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

Logo THEOPHEN COMPOUND ELIXIR

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

THEOPHEN COMPOUND ELIXIR

COMPOSITION:
Each 15 mL of elixir contains:
       
Theophylline        50,00 mg
        b-
Hydroxyethyl Theophylline        5,00 mg
       
Diphenylpyraline Hydrochloride        4,00 mg
       
Ammonium Chloride        360,00 mg
        Alcohol        20,00 %v/v

Preservative:
        Nipasept        0,04 %m/v

PHARMACOLOGICAL CLASSIFICATION:
A 10.1 Antitussives and Expectorants.

INDICATIONS:
For the alleviation of cough.

CONTRA-INDICATIONS:
Impaired hepatic or renal function, peptic ulcer, known hypersensitivity to antihistamines. Acute attacks of asthma. Safety in pregnancy and lactation has not been established.

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 not to drive a motor vehicle, operate dangerous machinery or climb dangerous heights, as impaired decision-making could lead to accidents.
KEEP OUT OF REACH OF CHILDREN.

DOSAGE AND DIRECTIONS FOR USE:
Adults and children over 12 years of age:
        Three medicine measures (15 mL) three times daily after meals.

Children from 6 - 12 years:
        Two medicine measures (10 mL) three times daily after meals.

Children from 1 - 5 years:
        One medicine measure (5 mL) three times daily after meals.

Above recommendations are averages. Dosage should be individualised.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Gastro-intestinal disturbances may occur.

Theophylline may cause nausea, vomiting, abdominal pain, gastro-intestinal bleeding, visual disorders, insomnia, headache, anxiety, confusion, restlessness, hyperventilation, vertigo and palpitations. It should be administered with caution to patients suffering from cardiac disease. The bronchodilator and toxic effects may be enhanced by sympathomimetics and by administration with other xanthines. Diphenylpyraline Hydrochloride which is an antihistamine may cause sedation, headache, blurred vision, tinnitus, elation or depression, irritability, nightmares, anorexia, difficulty in micturition, dryness of mouth, tightness of chest and tingling, heaviness and weakness of the hands. Anaphylaxis and allergy to the antihistamine and blood dyscrasias, have been reported. Paradoxical central nervous system stimulation may occur, especially in children, with insomnia, nervousness, tachycardia, tremors and convulsions. Epileptiform seizures may be precipitated in patients with focal lesions of the cerebral cortex.

Other side-effects include gastro-intestinal disturbances such as nausea, vomiting, diarrhoea or constipation, anorexia or increased appetite, and epigastric pain.

Theophylline should be given with caution to patients with hyperthyroidism, hypertension, cardiac arrhythmias or other cardiovascular disease as these conditions may be exacerbated. Should also be given with caution to patients with congestive heart failure, hepatic dysfunction or chronic alcoholism, acute febrile illness, severe hypoxia, cor pulmonale, acute pulmonary oedema, or other chronic lung disease, and to the elderly, since in all these circumstances Theophylline clearance may be decreased, resulting in increases in serum-theophylline concentrations and serum half-life. The bronchodilator and toxic effects of Theophylline and sympathomimetics or other xanthines are additive.

Diphenylpyraline Hydrochloride has antimuscarinic properties, and should be used with care in conditions such as narrow angle glaucoma, urinary retention and prostatic hypertrophy. Monoamine oxidase inhibitors may enhance the antimuscarinic effects of Diphenylpyraline Hydrochloride.

Sedation caused by CNS depressants, e.g. alcohol, barbiturates, hypnotics, narcotics, narcotic analgesics, sedatives and tranquillizers, taken concomitantly, may be enhanced by Diphenylpyraline Hydrochloride. The effect of anticholinergic drugs, e.g. atropine and tricyclic antidepressants, may also be enhanced.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Theophylline:
Severe overdosage or idiosyncrasy may lead to maniacal behaviour, diuresis and repeated vomiting with extreme thirst, tremor, delirium, hyperthermia, tachycardia, tachypnoea, electrolyte disturbances, convulsions, and death. Convulsions may not be preceded by milder symptoms of toxicity.

Diphenylpryraline Hydrochloride:
Overdosage may be fatal especially in infants and children in whom the main symptoms are CNS stimulation and antimuscarinic effects, including ataxia, excitement, hallucinations, muscle tremor, convulsions, dilated pupils, dry mouth, flushed face and hyperpyrexia. Deepening coma, cardiorespiratory collapse, and death may occur within 18 hours.

In adults, the usual symptoms are CNS depression with drowsiness, coma, and convulsions. Hypotension may also occur.

Ammonium Chloride:
Overdosage may cause nausea, vomiting, thirst, headache, hyperventilation, progressive drowsiness, mental confusion, hyperchloraemic acidosis and hypokalaemia.

TREATMENT:
Treatment is symptomatic and supportive.

IDENTIFICATION:
A dark brown syrupy liquid with a fruity flavour and a tangy aftertaste.

PRESENTATION:
Bottles of 100 mL and 200 mL.

STORAGE INSTRUCTIONS:
Store below 25 °C.
Keep tightly closed and protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
N/10.1/98

NAME AND BUSINESS ADDRESS OF APPLICANT:
S.A.D. SELF MEDICATION [PTY] LIMITED
Co. Reg. No. 92/04769/07
Robbie de Lange Road, Wilsonia, EAST LONDON, 5201
P O Box 422, EAST LONDON, 5200

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
May 1981

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