(and dosage form)
Each tablet contains:
|| 450 mg|
|| 10 mg|
|| 45 mg|
|| 5 mg|
A. 2.8 Analgesic Combinations
ADCO-DOL TABLETS have antipyretic, analgesic and antihistaminic properties.
ADCO-DOL TABLETS for adults:-
Symptomatic relief of mild to moderate pain, pain associated with tension, and fever.
Sensitivity to active ingredients. Safety in pregnancy has not been established.
Contra-indicated in respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion, after operations on the biliary tract, acute alcoholism, head injuries and conditions in which intracranial pressure is raised. It should not be given during an attack of bronchial asthma or in heart failure secondary to chronic lung disease.
Contra-indicated in patients taking monoamine oxidase inhibitors or within fourteen days of stopping such treatment.
This medicine may lead to drowsiness and impaired concentration which is aggravated by the simultaneous intake of alcohol or other central nervous system depressant agents.
Patients should be warned against taking charge of vehicles or machinery or performing potentially hazardous tasks where loss of concentration may lead to accidents.
Paracetamol dosages in excess of those recommended may cause severe liver damage.
Exceeding the prescribed dose, together with prolonged and continuous use of this medication, may lead to dependancy and addiction.
DOSAGE AND DIRECTIONS FOR USE:
Adults and children over 12 years : One or two tablets repeated four hourly if necessary. Do not exceed eight tablets per day.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Consult your doctor if no relief is obtained with the recommended dosage.
Do not use continuously for more than ten days without consulting your doctor.
ADCO-DOL TABLETS should not be given to children under 12 years of age.
Patients suffering from liver or kidney disease should take paracetamol under medical supervision.
Paracetamol may cause sensitivity reactions resulting in reversible skin rash or blood disorders.
The most common side-effect of doxylamine succinate is sedation which can vary from slight drowsiness to deep sleep, and including inability to concentrate, lassitude, dizziness, hypotension, muscular weakness and incoordination. Other side effects include gastro-intestinal disturbances such as nausea, vomiting, diarrhoea or constipation and epigastric pain.
Headache, 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 occur.
Symptoms of stimulation in adults include insomnia, nervousness, tachycardia, tremors, muscle twitching and convulsions.
Large doses may precipitate fits in epileptics. Allergy and anaphylaxis may occur. Blood dyscrasias including agranulocytosis and haemolytic anaemia may occur.
Doxylamine succinate has anticholinergic properties and should be used with care in conditions such as glaucoma and prostatic hypertrophy. The effects of atropine and tricyclic antidepressants may be enhanced.
The warning symptoms of damage caused by ototoxic drugs may be masked and the metabolism of drugs in the liver may be effected.
Doxylamine succinate may enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers.
Codeine may cause nausea, vomiting, constipation, drowsiness, confusion, dry mouth, sweating, facial flushing, vertigo, bradycardia, palpitations, orthostatic hypotension, hypothermia, restlessness, changes of mood and miosis. Micturition may be difficult and there may be ureteric or biliary spasm. Raised intracranial pressure may occur. Reactions such as urticaria and pruritus may occur.
Codeine should be given with caution to patients with hypothyroidism, adrenocortical insufficiency, impaired liver function, prostatic hypertrophy or shock. It should be used with caution in patients with inflammatory or obstructive bowel disorders. The dosage should be reduced in elderly and debilitated patients.
The depressant effects of codeine are enhanced by depressants of the central nervous system such as alcohol, anaesthetics, hypnotics and sedatives, and phenothiazines.
The prolonged use of high doses of codeine has produced dependance of the morphine type.
Caffeine may cause restlessness, excitement, muscle tremor, tinnitus, scintillating scotoma, tachycardia and extrasystoles. Caffeine increases gastric secretions and may cause gastric ulceration.
Caffeine should be given with care to patients with a history of peptic ulceration.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "SIDE-EFFECTS AND SPECIAL PRECAUTIONS".
In the event of overdosage consult a 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, but in the event of this not being available, empty the stomach by aspiration and lavage. Supportive therapy may be required.
Symptoms of 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.
TABLETS: Yellow, circular, flat tablet scored on one side only, and embossed with "ADCO" above and "DOL" below the score line.
TABLETS: Packages in push-through blister packs of 10 tablets in containers of 20 tablets, and in securitainers of 20, 100, and 500 tablets
Store below 25°C. Protect from light and moisture. Keep out of reach of children.
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue
Private Bag X69
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
16 August 1988
New addition to this site: April 2004
Source: Pharmaceutical Industry
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