For the treatment of mild to moderate pain and pyrexia. The suppositories may be particularly useful in patients unable to take oral forms of Paracetamol e.g. postoperatively or with nausea and vomiting.

The dose should not be repeated more frequently than every 4 hours. The recommended dose should not be exceeded. Higher doses do not produce any increase in analgesic effect. The product should not be used for more than 3 days, except on the advice of a doctor. Only whole suppositories should be administered – do not break the suppository before administration

1 - 5 years (10 – 18kg): 1 – 2 suppositories; maximum of 1g in 24 hours.

Dose may be repeated every 4–6 hours with a maximum of 4 doses in 24 hours. The dose should be based on age and weight i.e.

1 year (10kg) – (120mg) 1 suppository

5 years (18kg) – (240mg) 2 suppositories

Cetal Suppositories should not be combined with other analgesic medications that contain paracetamol. Paracetamol should be given with care to patients with impaired kidney or liver function.

Doses higher than those recommended involve a risk of very severe liver damage. Liver damage is also associated with certain risk factors (see also Section 4.5 Interaction with other medicinal products and other forms of interaction, and Section 4.9 Overdose). If liver damage is suspected then liver function tests should be performed.

Do not exceed the recommended dose. If symptoms persist consult your doctor. Keep out of the sight and reach of children.

Label and Leaflet will state the following warnings:

Label:

“Immediate medical advice should be sought in the event of an overdose, even if the child seems well”.

“Do not give with any other paracetamol-containing products.”

Leaflet:

“Immediate medical advice should be sought in the event of an overdose, even if the child seems well, because of the risk of delayed, serious liver damage.”

 Caution is advised if paracetamol 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.

Drugs which induce hepatic microsomal enzymes such as alcohol, barbiturates and other anticonvulsants, may increase the hepatotoxicity of paracetamol, particularly after overdosage.

The anti-coagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding. The effect appears to increase as the dose of paracetamol is increased, but can occur with doses as low as 1.5–2 g paracetamol per day for at least 5–7 days. Occasional doses have no significant effect.

Probenicid inhibits the glucuronidation of paracetamol which can affect the clearance of paracetamol. This should be considered when these medicines are administered concomitantly.

Paracetamol may affect the pharmacokinetics of chloramphenicol. This interaction should be considered when these medications are administered concomitantly, especially in malnourished patients.

Enzyme-inducing medicines, such as some antiepileptic drugs (phenytoin, phenobarbital, carbamazepine, primidone) have been shown in pharmacokinetic studies to reduce the plasma AUC of paracetamol to approx. 60 %. Other substances with enzyme-inducing properties, e.g. rifampicin and St. John's wort (hypericum) are also suspected of causing lowered concentrations of paracetamol. In addition, the risk of liver damage during treatment with maximum recommended doses of paracetamol will be higher in patients being treated with enzyme-inducing agents.

Caution should be taken when paracetamol is used concomitantly with flucloxacillin as concurrent intake has been associated with high anion gap metabolic acidosis, especially in patients with risks factors (see section 4.4)

 Phenytoin may reduce the analgesic and antipyretic effects of paracetamol and may increase the formation of the toxic N-acetyl-p-benzoquinone imine (NAPQI) metabolite of paracetamol leading to increased risk of hepatotoxicity.

Epidemologal studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use.

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

None.

Side-effects at therapeutic doses are rare.

Very rare cases of serious skin reactions have been reported.

There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.

Hepatic necrosis may occur after overdosage.

To report any side effects:

The National Pharmacovigilance Centre (NPC)

SFDA Call Center: 19999

Email: NPC.drug@sfda.gov.sa

Website: https://ade.sfda.gov.sa/

Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk Factors:

If the patient:

A- Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John’s Wort or other drugs that induce liver enzymes.

Or

B- Regularly consumes ethanol in excess of recommended amounts.

Or

C- It is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Symptoms:

Symptoms of paracetamol overdosage 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, haemorrage, hypoglycaemia, cerebral oedema and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Management:

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. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines.

Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of Paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.

Paracetamol is an antipyretic and analgesic proven in paediatric use.

Paracetamol produces antipyresis through action on the hypothalmic heatregulation centre and analgesia by elevation of the pain threshold. Paracetamol has analgesic and antipyretic actions similar to those of aspirin but it has no useful anti-inflammatory properties.   

Paracetamol has analgesic and antipyretic actions but only weak anti-inflammatory properties.

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Peak plasma concentrations occur within 0.5 to 2 hours, with slightly faster absorption of liquid preparations. Usual analgesic doses produce total serum concentrations of 5 to 20mcg/ml. A good correlation between serum concentration and analgesic effect has not been found. Serum protein binding varies from 20% to 50% at toxic serum concentrations.

Paracetamol is excreted in the urine mostly as metabolites; 2-4% is excreted unchanged. The average elimination half-life is 1 to 4 hours: half-life is slightly prolonged in neonates (2.2 to 5 hours) and in cirrhotics.

The overall elimination rate constant for paracetamol in children, from birth to 12 years of age, is the same as for adults but neonates have diminished capacity to form glucuronide conjugates of paracetamol.

None.

Propylene glycol monostearate, cremophor EL, hard fat.                      

None known.  

Store below 30˚C.

Carton box containing 1 or 20 (PVC/PE) strips of 5 suppositories each and inner leaflet.

For use on one occasion only. Discard any unused material. Do not use if strip is damaged.