MOBILIS 10 piroxicam 10mg capsule bottle

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

piroxicam, Quantity: 10 mg

זמין מ:

Alphapharm Pty Ltd

טופס פרצבטיות:

Capsule, hard

הרכב:

Excipient Ingredients: lactose monohydrate; maize starch; magnesium stearate; sodium starch glycollate; sodium lauryl sulfate; propylene glycol; ethanol; butan-1-ol; purified water; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide; titanium dioxide; iron oxide yellow; iron oxide red; Gelatin

מסלול נתינה (של תרופות):

Oral

יחידות באריזה:

50, 10, 14, 5 (sample)

סוג מרשם:

(S4) Prescription Only Medicine

סממני תרפויטית:

Symptomatic treatment of rheumatoid arthritis, osteoarthritis and ankylosing spondylitis.

leaflet_short:

Visual Identification: Size 2 capsule with brown opaque cap and ivory opaque body printed in black "PM10" on the body and the "alpha" symbol on the cap.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

מצב אישור:

Licence status A

תאריך אישור:

1995-05-02

עלון מידע

MOBILIS
® & MOBILIS
® D
M
O
B
I
L
I
S
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 MOBILIS?
MOBILIS contains the active ingredient piroxicam. MOBILIS 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 MOBILIS? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE MOBILIS?
Do not use if you have ever had an allergic reaction to MOBILIS, 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.
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. Do not take MOBILIS if you are
pregnant, or intend on becoming pregnant, unless your doctor
says otherwise. For more information, see Section 2. What should I
know before I use MOBILIS? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with MOBILIS 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 MOBILIS?
•
The usual dose 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 MOBILIS? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING MOBILIS?
THINGS YOU
SHOULD DO
•
If you become pregnant while taking MOBILIS, tell your doctor
imm

מאפייני מוצר

AUSTRALIAN PRODUCT INFORMATION
MOBILIS
® & MOBILIS
® D
_piroxicam capsule and dispersible tablet _
1
NAME OF THE MEDICINE
Piroxicam
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule or dispersible tablet contains piroxicam as the active
ingredient. Each MOBILIS capsule or
MOBILIS-D dispersible tablet contains 10 mg or 20 mg of the active
ingredient.
Excipients with known effect: sugars as lactose. The tablets and
capsules contain trace amounts of saccharin and
the capsules also contain trace amounts of sulfites.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
MOBILIS 10: Size 2 capsule with brown opaque cap and ivory opaque body
printed in black “PM10” on the
body and “α” on the cap.
MOBILIS 20: Size 2 capsule with light grey opaque cap and body printed
in black “PM20” on the body and “α”
on the cap.
MOBILIS D-10 dispersible tablets: White to slightly yellow flat bevel
edged tablet, approximately 10 mm in
diameter, blank on one side and breakline on reverse.
MOBILIS D-20 dispersible tablets: White to slightly yellow capsule
shaped tablets, 17 mm x 6 mm, with a
breakline on one side and blank on the reverse.
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.
The dose should be adjusted to each individual patient's response and
toleration. In studies to date, the optimal
response gene