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Logo PHYLLOCONTIN Tablets (Slow release)

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

PHYLLOCONTIN Tablets (Slow release)

COMPOSITION:
Each tablet contains:
225 mg
Aminophylline hydrate in a slow-release formulation.

PHARMACOLOGICAL CLASSIFICATION:
A 10.2 Bronchodilators.

PHARMACOLOGICAL ACTION:
PHYLLOCONTIN tablets possess a slow release mechanism, in which Aminophylline is released to give an effective therapeutic blood level, lasting up to 12 hours.
Aminophylline is the soluble salt of theophylline and ethylenediamine, and therefore produces various effects throughout the body associated with its ability to relax smooth muscle.

INDICATIONS:
For the treatment and prophylaxis of bronchospasm associated with asthma, emphysema and chronic bronchitis.

CONTRA-INDICATIONS:
Contra-indicated in acute myocardial infarction and in patients hypersensitive to aminophylline or other xanthine derivatives.

WARNINGS:
Patients undergoing routine haemodialysis may require increased doses. Care should be taken in patients with a history of peptic ulceration. In elderly patients or patients with impaired hepatic or renal function and congestive heart failure, the dosage must be reduced by about a third. Safety in pregnancy has not been established.

DOSAGE AND DIRECTIONS FOR USE:
The initial recommended adult dose is 1 tablet twice a day, taken morning and evening. This dosage may be increased to a maximum of 2 tablets twice a day depending on the patient's response. For night-long prophylaxis of bronchospasm, the dosage is 1 tablet on retiring to bed, increasing to 2 PHYLLOCONTIN tablets as required.
N.B. Tablets should be swallowed whole and not chewed because of the structure of the tablet. For optimum therapeutic benefit the dosage should be titrated to maintain serum levels of theophylline between 10 and 20 micrograms/mL.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects associated with Aminophylline are nausea, vomiting, gastric irritation, headache and Central nervous system stimulation. Slow release products take proportionally longer to achieve stable blood levels.
Other side effects include gastro-intestinal bleeding, insomnia, anxiety, confusion, restlessness, hyperventilation, vertigo, palpitations, diarrhoea, diuresis, anorexia, tremor and reduced exercising ability. Aminophylline should be administered with caution to elderly patients and those suffering from cardiac and liver diseases.
The bronchodilation and toxic effects of aminophylline may be enhanced by sympathomimetics and by administration of other xanthines.
The plasma theophylline concentration may be increased in patients receiving cimetidine, rifampicin, macrolide antibiotics, allopurinol and propranolol.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Toxic effects of overdosage are frequent vomiting, anorexia, unusual thirst and maniacal agitation leading in the severest cases to convulsions, shock and death. Treatment is symptomatic and supportive.

IDENTIFICATION:
Pale yellow filmcoated tablet. The NAPP logo is marked on the one side, and SA on the other.

PRESENTATION:
Securitainers of 60 tablets.

STORAGE DIRECTIONS:
Store in a cool place (below 25°C) protected from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
J/10.2/127

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
PHARMAFRICA (PTY) LTD.
Reg. No. 93/03911/07
33 HULBERT ROAD, NEW CENTRE, JOHANNESBURG 2001

UNDER LICENCE FROM:
Mundipharma AG Switzerland.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
5 December 1980

Updated on this site: October 2001

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