Feldene Melt 20mg tablets

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Piroxicam

Dostupné z:

DE Pharmaceuticals

ATC kód:

M01AC01

INN (Medzinárodný Name):

Piroxicam

Dávkovanie:

20mg

Forma lieku:

Orodispersible tablet

Spôsob podávania:

Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 10010100

Príbalový leták

Page 1 of 8
PATIENT INFORMATION LEAFLET
UNITED KINGDOM
FELDENE® MELT 20 MG
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 Melt is and what it is used for
2. Before you take Feldene Melt
3. How to take Feldene Melt
4. Possible side effects
5. How to store Feldene Melt
6. Further information
1.
WHAT FELDENE MELT IS AND WHAT IT IS USED FOR
Feldene Melt 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 Melt 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 Melt to you when you have had
unsatisfactory relief of
symptoms with other NSAIDs.
2.
BEFORE YOU TAKE FELDENE MELT
DO NOT TAKE FELDENE MELT

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 preve

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Feldene Melt 20mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Piroxicam 20mg.
Excipient with known effect: Aspartame
For full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Fast Dissolving Dosage Form (Tablet)
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 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. 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.
The fast
dissolving dosage form may be swallowed with water, or placed on the
tongu