Piroxicam 20mg capsules

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Piroxicam

Dostopno od:

Approved Prescription Services Ltd

Koda artikla:

M01AC01

INN (mednarodno ime):

Piroxicam

Odmerek:

20mg

Farmacevtska oblika:

Oral capsule

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 10010100

Navodilo za uporabo

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:
1.
2.
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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

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Piroxicam Capsules 20mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains Piroxicam 20 mg.
Excipient with known effect: Lactose.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Capsule, hard.
Hard gelatin capsule with a scarlet opaque cap and a scarlet opaque
body,
printed in white ink with PRX 20 and Crescent moon logo containing a
whitish to slightly yellowish, odourless, homogenous powder.
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 20 mg.
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 possible need for combination
therapy with gastro-
protective agents (e.g. misoprostol or proton pump inhibitors) should
be carefully
considered, in particular for elderly patients.
Adults
Initially
20mg
given
as
a
single
daily
dose. The
majority
of
patients
may
be
maintained on 20mg a day, a relatively small group of patients may be
maintained on
10mg daily.
Elderly
There are no specific modifications required