Feldene 10 mg capsules, hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Piroxicam

Available from:

Pfizer Limited

ATC code:

M01AC; M01AC01

INN (International Name):

Piroxicam

Dosage:

10 milligram(s)

Pharmaceutical form:

Capsule

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Oxicams; piroxicam

Authorization status:

Not marketed

Authorization date:

1979-04-03

Patient Information leaflet

Page 1 of 8
2016-0020113
PACKAGE LEAFLET: INFORMATION FOR THE USER
FELDENE® 10 MG AND 20 MG HARD CAPSULES
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 you doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Feldene is and what it is used for
2. What you need to know before you take Feldene
3. How to take Feldene
4. Possible side effects
5. How to store Feldene
6. Contents of the pack and other information
1.
WHAT FELDENE IS AND WHAT IT IS USED FOR
Feldene is one of a group of medicines called non-steroidal
anti-inflammatory drugs (NSAIDs). This means it
will help to relieve pain and reduce swelling affecting joints and
muscles.
Feldene is used to relieve some symptoms caused by osteoarthritis
(joint disease), rheumatoid arthritis, and
ankylosing spondylitis (rheumatism of the spine) such as swelling,
stiffness and joint pain. This medicine does
not cure arthritis and will help you only as long as you continue to
take it.
Your doctor will only prescribe Feldene to you when you have had
unsatisfactory relief of symptoms with other
NSAIDs.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FELDENE
DO NOT TAKE FELDENE

If you previously had an allergic reaction to piroxicam, (the active
ingredient in this medicine) or any of
the other ingredients of this medicine (listed in section 6), other
NSAIDs or any other medications,
especially serious skin reactions (regardless of severity) such as
erythema multiforme (patches of red,
raised skin), Stevens-Johnson syndrome or toxic epidermal necrolysis
(see below)

If you have previously had or

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Feldene 10 mg capsules, hard.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Capsules containing 10 mg piroxicam (anhydrous).
Excipients with known effect: Each capsule contains 243.23 mg lactose
monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsules, hard.
Red cap and blue body, coded ‘PFIZER’ and ‘FEL10’.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Feldene 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),_ Feldene
is not a first line option should an NSAID be indicated.
The decision to prescribe Feldene should be based on an assessment of
the individual patient’s overall risks_ (see_
_sections 4.3and 4.4)._
Treatment should only be initiated by specialist clinicians.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The prescription of Feldene should be initiated by physicians with
experience in the diagnostic evaluation and
treatment of patients with inflammatory or degenerative rheumatic
diseases.
Posology
The maximum recommended daily dose is 20 mg.
_Paediatric population_
Dosage recommendations and indications for use in children have not
been established.
_Elderly_
Elderly, frail or debilitated patients may tolerate side-effects less
well and such patients should be carefully supervised.
As with other NSAID's, caution should be used in the treatment of
elderly patients who are more likely to be suffering
from impaired renal, hepatic or cardiac function.
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.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_