HYDROXYCHLOROQUINE GH Tablets hydroxychloroquine sulfate 200 mg tablets bottle

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Beli sekarang

Download Risalah maklumat (PIL)
22-10-2020
Download Ciri produk (SPC)
05-07-2021
Download Laporan Penilaian Awam (PAR)
25-11-2017

Bahan aktif:

hydroxychloroquine sulfate, Quantity: 200 mg

Boleh didapati daripada:

Generic Health Pty Ltd

INN (Nama Antarabangsa):

Hydroxychloroquine sulfate

Borang farmaseutikal:

Tablet

Komposisi:

Excipient Ingredients: hypromellose; magnesium stearate; calcium hydrogen phosphate; polysorbate 80; colloidal anhydrous silica; pregelatinised maize starch; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350

Laluan pentadbiran:

Oral

Unit dalam pakej:

100

Jenis preskripsi:

(S4) Prescription Only Medicine

Tanda-tanda terapeutik:

Rheumatoid arthritis; mild systemic and discoid lupus erythematosus; the suppression and treatment of malaria.

Ringkasan produk:

Visual Identification: White to off white capsule shaped tablets embossed HCQS on one side plain on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Status kebenaran:

Licence status A

Tarikh kebenaran:

2015-02-02

Risalah maklumat

                                CONSUMER MEDICINE INFORMATION
HYDROXYCHLOROQUINE GH
(HYDROXYCHLOROQUINE SULFATE) TABLET
WHAT IS IN THIS LEAFLET
THIS LEAFLET ANSWERS SOME
COMMON QUESTIONS ABOUT
HYDROXYCHLOROQUINE GH.
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 using
this medicine against the
benefits they expect it will have
for you.
KEEP THIS LEAFLET WITH YOUR
MEDICINE. You may want to
read it again.
WHAT
HYDROXYCHLOROQUINE GH
IS USED FOR
Hydroxychloroquine GH may be
used for any of the following
conditions._ _
RHEUMATOID ARTHRITIS
Rheumatoid arthritis is a form of
arthritis with inflammation of the
joints, characterised by stiffness,
swelling and pain.
Hydroxychloroquine GH may be
used for short or long-term
rheumatoid arthritis treatment.
In treating rheumatoid arthritis,
Hydroxychloroquine GH may
slow down the process of joint
damage and relieve the
symptoms of the disease.
SYSTEMIC LUPUS
ERYTHEMATOUS (SLE)
SLE is a disease in which a
person’s normal immunity is
upset. The body produces an
excess of blood proteins called
antibodies and these antibodies
may cause problems in any
organ of the body.
These antibodies may end up,
for example, in the skin causing
a variety of skin rashes or
deposit in the kidney, brain, lung
and joints causing injury.
DISCOID LUPUS ERYTHEMATOUS
(DLE)
DLE is similar to SLE except it
only affects the skin and is
characterised by a scaling, red
rash.
MALARIA (TREATMENT AND CONTROL
OF SYMPTOMS)
Malaria is an infectious disease
caused by the presence of
parasites in red blood cells.
The disease is characterised by
chills, fever and sweats.
In malaria, Hydroxychloroquine
GH destroys the harmful
parasite which causes the
illness.
Your doctor may have
prescribed this medicine for
another reason. Ask your doctor
if you have any questions about
why Hydroxychloroquine GH
has been prescribed for you.
Hydroxychloroquine GH is not
addictive. This medicine is
available only 
                                
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Ciri produk

                                AUSTRALIAN PRODUCT INFORMATION – HYDROXYCHLOROQUINE GH
(HYDROXYCHLOROQUINE SULFATE) TABLET
1
NAME OF THE MEDICINE
Hydroxychloroquine sulfate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg hydroxychloroquine sulfate, which is
equivalent to 155 mg base.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Hydroxychloroquine GH 200 mg tablets: White to off-white, capsule
shaped tablets, embossed “HCQS”
on one side, plain on the other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rheumatoid arthritis; mild systemic and discoid lupus erythematosus;
the suppression and treatment of
malaria.
4.2 DOSE AND METHOD OF ADMINISTRATION
RHEUMATOID ARTHRITIS
Hydroxychloroquine is cumulative in action and will require several
weeks to exert its beneficial
therapeutic effects, whereas minor side effects may occur relatively
early. Several months of therapy
may be required before maximum effects can be obtained.
Initial Dosage
In adults, a suitable initial dosage is from 400–600 mg daily,
preferably taken at meal times. In a few
patients the side effects may require temporary reduction of the
initial dosage. Generally, after 5–10
days the dose may be gradually increased to the optimum response
level, frequently without return of
side effects.
Maintenance Dosage
When a good response is obtained (usually in 4–12 weeks) the dose
can be reduced to 200–400 mg daily
(but should not exceed 6 mg/kg per day) and can be continued as
maintenance treatment. The minimum
effective maintenance dose should be employed. The incidence of
retinopathy has been reported to be
higher when the maintenance dose is exceeded.
Hydroxychloroquine GH v5.0
Page 2 of 15
(hydroxychloroquine sulfate) tablet
If objective improvement (such as reduced joint swelling or increased
mobility) does not occur within
six months the drug should be discontinued.
If a relapse occurs after medication is withdrawn, therapy may be
resumed or continued on an
intermittent schedule if there are no
                                
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