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

Logo PHENORANT WITH CODEINE (SYRUP)

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

PHENORANT WITH CODEINE (SYRUP)

COMPOSITION:
Each 5 mL contains:
Codeine Phosphate 8.33 mg
Diphenhydramine Hydrochloride 13.33 mg
Ammonium Chloride 130 mg
Sodium Citrate 54.166 mg
Preservative:
  Nipastat 0.5 mg

PHARMACOLOGICAL CLASSIFICATION:
A.10.1 Antitussives and expectorants.
(Prevents/reduces coughing and medicines that promote coughing and expulsion of mucous).

PHARMACOLOGICAL ACTION:
Acts as a cough suppressant, as an expectorant in the relief of cough, aids in drying up excess mucous secretions.

INDICATIONS:
Relief of coughs.

CONTRA-INDICATIONS:
Sensitivity to the components. Patients with impaired renal or hepatic function.
Patients with respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion, after operations on the biliary tract, acute alcoholism, head injuries and conditions in which intracranial pressure is raised. It should not be given during an attack of bronchial asthma or in heart failure secondary to chronic lung disease.

WARNING:
The use of this medicine may lead to drowsiness and impaired concentration, which may be aggravated by the simultaneous intake of alcohol or other central nervous system depressant agents. Patients should be warned against performing potentially hazardous tasks where loss of concentration may lead to accidents. Exceeding the prescribed dose, together with prolonged and continuous use of this medication may lead to dependency and addiction.

DOSAGE AND DIRECTIONS FOR USE:
Every four hours.
Adults: One to two 5 mL medicine measures.
Children 6-12 years: One 5 mL medicine measure.
Children 1-6 years: Half a 5 mL medicine measure.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Codeine may cause vomiting, constipation, drowsiness, confusion, dry mouth, sweating, facial flushing, vertigo, bradycardia, palpitations, orthostatic hypotension, hypothermia, restlessness, changes of mood and miosis. Micturition may be difficult and there may be ureteric or biliary spasm. Raised intracranial pressure may occur.
Codeine should be given with caution to patients with hypothyroidism, adrenocortical insufficiency, impaired liver function, prostatic hypertrophy or shock. It should be used with caution in patients with inflammatory or obstructive bowel disorders. The dosage should be reduced in elderly and debilitated patients.
The depressant effects of codeine are enhanced by depressants of the central nervous system such as alcohol, anaesthetics, hypnotics and sedatives, and phenothiazines. Larger doses produce respiratory depression and hypotension, with circulatory failure and deepening coma. Convulsions may occur in children.
Prolonged use of high doses of codeine has produced dependence of the morphine type. Diphenhydramine HCL may give rise to the following side-effects: sedation, varying 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.
Diphenhydramine HCL may also cause headache, blurred vision, tinnitus, elation or depression, irritability, nightmares, anorexia, difficulty in micturition, dryness of the mouth, tightness of the chest and tingling, heaviness and weakness of the hands. Symptoms of cerebral stimulation may arise in some adults and they include insomnia, nervousness, tachycardia, tremors, muscle twitching and convulsions.
Large doses of diphenhydramine HCL may precipitate fits in epileptics.
Diphenhydramine HCL may enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers. It should be used with care in conditions which can be exacerbated or otherwise adversely affected by atropine, such as glaucoma and prostatic hypertrophy. The effects of anticholinergic drugs such as atropine and tricyclic antidepressants may be enhanced by concomitant administration.
Ammonium chloride –large doses may cause nausea, vomiting, thirst, headache, hyperventilation, and progressive drowsiness, and lead to profound acidosis and hypokalaemia.
Sodium citrate –hypernatraemia may occur and the symptoms include restlessness, weakness, thirst, reduced salivation and tear production, swollen tongue, flushing of the skin, pyrexia, dizziness, headache, oliguria, hypotension, tachycardia, delirium, hyperpnoea and respiratory arrest.
Sodium citrate should be used cautiously in patients with cardiac failure, hypertension, impaired renal function, peripheral and pulmonary oedema, and in toxaemia of pregnancy.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms as under side-effects. In addition, symptoms of codeine overdosage are the development of coma, respiratory depression, cyanosis and hypotension together with pin-point non-reactive pupils.
Symptoms of overdosage in infants and children may include convulsions and hyperpyrexia.
Treatment is supportive and symptomatic.

IDENTIFICATION:
A clear brown sweet syrupy liquid.

PRESENTATION:
Bottles with 100 mL and 200 mL
HDPE Polycans with 2,5 L

STORAGE INSTRUCTIONS:
Store in a cool place below 25ºC, protect from light.
KEEP OUT OF REACH OF CHILDREN.

REFERENCE NUMBER:
G 1053 (Act 101 of 1965)

NAME AND BUSINESS ADDRESS OF APPLICANT:
GULF DRUG COMPANY
22 BURNSIDE DRIVE
OLD MILL INDUSTRIAL PARK
MOUNT EDGECOMBE
4300

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
16 March 1992

New addition to this site: July 2010
Source: Pharmaceutical Industry

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