Arthrexin 25 mg capsule bottle

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

indometacin, Quantity: 25 mg

Disponível em:

Alphapharm Pty Ltd

Forma farmacêutica:

Capsule, hard

Composição:

Excipient Ingredients: sodium starch glycollate; sodium lauryl sulfate; magnesium stearate; lactose monohydrate; titanium dioxide; Gelatin; ethanol; Shellac; Pharmaceutical glaze; carbon black

Via de administração:

Oral

Unidades em pacote:

1000 capsules (20 capsules), 30 capsules, 90 capsules, 50 capsules, 250 capsules, 6 capsules (sample)

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

Arthrexin is indicated in active stages of rheumatoid arthritis, osteoarthritis, degenerative joint disease of the hip, ankylosing spondylitis and gout. It is also indicated for: Acute musculoskeletal disorders, such as bursitis, tendonitis, synovitis, tenosynovitis, capsulitis of the shoulder, sprains and strains; low back pain (commonly referred to as lumbago); inflammation, pain and oedema following orthopaedic surgical procedures and nonsurgical procedures associated with reduction and immobilisation of fractures or dislocations; pain and associated symptoms of primary dysmenorrhoea.

Resumo do produto:

Visual Identification: Size 3 white opaque hard gelatin capsule, marked IN-25 on both body and cap; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Status de autorização:

Registered

Data de autorização:

2021-06-01

Folheto informativo - Bula

ARTHREXIN
_indometacin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ARTHREXIN. 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 ARTHREXIN
against the benefits they expect it
will 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 need to read it again.
WHAT ARTHREXIN IS
USED FOR
ARTHREXIN contains the active
ingredient, indometacin. It belongs to
a group of medicines called Non-
Steroidal Anti-Inflammatory Drugs
(NSAIDs).
ARTHREXIN is used to relieve pain
and reduce inflammation (swelling,
redness and soreness) that may occur
in the following conditions:
•
different types of arthritis
including rheumatoid arthritis,
osteoarthritis, gouty arthritis,
ankylosing spondylitis and
degenerative joint disease of the
hip
•
gout
•
muscle and bone injuries such as
sprains, strains, low back pain
(lumbago) and tendonitis, such as
tennis elbow
•
pain and swelling after setting
broken or dislocated bones
•
menstrual cramps (period pain)
Although ARTHREXIN can relieve
the symptoms of pain and
inflammation, it will not cure your
condition.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
It is available only with a doctor's
prescription.
There is not enough information to
recommend the use of this medicine
for children under the age of 2 years
BEFORE YOU TAKE
ARTHREXIN
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE ARTHREXIN IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
indometacin
•
aspirin or any other NSAID
medicines
•
any of the ingredients listed at the
end of this leaflet
Many medicines used to treat
headache, period pain and other
aches and pains contain aspirin or
other NS

Características técnicas

AUSTRALIAN PRODUCT INFORMATION
ARTHREXIN
_indometacin capsules _
1
NAME OF THE MEDICINE
Indometacin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 25 mg of indometacin as the active ingredient.
Excipients with known effect: contains sugars (as lactose).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
ARTHREXIN capsules are size 3 white hard gelatin capsules, marked
“IN-25” on both body and cap.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ARTHREXIN is indicated in active stages of:
•
Rheumatoid arthritis
•
Osteoarthritis
•
Degenerative joint disease of the hip
•
Ankylosing spondylitis
•
Gout
It is also indicated for:
•
Acute musculoskeletal disorders, such as bursitis, tendonitis,
synovitis, tenosynovitis, capsulitis of the
shoulder, sprains and strains
•
Low back pain (commonly referred to as lumbago)
•
Inflammation,
pain
and
oedema
following
orthopaedic
surgical
procedures
and
nonsurgical
procedures associated with reduction and immobilisation of fractures
or dislocations
•
Pain and associated symptoms of primary dysmenorrhoea
4.2
DOSE AND METHOD OF ADMINISTRATION
The recommended dosage of ARTHREXIN is 50 to 200 mg daily in divided
doses and should be individually
adjusted to patient's response and tolerance. Use the lowest effective
dose for the shortest duration consistent
with individual patient treatment goals.
Patients on long term treatment should be reviewed regularly with
regards to efficacy, risk factors and ongoing
need for treatment.
ARTHREXIN – PRODUCT INFORMATION
2
Unlike some other potent antirheumatic agents, an initial high loading
dose of ARTHREXIN is not necessary.
In chronic rheumatic disorders, initiating therapy with low doses,
increasing gradually when necessary, and
continuing for an adequate period (up to one month is recommended).
This will produce maximum benefit
and minimise adverse reactions.
In patients with persistent night pain and/or morning stiffness, a
dose of up to 100 mg at bedtime may