APO-HYDROXYCHLOROQUINE 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:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Hydroxychloroquine sulfate

Pharmaceutical form:

Tablet

Composition:

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

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, 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; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2012-04-13

Patient Information leaflet

APO-HYDROXYCHLOROQUINE
1
APO
APO-HYDROXYCHLOROQUINE
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 APO-HYDROXYCHLOROQUINE?
APO-Hydroxychloroquine
contains the active ingredient hydroxychloroquine sulfate.
APO-Hydroxychloroquine
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
Apo-Hydroxychloroquine?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE APO-HYDROXYCHLOROQUINE?
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
Apo-Hydroxycholoroquine? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Apo-Hydroxycholoroquine 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 APO-HYDROXYCHLOROQUINE?
• Swallow tablets whole with a little water or other liquid at
mealtimes.
• The dosage will depend on why you are being treated with
APO-Hydroxychloroquine.
More instructions can be found in Section 4. How do I use
Apo-Hydroxychloroquine?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING APO-HYDROXYCHLOROQUINE?
THINGS YOU
SHOULD DO
Remind any doctor, dentist or pharmacist you visit that you are using
APO-Hydroxychloroquine.
THINGS YOU
SHOULD NOT DO
APO-Hydroxychloroquine
should not be used in children under 6 years.
APO-Hydroxychloroquine
should not be used in children over 6 years for long periods.
DRIVING OR
USING
MACHINES
APO-Hydroxychloroquine
may cause problems with the eyesight of some people. Make sure you
know ho

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO-HYDROXYCHLOROQUINE
(HYDROXYCHLOROQUINE SULFATE) TABLETS
1
NAME OF THE MEDICINE
Hydroxychloroquine sulfate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg hydroxychloroquine sulphate, as the active
ingredient.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
White to off-white, capsule-shaped tablets, debossed “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
APO- Hydroxychloroquine tablets are intended for oral administration.
DOSAGE
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.
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 h