Go-Pain P 120 mg/5 mL Syrup

GO-PAIN P is indicated for the symptomatic treatment of mild to moderate pain and fever.

DO NOT EXCEED THE RECOMMENDED DOSE.

Infants 3 to 12 months: 2,5 mL every six to eight hours

Children 1 to 6 years: 5 mL to 10 mL every six to eight hours

Children 7 to 12 years: 10 mL to 20 mL every six to eight hours

While symptoms persist, to be repeated every 4 hours if needed to a maximum of 4 doses per 24 hours for not longer than 5 days.

Method of administration

Dose to be taken orally.

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

GO-PAIN P contains paracetamol which may be fatal in overdose. In the event of over dosage or suspected overdose and notwithstanding the fact that the person may be asymptomatic, the nearest doctor, hospital or Poison Centre must be contacted immediately.

• Dosages of GO-PAIN P in excess of those recommended may cause severe liver damage.
• Consult a medical practitioner if pain or fever persists or gets worse at the recommended dosage, if new symptoms occur or if redness and swelling is present, as these could be signs of a more serious condition.
• Do not use this product continuously without consulting a medical practitioner:

• for pain u2013 for more than seven days in adults (5 days for children)
• for fever u2013 for more than 3 days.

Store in a safe place out of reach of children.

Patients suffering from hepatitis or alcoholism, or recovering from any form of liver disease, should not take excessive quantities of GO-PAIN P.

Use with caution in renal disease.

Serious skin reactions such as Acute Generalized Exanthematous Pustulosis (AGEP), Stevens u2013 Johnson syndrome (SJS), and Toxic Epidermal Necrolysis (TEN), have been reported infrequently in patients receiving paracetamol. The use of GO-PAIN P should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity such as swelling, itching, red severe rash (see Section 4.8).

Excipients with known effect

GO-PAIN P contains FD & C Yellow No 5 (Tartrazine) which may cause allergic reactions.

GO-PAIN P contains 1,565 g/5 mL of sucrose and 2,0 g/5 mL glucose. This should be taken into account in patients with diabetes mellitus.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

GO-PAIN P contains 10,56 % v/v of ethanol, that corresponds to 8,45 % w/v or 8,45 g/100 mL of ethanol. A dosage of 5 mL GO-PAIN P contains 422,50 mg ethanol. A dose of 5 mL of GO-PAIN P administered to a child 1 to 6 years of age and weighing 10 kg would result in exposure to 39,10 mg/kg/dose of ethanol which may cause a rise in blood alcohol concentration (BAC) of about 7,04 mg/100 mL. For comparison, for an adult drinking a glass of wine or 500 mL of beer, the BAC is likely to be about 50 mg/100 mL.

GO-PAIN P contains 1,0 mg propylene glycol in each 5 mL which may induce serious adverse effects in neonates. It may lead to the accumulation of ethanol as in GO-PAIN P and induce adverse effects, in particular in young children with low or immature metabolic capacity.

GO-PAIN P contains methyl- and propyl parahydroxybenzoate (as preservatives) which may cause allergic reactions (possibly delayed).

Hepatotoxic medicines u2013 Increased risk of hepatotoxicity.

Enzyme inducing medicines u2013 Increased risk of hepatotoxicity. Possible decrease in therapeutic effects of GO-PAIN P.

Metoclopramide u2013 Absorption of GO-PAIN P may be accelerated.

Cholestyramine u2013 Absorption of GO-PAIN P is reduced if given within one hour of cholestyramine.

Prolonged concurrent use of GO-PAIN P with salicylates increases the risk of adverse renal effects.

Warfarin and anticoagulants u2013 Concurrent, chronic, high-dose administration of GO-PAIN P may increase the anticoagulant effect. Paracetamol is recommended as the general analgesic and antipyretic of choice in patients on oral anticoagulant therapy. However, caution is needed since, although it has no effect on the gastric mucosa or on platelet function, some studies (with warfarin, anisindione, dicoumarol, or phenprocoumon) and isolated reports have found an increased risk of bleeding in patients taking regular doses of paracetamol while on an oral anticoagulant. An increase in INR has also been reported in controlled studies of the use of paracetamol in patients stabilised on warfarin. Increased monitoring of anticoagulant therapy may be appropriate for those also taking paracetamol regularly.

Antiepileptics u2013 The plasma-paracetamol concentrations considered an indication for antidote treatment should be halved in patients receiving enzyme inducing medicines such as carbamazepine, phenobarbital, phenytoin, or primidone.

Probenecid u2013 Pre-treatment with probenecid can decrease paracetamol clearance and increase its plasma half-life. Although urinary excretion of the sulphate and glucuronide conjugates of paracetamol are reduced, that of paracetamol is unchanged.

Antibacterials u2013 The plasma-paracetamol concentrations considered an indication for antidote treatment should be halved in patients receiving enzyme inducing medicines such as rifampicin. Severe hepatotoxicity at therapeutic doses or moderate overdoses of paracetamol has been reported in patients receiving isoniazid, alone or with other medicines for tuberculosis.

Antivirals u2013 Severe hepatotoxicity has occurred after use of paracetamol in a patient taking zidovudine and co-trimoxazole. However, neither short-term nor long-term studies (the latter also in an individual patient) have shown any alteration of zidovudine elimination in patients taking zidovudine and paracetamol. Paracetamol has also been found to enhance the antiviral effect of interferon alfa.

Pregnancy and lactation

Safety and efficacy in pregnancy and lactation have not been established.

It is not always possible to predict to what extent GO-PAIN P may interfere with the daily activities of a patient. Patients should ensure that they do not engage in the above activities until they are aware of the measure to which GO-PAIN P affects them.

Tabulated summary of adverse reactions

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

Prompt treatment is essential. In the event of an overdosage, consult a doctor immediately, or take the person to a hospital directly. 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 u2013 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.

Symptoms of paracetamol overdosage in the first 24 hours include pallor, nausea, vomiting, anorexia and possibly 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 the 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 for paracetamol overdosage

Although evidence is limited it is recommended that any adult person who has ingested 5 u2013 10 grams or more of paracetamol (or a child who has had more than 140 mg/kg) within the preceding four hours, should have the stomach emptied by lavage (emesis may be adequate for children) and a single dose of 50 g activated charcoal given via the lavage tube. Ingestion of amounts of paracetamol smaller than this may require treatment in patients susceptible to paracetamol poisoning (see above). In patients who are stuperose or comatose endotracheal intubation should precede gastric lavage in order to avoid aspiration.

N-acetylcysteine should be administered to all cases of suspected overdose as soon as possible preferably within eight 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 given intravenously over 15 minutes, followed by an infusion of 50 mg/kg in 500 mL dextrose injection over the next four hours, and then 100 mg/kg in 1000 mL dextrose injection over the next sixteen hours. The volume of intravenous fluid 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 every four hours for seventeen doses.

A plasma paracetamol level should be determined four hours after ingestion in all cases of suspected overdosage. Levels done before four hours, unless high, may be misleading. Patients at risk of liver damage, and hence requiring continued treatment with N-acetylcysteine, can be identified according to their plasma paracetamol level.

A semi-logarithmic plot of plasma-paracetamol concentration against hours after ingestion: Those whose plasma paracetamol levels are above the u201cnormal treatment lineu201d, should continue N-acetylcysteine treatment with 100 mg/kg IV over sixteen 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 ingestions for at least ninety-six hours.