PALEXIA 4 Mg/Ml Oral Solution

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

TAPENTADOL HYDROCHLORIDE

Доступна с:

Grünenthal Ltd

код АТС:

N02AX06

ИНН (Международная Имя):

TAPENTADOL HYDROCHLORIDE

дозировка:

4 Mg/Ml

Фармацевтическая форма:

Oral Solution

Тип рецепта:

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

Терапевтические области:

Other opioids

Статус Авторизация:

Authorised

Дата Авторизация:

2013-01-25

тонкая брошюра

Name:
GI PALEXIA 4MG/ML ORAL
Artikel-Nr.:
SOLUTION SC 
8 pt
R_JJ_180515_02
Klass.-Nr.:
50/030/23
 Bez. der Vorgängerdatei:
 Vorgängerdatei  gelöscht:
93020205
‒
Leistungsindex:
1B/X3
Größe:
185 X 297 MM
Druckfarbe:
SCHWARZ
Flattermarken:
Faserlauf:
297 MM
–
Sprache:
EN IRL
Code:
‒
Datum:
23.11.2015 
V 2
RZ geprüft:
Palm
SCHWARZ
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 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
agoni

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
PALEXIA 4mg/ml oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml oral solution contains 4 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 siuations.
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 4 MG/ML oral solution:
_Discontinuation of treatment_
Withdr