Palexia 4 mg/ml drank

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

TAPENTADOLHYDROCHLORIDE 4,7 mg/ml SAMENSTELLING overeenkomend met ; TAPENTADOL 4 mg/ml

Beschikbaar vanaf:

Grunenthal B.V. De Corridor 21K 3621 ZA BREUKELEN

ATC-code:

N02AX06

INN (Algemene Internationale Benaming):

TAPENTADOLHYDROCHLORIDE 4,7 mg/ml SAMENSTELLING overeenkomend met ; TAPENTADOL 4 mg/ml

farmaceutische vorm:

Drank

Samenstelling:

CITROENZUUR 1-WATER (E 330) ; FRAMBOZENSMAAKSTOF ; NATRIUMBENZOAAT (E 211) ; PROPYLEENGLYCOL (E 1520) ; SUCRALOSE (E 955) ; WATER, GEZUIVERD,

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Tapentadol

Product samenvatting:

Hulpstoffen: CITROENZUUR 1-WATER (E 330); FRAMBOZENSMAAKSTOF; NATRIUMBENZOAAT (E 211); PROPYLEENGLYCOL (E 1520); SUCRALOSE (E 955); WATER, GEZUIVERD;

Autorisatie datum:

2017-08-18

Bijsluiter

Palexia 4 mg/ml oral solution
13-12-2022
NL PIL
Version: 22.00-030
1
q-xx
PACKAGE LEAFLET: INFORMATION FOR THE USER
PALEXIA 4 MG/ML DRANK
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
children from 2 years of age and
_ _
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,
•

Productkenmerken

Palexia 4 mg/ml oral solution
19-09-2022
NL SmPC
Version 25.00
1
q-xx
1.
NAME OF THE MEDICINAL PRODUCT
Palexia 4 mg/ml drank
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml oral solution contains 4 mg tapentadol (as hydrochloride)
Excipients with known effect
Palexia 4 mg/ml oral solution contains propylene glycol, sodium
benzoate and sodium.
See section 4.4
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 children from 2 years of age and
in adults, which can be adequately managed only with opioid
analgesics.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The use of Palexia in children is restricted to hospital use where
appropriate equipment to enable
respiratory support is available.
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.
_Adults: _
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.
Palexia 4 mg/ml oral solution
19-09-2022
NL SmPC
Version 25.00
2
q-xx
Calculation table for Palexia
4
MG/ML
oral solution:
Single dose of tapentadol prescribed
Volume (ml) to be administered
25 mg
6.25 ml
50