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Logo ADIFAX 15 mg (withdrawn)

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

ADIFAX 15 mg (withdrawn)

COMPOSITION:
Each ADIFAX 15 mg capsule contains 15 mg
dexfenfluramine hydrochloride.

PHARMACOLOGICAL CLASSIFICATION:
A 11.3.2. Anorexogenics

PHARMACOLOGICAL ACTION:
In obesity with abnormal alimentary behaviour (carbohydrate craving), dexfenfluramine selectively inhibits the consumption of carbohydrates and thereby decreases the total kilojoule consumption, whilst not interfering with the ingestion of proteins.
Absorption of dexfenfluramine is virtually complete following oral administration. Peak plasma concentration is achieved 3 - 5 hours after administration.

With repeated administration of the therapeutic dose of one capsule morning and evening, steady state is attained after about 4 - 8 days and remains stable at the mean concentration of 40 - 45 ng/ mL.

Plasma protein binding is low (36%).

The compound is markedly metabolised with the formation of d-norfenfluramine, which participates in the overall activity of the compound. No amphetamine derivatives have been demonstrated. Plasma clearance is 45 litres per hour.

Elimination is virtually exclusively urinary, more than 90% of the dose being recovered in 7 days via this route.

Elimination half-life is approximately 18 hours.

INDICATIONS:
As an adjunct to diet in the treatment of obesity.

CONTRA-INDICATIONS:
Glaucoma, history of anorexia nervosa, history of depression, history of psychiatric disease, propensity to drug abuse, proven alcoholism.

Safety in pregnancy has not been established and treatment with Adifax should be avoided.

Safety in children has not been established.

Use during lactation: dexfenfluramine may be excreted in breast milk and administration of Adifax during lactation is therefore not recommended.

Use in the elderly is not recommended due to slower metabolism in the elderly.

Because of the serotonergic mechanism of action of dexfenfluramine, combination with MAOI is contraindicated (a washout period of at least two weeks must be allowed to elapse).

In the absence of any specific study in patients suffering from hepatic or renal insufficiency, administration of this compound should be avoided in such patients.

WARNING:
The use of this medication may lead to drowsiness and impaired concentration which may be aggravated by simultaneous intake of alcohol or other central nervous system depressants.
It is advisable that patients should refrain from hazardous activities e.g. driving a motor vehicle or operating machinery where loss of concentration could lead to an accident, until individualised reaction to Adifax is known.

Cases of pulmonary hypertension have been reported with dexfenfluramine. Symptomatology is indistinguishable from primary pulmonary hypertension.

DOSAGE AND DIRECTIONS FOR USE:
Two capsules per day in two divided doses, i.e. one capsule in the morning and one capsule in the evening, preferably during meals.
The duration of treatment should not exceed three months.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects
Those described most frequently are: dryness of the mouth, nausea, constipation, diarrhoea. These effects decrease with the discontinuation of treatment.
The following have been reported less frequently: sedation, drowsiness, dizziness, urinary frequency, headache, fatigue, mood disturbance, impaired concentration, reactive depression, insomnia, nervousness, conjunctivitis, stomach pain, itching.

Special precautions
Organic causes of obesity must be eliminated before prescription of this medicine. Use cautiously in individuals with arrhythmias.

Exertion dyspnoea, syncope, chest pain, palpitations and signs of cardiac insufficiency constitute prodromal symptoms of pulmonary hypertension, patients should be informed that if such symptoms occur, they should discontinue treatment immediately and seek medical attention.

Drug interactions
This product should not be prescribed in combination with another centrally acting appetite suppressant, nor an MAOI (see Contra-indications).
This compound may potentiate:
-        Medicines with depressant effects on the central nervous system (sedatives)
-        antihypertensive agents
-        the hypotensive effects of tricyclic antidepressants
-        hypoglycaemic sulfonylureas.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Few data are available concerning accidental overdose.
Emergency treatment includes:
-        gastric wash-out
-        forced diuresis with acidification of urine to accelerate excretion of the drug
-        intensive therapy with cardiac monitoring in the most severe cases.
In contrast to sympathomimetic appetite suppressants, routine administration of barbiturates is nor systematically required.

IDENTIFICATION:
Opaque white capsules marked "S5614"

PRESENTATION:
Carton of 60 capsules (containing two push-through blister strips of 30 capsules).

STORAGE INSTRUCTIONS:
Below 25°C in a dry place
Keep out of reach of children.

REGISTRATION NUMBER:
Z/11.3.2/60

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
SERVIER LABORATORIES (S.A.)(PTY) LTD.
1st Floor, Rivonia Gate,
Cnr. Rivonia Road/ 12th Avenue, Rivonia, Transvaal.
PO Box 930, RIVONIA 2128

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
January 1992

850/3/93
CTP ARTONE

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