Palexia 75mg tablets
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
18-06-2018
Summary of Product characteristics
(SPC)
18-06-2018
Active ingredient:
Tapentadol hydrochloride
Available from:
Grunenthal Ltd
ATC code:
N02AX06
INN (International Name):
Tapentadol hydrochloride
Dosage:
75mg
Pharmaceutical form:
Oral tablet
Administration route:
Oral
Class:
Schedule 2 (CD)
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 04070200; GTIN: 4032129029361 4032129024359
Patient Information leaflet
Name:
GI palexIa Ir 75 mG
artikel-Nr.:
9 pt
r-YJ-020614-02
Klass.-Nr.:
50/030/23
Bez. der Vorgängerdatei:
Vorgängerdatei gelöscht:
93015658
–
leistungsindex:
1B/x3
Größe:
185 x 297 mm
Druckfarbe:
schwarz
Flattermarken:
Faserlauf:
297 mm
xx
sprache:
eN
code:
xx
Datum:
06.06.2014
V 1
rz geprüft:
mazur
schwarz
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 75 mg film-coated
tablets’.
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 reli
Read the complete document
Summary of Product characteristics
OBJECT 1
PALEXIA 50 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 15-Oct-2014 | Grunenthal
Ltd
1. Name of the medicinal product
PALEXIA
®
50 mg film-coated tablets
PALEXIA
®
75 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 50 mg tapentadol (as hydrochloride)
Each film-coated tablet contains 75 mg tapentadol (as hydrochloride)
Excipient(s) with known effect:
PALEXIA 50 mg contains 24.74 mg lactose
PALEXIA 75 mg contains 37.11 mg lactose
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet (tablet)
50mg: White round shaped film-coated tablets of 7 mm diameter, marked
with Grünenthal logo on one
side and H6 on the other side.
75mg: Pale yellow round shaped film-coated tablets of 8 mm diameter,
marked with Grünenthal logo on
one side and H7 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.
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 re
Read the complete document
