(and dosage form):
Each tablet contains 0,25 mg Reserpine.
A 2.6.2 Rauwolfia: Alkaloids and combinations.
Reserpine acts centrally to produce characteristic sedation and tranquillisation; it also produces a generalised increase in parasympathetic activity and a depression of responses to peripheral adrenergic nerve activity. It causes a slowly developing fall in blood pressure, associated with bradycardia, which appears to involve both increased vagal and decreased sympathetic effects. Patients with chronic mental illness treated with reserpine become relaxed, sociable, and co-operative.
Reserpine is recommended for the treatment of hypertension, mild anxiety states and chronic psychoses. In severe hypertension or long established cases of hypertension, reserpine may be used together with more potent hypertensives (allowing them to be used in smaller doses) and in which case, the reserpine enhances the reaction to bring about the desired relief within a short time. Reserpine has a calming effect in chronic psychoses involving anxiety, psychomotor hyperactivity or aggressive behaviour. Patients vary in their response to reserpine and dosage must be adjusted to individual requirements.
Reserpine should not be administered to patients with pre-existing evidence of depression, and should be discontinued if symptoms or signs suggestive thereof develop.
DOSAGE AND DIRECTIONS FOR USE:
In psychiatric states:
4 to 20 tablets daily in divided doses.
In the treatment of hypertension :
½ to 2 tablets daily.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects commonly occurring include nasal congestion, lethargy, drowsiness, gastro-intestinal upsets, diarrhoea and vertigo; weight increase is sometimes experienced. Sodium and water retention is sometimes induced and can progress to congestive heart failure. Caution should also be exercised in debilitated patients and in the presence of peptic ulcer, ulcerative colitis, cardiac arrhythmia, cardiac infarction or severe cardiac damage, or of bronchitis or asthma.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Flushing, insomnia, bradycardia, severe mental depression and Parkinson like syndrome. Respiration may be affected, with death ultimately resulting from central respiratory depression.
If the patient is not in a coma, emesis should be induced or the stomach emptied by aspiration and lavage. Atropine sulphate may be used to relieve parasympathomimetic side-effects such as nasal congestion. Signs of motor dysfunction e.g. tremors, stiffness may be treated with benzhexol or other anti-Parkinsonism agents. Respiration may have to be assisted.
CONDITIONS OF REGISTRATION:
May be advertised to the professions only.
White bisected biconvex tablets.
Packs of 100, 500, 1000 and 5000 tablets.
Store below 25°C.
Protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN.
B886 (Act 101/1965).
NAME AND BUSINESS ADDRESS OF APPLICANT:
7 Fairclough Road
PORT ELIZABETH 6001
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
A & S PRINTERS
Updated on this site: October 2001
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