COMPOSITION: 60 mg Pseudoephedrine hydrochloride per tablet.
PHARMACOLOGICAL CLASSIFICATION: A 5.8 Preparations for the Common Cold, including Nasal Decongestants and Antihistamines
PHARMACOLOGICAL ACTION: Pseudoephedrine hydrochloride has decongestant properties.
INDICATIONS: For symptomatic relief of: Nasal, sinus and eustachian tube mucosal congestion.
ADCO-SUFEDRIN TABLETS are contra-indicated in persons under treatment with monoamine oxidase inhibitors, or within two weeks of stopping treatment. Contra-indicated in most types of cardiovascular diseases, hypertension, hyperthyroidism, hyperexcitability, phaechromocytoma and closed-angle glaucoma. Safety in pregnancy and lactation has not been established.
WARNINGS: It is dangerous to exceed the stated dose. ADCO-SUFEDRIN TABLETS should be used with caution in patients receiving chloroform, cyclopropane, halothane or other halogenated anaesthetics.
Hypertension and ventricular arrhythmias have been reported.
DOSAGE AND DIRECTIONS FOR USE:
Adults and children over 12 years:
1 tablet three times daily.
Children 6 to 12 years:
Half a tablet three times daily.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
ADCO-SUFEDRIN TABLETS may cause giddiness, headache, nausea, vomiting, sweating, thirst, tachycardia, precordial pain, palpitations, difficulty in micturition, muscular weakness and tremors, anxiety, restlessness and insomnia.
The following side-effects may occur: agitation, anginal pain, especially in patients suffering from angina pectoris, loss of appetite, reflex bradycardia, cardiac arrest, confusion, dizziness, dyspnoea, fainting, fear, flushing, disturbances of glucose metabolism, irritability, miosis, dry mouth, psychotic states vasoconstruction which may result in hypertension, cerebral haemorrhage and pulmonary oedema and weakness.
Rebound congestion may occur. ADCO-SUFEDRIN TABLETS should be used with caution in patients with diabetes mellitus, and occlusive vascular disorders (arterio- sclerosis). It should be used carefully in elderly and debilitated patients.
The effects of ADCO-SUFEDRIN TABLETS are diminished by guanethidine, reserpine, and probably methyldopa and may be diminished or enhanced by tricyclic antidepressants. ADCO-SUFEDRIN TABLETS may diminish the effects of guanethidine and may increase the possibility of arrhythmias in digitalised patients. Reversal of the effect of antihypertensive agents may occur.
Do not give together with quinidine.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: Symptoms may include irritability, convulsions, palpitations, hypertension and difficulty with micturition. Paranoid psychosis, delusions and hallucinations may also occur.
Treatment is supportive and symptomatic.
IDENTIFICATION: White to off white tablet scored on one side and with ADCO embossed on the other side.
PRESENTATION: Securitainers containing 20, 100, 250 and 500 tablets.
STORAGE INSTRUCTIONS: Store below 25°C and protect from light.
REGISTRATION NUMBER: 27/5.8/0188
NAME AND BUSINESS ADDRESS OF THE APPLICANT: ADCOCK INGRAM LIMITED
Adcock Ingram Park
17 Harrison Avenue
Private Bag X69, Bryanston, 2021
DATE OF PUBLICATION OF THIS PACKAGE INSERT: 7 January 1993
New addition to this site: April 2004
Source: Pharmaceutical Industry