(and dosage form):
Each 5 mL contains:
|| 30 mg|
|| 0,12% m/v|
|| 0,02% m/v|
A 5.8 Preparations for the Common Cold, including Nasal Decongestants and Antihistaminics.
Pseudoephedrine hydrochloride has decongestant properties.
For symptomatic relief of nasal, sinus, eustachian tube mucosal congestion.
In persons under treatment with monoamine oxidase inhibitors, or within two weeks of stopping treatment. Thyrotoxicosis. Safety in pregnancy and lactation has not been established.
DOSAGE AND DIRECTIONS FOR USE:
May be given two or three times daily.
Adults and children over 12 years: 10 mL
Children 6 to 12 years: 5 mL
Children 2 to 5 years: 2,5 mL
Children 6 months to 24 months: 1,25 mL three times daily on advice of physician only.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Fixed drug eruption due to pseudoephedrine has been reported.
Pseudoephedrine may give rise to side-effects such as giddiness, headache, nausea, vomiting, sweating, thirst, tachycardia, precordial pain, palpitations, difficulty in micturition, muscular weakness and tremors, anxiety, restlessness and insomnia.
Pseudoephedrine may cause hypertension resulting in intracranial haemorrhage.
Other side-effects include: agitation, anginal pain, especially in patients suffering from angina pectoris, loss of appetite, reflex bradycardia, cardiac arrhythmias, cardiac arrest, confusion, dizziness, dyspnoea, fainting, fear, flushing, disturbances of glucose metabolism, irritability, miosis, dry mouth, psychotic states and weakness.
Pseudoephedrine should be given with caution to patients with organic heart disease, cardiac decompensation or angina of effort and in patients receiving digitalis.
In patients with prostatic enlargement, it may increase difficulty with micturition.
ADCO-SUFEDRIN SYRUP should be used with caution in patients with diabetes mellitus, closed-angle glaucoma or occlusive vascular disorders (arteriosclerosis).
ADCO-SUFEDRIN SYRUP should also be used with care in hyper- susceptible individuals.
Pseudoephedrine should be used with caution in patients receiving chloroform, cyclopropane, halothane, or other halogenated anaesthetics. The effects of pseudoephedrine are diminished by guanethidine, reserpine and probably methyldopa and may be diminished or enhanced by antidepressants. It may also diminish the effects of guanethidine and may increase the possibility of arrythmias in digitalised patients. Concomitant use of ADCO-SUFEDRIN SYRUP with sympathomimetic agents, such as decongestants, appetite suppressants and amphetamine-like psycostimulants, or with monoamine oxidase inhibitors which interfere with the catabolism of sympathomimetic amines, may cause a rise in blood pressure.
ADCO-SUFEDRIN SYRUP may partially reverse the hypotensive action of drugs which interfere with sympathethic activity including bretylium, bethanidine, guanethidine, debrisoquine, methyldopa and beta adrenergic blocking agents.
ADCO-SUFEDRIN SYRUP should not be given together with tricyclic anti-depressants, cardiac glycosides and quinidine.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The symptoms may include irritability, convulsions, palpitations, hypertension, difficulty with micturition, and paranoid psychosis. Treatment is symptomatic and supportive.
Red raspberry-flavoured, clear syrup.
Amber glass bottles of 100 mL, 200 mL and 500 mL.
Store below 25°C. Protect from light. KEEP OUT OF REACH OF CHILDREN.
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:
29 January 1993
New addition to this site: April 2004
Source: Pharmaceutical Industry
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