PHARMACOLOGICAL CLASSIFICATION A 11.3 Anorexigenics
PHARMACOLOGICAL ACTION REDUPON's active ingredients provide an adjuvant treatment of obesity by means of daytime and early evening suppression of appetite. It provides a two-phase release action that lasts from noon to early evening and thereby simplifies the patient's dosage schedule.
INDICATIONS An aid to mass reduction together with a reduced kilojoule intake.
CONTRA-INDICATIONS Contra-indicated in patients with known hypersensitivity to any of the active ingredients.
It should not be used in patients anaesthetised with halogenated hydrocarbons, as these agents may sensitise the heart to the arrhythmic action of ephedrine hydrochloride.
Redupon should be used cautiously in patients with diabetes.
Contra-indicated in most types of cardiovascular disease, hypertension, hyperthyroidism, hyperexcitability, phaeochromocytoma and closed-angle glaucoma.
Contra-indicated in patients being treated with a monoamine oxidase inhibitor or within 14 days of stopping such treatment.
WARNINGS Ephedrine may cause hypertension resulting in intracranial haemorrhage. Ephedrine may induce anginal pain in patients with coronary insufficiency or ischaemic heart disease. The drug may also induce potentially fatal arrhythmias in patients with organic heart disease or who are receiving drugs that sensitise the myocardium.
DOSAGE AND DIRECTIONS FOR USE
First four days
one tablet per day
one or two tablets daily. The daily dosage to be taken an hour before lunch.
Please eat more vegetables and fresh fruit, and less fatty and starchy foods. Count your kilojoules - ask your pharmacist for a kilojoule chart. It is most important to eat only when hungry, and only as much as you really need. The reduction in mass will be gradual. Do not use for longer than four (4) weeks at any one time.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS Ephedrine hydrochloride may cause giddiness, headache, nausea, vomiting, sweating, thirst, tachycardia, precordial pain, palpitations, difficulty in micturition, muscular weakness and tremors, anxiety, restlessness and insomnia. In patients with prostatic enlargement, it may increase difficulty in micturition.
Tremor and acceleration of the heartbeat may be experienced. In such cases, treatment should be interrupted and recommenced with a reduced dosage - to start with: one tablet every second day for a week; thereafter reverting to the normal dosage as prescribed above. Interactions: Ephedrine should not be administered concomitantly with other sympathomimetic drugs because of possible additive effects and increased toxicity.
Alpha-adrenergic blocking may reduce the vasopressor response to ephedrine by causing vasodilation. Ephedrine may antagonise the neuron blockage produced by guanethidine, resulting in decreased antihypertensive effects and requiring increased dosage of the latter.
Ephedrine hydrochloride may increase the possibility of arrhythmias in digitalised patients. Pregnancy: Safety in pregnancy has not been established. Phenolphthalein: Acute allergy, Stevens-Johnson syndrome or symptoms of toxic epidermal necrosis, hypokalaemia or diarrhoea may occur. Caffeine: Nausea, headache and insomnia.
Large doses may cause restlessness, excitement, muscle tremor, tachycardia and increased gastric acid secretion.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT See "Side-effects and special precautions". Treatment is symptomatic and supportive.
IDENTIFICATION Pale green, coated tablets
PRESENTATION Tablets: 30', 60' and 100' in blister packs
STORAGE INSTRUCTIONS Store below 25°C in a dry place.
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER C/11.3.2/758
NAME AND BUSINESS ADDRESS OF THE APPLICANT NORISTAN LIMITED 326 MARKS STREET, WALTLOO, PRETORIA
DATE OF PUBLICATION OF THIS PACKAGE INSERT 25 February 1974
NORISTAN SELFMED Division of NORISTAN LIMITED, WALTLOO, PRETORIA