains 3.026 mg lactose.
PALEXIA Retard 100 mg contains 3.026 mg lactose.
PALEXIA Retard 150 mg contains 3.026 mg lactose.
PALEXIA Retard 200 mg contains 3.026 mg lactose.
PALEXIA Retard 250 mg contains 3.026 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablet
[25 mg]: Slightly brownish-orange film-coated oblong shaped tablets
(5.5 mm x 10 mm) marked with
Grünenthal logo on one side and “H9” on the other side.
[50 mg]: 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.
[100 mg]: 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.
[150 mg]: Pale pink film-coated oblong shaped tablets (6.5 mm x 15 mm)
marked with Grünenthal logo on
one side and “H3” on the other side.
[200 mg]: Pale orange film-coated oblong shaped tablets (7 mm x 17 mm)
marked with Grünenthal logo on
one side and “H4” on the other side.
[250 mg]: Brownish red film-coated oblong shaped tablets (7 mm x 17
mm)