PLAQUENIL 200 MG 60 TAB

* 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 abnormality. 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.

* Produced by: sanofi-aventis s.a.e. – Egypt. Under Licence of: sanofi-aventis – UK.