PLAQUENIL hydroxychloroquine sulfate 200 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

hydroxychloroquine sulfate, Quantity: 200 mg

Available from:

Sanofi-Aventis Australia Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: maize starch; calcium hydrogen phosphate dihydrate; macrogol 400; Carnauba Wax; magnesium stearate; titanium dioxide; hypromellose; polysorbate 80

Administration route:

Oral

Units in package:

100

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

Visual Identification: white to off-white peanut shaped tablets.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

1994-08-19

Patient Information leaflet

PLAQUENIL TABLETS
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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 PLAQUENIL?
Plaquenil contains the active ingredient hydroxychloroquine sulfate.
Plaquenil is used to treat rheumatoid arthritis and may slow
down the process of joint damage and relieve the symptoms of the
disease.
For more information, see Section 1. Why am I using Plaquenil? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE PLAQUENIL?
Do not use if you have ever had an allergic reaction to
hydroxychloroquine sulfate 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.
For more information, see Section 2. What should I know before I use
Plaquenil? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Plaquenil and affect how it works.
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 PLAQUENIL?
•
Swallow tablets whole with a little water or other liquid at
mealtimes.
•
The dosage will depend on why you are being treated with Plaquenil.
•
More instructions can be found in Section 4. How do I use Plaquenil?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING PLAQUENIL?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Plaquenil.
THINGS YOU
SHOULD NOT DO
•
Plaquenil should not be used in children under 6 years.
•
Plaquenil should not be used in children over 6 years for long
periods.
DRIVING
OR USING
MACHINES
•
Plaquenil may cause problems with the eyesight of some people. Make
sure you know how you react to
Plaquenil before you drive a car, operate machinery, or do anything
else that could be dangerous with
blurred vision.
LOOKING AFTER
YOUR MEDICINE
•
Keep your tabl

Summary of Product characteristics

plaquenil-ccdsv15-piv14-13jan22
Page 1 of 17
AUSTRALIAN PRODUCT INFORMATION – PLAQUENIL
(HYDROXYCHLOROQUINE SULFATE)
1
NAME OF THE MEDICINE
hydroxychloroquine sulfate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Film coated tablets containing hydroxychloroquine sulfate 200 mg
(equivalent to 155 mg
base).
For full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
White to off-white peanut shaped tablets, marked "Plaquenil" in black
ink on one face of the
tablet.
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
Plaquenil 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 to
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 five to ten 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 four
to twelve weeks) the
dose can be reduced to 200 to 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
plaquenil-ccdsv15-piv14-13jan22
Page 2 of 17
employed. The incidence of retinopathy has been reported to be higher
when the maintenance
dose is exceeded.
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 ocular contraindications.
Safe use of Plaquenil for the