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

Logo COLCLEER TABLETS

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

COLCLEER TABLETS

COMPOSITION:
Each tablet contains:
Chlorpheniramine maleate 2 mg
Ephedrine HCl 6 mg
Paracetamol 200 mg
Caffeine 20 mg
Nipastat (as preservative) 0,125% m/m

PHARMACOLOGICAL CLASSIFICATION :
A.5.8. Preparations for the common cold including nasal decongestants and antihistaminics.

PHARMACOLOGICAL ACTION:
Colcleer tablets have antihistaminic, analgesic, antipyretic and sympathomimetic properties.

INDICATIONS:
For the symptomatic relief of colds and influenza.

CONTRA-INDICATIONS:
Hypersensitivity to any of the active ingredients.
Cardiovascular disease coronary thrombosis, kidney disease, hypertension, hyperthyroidism, hyperexcitability, phaeochromocytoma, closed-angle glaucoma, prostatism, bladder dysfunction.
Patients being treated with monoamine oxidase inhibitors or within 14 days of stopping such treatment.
Epilepsy and all convulsive states.
During an attack of asthma.
Avoid during anaesthesia with cyclopropane, halothane or other halogenated anaesthetics.
The safe use of Colcleer tablets in pregnancy has not been established.

WARNINGS:
Dosages in excess of those recommended may cause severe liver damage.
Consult your doctor if no relief is obtained with the recommended dosage.
Do not use continuously for longer than ten days without consulting your doctor.
Patients suffering from liver or kidney disease should take paracetamol under medical supervision.
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.
Ephedrine HCl should be given with caution to patients with organic heart disease, cardiac decompensation or angina of effort.

DOSAGE AND DIRECTIONS FOR USE:
Adults: Two tablets every four hours.
Children: 7-12 years: One tablet every four hours.
Not recommended for children under 7 years.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Chlorpheniramine maleate may cause sedation varying from slight drowsiness to deep sleep, and including inability to concentrate, lassitude, dizziness, hypotension, muscular weakness and inco-ordination. Other side-effects include gastro-intestinal disturbances such as nausea, vomiting, diarrhoea or constipation, colic and epigastric pain. Headache, blurred vision, tinnitus, elation or depression, irritability, nightmares, anorexia, difficulty in micturition, dryness of the mouth, tightness of the chest and tingling, heaviness and weakness of the hands may also occur. It may occasionally cause allergy and dermatological reactions.
Symptoms of stimulation such as insomnia, nervousness, tachycardia, tremors, muscle twitching, convulsions and euphoria may arise.
Large doses may precipitate fits in epileptics.
Blood disorders, including agranulocytosis, haemolytic anaemia and leucopenia have been reported.
Photosensitisation of the skin may occur.
Should be used with caution in liver impairment, glaucoma, urinary retention and prostatic hypertrophy.
Elderly patients are more susceptible to the central nervous system depressant and hypotensive effects.
Positive skin test results may be suppressed.
Ephedrine may give rise to giddiness, headache, nausea, vomiting, sweating, hypersalivation, thirst tachycardia, precordial pain, palpitations, difficulty in micturition, urinary retention, muscular weakness and tremors, anxiety, restlessness and insomnia.
Hypertension and ventricular arrhythmias may occur.
Fixed drug eruption due to ephedrine, taking the form of erythematous nummular patches, has been reported.
Agitation, anginal pain especially in patients suffering from angina pectoris, loss of appetite, reflex bradycardia, cardiac arrest, confusion, hypotension with dizziness and fainting, flushing, dyspnoea, aneurisms, fear, disturbances of glucose metabolism, irritability, miosis, dry mouth, psychotic states and weakness may occur.
Paracetamol may cause sensitivity reactions resulting in reversible skin rash or blood disorders. Caffeine may cause insomnia, headache, nausea and gastric ulceration.
Chlorpheniramine maleate may enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, phenothiazines, hypnotics, narcotic analgesics, sedatives and tranquillisers.
The effects of anticholinergic drugs such as atropine and tricyclic antidepressants may also be enhanced.
Ephedrine should be used with caution in patients with diabetes mellitus, occlusive vascular disorders including arteriosclerosis and in patients receiving digitalis or chloroform. In patients with prostatic enlargement it may increase difficulty with micturition.
The effects of ephedrine are diminished by guanethidine, reserpine and probably methyldopa and may be enhanced or diminished by tricyclic antidepressants. Ephedrine may also diminish the effects of guanethidine and may increase the possibility of arrhythmias in patients receiving cardiac glycosides, quinidine or tricyclic antidepressants.
Reversal of the action of antihypertensive agents may occur.
Caffeine should be administered with caution to patients with a history of peptic ulceration or hyperacidity.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Chlorpheniramine overdosage - see Side-effects.
Symptoms of ephedrine overdosage include paranoid psychosis, delusions and hallucinations. See also Side-effects.
Symptoms of paracetamol overdosage include nausea and vomiting. Liver damage which may be fatal may only appear after a few days. Kidney failure has been described following acute intoxication.
Symptoms of caffeine overdosage include restlessness, excitement, sensory disturbances muscle tremor, tinnitus, diuresis, scintillating scotoma, tachycardia and extrasystoles and convulsions.
In the event of overdosage consult your doctor or take the patient to the nearest hospital immediately.
Specialised treatment is essential as soon as possible.
The latest information regarding the treatment of overdosage can be obtained from the nearest poison centre.

IDENTIFICATION:
Round, biconvex, violet, sugar-coated tablet.

PRESENTATION:
Containers holding 24, 100, 250 and 1 000 tablets.

STORAGE INSTRUCTIONS:
Store below 30°C in an airtight container. Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REFERENCE NUMBER:
C810 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
The Premier Pharmaceutical Co. Ltd.
Adcock Ingram Park
17 Harrison Avenue, Bryanston Ext.77
Private Bag X69, Bryanston, 2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
8/1970

        01316-01/98

Current: April 2005
Source: Community Pharmacy

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