Plaquenil

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Hydroxychloroquine sulfate 200mg

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Hydroxychloroquine sulfate 200 mg

Dosage:

200 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Hydroxychloroquine sulfate 200mg Excipient: Calcium hydrogen phosphate dihydrate Carnauba wax Ready to Use White Colorant (corresponding generic name to Opadry® YS-1-7443) Macrogol 400 Magnesium stearate Maize starch

Units in package:

Bottle, glass, 1x100, 100 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Chinoin Pharmaceutical & Chemical Works Co Ltd

Therapeutic indications:

Acute and chronic rheumatoid arthritis; mild systemic and discoid lupus erythematosus; the suppression and treatment of malaria.

Product summary:

Package - Contents - Shelf Life: Bottle, glass, 1x100 - 100 tablets - 60 months from date of manufacture stored at or below 30°C - Bottle, plastic, 100 mL HDPE/ child res. seal 1x100 - 100 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, 60 mL HDPE/ child res. seal 1x100 - 100 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

1969-12-31

Patient Information leaflet

Plaquenil
1
PLAQUENIL TABLETS
CONSUMER MEDICINE INFORMA�ON (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 ac�ve ingredient hydroxychloroquine sulfate.
Plaquenil is used to treat rheumatoid arthri�s and may slow
down the process of joint damage and relieve the symptoms of the
disease. For more informa�on, see Sec�on 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 reac�on 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
CONDI�ONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO
BECOME PREGNANT OR ARE BREAS�EEDING. For more informa�on, see
Sec�on 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 Sec�on 3. What if I am taking
other medicines? in the full CMI.
4.
HOW DO I USE PLAQUENIL?
•
Swallow tablets whole with a litle water or other liquid at
meal�mes. The dosage will depend on why you are being treated
with Plaquenil. More instruc�ons can be found in Sec�on 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, den�st 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 A�ER
YOUR MEDICINE
•
Keep your tablets in the b

Summary of Product characteristics

plaquenil-ccdsv16-19-dsv21-18dec23
Page 1
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
PLAQUENIL 200mg Tablet, film coated
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydroxychloroquine sulfate 200mg equivalent to 155mg
hydroxychloroquine.
For full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Film coated tablet.
White to off-white peanut shaped tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Acute and chronic 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.
plaquenil-ccdsv16-19-dsv21-18dec23
Page 2
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
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 treatment of juvenile rheumatoid
arthritis has not been established.
Use in Com