(and dosage form):
Each capsule contains:
50 mg d-Norpseudoephedrine Hydrochloride in a slow release form.
A 11.3 (Medicines acting on the gastro-intestinal tract) Anorexigenics.
d-Norpseudoephedrine HCl is used as an anorectic agent. It aids in mass reduction by assisting in making the lower kilojoule - intake diet more tolerable by its appetite suppressant action. It is a sympathomimetic compound. It has central activity as is the case with other phenylalkylamines.
Eetless capsules should only be used on a short-term basis as an aid to mass reduction. A corrective, well-balanced reduced kilojoule diet is essential for long-term mass control.
An aid to mass reduction together with a reduced kilojoule intake.
The use of Eetless capsules is contra-indicated in pregnancy. Eetless capsules should not be taken by patients being treated with monoamine oxidase inhibitors or within 2 weeks of stopping such treatment.
DOSAGE AND DIRECTIONS FOR USE:
Swallow one capsule (whole) daily after breakfast with a little water. The capsules must not be chewed or crushed.
Eetless capsules should not be used for more than 4 weeks at a time.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
In large doses giddiness, headache, nausea, vomiting, sweating, dryness of the mouth and thirst, tachycardia, precordial pain, palpitation, difficulty in micturition, muscular weakness and tremors, anxiety, restlessness and insomnia may occur.
Some patients may exhibit these symptoms with the therapeutic dose. These agents may produce psychotic reactions, agitation and excitability. They should be used with caution in patients with history of psychiatric illness. Prolonged administration has no cumulative effect but tolerance with dependence has been reported.
Use with caution in patients receiving chloroform, cyclopropane, halothane or other halogenated anaesthetics.
d-Norpseudoephedrine may diminish the effects of guanethidine and may increase the possibility of arrythmias in digitalised patients. d-Norpseudoephedrine should be taken with caution by patients with organic heart disease, cardiac decompensation or angina of effort in patients receiving digitalis.
The effects of d-Norpseudoephedrine may be diminished or enhanced by tricyclic anti-depressants.
In patients with prostatic enlargement, it may increase difficulty with micturition.
The preparation should not be taken late in the afternoon because of its stimulant effect on the central nervous system.
These agents are liable to be abused. They should be used with extreme caution in patients with a history of drug or alcohol abuse and in patients with personality disorders. There is a lack of evidence for efficacy in the long-term management of obesity.
Systolic and diastolic blood pressure may be increased, especially with high doses and anginal pain or cardiac arrhythmia's may occur.
These agents should be administered cautiously to patients suffering from cardiovascular disease (especially coronary insufficiency), hypertension, thyrotoxicosis and narrow angle glaucoma.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Insomnia, paranoid psychosis, delusions, hallucinations, precordial pain, tachycardia. Treatment of overdosage is symptomatic. In case of severe toxicity the stomach should be emptied by aspiration and lavage.
Red and yellow transparent capsules containing white-grey to light yellow pellets.
Blister packs 5, 12, 24, 36 and 48 capsules.
Store below 25°C and protect from light. KEEP OUT OF REACH OF CHILDREN
NAME AND BUSINESS ADDRESS OF APPLICANT:
Adcock Ingram Limited
17 Harrison Avenue
Bryanston Ext. 77
Private Bag X69
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
New addition to this site: April 2004
Source: Pharmaceutical Industry
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