PARASERTS

Method of administration:

Rectal Children aged 1 to 5 years: 1 to 3 years: 1 suppository every 4 to 6 hours. 4 to 5 years: 1-2 suppositories every 4 to 6 hours These doses may be repeated up to a maximum of 4 times in 24 hours. 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 pharmacist or doctor. Only whole suppositories should be administered – do not break the suppository before administration.

Adverse drug reactions (ADRs) are listed below by System Organ Class (SOC).

The frequencies are defined according to the following convention:

Very common ≥ 1/10 Common ≥ 1/100 to <1/10 Uncommon ≥ 1/1,000 to <1/100) Rare ≥ 1/10,000 to <1/1,000 Very rare <1/10,000 System Organ Class Frequency Adverse Drug Reaction Blood and lymphatic system disorders Not known Blood disorder (including thrombocytopenia and agranulocytosis)1 Immune system disorders Very rare Very rare Anaphylactic reaction Hypersensitivity Hepatobiliary disorders Not known Liver injury2 Skin and subcutaneous tissue disorders Very rare Not known Not known Not known Rash Fixed eruption Rash pruritic Urticaria Renal and urinary disorders Rare Increase in creatinine (mostly secondary to hepatorenal syndrome) Investigations Not known Transaminases increased3 Metabolism and nutrition disorders Not known High anion gap metabolic acidosis General disorders and administration site conditions Common Anorectal erythema 1 Reported following paracetamol use, but not necessarily causally related to the drug 2 Chronic hepatic necrosis has been reported in a patient who took daily therapeutic doses of paracetamol for about a year 3 Low level transaminase elevations may occur in some patients taking therapeutic doses of paracetamol; these elevations are not accompanied with liver failure and usually resolve with continued therapy or discontinuation of paracetamol.

Very rare cases of serious skin reactions have been reported. 4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Paraserts 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. In general, the habitual use of painkillers, especially with combinations of more than one pain killing active ingredient, can lead to permanent kidney damage with the risk of liver failure (analgesic nephropathy).

The label and leaflet contain the following statements:

Label: CONTAINS PARACETAMOL. Do not give more medicine than the label tells you to. If your child does not get better, talk to a doctor. Do not give anything else containing paracetamol while giving this medicine. Talk to a doctor at once if your child uses much of this medicine, even if they seem well.

Leaflet:

Talk to a doctor at once if your child uses too much of this medicine, even if they seem well. This is because too much paracetamol can cause delayed, serious liver damage. 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.

1. Paraserts Suppositories contain soya oil. If you are allergic to peanut or soya, do not use this medicinal product.