Feldene 20 capsules

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Piroxicam

Disponibil de la:

Pfizer Ltd

Codul ATC:

M01AC01

INN (nume internaţional):

Piroxicam

Dozare:

20mg

Forma farmaceutică:

Oral capsule

Calea de administrare:

Oral

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 10010100; GTIN: 5013457012521 5013457012545

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE USER
FELDENE® 10MG AND 20MG CAPSULES
PIROXICAM
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
•
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. Do not pass it on to
others. It may harm them, even if
their symptoms are the same as yours.
•
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Feldene is and what it is used for
2. Before you take Feldene
3. How to take Feldene
4. Possible side effects
5. How to store Feldene
6. Further 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.
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.
BEFORE YOU TAKE FELDENE
DO NOT TAKE FELDENE
•
If you have previously had or currently have a stomach or intestinal
ulcer, bleeding or
perforation.
•
If you have, or have previously had disorders of the stomach or
intestines such as ulcerative
colitis, Crohn’s disease, gastrointestinal cancers or diverticulitis
(inflamed or infected
pouches/pockets in the colon).
•
If you are taking other NSAIDs such as ibuprofen, celecoxib or
acetylsalicylic acid (aspirin), a
substance present in many medicines used to relieve pain and lower
fever.
•
If you are taking anticoagulants, such as warfarin, to prevent blood
clots.
Page 1 of 8
•
If you previously ha

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
FELDENE 20mg CAPSULES
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient: piroxicam 20 mg (anhydrous).
Excipient with known effect: Lactose.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsules for oral administration.
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 4.3 and 4.4).
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.
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
need
for
possible
combination
therapy
with
gastro-
protective agents (e.g. misoprostol or proton pump inhibitors) should
be carefully considered,
in particular for elderly patients.
USE IN THE 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.
For oral administration. To be taken preferably with or after food.
Undesirable effects may be minimised by using