Piroxicam 10mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Piroxicam

Available from:

Mawdsley-Brooks & Company Ltd

ATC code:

M01AC01

INN (International Name):

Piroxicam

Dosage:

10mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010100

Patient Information leaflet

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
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approved for print/date
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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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Piroxicam 10mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 10mg of Piroxicam
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Appearance: Hard gelatin capsule with a violet body and turquoise cap,
printed “CX45” both on body and cap in white.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Piroxicam is a non-steroidal anti-inflammatory agent.
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
For oral administration
To be taken preferably with or after food
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 possible need for combination
therapy with
gastro- protective agents (e.g. misoprostal or proton pump inhibitors)
should be
carefully
considered, in particular for elderly patients.
_Rheumatoid arthritis osteoarthritis, ankylosing spondylitis_: The
recommended
starting dose is 20mg given as a single daily dose. The majority of
patients
will be maintained on 20mg daily. A relatively small group of patients
may be
maintained on 10mg daily