Feldene 10mg capsules

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Piroxicam

Διαθέσιμο από:

Pfizer Ltd

Φαρμακολογική κατηγορία (ATC):

M01AC01

INN (Διεθνής Όνομα):

Piroxicam

Δοσολογία:

10mg

Φαρμακοτεχνική μορφή:

Oral capsule

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 10010100; GTIN: 5013457012507 5013457012514

Φύλλο οδηγιών χρήσης

Mock up from 8814717
•
Yellowing of the skin and the whites of your eyes
(jaundice)
•
Inflammation of the liver (hepatitis)
•
Increased risk of heart attack (myocardial infarction)
•
Increased risk of stroke
•
Fixed drug eruption (may look like round or oval patches
of redness and swelling of the skin), blistering (hives),
itching
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via
the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
or search for MHRA Yellow Card in the Google Play or
Apple App Store. By reporting side effects you can help
provide more information on the safety of this medicine.
5. HOW TO STORE FELDENE
Keep all medicines out of the reach and sight of children.
Store below 30˚C.
Do not use Feldene after the expiry date which is stamped
on the carton and the bottle label. The expiry date refers to
the last day of that month.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.
6. FURTHER INFORMATION
What Feldene contains
The active substance in Feldene capsules is piroxicam.
Feldene comes in two strengths; 10mg or 20mg.
The other ingredients are: lactose, corn starch, vegetable
magnesium stearate and sodium lauryl sulphate (see section
2 “Important information about some of the ingredients of
Feldene”).
The 10mg capsule shells contain gelatin, red iron oxide
(E172), indigotin (E132) and titanium dioxide (E171).
The 20mg capsule shells contain gelatin and titanium dioxide
(E171).
What Feldene looks like and contents of the pack
Feldene 10mg capsules are blue and red.
Feldene 20mg capsules are white.
The 10mg capsules come in containers of 30 and 20mg
capsules come in containers of 30.
Marketing Authorisation Holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
Manufacturer
Farev

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
FELDENE 10mg CAPSULES
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient: piroxicam 10 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