GSL: General Sales Licence
This information is intended for use by health professionals
Adults:Two tablets up to 4 times daily as required.Do not exceed 8 tablets in 24 hours.
Elderly:As for adults.
Children:Not recommended for children under 12 years.
Method of administrationParacetamol and caffeine 500 mg/65 mg Soluble Tablets are for oral administration only.
Pack Label:Immediate medical advice should be sought in the event of an overdose, even if you feel well.Do not take with other paracetamol-containing products.
Patient Information Leaflet:Immediate medical advice should be sought in the event of overdose even if you feel well, because of the risk of delayed, serious liver damage.
Post marketing data
|Body System||Undesirable effect|
|Blood and lymphatic system disorders||Thrombocytopenia Agranulocytosis|
|Immune system disorders||Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angiodema and Stevens Johnson syndrome/toxic epidermal necrolysis|
|Respiratory, thoracic and mediastinal disorders||Bronchospasm*|
|Hepatobiliary disorders||Hepatic dysfunction|
|Central Nervous system||Nervousness Dizziness|
|When the recommended paracetamol-caffeine dosing regimen is combined with dietary caffeine intake, the resulting higher dose of caffeine may increase the potential for caffeine-related adverse effects such as insomnia, restlessness, anxiety, irritability, headaches, gastrointestinal disturbances and palpitations.|
ParacetamolLiver damage is possible in adults who have taken 10 g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).
Risk factorsIf the patienta) Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.orb) Regularly consumes ethanol in excess of recommended amounts.orc) Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
SymptomsSymptoms of paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrythmias and pancreatitis have been reported.
ManagementImmediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of the overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24 h from ingestion should be discussed with the NPIS or a liver unit.
SymptomsOverdose of caffeine may result in epigastric pain, vomitting, diuresis, tachycardia or cardia arrhythmia, CNS stimulation (insomnia, restlessness, excitement, agitation, jitteriness, tremors and convulsions).It must be noted that for clinically significant symptoms of caffeine overdose to occur with this product, the amount ingested would be associated with serious paracetamol-related toxicity.
ManagementPatients should receive general supportive care (e.g. hydration and maintenance of vital signs). The administration of activated charcoal may be beneficial when performed within one hour of the overdose, but can be considered for up to four hours after the overdose. The CNS effects of overdose may be treated with intravenous sedatives.
Sodium bicarbonateHigh doses of sodium bicarbonate may be expected to induce gastrointestinal symptoms including belching and nausea. In addition, high doses of sodium bicarbonate may cause hypernatraemia; electrolytes should be monitored and patients managed accordingly.
Tube:The product should be stored below 25°C.Moisture sensitive: store the tablets in the tube, and keep the tube tightly closed.
Sachet:The product should be stored below 30°C.
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