RUSQUEN TABLETS 200 mg hydroxychloroquine sulfate 200 mg tablets bottle

Држава: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

hydroxychloroquine sulfate, Quantity: 200 mg

Доступно од:

GM Pharma International Pty Ltd

INN (Међународно име):

Hydroxychloroquine sulfate

Фармацеутски облик:

Tablet

Састав:

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

Пут администрације:

Oral

Јединице у пакету:

100

Тип рецептора:

(S4) Prescription Only Medicine

Терапеутске индикације:

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

Резиме производа:

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

Статус ауторизације:

Registered

Датум одобрења:

2015-02-02

Информативни летак

RUSQUEN TABLETS 200 MG
CONSUMER MEDICINE INFORMATION
Version 1.0
COMMERCIAL-IN-CONFIDENCE
- 1 -
RUSQUENTABLETS 200 MG
(HYDROXYCHLOROQUINE SULFATE 200 MG FILM COATED TABLETS)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE. ASK YOUR
DOCTOR OR PHARMACIST IF YOU DO NOT
UNDERSTAND ANYTHING OR ARE WORRIED ABOUT TAKING YOUR MEDICINE.
This leaflet answers some common questions about hydroxychloroquine.
It does not contain all the available
information. It does not take the place of talking to your doctor or
pharmacist.
The information in this leaflet was last updated on the date listed on
the last page. Some more recent
information on your medicine may be available. Speak to your
pharmacist or doctor to obtain the most up-to-
date information.
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 RUSQUEN IS USED FOR
The name of your medicine is Rusquen Tablets 200 mg. It contains the
active ingredient hydroxychloroquine
sulfate.
It may be used for any of the following conditions:_ _
_ _
_RHEUMATOID ARTHRITIS _
Rheumatoid arthritis is a form of arthritis with inflammation of the
joints, characterized by stiffness, swelling
and pain.
Hydroxychloroquine may be used for short or long-term rheumatoid
arthritis treatment.
In treating rheumatoid arthritis, hydroxychloroquine 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 SL

Карактеристике производа

RUSQUEN TABLETS 200 MG
Hydroxychloroquine sulfate 200 mg
NAME OF THE MEDICINE
AUSTRALIAN APPROVED NAME
Hydroxychloroquine sulfate.
Chemical Name:
(_RS_)-2-N-[4-(7-chloro-4-quinolylamino)pentyl]-_N_-ethylaminoethanol
sulfate
Structural Formula:
Molecular Formula: C
18
H
26
ClN
3
O.H
2
SO
4
Molecular Weight: 433.95
CAS Registry Number: 747-36-4
DESCRIPTION
Hydroxychloroquine sulfate is a colourless crystalline solid, soluble
in water to at least 20%. Each tablet contains
200 mg hydroxychloroquine sulfate, which is equivalent to 155 mg base.
In addition, each tablet contains the
following
inactive
ingredients:
anhydrous
calcium
hydrogen
phosphate,
pregelatinised
maize
starch,
hypromellose, magnesium stearate, polysorbate 80, colloidal anhydrous
silica and Proprietary Ingredient Opadry
II White 85F18422.
PHARMACOLOGY
Hydroxychloroquine is an anti-malarial. It also exerts a beneficial
effect in mild systemic and discoid lupus
erythematosus and rheumatoid arthritis. The precise mechanism of
action is not known.
MALARIA
Like chloroquine phosphate, hydroxychloroquine is highly active
against the erythrocytic forms of _Plasmodium _
_vivax _and _P. malariae _and most strains of _P. falciparum _(but not
the gametocytes of _P. falciparum_).
Hydroxychloroquine does not prevent relapses in patients with vivax or
malariae malaria because it is not
effective against exo-erythrocytic forms of the parasite, nor will it
prevent vivax or malariae infection when
administered as a prophylactic. It is highly effective as a
suppressive agent in patients with vivax or malariae
malaria, in terminating acute attacks and significantly lengthening
the interval between treatment and relapse. In
patients with falciparum malaria, it abolishes the acute attack and
effects complete cure of the infection, unless
due to a resistant strain of _P. falciparum_.
INDICATIONS
Rheumatoid arthritis; mild systemic and discoid lupus erythematosus;
the suppression and treatment of malaria.
CONTRAINDICATIONS
Hydroxychloroquine is contraindicated in:
•
patien