FELDENE 20mg capsule blister pack

Country: অস্ট্রেলিয়া

ভাষা: ইংরেজি

সূত্র: Department of Health (Therapeutic Goods Administration)

সক্রিয় উপাদান:

piroxicam

থেকে পাওয়া:

Pfizer Australia Pty Ltd

অনুমোদন অবস্থা:

Registered

তথ্য লিফলেট

FELDENE
®
; FELDENE-D
®
_Piroxicam (pir-oks-i-kam)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about FELDENE. It does
not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking FELDENE
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
READ THIS LEAFLET CAREFULLY BEFORE
STARTING FELDENE AND KEEP IT
WITH YOUR MEDICINE. YOU MAY NEED
TO READ IT AGAIN.
WHAT FELDENE IS
USED FOR
FELDENE treats the symptoms of
•
rheumatoid arthritis
•
osteoarthritis
•
ankylosing spondylitis, a chronic
inflammatory rheumatic disorder
that primarily affects, but is not
limited to, the spine.
Although FELDENE can relieve the
symptoms of pain and inflammation,
it will not cure your condition.
FELDENE belongs to a group of
medicines called Non-Steroidal Anti-
inflammatory Drugs (NSAIDs).
These medicines work by relieving
pain and inflammation (heat,
throbbing, swelling, redness).
Your doctor may have prescribed
FELDENE for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY FELDENE
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
FELDENE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE FELDENE IF YOU HAVE
AN ALLERGY TO:
•
piroxicam (the active ingredient
in FELDENE) or any of the
capsule or tablet ingredients listed
at the end of this leaflet (see
Product Description)
•
other medicines containing
piroxicam e.g. PIRIFEL,
FELDENE Gel. Other brands are
available.
•
any medicine that is a COX-2
inhibitor
•
aspirin
•
any other medicine that is also an
NSAID.
Many medicines used to treat
headache, period pain and other
aches and pains contain aspirin or
NSAID medicines.
IF YOU ARE NOT SURE IF YOU ARE
TAKING ONE OF THESE MEDICINES, ASK
YOUR PHARMACIST.
Symptoms of an allergic reaction to
the

পণ্য বৈশিষ্ট্য

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Supersedes: pfpfelda11021
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AUSTRALIAN
PRODUCT
INFORMATION
–
FELDENE
® AND FELDENE-D
® (PIROXICAM)
1.
NAME OF THE MEDICINE
Piroxicam
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
FELDENE (piroxicam) 10 mg and 20 mg capsules.
FELDENE-D (piroxicam) 20 mg tablets.
EXCIPIENT(S) WITH KNOWN EFFECT
FELDENE 10 mg and 20 mg capsules contain lactose monohydrate.
FELDENE-D 20 mg dispersible tablets contain lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
FELDENE 10 mg capsules are blue and red in colour, marked
_FEL10_
on one side and
_Pfizer _
on the other.
FELDENE 20 mg capsules are maroon in colour, marked
_FEL20_
on one side and
_Pfizer_
on the
other.
FELDENE-D 20 mg dispersible tablets are white, oblong, scored,
capsule-shaped and marked
_FEL/20_
on one side and plain on the other.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Piroxicam is indicated for symptomatic treatment of rheumatoid
arthritis, osteoarthritis and
ankylosing spondylitis.
4.2 DOSE AND METHOD OF ADMINISTRATION
Pregnancy: see Section 4.6 Fertility, pregnancy and lactation.
RHEUMATOID ARTHRITIS, OSTEOARTHRITIS AND ANKYLOSING SPONDYLITIS
After assessing the risk versus benefit for each patient, use the
minimum effective dose for the
shortest duration possible. The duration of treatment should
preferably be limited to 14 days.
If continued treatment is considered necessary, this should be
accompanied by evaluation at
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14 days and subsequent frequent review with regards to efficacy, risk
factors and ongoing need
for treatment.
The dose should be adjusted to each individual patient’s response
and toleration. In studies to
date, the optimal response generally has been achieved at a daily dose
of 20 mg, given as a
single dose. The recommended starting dose is 10 mg and administration
of doses higher than
20 mg daily carries an increased risk of adverse effects and is not
recommended.
FELDENE-