Beechams Active Cold Relief Caplets (pack of 14)-Hyperdrug

Contraindications Known hypersensitivity to paracetamol or any of the other constituents. Hepatic or severe renal impairment, hypertension, hyperthyroidism, diabetes, and heart disease. Patients taking tricyclic antidepressants, or beta-blocking drugs and those who are taking or who have taken within the last two weeks monoamine oxidase inhibitors. Special warnings and precautions for use Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease. Do not exceed the stated dose. Patients should be advised not to take other paracetamol-containing products concurrently. If symptoms persist consult your doctor. Keep out of the reach and sight of children. Consult your doctor if you are taking warfarin. Special Label Warnings Do not take with other flu, cold or decongestant products. Do not take with any other paracetamol-containing products. Immediate medical advice should be sought in the event of an overdose, even if you feel well. Special Leaflet Warnings Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage. Interaction with other medicinal products and other forms of interaction The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding. Occasional doses have no significant effect. Enzyme-inducing drugs may increase hepatic damage, as does excessive intake of alcohol. The speed of absorption of paracetamol may be increased by metoclopromide or domperidone and absorption reduced by colestyramine. These interactions are considered to be of unlikely clinical significance in acute use at the dosage regimen proposed. Hypertensive interactions occur between sympathomimetic amines such as phenylephrine and monoamine oxidase inhibitors. Phenylephrine may reduce the efficacy of beta-blocking drugs and antihypertensive drugs. Conditions where these drugs are used are contraindications for the product. Undesirable effects Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur. There have been very rare reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these were not necessarily causally related to paracetamol. Phenylephrine may produce tachycardia, palpitations, nausea, headache and changes in blood pressure.

Pregnancy and lactation Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use. Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data on paracetamol do not contraindicate breast feeding. Phenylephrine should not be used during pregnancy since it may cause foetal hypoxia at high doses. Consequently the product should not be used during pregnancy unless considered essential by the physician Overdose Liver damage is possible in adults who have taken 10g 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 factors If the patient a, Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes. Or b, Regularly consumes ethanol in excess of recommended amounts. Or c, Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia. Symptoms Symptoms of paracetamol overdosage 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 arrhythmias and pancreatitis have been reported. Management Immediate 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 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 24h from ingestion should be discussed with the NPIS or a liver unit. Caffeine Symptoms Overdose of caffeine may produce nervousness, restlessness, insomnia, excitement, diuresis, facial flushing, muscle twitching, GI disturbance, tachycardia or cardiac arrhythmia, “rambling” flow of thought and speech, psychomotor agitation, or periods of inexhaustibility. Management Patients 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. Summary Treatment of overdose with Beechams Active Cold Relief Caplets requires assessment of plasma paracetamol levels for antidote treatment, with signs and symptoms of caffeine toxicity being managed symptomatically. Overdose of phenylephrine may produce hypertension. However the amount required to produce toxicity would be greater than that producing paracetamol toxicity.