* Therapeutic indications: (Antirheumatic)   Treatment of rheumatoid arthritis, juvenile chronic arthritis, discoid and systemic lupus   erythematosus, and dermatological conditions caused or aggravated by sunlight. * Posology and method of administration:   # Adults (including the elderly):   - The minimum effective dose should be employed. This dose should not exceed 6.5 mg/kg/day   (calculated from ideal body weight) and will be either 200 mg or 400 mg per day.   - In patients able to receive 400 mg daily:   Initially 400 mg daily in divided doses. The dose can be reduced to 200 mg when no   further improvement is evident. The maintenance dose should be increased to 400 mg   daily if the response lessens.   # Children:   The minimum effective dose should be employed and should not exceed 6.5 mg/kg/day   based in ideal body weight. The 200 mg tablet is therefore not suitable for use in children   with an ideal body weight of less than 35 kg.   # Each dose should be taken with a meal or glass of milk.   # Hydroxychloroquine is cumulative in action and will require several weeks to exert its   beneficial effects, whereas minor side effects may occur relatively early. For rheumatic   disease, treatment should be discontinued if there is no improvement by 6 months. In   light sensitive diseases, treatment should only be given during periods of maximum   exposure to light.   # The tablets are for oral administration. * Contraindications:   - Known hypersensitivity to 4-aminoquinoline compounds.   - Pre-existing maculopathy of the eye.   - Below 6 years of age (200 mg tablets not adapted for Children weight < 35 Kg). * Special warnings and special precautions for use:   # General:   - Before starting a long term treatment, both eyes should be examined by careful   ophthalmoscopy for visual acuity, central visual field and color vision, and   funduscopy. Then, the examination should be repeated at least annually.   - Retinal toxicity is largely dose-dependent. The risk of retinal damages is small   with daily doses of up to 6.5 mg/kg body weight. Exceeding the recommended   daily dose sharply increase the risk of retinal toxicity.   This examination should be more frequent and adapted to the patient, in the following   situations:   . daily dosage exceeding 6.5 mg/kg ideal (lean) body weight. Absolute body weight   used as a guide to dosage, could result in an overdosage in the obese;   . renal insufficiency;   . cumulative dose more than 200 g;   . elderly;   . impaired visual acuity.   If any visual disturbance occurs (visual acuity, color vision...), the drug should be   immediately discontinued and the patient closely observed for possible progression   of the abnormailty. Retinal changes (and visual disturbances) may progress even after   cessation of the therapy.   - Observe cautiously in patients with hepatic or renal disease, in whom a reduction in   dosage may be necessary, as well as in those taking medicines known to affect these organs.   - Observe cautiously also in patients with gastrointestinal, neurological, or blood disorders,   in those with a sensitivity to quinine, and in glucose-6-phosphate dehydrogenase deficiency,   porphyry and psoriasis.   - Patients on long-term therapy should have periodic full blood counts, and hydroxychloroquine   should be discontinued if abnormalities develop.   - Younger children are particularly sensitive to the toxic effects of 4-aminoquinolines, therefore   patients should be warned to keep hydroxychloroquine out of reach of children.   - All patients on long-term therapy should undergo periodic examination of skeletal muscle function   and tendon reflexes. If weakness occurs, the drug should be withdrawn.   - Malaria:   Hydroxychloroquine is not effective against chloroquine-resistant strains of P.falciparum and   is not active against the exo-erythrocytic forms of P.vivax, P.ovale and P.malariae and therefore   with neither prevent infection due to these organisms when given prophylactically, nor prevent   relpase of infection due to these organisms. * Pregnancy and lactation:   - Hydroxychloroquine crosses the placenta. Data are limited regarding the use of hydroxychloroquine   during pregnancy. It should be noted that 4-aminoquinolines in therapeutic doses have been   associated with central nervous system damage, including ototoxicity (auditory and vestibular   toxicity, congenital deafness), retinal hemorrhages and abnormal retinal pigmentation.   Hydroxychloroquine should be avoided in pregnancy except when, in the judgment of   the physician, the potential benefits outweigh the potential hazards.   - Careful consideration should be given to using hydroxychloroquine during lactation, since it has   been shown to be excreted in small amounts in human breast milk and it is known that infants   are extremely sensitive to the toxic effects of 4-aminoquinolines. * Effects on ability to drive and use machines:   Patients should be warned about driving and operating machinery since hydroxychloroquine   can impair accommodation and cause blurring of vision. If the condition is not self-limiting, dosage   may need to be temporarily reduced. * Store below 25 degrees C. * Old Product: Manufactured by: Sanofi-Synthelabo Ltd. - UK. Imported by: RAMCO.   New Product: Produced by: sanofi-aventis s.a.e. - Egypt. Under Licence of: sanofi-aventis - UK. * Code of Old Product: 3582910007449