(and dosage form):
Each Diffucaps capsule contains 50 mg d-norpseudoephedrine HCl in slow release form.
A 11.3 Anorexigenics
d-Norpseudoephedrine HCl is a sympathomimetic compound and is used as an anorectic agent in the treatment of excessive mass due to a positive energy balance. This implies central activity as is the case with other phenylalkylamines but differing in degree to that of the amphetamine group of compounds.
An aid to mass reduction when used in combination with a reduced kilojoule intake.
Must not be used in hypertension, coronary thrombosis, hyperthyroidism and closed-angled glaucoma. Dietene should not be taken by patients being treated with a monoamine oxidase inhibitor or within 2 weeks of stopping such treatment. Not to be taken during pregnancy.
DOSAGE AND DIRECTIONS FOR USE:
One capsule per day after breakfast with a little water. Do not chew. Many people take the main part of their nourishment in the form of midday and evening meals. Dietene should, therefore be taken with the ordinary or dietetic breakfast. It is important that the user should acquaint himself with good eating habits and refer to a reliable reducing diet as the product is intended to make it easier to adhere to a regimen leading to loss of mass. Dietene 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, thirst, tachycardia, precordial pain, palpitations, difficulty in micturition, muscular weakness and tremors, anxiety, restlessness and insomnia may occur. Some patients may exhibit these symptoms with the therapeutic dose.
Administer with caution in patients with organic heart disease, cardiac decompensation, or angina of effort and in patients receiving digitalis. In patients with prostatic enlargement, it may increase difficulty with micturition.
Due to its stimulant effects on the CNS it should not be taken after about 4 pm. Use with caution in patients receiving chloroform, cyclopropane, halothane or other halogenated anaesthetics.
d-Norspseudoephedrine HCl may diminish the effects of guanethidine any may increase the possibility of arrhythmias in digitalised patients. The effect of d-norpseudoephedrine HCl may be diminished or enhanced by tricyclic anti-depressants. Prolonged administration has no cumulative effect but tolerance with dependence has been reported.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms as under 'Side-effects' and may also include paranoid psychosis, delusions and hallucinations.
Clear capsule with green top containing cream plus white to off - white spherical microencapsulated granules.
Packs of 15 and 30 slow release capsules
Store in a cool, dry place (below 30°C), out of the reach of children
NAME AND BUSINESS ADDRESS OF APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue
Private Bag X69, Bryanston, 2021
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
New addition to this site: April 2004
Source: Pharmaceutical Industry
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