Feldene Melt 20mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Piroxicam

Available from:

Pfizer Ltd

ATC code:

M01AC01

INN (International Name):

Piroxicam

Dosage:

20mg

Pharmaceutical form:

Orodispersible tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010100; GTIN: 5013457012552 5013457010190

Patient Information leaflet

Take special care with Feldene as like all NSAIDs,
Feldene can cause serious reactions in the stomach
and intestines, such as pain, bleeding, ulceration
and perforation.
You should STOP TAKING FELDENE IMMEDIATELY and
TELL YOUR DOCTOR if you have stomach pain or any
sign of bleeding in the stomach or intestines, such
as passing black or bloodstained bowel movements
or vomiting blood.
Your doctor may prescribe Feldene Melt together
with another medicine to protect your stomach and
intestines from side effects, particularly if you are
over 70 years old, or you are taking other medicines
like corticosteroids (medicines given to treat a
variety of conditions such as allergies and hormone
imbalances), certain medicines for depression called
selective serotonin reuptake inhibitors (SSRIs) or low
dose acetylsalicylic acid (aspirin) to help prevent
heart attack or stroke.
Feldene Melt may make it more difficult to become
pregnant. You should inform your doctor if you
are planning to become pregnant or if you have
problems becoming pregnant.
PATIENTS OVER 70 YEARS OF AGE
If you are over 70 years old, your doctor may wish to
minimise the length of your treatment and to see you
more often while you are taking Feldene Melt.
You should not take this medicine if you are over
80 years of age.
TAKING OTHER MEDICINES
Tell your doctor about any other medicines you
are taking or took recently (in the last week) -
even medicines you bought yourself without a
prescription. Medicines can sometimes interfere with
each other.
Your doctor may limit your use of Feldene or other
medicines, or you may need to take a different
medicine.
The following medicines MUST NOT BE TAKEN WITH
FELDENE:
• aspirin or other non-steroidal anti-inflammatory
drugs for pain relief
• anticoagulants such as warfarin to prevent blood
clots
Tell your doctor BEFORE you take Feldene Melt if you
are taking any of the following medicines:
• corticosteroids, which are medicines given to
treat a variety of conditions such as allergies and
hormone imbalances
• lo

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Feldene Melt 20mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Piroxicam 20mg.
Excipient with known effect
Each Feldene Melt 20 mg tablet contains 0.25 mg 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