FELDENE 10mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

piroxicam, Quantity: 10 mg

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: lactose monohydrate; sodium lauryl sulfate; maize starch; magnesium stearate

Administration route:

Oral

Units in package:

50

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Feldene is indicated for the symptomatic treatment of rheumatoid arthritis, osteoarthritis and ankylosing spondylitis.

Product summary:

Visual Identification: Size 2 hard gelatin capsule with a blue opaque body and red opaque cap printed with "Fel 10" and "Pfizer".; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1994-01-24

Patient Information leaflet

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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING FELDENE?
FELDENE contains the active ingredient piroxicam. FELDENE is used to
treat the symptoms of rheumatoid arthritis, osteoarthritis
and ankylosing spondylitis, a chronic inflammatory rheumatic disorder
that primarily affects, but is not limited to, the spine.
For more information, see Section 1. Why am I using FELDENE? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE FELDENE?
Do not use if you have ever had an allergic reaction to FELDENE, any
other medicine containing piroxicam, any COX-2 inhibitor,
aspirin or NSAID medicines or any of the ingredients listed at the end
of the CMI.
Do not take FELDENE if you are pregnant, or intend on becoming
pregnant, unless your doctor says otherwise
Talk to your doctor if you have any other medical conditions, take any
other medicines, or are pregnant or plan to become pregnant
or are breastfeeding. For more information, see Section 2. What should
I know before I use FELDENE? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with FELDENE and affect how it works.
Examples of such medicines include aspirin or other
NSAIDs, warfarin, digoxin, medicine for diabetes or epilepsy or
depression, certain antibiotics, diuretics, medicine for blood
pressure
or cholesterol and alcohol. A list of these medicines is in Section 3.
What if I am taking other medicines? in the full CMI.
4.
HOW DO I USE FELDENE?
The usual dose of FELDENE is between 10 mg and 20 mg, taken as a
single dose each day. However, depending on your condition
and how you react to the medicine, your doctor may ask you to take
some other dose.
More instructions can be found in Section 4. How do I use FELDENE? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING FELDENE?
THINGS

Summary of Product characteristics

Version: pfpfelda10822
Supersedes: pfpfelda10122
Page 1 of 16
AUSTRALIAN
PRODUCT
INFORMATION
–
FELDENE
® AND FELDENE-D
® (PIROXICAM)
1.
NAME OF THE MEDICINE
Piroxicam
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
FELDENE (piroxicam) 10 mg capsules.
FELDENE-D (piroxicam) 20 mg tablets.
EXCIPIENT(S) WITH KNOWN EFFECT
FELDENE 10 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-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
14 days and subsequent frequent review with regards to efficacy, risk
factors and ongoing need
for treatment.
Version: pfpfelda10822
Supersedes: pfpfelda10122
Page 2 of 16
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-D dispersible tablets should be dispersed in a minimum of 50
mL of water and then
swallowed.
4.3 CONTRAINDICATIONS
Piro