PALEXIA 20 Mg/Ml Oral Solution

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:

20 Mg/Ml

Pharmaceutical form:

Oral Solution

Prescription type:

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

Therapeutic area:

Other opioids

Authorization status:

Authorised

Authorization date:

2013-01-25

Patient Information leaflet

Name:
GI PALEXIA OS 20MG_ML
Artikel-Nr.:
 8 
pt
93020343
Klass.-Nr.:
50/030/23
 Bez. der Vorgängerdatei:
 Vorgängerdatei  gelöscht:
93017916
‒
Leistungsindex:
2B/X3
Größe:
185 X 297 MM
Druckfarbe:
SCHWARZ
Flattermarken:
Faserlauf:
297 MM
2/14
Sprache:
EN IRL
Code:
276
Datum:
25.11.2015 
V 3
RZ geprüft:
Reinders
SCHWARZ
1.  WHAT PALEXIA IS AND WHAT IT IS USED FOR
The full name of your medicine is ‘PALEXIA 20 mg/ml oral
solution’. It is referred to as 
‘PALEXIA’ in the rest of this leaflet.
Tapentadol - the active substance in PALEXIA - is a strong painkiller
which belongs to the class 
of opioids. PALEXIA is used in adults for the treatment of moderate to
severe pain of recent 
onset 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 no bowel movement as shown by severe constipation
and bloating which may be 
accompanied by pain or discomfort in the lower stomach
•  if you have poisoning with alcohol, sleeping pills, pain
relievers or 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 are not fully
conscious
•  have had a head injury or brain tumors
•  have had an epileptic fit or if you are at risk of having
epileptic fits
•  suffer from liver or kidney problems (see “How to take
PALEXIA”)
•  suffer from a pancreatic disease including inflammation of the
pancreas (pancreatitis) or 
disease of the bile duct (biliary tract disease)
•  are taking medicines referred to as mixed opioid
agonist/antagonists (e

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
PALEXIA 20mg/ml oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml oral solution contains 20 mg tapentadol (as hydrochloride)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution
Clear, colourless solution
pH 3.5 to 4.5
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 oral solution 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 oral solution is 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 possibility of
switching the patient to therapy with PALEXIA prolonged-release
tablets should be considered.
As with all symptomatic treatments, the continued use of tapentadol
must be evaluated on an ongoing basis.
Calculation table for PALEXIA 20 MG/ML oral solution:
Single dose of tapentadol to be
p