PALEXIA 50 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TAPENTADOL HYDROCHLORIDE

Available from:

Grünenthal Ltd

ATC code:

N02AX06

INN (International Name):

TAPENTADOL HYDROCHLORIDE

Dosage:

50 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

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

Therapeutic area:

Other opioids

Authorization status:

Authorised

Authorization date:

2010-12-21

Patient Information leaflet

Name:
GI PALEXIA IR 50MG 
Artikel-Nr.:
 9 pt
93020346
Klass.-Nr.:
50/030/23
Bez. der Vorgängerdatei:
Vorgängerdatei gelöscht:
93016461
–
Leistungsindex:
–/X3
Größe:
185 X 297 MM
Druckfarbe:
schwARz
Flattermarken:
Faserlauf:
297 MM
1
sprache:
EN IRL
code:
35
Datum:
20.11.2015 
V 2
Rz geprüft:
Palm
schwARz
schwARz
26
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
The full name of your medicine is ‘PALEXIA 50 mg film-coated
tablets’. 
It is referred to as ‘PALEXIA’ in the rest of this leaflet.
The active ingredient of PALEXIA is tapentadol.
PALEXIA belongs to the class of opioids and is used in adults to
treat 
sudden moderate to severe pain, when your doctor recommends the use 
of a strong 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 no bowel movement as shown by severe constipation
and 
bloating which may be

Summary of Product characteristics

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 50 mg tapentadol (as hydrochloride).
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 treat