Ridaura Tablets

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

auranofin, Quantity: 3 mg

Commercializzato da:

Amdipharm Mercury Australia Pty Ltd

Forma farmaceutica:

Tablet, film coated

Composizione:

Excipient Ingredients: titanium dioxide; maize starch; lactose monohydrate; magnesium stearate; iron oxide yellow; microcrystalline cellulose; hypromellose; purified water; sodium starch glycollate; propylene glycol; ethanol

Via di somministrazione:

Oral

Confezione:

60 Tablets (E), 15 Tablets, 60 Tablets

Classe:

Medicine Registered

Tipo di ricetta:

Not scheduled. Not considered by committee, (S4) Prescription Only Medicine

Indicazioni terapeutiche:

INDICATIONS AS AT 14 NOVEMBER 2000: Adjunctive treatment of active classical or definite rheumatoid arthritis in adults who have an insufficient therapeutic response to, or are intolerant of, an adequate trial of a baseline therapeutic program, including among other measures, full doses of one or more non-steroidal anti-inflammatory drugs. RIDAURA is not indicated in non-rheumatoid arthropathies such as osteoarthrosis. RIDAURA should be added to a comprehensive baseline therapeutic program.

Dettagli prodotto:

Visual Identification: Pale yellow square, bevel-edged, film coated tablet having raised domes on both faces.; Container Type: Bottle; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

1991-08-14

Foglio illustrativo

CONSUMER MEDICINE INFORMATION
1
RIDAURA
®
_ _
_AURANOFIN _
_ _
3 mg Film-coated tablets
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start taking Ridaura.
This leaflet answers some of the common questions about Ridaura. It
does not contain all the
available information.
Reading this leaflet 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 Ridaura
against the benefits this medicine is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT RIDAURA IS USED FOR
Ridaura contains auranofin, a synthetic gold compound. It is used
together with other
treatments, such as non-steroidal anti-inflammatory drugs (NSAIDs),
for active rheumatoid
arthritis.
It is thought to modify the progress of active rheumatoid arthritis.
Ridaura may prevent or
reduce further damage to the joints. Ridaura can also reduce the
inflammation in the joints.
Rheumatoid arthritis can affect most joints, but the small joints of
the hands and feet are
frequently affected. The joints become swollen, warm and tender. This
leads to pain and loss
of joint movement. Deformity occurs with time. Morning stiffness in
affected joints is a common
symptom of rheumatoid arthritis.
Your doctor may have prescribed this medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED
FOR YOU.
Ridaura is only available with a doctor’s prescription.
There is no evidence that Ridaura is addictive.
CONSUMER MEDICINE INFORMATION
2
BEFORE YOU TAKE RIDAURA
_ _
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE RIDAURA IF:
▪
you have previously had a severe reaction to Ridaura, or to other
products containing gold
(e.g. Myocrisin, Gold-50) or other heavy metals, or you have had lung
or gut problems
caused by gold
▪
you have or have had any of the following medical conditions:
o
severe liver p

Scheda tecnica

RIDAURA
®
1
AUSTRALIAN PRODUCT INFORMATION
RIDAURA
(AURANOFIN)
TABLET
1
NAME OF THE MEDICINE
Auranofin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Ridaura tablet contains auranofin 3 mg.
Excipients with known effect: Sugars (as lactose monohydrate)
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Ridaura tablets are square, bevel-edged, pale yellow, film-coated
tablets having raised
domes on both faces.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adjunctive treatment of active classical or definite rheumatoid
arthritis in adults who have
an insufficient therapeutic response to, or are intolerant of, an
adequate trial of a baseline
therapeutic program, including among other measures, full doses of one
or more nonsteroidal
anti-inflammatory drugs. Ridaura is not indicated in non-rheumatoid
arthropathies such as
osteoarthrosis. Ridaura should be added to a comprehensive baseline
therapeutic program.
4.2 DOSE AND METHOD OF ADMINISTRATION
The usual adult dosage is 6 mg per day with food.
Ridaura may be co-prescribed with anti-inflammatory
medicine/analgesics as part of a
comprehensive treatment program. Such concomitant therapy may be
necessary especially
during the first weeks of Ridaura therapy, before full benefit of
Ridaura is seen. Ridaura has
also been used successfully with low dose (less than 10 mg)
corticosteroid therapy. RIDAURA
®
2
For patients who have not shown satisfactory response to Ridaura
therapy with 6 mg/day
after 4-6 months, the daily dosage may be increased to 9 mg/day by
giving one Ridaura tablet
three times a day with meals. Daily dosages above 9 mg are not
recommended because of
insufficient experience in human studies and increased risk of adverse
effects.
Clinical studies have shown that patients may be safely transferred to
Ridaura from
injectable gold salt therapy without the need for overlap or a washout
period.
4.3 CONTRAINDICATIONS
•
Hypersensitivity to the active substance or to any of the excipients
(see Section 6.1 List
of exci