Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
hydroxychloroquine sulfate, Quantity: 200 mg
Generic Health Pty Ltd
Hydroxychloroquine sulfate
Tablet
Excipient Ingredients: hypromellose; magnesium stearate; calcium hydrogen phosphate; polysorbate 80; colloidal anhydrous silica; pregelatinised maize starch; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350
Oral
100
(S4) Prescription Only Medicine
Rheumatoid arthritis; mild systemic and discoid lupus erythematosus; the suppression and treatment of malaria.
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
Licence status A
2015-02-02
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 Prečítajte si celý dokument
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 Prečítajte si celý dokument