INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo BAN PAIN TABLETS

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

BAN PAIN TABLETS

COMPOSITION:
Each tablet contains:
Paracetamol 320 mg
Codeine Phosphate 8 mg
Caffeine Anhydrous 32 mg
Meprobamate 150 mg
Nipastat 0,025% m/m (perservative)
Contains TARTRAZINE 
PHARMACOLOGICAL CLASSIFICATION:
A2.8 Analgesic combinations.

PHARMACOLOGICAL ACTION:
BAN PAIN tablets have analgesic and skeletal muscle relaxing properties.

INDICATIONS:
Pain and pain associated with tension.

CONTRA INDICATIONS:
Hypersensitivity to any of the ingredients. It should not be administered to patients with acute intermittent porphyria. Patients with renal or hepatic insufficiency. Use of BAN PAIN during pregnancy should be avoided. Asthma, respiratory depression especially in the presence of cyanosis and excessive bronchial secretion, head injuries and conditions in which intracranial pressure is raised, heart failure secondary to chronic lung disease, a history of cardiac disease, epilepsy, and all convulsion states, patients taking monoamine oxidase inhibitors or within 14 days of stopping such treatment, acute alcoholism.

WARNINGS:
The use of this medicine leads to drowsiness which is aggravated by the simultaneous intake of alcohol and it is dangerous to drive a vehicle or be in charge of machinery while on treatment with this product. Paracetamol adminisration in excess of the recommended dosage may cause severe liver damage. BAN PAIN tablets contain Tartrazine which may cause allergic-type reactions including bronchial asthma in certain individuals. The over-all incidence of tartrazine sensitivity is low. It is however, frequently seen in patients who also have aspirin sensitivity.

DOSAGE AND DIRECTIONS FOR USE:
Not recommended for children under the age of 12 years
ADULTS: Two tablets every 6 to 8 hours.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Paracetamol may cause sensitivity reactions resulting in reversible skin rash or blood disorders. Meprobamate may cause drowsiness, nausea, vomiting, diarrhoea, paraesthesia, weakness and central effects such as headache, paradoxical excitement, dizziness, ataxia and disturbances of vision. It may cause hypotension, tachycardia and cardiac arrhythmias. Hypersensitivity reactions such as skin rashes, urticaria, purpura, angioedema, bronchospasm or anuria may occur. Erythema multiforme and exfoliative or bullous dermatitis may occur. Blood disorders such as agranulocytosis, eosinophilia, leucopenia, thrombocytopenia and aplastic anaemia may occur.
Symptoms of porphyria may be exacerbated. Due to the dependence potential, meprobamate should be gradually withdrawn after longterm treatment.
Codeine may cause respiratory depression, bradycardia, circulatory failure, hypotension, orthostatic hypotension, palpitations, deepening coma, confusion, drowsiness, euphoria, mood changes, restlessness, vertigo, flushing, hypothermia, increased intracranial pressure, miosis, dry mouth, muscle rigidity, nausea, vomiting, constipation, pruritus, urticaria, sweating, urinary retention, uteric and biliary spasm, and an antidiuretic effect.
Codeine should be used with caution or in reduced doses in patients with adrenocortical insufficiency. Should be used with caution in patients with obstructive bowel disorders. Dosage should be reduced in debilitated and in elderly patients. Should be used with caution or reduced doses in patients with hypothyroidism. Should be used with caution in patients with liver impairment, myasthenia gravis, prostatic hypertrophy, impaired renal function or shock.
Prolonged use of high doses of codeine may lead to dependence. Caffeine should be taken with care by patients with a history of peptic ulceration or hyperacidity. With prolonged use some degree of tolerance and psychic dependence may occur.
Caffiene may cause headaches, nausea, insomnia, restlessness, excitement and muscle tremor. Meprobamate may lower the tolerance to alcohol and other central nervous system depressants. Meprobamate may enhance the metabolism of oral contraceptives, corticosteroids, phenytoin, phenothiazines and tricyclic antidepressants.

INTERACTION OF CODEINE:
May affect the activity of other medicines by delaying their absorption. The depressant effects are aggravated by alcohol, anaesthetics, hypnotics, sedatives, tricyclic antidepressants and phenothiazines

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms of overdosage include the following: nausea, vomiting, restlessness, sensory disturbances, muscle tremor, diuresis, palpitations, stupor, shock, central stimulation with exhilaration, convulsions, drowsiness, respiratory depression, hypotension with circulatory failure, respiratory collapse, cyanosis and coma. Liver damage which may be fatal may only appear after a few days. Kidney failure has been described following acute intoxication. In the event of overdosage, consult your doctor or take the patient to the nearest hospital immediately. Specialized treatment is essential as soon as possible. The latest information regarding the treatment of overdosage can be obtained from the nearest poison centre.
Treatment is symptomatic and supportive.

IDENTIFICATION:
Green, round, flat tablet, bisected.

PRESENTATION:
Package in push-through blister packs of 10 tablets in containers of 20 and 100 tablets and bottles of 500 and 1000 tablets.

STORAGE DIRECTIONS:
Store below 25°C. Protect from strong light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
Y/2.8/51

NAME AND BUSINESS ADDRESS OF APPLICANT:
BROVAR S & P (PTY) LTD
24 DOGAR STREET
DELVILLE EXT 1
GERMISTON
1401

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
23/11/1990

BPT PI/01
Britepak

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996,1997,1998