PALEXIA 4 mg/ml oral solution

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

Tapentadol hydrochloride

Доступна с:

Grunenthal Pharma Ltd

код АТС:

N02AX; N02AX06

ИНН (Международная Имя):

Tapentadol hydrochloride

дозировка:

4 milligram(s)/millilitre

Фармацевтическая форма:

Oral solution

Тип рецепта:

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

Терапевтические области:

Other opioids; tapentadol

Статус Авторизация:

Marketed

Дата Авторизация:

2013-01-25

тонкая брошюра

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PALEXIA 4 MG/ML ORAL SOLUTION
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 4 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 children from 2 years of age and 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 shal

Характеристики продукта

Health≙Products≙Regulatory≙Authority
23≙February≙2023
CRN00D7H6
Page≙1≙of≙12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
PALEXIA≙4≙mg/ml≙oral≙solution
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≙
effec