Pacipayn 500 mg Tablet

PACIPAYN is indicated for the symptomatic relief of:

• Mild to moderate pain.
• Fever.

DO NOT EXCEED THE RECOMMENDED DOSE.

Usual adult dose

One tablet every 3 hours or one to two tablets (0,5 to 1 g) every 4 - 6 hours up to a maximum of 4 g daily (8 tablets).

Paediatric population

Usual paediatric dose 6 to 12 years: 250 - 500 mg (half to one tablet) three to four times a day as required. Not suitable for children under 6 years of age.

Method of administration

PACIPAYN is for oral administration.

• Hypersensitivity to the paracetamol or to any of the excipients listed in section 6.1.
• Severe renal function impairment.
• Severe liver function impairment.

PACIPAYN contains paracetamol which may be fatal in overdose. In the event of overdosage or suspected overdose and notwithstanding the fact that the person may be asymptomatic, the nearest medical practitioner, hospital or Poison Centre must be contacted immediately. Dosages in excess of those recommended may cause severe liver damage.

Consult a medical practitioner if no relief is obtained from the recommended dosage. Do not use continuously for more than 10 days without consulting a medical practitioner.

PACIPAYN contains FD & C Yellow No. 5 (Tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of tartrazine sensitivity in the general population is currently thought to be low, it is frequently seen in patients who also have aspirin sensitivity.

Do not use with any other paracetamol-containing products. Patients should be advised to consult their medical practitioner if their headaches become persistent. Patients should be advised to consult a medical practitioner if they suffer from non-serious arthritis and need to take painkillers every day.

Caution should be exercised in patients with glutathione depleted states, as the use of paracetamol may increase the risk of metabolic acidosis (see section 4.9). Use with caution in patients with glutathione depletion due to metabolic deficiencies. If symptoms persist, medical advice must be sought.

Severe cutaneous adverse reactions (SCARs) such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), acute generalised exanthematous pustulosis (AGEP), eosinophilia and systemic (DRESS)/Drug-induced hypersensitivity syndrome (DIHS) and fixed drug eruptions (FDE) have been reported in patients treated with paracetamol containing medicines. If a patient develops SCAR, treatment with PACIPAYN must immediately be discontinued and appropriate treatment instituted.

Concomitant use of PACIPAYN with hepatotoxic medicines or medicines that induce liver enzymes may increase the risk of hepatotoxicity of PACIPAYN. Possible decrease in therapeutic effects of PACIPAYN.

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine.

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

Probenecid may decrease the clearance and increase the plasma half-life of paracetamol.

Prolonged concurrent use of PACIPAYN with salicylates increases the risk of adverse renal effects.

Chronic use of isoniazid may increase the risk of liver damage when combined with PACIPAYN, even at recommended doses.

Pregnancy

Safety and efficacy in pregnancy have not been established.

Breastfeeding

Safety and efficacy in lactation have not been established.

Fertility

There are no fertility data.

None

System Organ Class Frequency Frequent Less Frequent Not known

• Blood and lymphatic system disorders Agranulocytosis, thrombocytopenia, leucopenia, pancytopenia, neutropenia, anaemia.
• Immune system disorders Anaphylaxis Cutaneous hypersensitivity reactions including, among others, skin rashes and angioedema. Very rare cases of serious skin reactions have been reported.
• Respiratory, thoracic and mediastinal disorders Bronchospasm*
• Gastrointestinal disorders Pancreatitis.
• Hepatobiliary disorders Hepatitis. Hepatic dysfunction
• Skin and subcutaneous tissue disorders Dermatitis, Skin rashes, and other allergic reactions. The rash is usually erythematous or urticarial but sometimes more serious and accompanied by fever and mucosal lesions.
• Risk of Fixed drug eruptions (FDE)
• Risk of Drug-induced hypersensitivity syndrome (DIHS)
• Renal and urinary disorders Renal colic, renal failure and sterile pyuria.

* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatic sensitive to aspirin or to other NSAIDs.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reaction Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8

Symptoms

Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and possible 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 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

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 medicines that induce liver microsomal oxidation such as barbiturates, isoniazid, rifampicin, phenytoin and carbamazepine.

N-acetylcysteine should be administered to all cases of suspected overdosage as soon as possible preferably within 8 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 over the next 4 hours and then 100 mg/kg in 1000 ml dextrose injection over the next 16 hours. The volume of intravenous fluids 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 solution every 4 hours for 17 doses.

A plasma paracetamol level should be determined 4 hours after ingestion in all cases of suspected overdosage. Levels done before 4 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 16 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 ingestion for at least 96 hours.