Palexia SR 200mg 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
Available from:
Grunenthal Ltd
ATC code:
N02AX06
INN (International Name):
Tapentadol
Dosage:
200mg
Pharmaceutical form:
Modified-release tablet
Administration route:
Oral
Class:
Schedule 2 (CD)
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 04070200; GTIN: 4032129029439
Patient Information leaflet
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PALEXIA SR 50 MG, 100 MG, 150 MG, 200 MG AND 250 MG PROLONGED-RELEASE
TABLETS
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 SR is and what it is used for
2.
What you need to know before you take PALEXIA SR
3.
How to take PALEXIA SR
4.
Possible side effects
5.
How to store PALEXIA SR
6.
Contents of the pack and other information
1.
WHAT PALEXIA SR IS AND WHAT IT IS USED FOR
The full name of your medicine is ‘PALEXIA SR 50 mg, 100 mg, 150 mg,
200 mg or 250 mg prolonged-
release tablets’. It is referred to as ‘PALEXIA SR’ in the rest
of this leaflet.
Tapentadol - the active substance in PALEXIA SR - is a strong
painkiller which belongs to the class of
opioids. PALEXIA SR is used in adults for the treatment of severe
long-term pain that can only be
adequately managed with an opioid painkiller.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PALEXIA SR
DO NOT TAKE PALEXIA SR
•
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 SR’)
WARNINGS AND PRECAUTIONS
Talk to yo
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Summary of Product characteristics
OBJECT 1
PALEXIA SR PROLONGED RELEASE TABLETS
Summary of Product Characteristics Updated 03-Jan-2018 | Grunenthal
Ltd
1. Name of the medicinal product
PALEXIA
®
SR 50 mg prolonged-release tablets
PALEXIA
®
SR 100 mg prolonged-release tablets
PALEXIA
®
SR 150 mg prolonged-release tablets
PALEXIA
®
SR 200 mg prolonged-release tablets
PALEXIA
®
SR 250 mg prolonged-release tablets
2. Qualitative and quantitative composition
Each prolonged-release tablet contains 50 mg tapentadol (as
hydrochloride).
Each prolonged-release tablet contains 100 mg tapentadol (as
hydrochloride).
Each prolonged-release tablet contains 150 mg tapentadol (as
hydrochloride).
Each prolonged-release tablet contains 200 mg tapentadol (as
hydrochloride).
Each prolonged-release tablet contains 250 mg tapentadol (as
hydrochloride).
Excipient(s) with known effect:
PALEXIA SR 50 mg contains 3.026 mg lactose.
PALEXIA SR 100 mg contains 3.026 mg lactose.
PALEXIA SR 150 mg contains 3.026 mg lactose.
PALEXIA SR 200 mg contains 3.026 mg lactose.
PALEXIA SR 250 mg contains 3.026 mg lactose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged-release tablet
50 mg: White film-coated oblong shaped tablets (6.5 mm x 15 mm) marked
with Grünenthal logo on one
side and “H1” on the other side.
100 mg: Pale yellow film-coated oblong shaped tablets (6.5 mm x 15 mm)
marked with Grünenthal logo
on one side and “H2” on the other side.
150 mg: Pale pink film-coated oblong shaped tablets (6.5 mm x 15 mm)
marked with Grünenthal logo on
one side and “H3” on the other side.
200 mg: Pale orange film-coated oblong shaped tablets (7 mm x 17 mm)
marked with Grünenthal logo on
one side and “H4” on the other side.
250 mg: Brownish red film-coated oblong shaped tablets (7 mm x 17 mm)
marked with Grünenthal logo
on one side and “H5” on the other side.
4. Clinical particulars
4.1 Therapeutic indications
PALEXIA SR is indicated for the management of severe chronic pain in
adults, which can be adequately
managed only with op
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