Adco-Dol Tablets

ADCO-DOL tablets for adults: Symptomatic relief of mild to moderate pain, pain associated with tension, and fever.

Adults and children over 12 years: One or two tablets repeated four hourly if necessary. Do not exceed eight tablets per day. u201cDO NOT EXCEED THE RECOMMENDED DOSE.

Sensitivity to active ingredients. Contraindicated 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. Contraindicated in patients taking monoamine oxidase inhibitors or within fourteen days of stopping such treatment.

Paracetamol dosages in excess of those recommended may cause severe liver damage. Patients suffering from liver or kidney disease should take paracetamol under medical supervision. The effects of atropine and tricyclic antidepressants may be enhanced. 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 (see INTERACTIONS). Patients should be warned against taking charge of vehicles or machinery or performing potentially hazardous tasks where loss of concentration may lead to accidents. 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 prolonged use of high doses of codeine has produced dependence of the morphine type. Caffeine should be given with care to patients with a history of peptic ulceration. Exceeding the prescribed dose, together with prolonged and continuous use of this medication, may lead to dependency and addiction. Large doses may precipitate fits in epileptics. 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.

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 (Refer to u201cSpecial warnings and precautions for useu201d). The warning symptoms of damage caused by ototoxic drugs may be masked and the metabolism of drugs in the liver may be affected (see SIDE EFFECTS). Doxylamine succinate may enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers. Doxylamine may decrease emetic response to apomorphine. The depressant effects of codeine are enhanced by depressants of the central nervous system such as alcohol, anaesthetics, hypnotics and sedatives, and phenothiazines.

Safety in pregnancy and lactation has not been established.

Patients should be warned against taking charge of vehicles or machinery or performing potentially hazardous tasks where loss of concentration may lead to accidents.

Frequency System Organ classification Side effects Frequent Nervous system disorders Sedation, Drowsiness, deep sleep, including inability to concentrate, lassitude, inco-ordination, dizziness, headache, dryness of the mouth, nervousness, tremors, muscle twitching and convulsions Vascular disorders Hypotension Frequency unknown Blood and lymphatic system disorders Agranulocytosis, anemia, thrombocytopenia or blood disorders, Blood dyscrasias including and haemolytic anaemia Cardiac disorders Tightness of the chest and tingling, heaviness and weakness of the hands, tachycardia, Bradycardia, palpitations and extrasystoles Ear and labyrinth disorders Tinnitus, Vertigo Eye disorders Scintillating scotoma, Miosis Gastrointestinal disorders Nausea, vomiting, diarrhoea, constipation, epigastric pain, constipation, dry mouth, gastric ulceration General disorders and administration site conditions Hypothermia Hepato-biliary disorders Hepatitis, Biliary spasm Immune system disorders Allergy, anaphylaxis Musculoskeletal and connective tissue disorders Muscle tremor, Muscular weakness Psychiatric disorders Irritability, elation or depression, anorexia, nightmares, insomnia, changes of mood, confusion, restlessness and raised intracranial pressure. Restlessness, excitement. Renal and urinary disorders Renal colic, renal failure, sterile pyuria, Difficulty in micturition, ureteric spasm Skin and subcutaneous tissue disorders Skin rash, Urticarial, pruritus and sweating Vascular disorders Orthostatic hypotension, facial flushing

Prompt treatment is essential. In the event of an overdosage, consult a doctor immediately, or take the person directly to a hospital. A delay in starting treatment may mean that antidote is given too late to be effective. Evidence of liver damage is often delayed until after the time for effective treatment has lapsed. Susceptibility to paracetamol toxicity is increased in patients who have taken repeated high doses (greater than 5 -10 g/day) of paracetamol for several days, in chronic alcoholism, chronic liver disease, AIDS, malnutrition, and with the use of drugs that induce liver microsomal oxidation such as barbiturates, isoniazid, rifampicin, phenytoin and carbamazepine. Symptoms of paracetamol overdosage in the first 24 hours include pallor, nausea, vomiting, anorexia and possibly abdominal pain. Mild symptoms during the first two days of acute poisoning, do not reflect the potential seriousness of the overdosage. Liver damage may become apparent 12 to 48 hours, or later after ingestion, initially by elevation of the serum transaminase and lactic dehydrogenase activity, increased serum bilirubin concentration and prolongation of the prothrombin time. Liver damage may lead to encephalopathy, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Abnormalities of glucose metabolism and metabolic acidosis may occur. Cardiac arrhythmias have been reported. Treatment for paracetamol overdosage: Although evidence is limited it is recommended that any adult person who has ingested 5 - 10 grams or more of paracetamol (or a child who has had more than 140 mg/kg) within the preceding four hours, should have the stomach emptied by lavage (emesis may be adequate for children) and a single dose of 50 g activated charcoal given via the lavage tube. Ingestion of amounts of paracetamol smaller than this may require treatment in patients susceptible to paracetamol poisoning (see above). In patients who are stuperose or comatose endotracheal intubation should precede gastric lavage in order to avoid aspiration. N-acetylcysteine should be administered to all cases of suspected overdose as soon as possible preferably within eight hours of overdosage, although treatment up to 36 hours after ingestion may still be of benefit, especially if more than 150 mg/kg of paracetamol was taken. An initial dose of 150 mg/kg N-acetylcysteine in 200 ml dextrose injection given intravenously over 15 minutes, followed by an infusion of 50 mg/kg in 500 ml dextrose injection over the next four hours, and then 100 mg/kg in 1 000 ml dextrose injection over the next sixteen hours. The volume of intravenous fluid should be modified for children. Although the oral formulation is not the treatment of choice, 140 mg/kg dissolved in water may be administered initially, followed by 70 mg/kg every four hours for seventeen doses. A plasma paracetamol level should be determined four hours after ingestion in all cases of suspected overdosage. Levels done before four hours may be misleading. Patients at risk of liver damage, and hence requiring continued treatment with N-acetylcysteine, can be identified according to their 4-hour plasma paracetamol level. The plasma paracetamol level can be plotted against time since ingestion in the nomogram below. The nomogram should be used only in relation to a single acute ingestion. Those whose plasma paracetamol levels are above the u201cnormal treatment lineu201d, should continue N-acetylcysteine treatment with 100 mg/kg IV over sixteen hours repeatedly until recovery. Patients with increased susceptibility to liver damage as identified above, should continue treatment if concentrations are above the u201chigh risk treatment lineu201d. Prothrombin index correlates best with survival. Monitor all patients with significant ingestions for at least ninety-six hours.