Paracetamol

Registered South African indications:

• Pain
• Fever

Drop, syrup and solution

This product 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 doctor, hospital or Poison Centre must be contacted immediately.

Suspension

This product contains paracetamol which may be fatal in overdose. Do not use with any other paracetamolcontaining products. The concomitant use with other products containing paracetamol may lead to an overdose. In the event of overdosage or suspected overdose and notwithstanding the fact that the person may be asymptomatic, the nearest doctor, hospital or Poison Centre must be contacted immediately.

Registered South African contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Severe hepatic impairment (Child Pugh C)

Contraindications registered in other jurisdictions

• Hypersensitivity to the active ingredient or any of its excipients

South African recommendations

Caution in the following patient groups

• Renal impairment
• Mild to moderate hepatic impairment

Suspension

Paracetamol overdose

• Paracetamol overdose may cause liver failure which may require liver transplant or lead to death
• Underlying liver disease increases the risk of paracetamol-related liver damage
• Patients who have been diagnosed with liver or kidney impairment must seek medical advice before taking this medication
• Cases of hepatic dysfunction/failure have been reported in patients with depleted glutathione levels, such as those who are severely malnourished, anorexic, have a low body mass index, are chronic heavy users of alcohol or have sepsis
• In patients with glutathione-depleted states the use of paracetamol may increase the risk of metabolic acidosis
• If symptoms persist, medical advice must be sought

Hereditary conditions

• Patients with rare hereditary problems of fructose intolerance should not take this medicine

Excipient(s) with known effect

• Each 24 mg/ml (120 mg/5 ml) suspension contains sorbitol (E420) at 666.5 mg (2.0 ml) glucose (0.75 ml) per 5 ml and suspension
• Sodium methyl-, sodium ethyl- and sodium propyl- parahydroxybenzoates (E219, E215, E217) may cause allergic reactions (possibly delayed)

Severe skin reactions

• Very rare cases of serious skin reactions have been reported

Drops

Paracetamol overdose

• Dosages in excess of those recommended may cause severe liver damage

Use in specific conditions

• Patients suffering from liver or kidney disease should take paracetamol under medical supervision

Doctor consultation

• Patient should consult a doctor if no relief is obtained with the recommended dosage

Duration of use

• Should not be used continuously for more than 10 days without consulting a doctor

Storage

• Store in a safe place out of reach of children

Syrup

Paracetamol overdose

• Dosages of paracetamol syrup in excess of those recommended may cause severe liver damage

Doctor consultation

• Patient should 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

Duration of use

•  Should not be used continuously for more than 10 days without consulting a doctor

Sorbitol and sucrose content

• Paracetamol syrup contains sorbitol and may cause gastrointestinal discomfort and mild laxative effect
• Patients with the rare hereditary condition of sorbitol intolerance should not take paracetamol syrup
• Paracetamol syrup contains sucrose. Patients with rare hereditary conditions such as fructose intolerance, glucose-galactose mal-absorption or sucrase-isomaltase insufficiency should not take paracetamol syrup
• Paracetamol syrup contains sucrose which may have an effect on the glycaemic control of patients with diabetes mellitus

Liver disease

• Patients suffering from hepatitis or alcoholism, or recovering from any form of liver disease, should not take excessive quantities of paracetamol syrup

Renal and liver function

• Paracetamol should be given with care to patients with impaired kidney or liver function
• Use with caution in renal disease, alcohol dependence, chronic malnutrition or dehydration

Severe cutaneous adverse reactions

• Severe cutaneous adverse reactions (SCARs): Severe cutaneous adverse reactions such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), acute generalized 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 paracetamol syrup must immediately be discontinued and appropriate treatment instituted

Effects on ability to drive and use machines

• Paracetamol solution has no or negligible influence on the ability to drive and use machines

Solution

Paracetamol overdose

• Dosages of paracetamol solution in excess of those recommended may cause severe liver damage

Doctor consultation

• Patient should consult doctor if no relief is obtained with the recommended dosage or 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

Duration of use

• Should not be used continuously for longer than ten days without consulting your doctor

Renal and liver function

• Paracetamol solution should be given with care to patients with impaired kidney or liver function
• Patients suffering from hepatitis or alcoholism, or recovering from any form of liver disease, should not take excessive quantities of paracetamol solution. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease
• Use paracetamol solution with caution in renal disease, alcohol dependence, chronic malnutrition or dehydration

Coadministration with flucloxacillin

• Caution is advised if paracetamol, as in paracetamol solution, is administered concomitantly with flucloxacillin due to increased risk of high anion gap metabolic acidosis (HAGMA), particularly in patients with severe renal impairment, sepsis, malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism), as well as those using maximum daily doses of paracetamol. Close monitoring, including measurement of urinary 5-oxoproline, is recommended

Severe cutaneous adverse reactions

• Severe cutaneous adverse reactions (SCARs): Severe cutaneous adverse reactions such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), acute generalized 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 paracetamol solution must immediately be discontinued and appropriate treatment instituted

Effects on ability to drive and use machines

• Paracetamol solution has no or negligible influence on the ability to drive and use machines

Recommendations in other jurisdictions

Caution in the following patient groups

• Renal impairment
• Hepatic impairment

Available formulation in other jurisdiction: Suspension

Overdose

• Do not exceed the recommended dose. Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help straight away. Quick medical attention is critical for adults as well as children even if signs and symptoms are not noticed

Paracetamol-containing products

• Taking this product with other paracetamol-containing medicines could lead to overdose and should therefore be avoided

Renal and hepatic impairment

• Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease. Chronic alcohol users should consult a doctor before use

High anion gap metabolic acidosis (HAGMA)

• Cases of high anion gap metabolic acidosis (HAGMA) due to pyroglutamic acidosis have been reported in patients with severe illness such as severe renal impairment and sepsis, or in patients with malnutrition or other sources of glutathione deficiency (e.g. chronic alcoholism), who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin. If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring, is recommended. The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors

Sorbitol and maltitol

• Sorbitol and maltitol may cause gastrointestinal discomfort and have a mild laxative effect. Each 5 ml spoonful of this product contains 0.97g sorbitol liquid and 2.72g of maltitol liquid. Calorific values: 2.6 kcal/g sorbitol and 2.3 kcal/g maltitol

Fructose intolerance

• Due to the presence of maltitol liquid (E965) and sorbitol liquid (E420), patients with rare hereditary problems of fructose intolerance should not take this medicine

Allergic reactions

• Ethyl (E214), Propyl (E216) and Methyl (E218) parahydroxybenzoate may cause allergic reactions (possibly delayed)
• Carmoisine (E122) may cause allergic reactions

Sodium content

• This medicine contains less than 1 mmol sodium (23 mg) per 5ml, that is to say essentially 'sodium-free'

Propylene glycol

• This medicine contains 14.32mg propylene glycol (E1520) in each 5ml dose, which is equivalent to 2.86mg/ml. Caution in babies less than 4 weeks old. Co-administration with any substrate for alcohol dehydrogenase such as ethanol may induce serious adverse effects in neonates

Benzyl alcohol

• This medicine contains 0.16mg benzyl alcohol in each 5ml which is equivalent to 0.03mg/ml. Benzyl alcohol may cause allergic reactions. Benzyl alcohol has been linked with the risk of severe side effects including breathing problems (“gasping syndrome”) in young children. Caution in newborn babies (up to 4 weeks old). Caution in children under 3 years old; do not use for more than 1 week due to increased risk due to accumulation

Pregnancy and breastfeeding

• Ask your doctor or pharmacist for advice if you are pregnant or breastfeeding, or if you have a liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called "metabolic acidosis")

Severe skin reactions

• Patients should be informed about the signs of serious skin reactions and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity

No adult dose recommendations provided

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For other formulations see Paracetamol (EFT/CAP/TAB/FCT)

Paed. forms avail. in SA and covered in this monograph: syr, sus, drp

Paed. dosages below include:

• South African Standard Treatment Guidelines indications and dosages
• South African registered indications and dosages

South African Standard Treatment Guidelines indications and dosages

• Click here for the Pain Control (Standard Treatment Guidelines And Essential Medicines List For South Africa, Hospital Level, Paediatrics, 2023 Edition)
• Click here for the Anaesthetics (Standard Treatment Guidelines And Essential Medicines List For South Africa, Hospital Level, Paediatrics, 2023 Edition)
• Click here for the Palliative Care (Standard Treatment Guidelines And Essential Medicines List For South Africa, Hospital Level, Paediatrics, 2023 Edition)

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South African registered indications and dosages

Symptomatic relief of mild to moderate pain such as headache, sore throat, toothache, teething pains and fever associated with colds and flu

Suspension

Younger than 3 months

• Oral (sus): Not recommended

Older than 3 months

• Oral (sus): As per below table; given three to four times dly with an interval of 4hrs between each dose; Max: 4 doses/24hrs

Age	Weight (kg)	Dose
3-6 months	6-8	90mg
6-24 months	8-12	120mg
2-4 years	12-16	180mg
4-6 years	16-20	240mg

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Consult doctor if no relief is obtained with the recommended dosage

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Do not exceed recommended dose

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Relief of mild to moderate pain and fever

Younger than 3 months

• Oral (syr): 10mg/kg, 4hrly if necessary; Treatment duration: Not longer than 5 days; Max: 4 doses/24hrs

Between 3 months to 1 year

• Oral (drp): 60-120mg, 4hrly if necessary; Max: 4 doses/24hrs
• Oral (syr): 60-120mg, 4hrly if necessary; Treatment duration: Not longer than 5 days; Max: 4 doses/24hrs
• Oral (sol): 60-120mg, 3-4 times dly with an interval of 4hrs between each dose

Between 1 to 5 years

• Oral (syr): 120-240mg, 4hrly if necessary; Treatment duration: Not longer than 5 days; Max: 4 doses/24hrs
• Oral (sol): 120-240mg, 3-4 times dly with an interval of 4hrs between each dose

Between 6 to 12 years

• Oral (syr): 240-480mg, 4hrly if necessary; Treatment duration: Not longer than 5 days; Max: 4 doses/24hrs
• Oral (sol): 240-480mg, 3-4 times dly with an interval of 4hrs between each dose

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Do not exceed recommended dose

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

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For other formulations see Paracetamol (EFT/CAP/TAB/FCT)

Pregnancy

• Safe
• Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage. A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity
• When given to the mother in therapeutic doses (1g single dose), paracetamol crosses the placenta into foetal circulation as early as 30 minutes after ingestion and is metabolised in the foetus by conjugation with sulfate and increasingly with glutathione
• Paracetamol can be used during pregnancy if clinically needed however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency

Breastfeeding

• Compatible
• Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breastfeeding

Fertility

• There is no information relating to the effects of paracetamol on fertility

• Caution; dose adjustment recommended

CrCl (ml/min)	Maximum Dose
≥ 50	No adjustment necessary
10-50	500mg, 6hrly
< 10	500mg, 8hrly

South African recommendations

• Mild to moderate: Caution, no dose adjustment recommended
  Patients suffering from liver disease should take paracetamol under medical supervision (drp)
  Patients suffering from hepatitis or alcoholism, or recovering from any form of liver disease, should not take excessive quantities of paracetamol (syr)
  Paracetamol overdose may cause liver failure which may require liver transplant or lead to death. Underlying liver disease increases the risk of paracetamol-related liver damage. Patients who have been diagnosed with liver impairment must seek medical advice before taking this medication (sus)
  Paracetamol should be given with care to patients with impaired liver function (sol)
• Severe: Contraindicated

Recommendations in other jurisdictions

• Caution; no dose adjustment recommended
  Care is advised in the administration of paracetamol to patients with severe hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease. Chronic alcohol users should consult a doctor before use

• No dose adjustment recommended

Respiratory Disorders

• Bronchospasm

Gastrointestinal Disorders 

• Acute pancreatitis

Hepatobiliary Disorders

• Hepatic impairment
• Liver injury (sus)
• Chronic hepatic necrosis (sus)
• Increased transaminases (sus)

Genitourinary Disorders

• Toxic nephropathy (sus)
• Renal papillary necrosis (sus)

Endocrine and Metabolic Disorders

• Acute pancreatitis

Skin and Subcutaneous Tissue Disorders

• Toxic Epidermal Necrolysis
• Steven-Johnson syndrome
• Acute generalised exanthematous pustulosis
• Fixed drug eruption
• Rash (sus)
• Rash pruritic (sus)
• Urticaria (sus)

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity
• Anaphylactic shock
• Angioedema
• Stevens-Johnson syndrome
• Blood dyscrasias
• Thrombocytopenia
• Agranulocytosis

• Metoclopramide
• Domperidone
• Cholestyramine
• Oral anticoagulants
• Warfarin
• Chloramphenicol
• Anti-convulsants
• Carbamazepine (sus)
• Fosphenytoin (sus)
• Phenytoin (sus)
• Barbiturates
• Phenobarbital (sus)
• Primidone (sus)
• Alcohol
• Tricyclic antidepressants
• Oral contraceptives

None routine. Specific cases may require

• Hepatic function

The mechanism of analgesic action has not been fully determined. Paracetamol may act predominantly by inhibiting prostaglandin synthesis in the central nervous system (CNS) and, to a lesser extent, through a peripheral action by blocking pain impulse generation. The peripheral action may also be due to inhibition of prostaglandin synthesis or to inhibition of the synthesis or actions of other substances that sensitise pain receptors to mechanical or chemical stimulation. Paracetamol probably produces antipyresis by acting centrally on the hypothalamic heat regulating centre to produce peripheral vaso-dilation resulting in increased blood flow through the skin, sweating and heat loss. The central action probably involves inhibition of prostaglandin synthesis in the hypothalamus.

Tablet 500mg

• Actamol (Medicine Dev)
• Adco-Napamol (Adcock)
• Adco Prolief (Adcock)
• Antalgic  (Caps Pharmaceuticals)
• Austell-Paracetamol (Austell)
• Cetapon ( Resmed Healthcare)
• Codorol (Medicine Dev)
• Clicks Paracetamol (Ranbaxy Pharmaceuticals)
• Dis-Chem Paracetamol (Dischem)
• Dolorol (Pharmacare)
• Dynadol Tablets (Arya Pharma)
• Entalgic (Thebe)
• Gulf Paracetamol (Gulf Drug)
• Gencetamol (Alliance)
• JP Paracetamol (Gulf Drug)
• Pacimol (Austell)
• Panado (Adcock) originator
• Panado Spartan Pack (Adcock) originator
• Painamol (Ranbaxy)
• Painogesic (Innovata Pharmaceuticals)
• Painblok (Gulf Drug)
• Paracet (Be-tabs)
• Parapane (F.D.C SA)
• Pyngesic T (Cipla Medpro)
• Von Paracetamol (Gulf Drug)
• Varipan (LeBasi)
• Zydus Paracetamol (Zydus)
• Zypol (Unimed Healthcare)

Capsule 500mg

• Panado (Adcock) originator

Tablet effervescent 500mg

• Parafizz (Cipla)

Suspension (per 5ml) 120mg

• Calpol (Johnson & Johnson)

Syrup (per 5ml) 120mg

• Antalgic sf (Caps Pharmaceuticals)
• Adco-Napamol (Adcock)
• Adco-Paracetamol (Adcock)
• Barrs Paracetamol (Barrs Pharmaceuticals)
• Entalgic (Thebe)
• Feverpain (Medicine Developers)
• Go-Pain (Glenmark)
• Paracet (Be-tabs)
• Paracetamol Elixir Syrup (Pharmacare) Discontinued: 01/04/2018
• Paracetamol Red (Pharmacare)
• Panado paediatric alcohol and sugar free (Adcock) originator
• Panado paediatric strawberry (Adcock) originator
• Panado paediatric (Adcock) originator
• Painblok (Gulf Drug)
• Painamol (Ranbaxy)
• Pyngesic S (Cipla Medpro)
• Painogesic (Innovata Pharmaceuticals)
• Pyralen (Thebe)
• Woodward's Paracetamol (Pharmacare)

Caplets 650mg

• Tylenol Extended Relief (Johnson & Johnson)

Infant drops 60mg

• Panado (Adcock) originator

Also available in the following forms: injection and suppository.

COMBINATION PREPARATIONS

Aspirin/ Paracetamol/ Caffeine

Tablet 226.8mg/162mg/32.4mg

• Grand-pa (GSK)

Paracetamol/ Aspirin/ Caffeine

Tablet 100mg/400mg/30mg 

• Compral (Adcock)

Paracetamol/ Aspirin/ Caffeine

Powder 324mg/453.6mg/64.8mg

• Compral (Adcock)

Ibuprofen/ Paracetamol

Tablet 200mg/350mg

• Ibumol (Pharmacare)

Tablet 400mg/325mg

• Mypaid forte (Adcock) originator

Capsule 200mg/250mg 

• Ibupain (Sandoz SA)
• Dentopain (Sandoz SA)
• Mypaid  (Adcock) originator
• Panado Plus (Adcock)

Ibuprofen/ Paracetamol

Syrup (per 10ml) 200mg/250mg

• Ibumol (Pharmacare)
• Lotem (Adcock) originator

Codeine/ Paracetamol

Syrup (per 5ml) 5mg/120mg

• Infapain (Alliance) originator

Syrup (per 5ml) 4mg/150mg

• Supragesic (Innovata Pharmaceuticals)
• Tensopyn Paed syrup (Mirren)

Tablet 8mg/320mg

• Spectrapain (Akacia)

Tablet 8mg/500mg 

• Painamol plus (Be-Tabs)
• Paincodein (Innovata Pharmaceuticals)
• Vari-Cocodamol (LeBasi)
• Cogesic (Medicine Dev)
• Rocodin (Pharma Q)
• Dino-cod (Pharma Q)
• Dolorol forte (Pharmacare)

Tablet effervescent 8mg/500mg 

• Parafizz co  (Cipla)

Tablet 10mg/500mg 

• Kodapon (Gulf Drug) 

Paracetamol/ Mephenesin

Tablet 500/150mg 

• Spasmend (Adcock) originator

Paracetamol/ Doxylamine/ Caffeine/ Codeine

Tablet 450mg/5mg/30mg/10mg

• Abflex-4 (Cipla)
• Syndol  (Adcock) originator
• Tensopyn (Mirren)
• Resdol (Adcock)

Tablet 450mg/5mg/45mg/10mg

• Acurate (Pharmascript)
• Adco-dol (Adcock)
• Pynstop (Adcock )

Tablet  450mg/5mg/50mg/10mg

• Betapyn (Adcock)

Tablet effervescent 450mg/5mg/50mg/10mg

• Tensopyn (Mirren )

Tablet effervescent 450mg/5mg/30mg/10mg

• Doxy Co (Gulf Drug )
• Sedinol (Pharmacare)
• Sedapain (Pharmacare)
• Lenapain (Pharmacare)

Tablet effervescent 500mg/5mg/30mg/10mg

• Pharmadol (Medicine Developers)

Paracetamol/ Codeine/ Caffeine/ Phenyltoloxamine

Tablet 400mg/8mg/32mg/12mg

• Suncodin (Winthrop) originator

Codeine/ Meprobamate /Paracetamol

Capsule 8mg/200mg/400mg

• Synaleve (Adcock)
• Trinagesic (Adcock) originator

Tablet 10mg/125mg/500mg

• Meprogesic (Adcock) originator

Capsule 8mg/150mg/320mg 

• Stilpane (Pharmacare)

Codeine/ Promethazine/ Paracetamol

Syrup 5mg/6.5mg/120mg

• Lentogesic (Adcock)
• Goldgesic (Medicine Developers)

Orphenadrine/ Paracetamol

Tablet 35mg/450mg

• Betaflex NC (Adcock)
• Besemax (Adcock)
• Norflex Co (iNova) originator
• Uniflex (Adcock)

Tramadol/ Paracetamol

Tablet 37.5mg/325mg

• Tramacet (Janssen) originator
• Tramazac Co (Zydus)
• Tramahexal Co (Zydus)
• Ultracet (Janssen)

Paracetamol/ Codeine/ Caffeine/ Diphenhydramine

Tablet 400mg/10mg/50mg/5mg

• Lenadol (Pharmacare)
• Propain (Adcock)
• Tensolve (Pharmacare)

Paracetamol/ Codeine/ Diphenhydramine

Syrup (per 5ml) 150mg/4mg/10mg

• Meridol-D Paediatric Syrup (Medicine Dev)

Paracetamol/ Caffeine/ Codeine/ Meprobamate

Tablet 320mg/48mg/8mg/150mg

• Spectrapain forte (Akacia)
• Stopayne  (Adcock) originator

Paracetamol/ Caffeine/ Codeine/ Meprobamate

Tablet 320mg/32mg/8mg/150mg

• Adco-Payne (Adcock)
• Adco-Salterpyn (Adcock)
• Antipyn Forte (Pharmacare)
• Goldgesic (Medicine Dev)
• Go-Pain (Glenmark)
• Megapyn (Pharmacare)
• Nucopain (Gulf Drug)
• Pynmed (Cipla Medpro)
• Xergesic (Adcock) originator
• Hopyn (Innovata Pharmaceuticals)
• Stilpane (Pharmacare)

Paracetamol/ Codeine/ Meprobamate

Capsule 400mg/200mg/8mg 

• Synaleve (Adcock)
• Trinagesic (Adcock) originator

Tablet 500mg/125mg/10mg

• Meprogesic (Adcock) originator

Capsule 320mg/150mg/8mg 

• Stilpane (Pharmacare)

Paracetamol/ Codeine/ Ibuprofen

Capsule 250mg/10mg/200mg

• Dentopain Forte (Sandoz SA)
• Gen-Payne (Adcock)
• Ibupain Forte (Sandoz SA)
• Myprodol (Adcock) originator

Capsule 350mg/10mg/200mg

• Mybulen (Pharmacare)
• Mybucod (Pharmacare)

Suspension (per 10ml) 250mg/10mg/200mg

• Myprodol (Adcock) originator
• Mybulen (Pharmacare)