Piroxicam 10mg capsules

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Piroxicam

Saatavilla:

Approved Prescription Services Ltd

ATC-koodi:

M01AC01

INN (Kansainvälinen yleisnimi):

Piroxicam

Annos:

10mg

Lääkemuoto:

Oral capsule

Antoreitti:

Oral

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 10010100

Pakkausseloste

260x210 Leaflet Reel Fed Bi Fold Profile (BST)
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Piroxicam, Capsules, 10 & 20mg
28s & 56s - UK
260x210 (Reel Fed)
50985207
Leaflet for Bottle
7872
RH
05-12-19
* Please note that ONLY Artwork Studio is permitted to make changes to
the above artwork.
No changes are permitted by any 3rd party other than added notes and
mark ups for required changes.
approved for print/date
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NON PRINTING COLOURS
COLOURS
DATE SENT:
DATE RECEIVED:
Item number:
ORIGINATOR:
ORIGINATION DATE:
REVISION DATE:
REVISED BY:
DIMENSIONS:
MIN BODY TEXT SIZE:
SUPPLIER:
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GTIN 13
(Belgium & Slovenia):
[e-mail]
PIROXICAM ALL STRENGTHS CAPSULES PIL - UK
Black
BBBA7192
R.Paul
02.01.2020
03.01.2020
R.Paul
210x260 reel fed
7.5pt
Accord Barnstaple
n/a
3
Version 6
12.12.2019
Profile
page 1
page 4
German GTIN 14
(incorporating PZN):
50985207 BBBA7192
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.
•
The full name of this medicine is
Piroxicam 10mg and 20mg Capsules
but within this leaflet it will be referred
to as Piroxicam capsules.
WHAT IS IN THIS LEAFLET:
1
WHAT PIROXICAM CAPSULES ARE AND
WHAT THEY ARE USED FOR
2
WHAT YOU NEED TO KNOW BEFORE
YOU TAKE PIROXICAM CAPSULES
3
HOW TO TAKE PIROXICAM CAPSULES
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE PIROXICAM CAPSULES
6 CONTENTS OF THE PACK AND OTHER
INFORMATION
1
WHAT PIROXICAM CAPSULES ARE AND
WHAT THEY ARE USED FOR
Piroxicam belongs to a grou

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Piroxicam Capsules 10mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 10mg Piroxicam PhEur.
Excipient with known effect: 210.60mg lactose monohydrate per tablet
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Pink and turquoise hard gelatin capsules printed “C” and the
identifying letters
“YA” in black.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Piroxicam is indicated for symptomatic relief of osteoarthritis,
rheumatoid
arthritis, or ankylosing spondylitis.
Due to its safety profile (see sections 4.2, 4.3 and 4.4), piroxicam
is not a first
line option should an NSAID be indicated. The decision to prescribe
piroxicam should be based on an assessment of the individual patient's
overall
risks (see sections 4.3 and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The prescription of piroxicam should be initiated by physicians with
experience in the diagnostic evaluation and treatment of patients with
inflammatory or degenerative rheumatic diseases.
The maximum recommended daily dose is 20mg.
Undesirable effects may be minimised by using the minimum effective
dose
for the shortest duration necessary to control symptoms. The benefit
and
tolerability of treatment should be reviewed within 14 days. If
continued
treatment is considered necessary, this should be accompanied by
frequent
review.
Given that piroxicam has been shown to be associated with an increased
risk
of gastrointestinal complications, the need for possible combination
therapy
with gastroprotective agents (e.g. misoprostol or proton pump
inhibitors)
should be carefully considered, in particular for elderly patients.
_ _
_ _
_Elderly_
Elderly, frail or debilitated patients may tolerate side-effects less
well and such
patients should be carefully supervised. As with other NSAIDs, caution
should
be used in the treatment of elderly patients who are more likely to be
suffering
from impaired renal, hepatic or cardiac function.
_ _