Para-Supps Paracetamol 125 Mg Suppositories
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Para-Supps Paracetamol 125 mg Suppositories
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains 125 mg paracetamol For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Suppository
White to ivory-coloured, torpedo-shaped, about 26 mm in length
4 CLINICAL PARTICULARS
4.1 Therapeutic Indications
For the treatment of mild to moderate pain and fever in children.
Suppositories are useful in patients unable to take oral forms of paracetamol, e.g. post-operatively or with nausea and vomiting.
4.2 Posology and method of administration
Para-Supps Paracetamol suppositories are for rectal administration.
For children 1-5 years: 1-2 suppositories. The dosage should be based on age and
weight:
1 year (10 kg): 1 suppository 5 years (20 kg): 2 suppositories
The doses may be repeated every 4 to 6 hours, up to a maximum of 4 times in 24 hours. The recommended dose should not be exceeded. Only whole suppositories should be administered.
4.3 Contraindications
Para-Supps Paracetamol 125 mg Suppositories should not be used by patients with known hypersensitivity to paracetamol or to any other ingredient of the suppositories.
4.4 Special Warnings and Special Precautions for Use
Para-Supps Paracetamol 125 mg Suppositories should not be combined with other analgesic medications containing paracetamol.
Para-Supps Paracetamol 125 mg Suppositories should be given with care in
patients with impaired liver or kidney function
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.
The following warnings are required on the label:
• Do not give more medicine than the label tells you to. If your child does not get better, talk to your doctor
• Do not give anything else containing paracetamol while giving this medicine
• Talk to a doctor at once if your child takes too much of this medicine, even if they seem well
The following warning is required in the leaflet:
• Talk to a doctor at once if your child takes too much of this medicine even if they seem well. This is because too much paracetamol can cause delayed, serious liver damage
4.5 Interaction with other medicinal products and other forms of interaction
Drugs that 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 1.5-2.0 g paracetamol per day for 5-7 days. Occasional doses have no significant effect.
Enzyme-inducing medicines, such as some anti-epileptic drugs (phenytoin, phenobarbital, carbamazepine) have been shown in pharmacokinetic studies to reduce the plasma AUC of paracetamol by approximately 40%. Other substances with enzyme-inducing properties, eg 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 the maximum recommended doses of paracetamol will be higher in patients being treated with enzyme-inducing agents.
4.6 Pregnancy and Lactation
Epidemiological 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.
4.7 Effects on ability to drive and use machines
None likely
4.8 Undesirable effects
Side-effects at therapeutic doses are rare.
|
Frequency |
System Organ Class |
Adverse Event |
|
Common (>1/100 to <1/10) |
Miscellaneous |
Redness of the rectal mucous membranes |
|
Rare (>1/10,000 to <1/1,000) |
General |
Allergic reactions |
|
Skin |
Exanthema, urticaria | |
|
Liver |
Liver damage | |
|
Genitourinary |
Increase in creatinine (mostly secondary to hepatorenal syndrome) |
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 (see below).
4.9 Overdose
Symptoms of paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion and clinical symptoms generally culminate after 4-6 days.
Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.
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. Administration of oral methionine or intravenous N-acetylcysteine, which may have a beneficial effect up to at least 48 hours after the overdose, may be required. General supportive measures must be available.
Toxicity: 5 g during 24 hours in a child aged 3% years or 15-20 g in adults may cause fatal intoxication. The toxic dose for children and adults is generally > 140 mg/kg. Malnutrition, dehydration, medication with enzyme-inducing drugs such as some anti-epileptic drugs (phenytoin, phenobarbital, carbamazepine), rifampicin and St. John's wort (hypericum) are risk factors, and even slight overdosage can then cause marked liver damage. Even subacute “therapeutic” overdose has resulted in severe intoxication, with doses varying from 6 g/24 hours for a week, 20 g for 2-3 days, etc.
5.1 Pharmacodynamic properties
ATC Code N02B E01
Paracetamol is an aniline derivative with analgesic and antipyretic actions similar to those of aspirin but with no demonstrable anti-inflammatory activity. Paracetamol is less of an irritant to the stomach than aspirin. It does not affect thrombocyte aggregation or bleeding time. Paracetamol is generally well tolerated by patients hypersensitive to acetylsalicylic acid.
5.2 Pharmacokinetic properties
Paracetamol is well absorbed after both oral and rectal administration. Peak plasma concentrations are reached within 2 to 3 hours after rectal administration. The plasma half-life is about 2 hours.
Paracetamol is primarily metabolised in the liver to glucuronide and sulphate conjugates. A small amount (about 3-10%) is metabolised by oxidation and the reactive intermediate metabolite thus formed is bound preferentially to liver glutathione and excreted as cystein and mercapturic acid conjugates. Excretion occurs via the kidneys, with 2-3% excreted unchanged, 80-90% as glucuronide and sulphate conjugates and a smaller amount as cystein and mercapturic acid derivatives.
5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to those already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Hard fat
6.2 Incompatibilities
None
6.3 Shelf life
4 years
6.4 Special precautions for storage
Do not store above 25° C. Keep in the outer carton.
6.5 Nature and contents of container
Para-Supps Paracetamol 125 mg suppositories are available in LDPE-coated aluminium foil strips in packs containing 10 suppositories.
6.6 Special precautions for disposal
The blister should be opened immediately before use.
7 MARKETING AUTHORISATION HOLDER
Amdeepcha Limited,
85 Yarmouth Road,
Blofield,
Norwich,
Norfolk NR13 4LQ
8 MARKETING AUTHORISATION NUMBER(S)
PL 19255/0001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
27/02/2013
10 DATE OF REVISION OF THE TEXT
27/02/2013