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.
CONTRA-INDICATIONS: ACUNASO Tablets are contra-indicated in persons on treatment with monoamine oxidase inhibitors, or within 2 weeks of stopping treatment. Contra-indicated in most types of cardiovascular disease, hypertension, hyperthyroidism, hyperexcitability, phaeochromocytoma and closed-angle glaucoma. Safety in pregnancy and lactation has not been established.
WARNINGS: It is dangerous to exceed the stated dose. ACUNASO Tablets should be used with caution in patients receiving chloroform, cyclopropane, halothane or other halogenated anaesthetics. Hypertension and ventricular arrhytmias have been reported. Do not use this product without consulting a doctor or pharmacist if you are presently taking monoamine oxidase inhibitors or other medicines for depression, psychiatric or emotional conditions or hypertension.
DOSAGE AND DIRECTIONS OF 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: ACUNASO 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, vasoconstriction which may result in hypertension, cerebral haemorrhage and pulmonary oedema, and weakness. Rebound congestion may occur. ACUNASO Tablets should be used with caution in patients with diabetes mellitus, and occlusive vascular disorders (arteriosclerosis). It should be used carefully in elderly and debilitated patients. The effects of ACUNASO Tablets are diminished by guanethidine, reserpine, and probably methyldopa and may be diminished or enhanced by tricyclic antidepressants. ACUNASO Tablets may diminish the effects of guanethidine and may increase the possibility of arrhythmias in digitalised patients. Reversal of the effects 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, biconvex, scored tablet.
PRESENTATION: Securitainers containing 20 and 200 tablets.
STORAGE INSTRUCTIONS: Store below 25°C and protect from light
KEEP OUT OF REACH OF CHILDREN
REGISTRATION NUMBER: Z/5.8/223
NAME AND BUSINESS ADDRESS OF APPLICANT: ACUPHARM (Pty) Ltd.
43 Richards Drive
DATE OF PUBLICATION OF THIS PACKAGE INSERT: 10 January 1992
94H 0894 ACI 039