BAN PAIN SYRUP

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

BAN PAIN SYRUP

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

BAN PAIN SYRUP

COMPOSITION:
Each 5 mL of syrup contains:

Paracetamol	120 mg
Codeine Phosphate	5 mg
Promethazine Hydrochloride	6,5 mg

Preserved with:

Methylparaben	0,10% m/v
Propylparaben	0,01% m/v
Alcohol content	12,5% v/v

PHARMACOLOGICAL CLASSIFICATION:
A.2.8 Analgesic combinations.

PHARMACOLOGICAL ACTION:
BAN PAIN syrup has analgesic, antipyretic and antihistaminic properties.

INDICATIONS:
For the relief of mild to moderate pain, associated with fever.

CONTRA-INDICATIONS:
Hypersensitivity to paracetamol, opiates or phenothiazines. During an attack of bronchial asthma, respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion, heart failure secondary to chronic lung disease, head injuries and where the intracranial pressure is raised, a history of cardiac disease, epilepsy and all convulsive conditions.
Premature infants and neonates, comatose patients.

WARNINGS:

1.	If no symptomatic improvement results, a doctor should be consulted.
2.	Do not use continuously for more than 10 days without consulting your doctor.
3.	The use of this medicine leads to drowsiness which is aggravated by the simultaneous intake of alcohol and other central nervous system depressants. Patients should be warned against performing potentially hazardous tasks, where impaired mental alertness may lead to accidents.
4.	Should be used with extreme caution in patients receiving monoamine-oxidase inhibitors.
5.	Pigments should be examined periodically for abnormal skin pigmentation or eye changes.

DOSAGE AND DIRECTIONS FOR USE:
Not recommended for children under 1 year of age

1 to 5 years:	5 mL three times a day.
6 years and older:	5-10 mL three times a day.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Constipation and sensitivity reactions resulting in skin rash or blood disorders may occur. Do not administer to patients with liver or kidney damage. If taken in excess, this medicine may cause liver damage which may be fatal.
Common side-effects of codeine include nausea, vomiting, constipation, drowsiness and confusion.
Dryness of the mouth, sweating, facial flushing, vertigo, bradycardia, palpitations, respiratory depressions, orthostatic hypotension, hypothermia, restlessness, changes of mood and miosis also occur. Difficulty in micturition, ureteric or billiary spasm and an anti-diuretic effect may also occur.
Raised intracranial pressure may occur. Due to the histamine releasing effect, reactions such as urticaria and pruritis may occur. Contact dermatitis and muscle rigidity has been reported.
Convulsions may occur in infants and children.
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 PATIENTS.
SHOULD BE USED WITH CAUTION OR IN REDUCED DOSES IN PATIENTS WITH HYPOTHYROIDISM. SHOULD BE USED WITH CAUTION IN PATIENTS WITH LIVER IMPAIRMENT, MYASTHENIA GRAVIS IMPAIRED RENAL FUNCTION OR SHOCK.
Prolonged use of high doses of codeine has produced dependence.
The most common side-effect of promethazine is sedation which can vary from slight drowsiness to deep sleep and including inability to concentrate, lassitude, dizziness, hypotension, muscular weakness and inco-ordination. Other side-effects include gastro-intestinal disturbances such as nausea, vomiting, diarrhoea or constipation and epigastric pain. Headache, tinnitus, elation or depression, irritability, nightmares, anorexia or increased appetite, difficulty in micturating, dryness of the mouth, tightness of the chest and tingling, heaviness and weakness of the hands may occur.
Photosensitivity reactions may occur. In infants and children it may act as a cerebral stimulant.
Symptoms of stimulation include insomnia, nervousness, tachycardia, tremors, muscle twitching and convulsions. Large doses may precipitate fits in epileptics. Allergic reactions and anaphylaxis may occur. Blood dyscrasias including agranulocytosis, leucopenia and haemolytic anaemia may occur. Extrapyramidal symptoms may develop.
Promethazine has anticholinergic properties and should be used with care in conditions such as glaucoma and prostatic hypertrophy. Care should be taken when administering promethazine during the first trimester of pregnancy. Promethazine should be used cautiously in patients with cardiac failure, hypertension, impaired renal function, hepatic disorders, peripheral and pulmonary oedema and in toxaemia of pregnancy. In young children spasm of the glottis may occur.
INTERACTIONS OF CODEINE:
The depressant effects of codeine are enhanced by depressants of the central nervous system such as alcohol, anaesthetics, hypnotics and sedatives, tricyclic antidepressants and phenothiazines. The gastrointestinal effects may delay absorption as with mexilitine or may be counteractive as with metoclopramide.
Promethazine may mask the warning symptoms of damage caused by ototoxic medicines and may affect the metabolism of other medicines in the liver. It may enhance the sedative effect of the central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers. Promethazine may enhance the anticholinergic effects of atropine and tricyclic antidepressants.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:

PARACETAMOL:	Symptoms of overdosage include nausea and vomiting. Kidney failure has been reported and liver damage which could be fatal may appear a few days later.
CODEINE:	Symptoms of overdosage include excitement, convulsions and respiratory failure.
PROMETHAZINE:	Overdosage may be fatal, especially in infants and children in whom main symptoms are central nervous system stimulation and antimuscarinic effects including ataxia, excitement, hallucinations, muscle tremor, convulsions, dilated pupils, dry mouth, flushed face and hyperexia and respiratory collapse.

Specialised treatment of overdosage is essential and the patients should be removed to a hospital as soon as possible. Treatment of overdosage is symptomatic and supportive.

IDENTIFICATION:
Mauve to maroon-coloured clear syrup with a distinctive flavour of blackcurrant.

PRESENTATION:
Amber plastic bottles containing 100 mL of syrup.

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

REGISTRATION NUMBER:
X/2.8/32

NAME AND BUSINESS ADDRESS OF APPLICANT:
BROVAR S & P (PTY) LTD
Montrose Place
2 Bella Rosa Street
Belville 7530

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

20/2/91

Code: BPS PI/00