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Components:
Codeine, Acetaminophen
Method of action:
Analgesic, Antitussive Opioid, Opioid
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Medically reviewed by Oliinyk Elizabeth Ivanovna, Pharmacy. Last updated on 2019.12.09

Effects on ability to drive and use machines

The information provided in Effects on ability to drive and use machines of Acet Codeine is based on data of another medicine with exactly the same composition as the Acet Codeine of the medicine (Codeine, Acetaminophen). Be careful and be sure to specify the information on the section Effects on ability to drive and use machines in the instructions to the drug Acet Codeine directly from the package or from the pharmacist at the pharmacy.
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This medicine can impair cognitive function and can affect a patient's ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When taking this medicine, patients should be told:

- The medicine is likely to affect your ability to drive

- Do not drive until you know how the medicine affects you

- It is an offence to drive while under the influence of this medicine

- However, you would not be committing an offence (called 'statutory defence') if:

oThe medicine has been taken to treat a medical or dental problem and

oYou have taken it according to the information provided with the medicine and

oIt was not affecting your ability to drive safely

Undesirable effects

The information provided in Undesirable effects of Acet Codeine is based on data of another medicine with exactly the same composition as the Acet Codeine of the medicine (Codeine, Acetaminophen). Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug Acet Codeine directly from the package or from the pharmacist at the pharmacy.
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Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur. Very rare cases of serious skin reactions have been reported.

There have been some reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but there were not necessarily causally related to paracetamol.

Codeine may sometimes cause constipation.

Regular prolonged use of codeine is known to lead to addiction and symptoms of restlessness and irritability may result when treatment is then stopped.

Prolonged use of a painkiller for headaches can make them worse.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Overdose

The information provided in Overdose of Acet Codeine is based on data of another medicine with exactly the same composition as the Acet Codeine of the medicine (Codeine, Acetaminophen). Be careful and be sure to specify the information on the section Overdose in the instructions to the drug Acet Codeine directly from the package or from the pharmacist at the pharmacy.
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Codeine

The effects in overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs.

Symptoms

Central nervous system depression, including respiratory depression, may develop but is unlikely to be severe unless other sedative agents have been co-ingested, including alcohol, or the overdose is very large. The pupils may be pin-point in size; nausea and vomiting are common. Hypotension and tachycardia are possible but unlikely.

Management

This should include general symptomatic and supportive measures including a clear airway and monitoring of vital signs until stable. Consider activated charcoal if an adult presents within one hour of ingestion of more than 350 mg or a child more than 5 mg/kg.

Give naloxone if coma or respiratory depression is present. Naloxone is a competitive antagonist and has a short half-life so large and repeated doses may be required in a seriously poisoned patient. Observe for at least four hours after ingestion, or eight hours if a sustained release preparation has been taken.

Paracetamol

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, rimidone, 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.

Pharmacodynamic properties

The information provided in Pharmacodynamic properties of Acet Codeine is based on data of another medicine with exactly the same composition as the Acet Codeine of the medicine (Codeine, Acetaminophen). Be careful and be sure to specify the information on the section Pharmacodynamic properties in the instructions to the drug Acet Codeine directly from the package or from the pharmacist at the pharmacy.
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Pharmacotherapeutic group: Other Analgesics and Antipyretics, ATC code: N02B.

Acet Codeine has analgesic and antipyretic actions.

Codeine is a centrally acting weak analgesic. Codeine exerts its effect through μ opioid receptors, although codeine has low affinity for these receptors, and its analgesic effect is due to its conversion to morphine. Codeine, particularly in combination with other analgesics such as paracetamol, has been shown to be effective in acute nociceptive pain.

Pharmacokinetic properties

The information provided in Pharmacokinetic properties of Acet Codeine is based on data of another medicine with exactly the same composition as the Acet Codeine of the medicine (Codeine, Acetaminophen). Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug Acet Codeine directly from the package or from the pharmacist at the pharmacy.
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Not applicable.

Pharmacotherapeutic group

The information provided in Pharmacotherapeutic group of Acet Codeine is based on data of another medicine with exactly the same composition as the Acet Codeine of the medicine (Codeine, Acetaminophen). Be careful and be sure to specify the information on the section Pharmacotherapeutic group in the instructions to the drug Acet Codeine directly from the package or from the pharmacist at the pharmacy.
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Other Analgesics and Antipyretics, ATC code: N02B.

Preclinical safety data

The information provided in Preclinical safety data of Acet Codeine is based on data of another medicine with exactly the same composition as the Acet Codeine of the medicine (Codeine, Acetaminophen). Be careful and be sure to specify the information on the section Preclinical safety data in the instructions to the drug Acet Codeine directly from the package or from the pharmacist at the pharmacy.
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None.

Incompatibilities

The information provided in Incompatibilities of Acet Codeine is based on data of another medicine with exactly the same composition as the Acet Codeine of the medicine (Codeine, Acetaminophen). Be careful and be sure to specify the information on the section Incompatibilities in the instructions to the drug Acet Codeine directly from the package or from the pharmacist at the pharmacy.
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None known.

Special precautions for disposal and other handling

The information provided in Special precautions for disposal and other handling of Acet Codeine is based on data of another medicine with exactly the same composition as the Acet Codeine of the medicine (Codeine, Acetaminophen). Be careful and be sure to specify the information on the section Special precautions for disposal and other handling in the instructions to the drug Acet Codeine directly from the package or from the pharmacist at the pharmacy.
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None.

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