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Logo ACTOPHLEM COUGH SYRUP

SCHEDULING STATUS:
S 2


PROPRIETARY NAME:
(and dosage form):

ACTOPHLEM COUGH SYRUP
Syrup

COMPOSITION:
Each 30 mL contains:
Theophylline 100 mg
Etofylline 10 mg
Diphenylpyraline hydrochloride 8 mg
Ammonium chloride 720 mg
Sodium citrate 300 mg
Alcohol 20% v/v
Chloroform 0,20% v/v

PHARMACOLOGICAL CLASSIFICATION:
A 10.1 Antitussives and expectorants

PHARMACOLOGICAL ACTION:
ACTOPHLEM COUGH SYRUP has bronchodilatory, antihistaminic and expectorant properties.

INDICATIONS:
ACTOPHLEM COUGH SYRUP is indicated for the alleviation of cough.

CONTRA-INDICATIONS:
ACTOPHLEM COUGH SYRUP is contra-indicated in diabetes, alcoholism (rehabilitated alcoholics), severe hypotension, peptic ulcer, gout, renal or hepatic disease and hypersensitivity to any of the active ingredients.

WARNINGS:
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 taking charge of vehicles or machinery or performing potentially hazardous tasks where loss of concentration may lead to accidents. The concomitant administration of other theophylline - containing preparations and Actophlem Cough Syrup may lead to toxic levels of theophylline and patients should be cautioned accordingly.

DOSAGE AND DIRECTIONS FOR USE:
Adults:                Three medicine measurefuls (15 mL) three times daily after meals and at bedtime.
Children (7 years and older): Two medicine measurefuls (10 mL) three times daily after meals.
Children (3 - 6 years): One medicine measureful (5 mL) three times daily after meals.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Theophylline may cause nausea, vomiting, gastro-intestinal bleeding, visual disorders, insomnia, headache, anxiety, confusion, restlessness, hyperventilation, vertigo and palpitations.
Children are particularly sensitive to the effects of theophylline and it should not be administered more frequently than every eight hours.
Theophylline should be administered with caution to elderly patients and those suffering from cardiac disease.
The bronchodilator and toxic effects of theophylline may be enhanced by sympathomimetics and by administration with other xanthines. Smokers may require increased doses as may patients undergoing routine haemodialysis.
The most common side-effect of diphenylpyraline hydrochloride is sedation which can vary from slight drowsiness to deep sleep, and includes the inability to concentrate, lassitude, dizziness, hypotension, muscular weakness and incoordination. Other side-effects include gastrointestinal disturbances such as nausea, vomiting, diarrhoea or constipation and epigastric pain.
Headache, 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 may occur.
In infants and children diphenylpyraline hydrochloride may act as a cerebral stimulant. Symptoms of stimulation in adults include insomnia, nervousness, tachycardia, tremors, muscle twitching and convulsions.
Diphenylpyraline hydrochloride may precipitate fits in epileptics. Allergy and anaphylaxis may occur. Blood dyscrasias including agranulocytosis and haemolytic anaemia may occur.
Diphenylpyraline hydrochloride has anticholinergic properties and should be used with care in conditions such as glaucoma and prostatic hypertrophy. The effects of atropine and tricyclic antidepressants may be enhanced.
The warning symptoms of damage caused by ototoxic drugs may be masked and the metabolism of drugs in the liver may be affected.
Diphenylpyraline hydrochloride may enhance the sedative effect of the central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Ammonium chloride causes symptoms such as nausea, vomiting, thirst, headache, hyperventilation, progressive drowsiness, hypokalaemia, mental confusion and hyperchloraemic acidosis.
Overdosage of theophylline or idiosyncrasy may lead to maniacal behaviour, repeated vomiting with extreme thirst, delirium, hyperthermia and convulsions. It is important to keep Actophlem Cough Syrupout of reach of young children. If a large overdose has just been taken, empty the stomach by gastric lavage. Treatment is symptomatic and supportive.

IDENTIFICATION:
ACTOPHLEM COUGH SYRUP is a yellowish brown syrup with a blackcurrant flavour.

PRESENTATION:
Bottles of 200 mL and 500 mL.

STORAGE INSTRUCTIONS:
Store below 25°C. Keep the bottle tightly closed, out of reach of children.

REGISTRATION NUMBER:
W/10.1/194

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
ADCOCK INGRAM LIMITED
Adcock Ingram Park
17 Harrison Avenue
Bryanston Ext 77
Private Bag X69
Bryanston 2021.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
4 November 1988

New addition to this site: March 2004
Source: Pharmaceutical Industry

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