When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Section 4.4
Caution is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. Underlying liver disease increases the risk of paracetamol-related liver damage. Patients with renal or hepatic impairment should seek medical advice prior to treatment with paracetamol. 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 or have been diagnosed with liver or kidney disease.
Section 4.8
Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur.
Adverse events associated with paracetamol from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labeled dose and considered attributable are tabulated below by System Organ Class and frequency. Frequencies are defined as: very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10,000, <1/1000) and very rare (<1/10,000) including isolated reports.
Immune system disorders
Very rare (< 1/10,000) Cutaneous hypersensitivity reactions, including skin rashes, angioedema and Stevens Johnson syndrome. Anaphylaxis.
Haematological system disorders
Very rare (<1/10,000) thrombocytopaenia
Respiratory system disorders
Very rare (<1/10,000) aggravation of bronchospasm has been reported in asthmatic patients known to be sensitive to aspirin and other non-steroidal anti-inflammatory drugs
Hepatobiliary disorders
Very rare (<1/10,000) Liver dysfunction
Section 5.1
ATC Code : N02BE01
Paracetamol is an analgesic and antipyretic. Its mechanism of action is believed to include inhibition of prostaglandin synthesis, primarily within the central nervous system
Section 1: Hedex 500mg Film-coated Tablets
Section 2: Each tablet contains paracetamol 500mg.
For a full list of excipients, see section 6.1.
Section 6.5: Opaque PVC/aluminium foil blister strips packed into cardboard boxes containing 12, 16, 24 or 40 tablets.
Not all pack sizes may be marketed.
Section 9: Date of last renewal: 20 August 2007
Section 10: November 2008
Section 3 The first sentence was changed to say "Film-coated tablet".
Section 4.9 Changed to the following:
Symptoms 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, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported. Liver damage is possible in adults who have taken 10g or more of paracetamol. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested), become irreversibly bound to liver tissue.
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 and any patient who has ingested around 7.5g or more of paracetamol in the preceding 4 hours should undergo gastric lavage. Administration of oral methionine or intravenous N-acetylcysteine which may have a beneficial effect up to at least 48 hours after the overdose, may be required. General supportive measures must be available.
Section 10 the date of revision of the text was changed to say January 2005.