SCHEDULING STATUS
S0
1. NAME OF THE MEDICINE
CETAPON JUNIOR PAEDIATRIC SYRUP
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of CETAPON JUNIOR PAEDIATRIC SYRUP contains 120 mg Paracetamol.
The syrup is preserved with Benzoic acid 0,3% m/v.
CETAPON JUNIOR PAEDIATRIC SYRUP is sugar free and tartrazine free.
It contains sweetener: 6 mg sodium saccharin per 5 ml.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Syrup.
CETAPON JUNIOR PAEDIATRIC SYRUP is a green syrupy liquid with a characteristic smell of peppermint.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
CETAPON JUNIOR PAEDIATRIC SYRUP is used for the relief of mild to moderate pain and fever.
4.2 Posology and method of administration
Children
| Age group | Dose |
|---|---|
| 7 – 12 years | Up to 20 ml |
| 1 – 6 years | 5 – 10 ml |
| 3 months to 1 year | 2,5 – 5 ml |
Repeat dosage 3 to 4 hourly, if necessary, but not more than 4 doses in 24 hours.
DO NOT EXCEED THE RECOMMENDED DOSE.
Do not use continuously for more than ten days without consulting your doctor.
Method of administration
Dose to be taken orally.
4.3 Contraindications
CETAPON JUNIOR PAEDIATRIC SYRUP must not be used in patients with hypersensitivity to paracetamol or any of the other ingredients.
CETAPON JUNIOR PAEDIATRIC SYRUP must not be used in patients with severe liver function impairment.
4.4 Special warnings and precautions for use
CETAPON JUNIOR PAEDIATRIC SYRUP contains paracetamol, which may be fatal in overdose.
In the event of overdosage or suspected overdose, and even if the person may be asymptomatic, the nearest doctor, hospital or Poison Centre must be contacted immediately.
Dosages of CETAPON JUNIOR PAEDIATRIC SYRUP 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 are present, as these may be signs of a more serious condition.
Do not use this product continuously for more than 10 days without consulting your doctor.
Patients suffering from hepatitis or alcoholism, or recovering from any form of liver disease, should not take excessive quantities of CETAPON JUNIOR PAEDIATRIC SYRUP.
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, also known as SCARs, have been reported in patients treated with paracetamol-containing medicines.
These reactions include:
| Severe skin reaction | Abbreviation |
|---|---|
| Toxic epidermal necrolysis | TEN |
| Stevens-Johnson syndrome | SJS |
| Acute generalised exanthematous pustulosis | AGEP |
| Drug rash with eosinophilia and systemic symptoms | DRESS |
| Drug-induced hypersensitivity syndrome | DIHS |
| Fixed drug eruptions | FDE |
If a patient develops signs of severe cutaneous adverse reactions, treatment with CETAPON JUNIOR PAEDIATRIC SYRUP must be discontinued immediately and appropriate treatment must be instituted.
4.5 Interaction with other medicines and other forms of interaction
The following interactions should be considered when using CETAPON JUNIOR PAEDIATRIC SYRUP.
| Medicine / medicine group | Interaction information |
|---|---|
| Hepatotoxic medicines | Increased risk of hepatotoxicity. |
| Enzyme inducing medicines | Increased risk of hepatotoxicity and possible decrease in therapeutic effects of CETAPON JUNIOR PAEDIATRIC SYRUP. |
| Metoclopramide | Absorption of CETAPON JUNIOR PAEDIATRIC SYRUP may be accelerated. |
| Cholestyramine | Absorption of CETAPON JUNIOR PAEDIATRIC SYRUP is reduced if given within one hour of cholestyramine. |
| Salicylates | Prolonged concurrent use with CETAPON JUNIOR PAEDIATRIC SYRUP increases the risk of adverse renal effects. |
| Warfarin and anticoagulants | Concurrent, chronic, high-dose administration may increase the anticoagulant effect. |
| Antiepileptics | 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 | Pre-treatment with probenecid can decrease paracetamol clearance and increase its plasma half-life. |
| Antibacterials | Plasma-paracetamol concentrations considered an indication for antidote treatment should be halved in patients receiving enzyme-inducing medicines such as rifampicin. |
| Isoniazid | Severe hepatotoxicity at therapeutic doses or moderate overdoses of paracetamol has been reported in patients receiving isoniazid, alone or with other medicines for tuberculosis. |
| Flucloxacillin | Caution is advised due to increased risk of high anion gap metabolic acidosis, especially in patients with risk factors for glutathione deficiency. |
| Antivirals | Severe hepatotoxicity has occurred after use of paracetamol in a patient taking zidovudine and co-trimoxazole. |
Paracetamol is recommended as the general analgesic and antipyretic of choice in patients on oral anticoagulant therapy. However, caution is needed because some studies and isolated reports have found an increased risk of bleeding in patients taking regular doses of paracetamol while on oral anticoagulants. Increased monitoring of anticoagulant therapy may be appropriate for patients also taking paracetamol regularly.
Close monitoring is recommended when paracetamol is administered with flucloxacillin to detect acid-base disorders, including high anion gap metabolic acidosis and urinary 5-oxoproline.
4.6 Fertility, pregnancy and breastfeeding
Safety and efficacy in pregnancy and breastfeeding have not been established.
No data are available on fertility.
4.7 Effects on ability to drive and use machines
CETAPON JUNIOR PAEDIATRIC SYRUP has no or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects
Like all medicines, CETAPON JUNIOR PAEDIATRIC SYRUP may cause undesirable effects. Not all patients will experience these effects.
Tabulated list of adverse reactions
| System Organ Class | Frequent | Less frequent | Frequency not known |
|---|---|---|---|
| Blood and lymphatic system disorders | Agranulocytosis, thrombocytopenia, leucopoenia, pancytopenia, neutropenia, anaemia | ||
| Metabolism and nutrition disorders | Pyroglutamic aciduria, also known as 5-oxoprolinuria, and high-anion gap metabolic acidosis | ||
| Ear and labyrinth disorders | Hearing loss | ||
| Cardiac disorders | Possible increase in the risk of hypertension | ||
| Gastrointestinal disorders | Pancreatitis | Nausea and vomiting | |
| Hepatobiliary disorders | Hepatitis | ||
| Skin and subcutaneous tissue disorders | Dermatitis, skin rash and other allergic reactions such as toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalised exanthematous pustulosis, drug rash with eosinophilia and systemic symptoms, drug-induced hypersensitivity syndrome and fixed drug eruptions. The rash is usually erythematous or urticarial but may sometimes be more serious and accompanied by fever and mucosal lesion. Mild rashes and other hypersensitivity reactions may also occur occasionally. | ||
| Renal and urinary disorders | Renal colic, renal failure and sterile pyuria | Nephropathy | |
| Investigations | Increased transaminases. Low-level transaminase elevations may occur in some patients taking therapeutic doses of paracetamol. These elevations are not accompanied by liver failure and usually resolve with continued therapy or discontinuation of paracetamol. |
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 providers are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”.
4.9 Overdose
Prompt treatment is essential.
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 the antidote is given too late to be effective.
Evidence of liver damage is often delayed until after the time for effective treatment has passed.
Susceptibility to paracetamol toxicity is increased in patients who have taken repeated high doses 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 overdose
Symptoms of paracetamol overdosage in the first 24 hours may include:
| Symptom |
|---|
| Pallor |
| Nausea |
| Vomiting |
| Anorexia |
| 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. Initial signs may include elevation of 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 of overdosage
N-acetylcysteine should be administered to all cases of suspected overdose as soon as possible, preferably within eight hours of overdosage.
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 may be 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 1 000 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 may be misleading.
Patients at risk of liver damage, and therefore 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. The nomogram should be used only in relation to a single acute ingestion.
Patients whose plasma paracetamol levels are above the normal treatment line should continue N-acetylcysteine treatment with 100 mg/kg intravenously over sixteen hours repeatedly until recovery.
Patients with increased susceptibility to liver damage should continue treatment if concentrations are above the high-risk treatment line.
Prothrombin index correlates best with survival.
All patients with significant ingestions should be monitored for at least 96 hours.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: A 2.7 Anti-pyretic or anti-pyretic and anti-inflammatory analgesics.
Paracetamol has analgesic and antipyretic actions.
5.2 Pharmacokinetic properties
Absorption
Following oral administration, paracetamol is well absorbed, with peak plasma concentrations obtained after 0,5 to 1 hour.
The plasma half-life is about 2 hours.
Distribution
Plasma protein binding is variable.
Paracetamol is distributed into most body tissues.
It crosses the placenta and is present in breast milk.
Elimination
Paracetamol is metabolised in the liver primarily by conjugation with glucuronic acid, sulphuric acid and cysteine.
Paracetamol is renally excreted primarily as conjugated metabolites.
5.3 Preclinical safety data
No additional preclinical safety data are included.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
CETAPON JUNIOR PAEDIATRIC SYRUP contains the following excipients:
| Excipient |
|---|
| Glycerin |
| Propylene glycol |
| Polyethylene glycol |
| Povidone |
| Sodium benzoate |
| Sodium saccharin |
| Quinoline yellow |
| Sunset yellow |
| Brilliant blue |
| Peppermint flavour |
| Purified water |
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
2 years.
6.4 Special precautions for storage
Store in a cool place at or below 25 °C.
Protect from light.
KEEP OUT OF REACH OF CHILDREN.
6.5 Nature and contents of container
CETAPON JUNIOR PAEDIATRIC SYRUP is supplied in amber bottles of:
| Pack size |
|---|
| 50 ml |
| 100 ml |
6.6 Special precautions for disposal and other handling
Not applicable.
7. HOLDER OF CERTIFICATE OF REGISTRATION
Resmed Healthcare
71 Rochdale Road
Springfield Park
Durban
4051
8. REGISTRATION NUMBERS
Q/2.7/96
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
20/09/1982
10. DATE OF REVISION OF THE TEXT
06/02/2024
