A.5.8. Preparations for the common cold including nasal decongestants and antihistaminics.
PHARMACOLOGICAL ACTION: CORYX has analgesic, antipyretic, antihistaminic and decongestant properties.
INDICATION: For the treatment of symptoms associated with colds and influenza.
CONTRA-INDICATIONS: Sensitivity to any of the ingredients.
Patients with coronary disease, hypertension, cardiovascular disease, hyperthyroidism, epilepsy. Pregnancy and breastfeeding.
CORYX effervescent tablets are also contra-indicated in patients being treated with monoamine oxidase inhibitors or within 14 days of stopping such treatment.
Patients with peptic ulcers, haemophillia or intolerance (sensitivity) to aspirin, severe renal impairment and patients receiving oral anti-coagulant therapy.
Children under the age of 12 years.
WARNINGS: Do not use continuously for more than 10 days without consulting your doctor. Prolonged use of high doses may lead to anaemia, blood dyscrasias, gastro-intestinal haemorrhage, peptic ulceration, and renal papillary necrosis.
Patients suffering from kidney disease should take CORYX under medical supervision. The use of this medicine may lead to drowsiness and impaired concentration which may be aggravated by the simultaneous intake of alcohol or other central nervous system depressants. Aspirin has been implicated in Reyes s syndrome, a rare but serious illness, in children and teenagers with chickenpox and influenza. A doctor should be consulted before CORYX is used in such patients.
PHENYLKETONURICS: CONTAINS PHENYLALANINE.
DOSAGE AND DIRECTIONS FOR USE:
Adults and children over 12 years: One tablet every 8 hours if necessary. Place one tablet in a glass of warm (or cold if so wished) water and allow to dissolve. Drink the contents immediately once the whole tablet has dissolved.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Pseudoephedrine hydrochloride fear, anxiety, restlessness, tremor, insomnia, confusion, irritability, weakness and psychotic states. Appetite may be reduced and nausea and vomiting may occur.
Vasoconstriction with resultant hypertension. The rise in blood pressure may produce cerebral haemorrhage and pulmonary oedema. There may also be a reflex bradycardia; but stimulation of B -adrenergic receptors of the heart may produce tachycardia and cardiac arrythmias, anginal pain, palpitations and cardiac arrest. Hypotension with dizziness and fainting and blushing may occur.
Difficulty in micturition and urinary retention, dyspnoea, altered metabolism, including disturbances of glucose metabolism, sweating and hypersalivation. Headache is also common.
Should be used with caution in patients with: hyperthyroidism; cardiovascular disease such as ischaemic heart disease, arrhythmia or tachycardia; occlusive vascular disorders, including arteriosclerosis, hypertension or aneurysms; diabetis melletus; or closed-angle glaucoma.
Anginal pains may be precipitated in patients with angina pectoris.
Should be avoided or used with caution in patients undergoing anaesthesia with cyclopropane, halothane or other halogenated anaesthetics as they may induce ventricular fibrillation.
An increased risk of arrthythmias may occur given to patients receiving cardiac glycosides, quinidine or tricyclic antidepressants. Chlorpheniramine maleate Because CORYX tablets may produce sedation, patients should not operate machinery, drive cars, climb dangerous heights or perform potentially dangerous tasks where impaired decision making could lead to accidents. Other central nervous system depressants, such as narcotic analgesics, hypnotics, sedatives and tranquilizers, if taken concomitantly, will enhance sedation. Care should be observed when tricyclic anti-depressants, guanethidine, reserpine, methyldopa or atropine are taken concomitantly.
Other untoward reactions referable to central actions include dizziness, tinnitus, lassitude, incoordination, fatigue, blurred vision, diplopia, euphoria, nervousness, insomnia, and tremors.
Digestive tract loss of appetite, nausea, vomiting, epigastric distress, and constipation or diarrhoea. Their incidence may be reduced by giving the drug with meals. Other side effects include dryness of the mouth, throat and respiratory passages; urinary frequency and dysuria; palpitation; hypotension, headache; tightness of the chest; and tingling, heaviness, and weakness of the hands. Aspirin Gastro-intestinal disturbances such as nausea, dyspepsia, and vomiting. Irritation of the gastric mucosa with erosion, ulceration, haematemesis and melaena may occur. Slight blood loss is not usually of clinical significance but may, in a few patients, cause iron-deficiency anaemia during long-term salicylate therapy. CORYX should be given with care to patients with a history of peptic ulceration.
Some persons, especially asthmatics, exhibit notable sensitivity to aspirin which may provoke various reactions including urticaria and other skin eruptions, angioedema, rhinitus, and severe, even fatal, paroxysmal bronchospasm and dyspnoea. Persons sensitive to aspirin may not tolerate therapeutic doses.
Aspirin increases the bleeding time, decreases platelet adhesiveness, and, in large doses, may cause hypoprothrombinaemia. CORYX may enhance the activity of coumarin anticoagulants and oral anti-diabetic preparations and sulphonamides. CORYX deminishes the effects of anti-gout preparations such as probenecid and sulphinpyrazone. Barbiturates and other sedatives may mask the respiratory symptoms of aspirin overdosage and have been reported to enhance its toxicity. Vitamin C is usually well tolerated. Large doses are reported to cause diarrhoea and other gastro-intestinal disturbances and are associated with the formation of renal calcium oxalate calculi. Ascorbic acid should be given with care to patients with hyperoxaluria. Tolerance may be induced with prolonged use of large doses.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: See Side Effects. CORYX overdosage may result in convulsions and hypertension in susceptible patients. Overdosage may also cause tachycardia, arrhythmias and anginal pain, nausea, dizziness, hyperventilation, respiratory alkalosis, metabolic acidosis, vomiting, irritation of gastric mucosa with dyspepsia, haematemesis and melaena. The patient must be taken to a doctor or hospital immediately as specialized treatment may be necessary. Treatment is supportive and symptomatic, the serum salicylate levels should be closely monitored and forced alkaline diuresis instituted if appropriate.
IDENTIFICATION: Round, biplane, beige to lightly yellow coloured effervescent tablets, producing a light yellow solution with a pineapple flavour once dissolved in ± 200 mL of water.
PRESENTATION: Available in packs of 12's.
STORAGE DIRECTIONS: Keep tube tightly closed and store in a dry place below 25°C. Keep out of reach of children.
REGISTRATION NUMBER: 27/A.5.8/435
NAME AND BUSINESS ADDRESS OF THE APPLICANT: MIRREN (PTY) LTD
18 Golden Drive,