Piroxicam 20mg capsules

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Piroxicam

Dostopno od:

Sandoz 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

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER
PIROXICAM CAPSULES BP 10MG & 20MG
PIROXICAM
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 or
nurse. This
includes any possible side effects not listed in this leaflet. See
section 4.
IN THIS LEAFLET:
1. What Piroxicam is and what it is used for
2. What you need to know before you take Piroxicam
3. How to take Piroxicam
4. Possible side effects
5. How to store Piroxicam
6. Contents of the pack and other information
1. WHAT PIROXICAM IS AND WHAT IT IS USED FOR
Piroxicam is one of a group of medicines called non-steroidal anti-
inflammatory drugs (NSAIDs). It will help to relieve pain and reduce
swelling affecting joints.
Before prescribing Piroxicam, your doctor will assess the benefits
this
medicine may give you against your risk of developing side effects.
Your
doctor may need to give you check-ups and will tell you how often you
need
to be checked, due to your taking Piroxicam.
Piroxicam is used to relieve some symptoms caused by osteoarthritis
(arthrosis, degenerative joint disease), rheumatoid arthritis and
ankylosing
spondylitis (rheumatism of the spine), such as swelling, stiffness and
joint
pain. It does not cure arthritis and will help you only as long as you
continue
to take it.
Your doctor will prescribe Piroxicam to you only when you have had
unsatisfactory relief of symptoms with other Non-steroidal anti-
inflammatory medicines (NSAIDs).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PIROXICAM
DO NOT TAKE PIROXICAM CAPSULES IF YOU:

are allergic (hypersensitive) to Piroxicam or any of the other
ingredients
of these capsules (see section 6

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