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Alvedon Suppositories 60, 125, 250 mg

Last Updated on eMC 20-Oct-2014 View changes  | AstraZeneca UK Limited Contact details

1. Name of the medicinal product

Alvedon Suppositories 60 mg

Alvedon Suppositories 125 mg

Alvedon Suppositories 250 mg

2. Qualitative and quantitative composition

Alvedon Suppositories 60 mg: Each suppository contains Paracetamol 60 mg.

Alvedon Suppositories 125 mg: Each suppository contains Paracetamol 125 mg.

Alvedon Suppositories 250 mg: Each suppository contains Paracetamol 250 mg.

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Suppositories.

4. Clinical particulars
4.1 Therapeutic indications

For the treatment of mild to moderate pain and pyrexia in children:

Alvedon 60 mg is indicated in children aged up to 1 year.

Alvedon 125 mg is indicated in children aged 1 to 5 years.

Alvedon 250 mg is indicated in children aged 6 to 12 years.

Alvedon suppositories may be especially 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

Posology

Children under 3 months of age (60 mg suppositories)

One suppository (60 mg) is suitable for babies who develop a fever following immunisation at 2 months. Otherwise only use in babies aged less than 3 months on a doctor's advice.

Children 3 months to 1 year (60 mg suppositories)

The dosage should be based on age and weight i.e.

3 months (5 kg)

-

60mg (1 suppository)

1 year (10 kg)

-

120mg (2 suppositories)

Children 1 to 5 years (125 mg suppositories)

The dosage should be based on age and weight i.e.

1 year (10 Kg)

-

125mg (1 suppository)

5 years (20 Kg)

-

250mg (2 suppositories)

Children 6 to 12 years (250 mg suppositories)

The dosage should be based on age and weight i.e.

6 years (20 Kg)

-

250mg (1 suppository)

12 years (40 Kg)

-

500mg (2 suppositories)

Method of administration

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. Only whole suppositories should be administered – do not break suppository before administration.

4.3 Contraindications

Hypersensitivity to paracetamol or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Alvedon 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.”

4.5 Interaction with other medicinal products and other forms of interaction

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.

4.6 Fertility, pregnancy and lactation

Not applicable.

4.7 Effects on ability to drive and use machines

Not relevant.

4.8 Undesirable effects

Side-effects at therapeutic doses are rare.

Frequency

System Organ Class (SOC)

Event

Common

(≥1/100 to <1/10)

Gastrointestinal disorders

Redness of the rectal mucous membranes

Rare

(≥1/10,000 to <1/1,000)

Immune system disorders

Allergic reaction

 

Hepatobiliary disorders

Liver damage

 

Skin and subcutaneous tissue disorders

Exanthema, urticaria, angioedema

 

Investigations

Increase in creatinine (mostly secondary to hepatorenal syndrome)

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 (see below).

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme.

Website: www.mhra.gov.uk/yellowcard.

4.9 Overdose

Toxicity

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

Risk factors

If the patient

• is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's wort or other drugs that induce liver enzymes,

or

• is likely to be glutathione depleted 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 administration and clinical symptoms generally culminate after 4 to 6 days. Abnormalities of glucose metabolism and metabolic acidosis may occur.

In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, 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 clinically significant early symptoms, patients should be referred urgently to hospital for immediate medical attention. This is because early 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 - see BNF overdose section.

As concentrations soon after paracetamol ingestion are unreliable, plasma paracetamol concentration should be measured at 4 hours or later after the initial administration. Treatment with N-acetylcysteine may be used for up to 24 hours after administration of paracetamol; however, the maximum protective effect is only obtained up to 8 hours post-administration. The effectiveness of this antidote declines sharply after this 8 hour time period. If required, the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, then oral methionine may be a suitable alternative for remote areas, outside hospital.

Management of those patients presenting with serious hepatic dysfunction 24 hours after paracetamol administration should be discussed with the National Poisons Information Centre (NPIS) or a liver unit.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Anilides

ATC code: N02BE01

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 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

Absorption

Paracetamol is well absorbed by both oral and rectal routes. Peak plasma concentrations occur about 2 to 3 hours after rectal administration. The plasma half life is about 2 hours.

Biotransformation

Paracetamol is primarily metabolised in the liver by conjugation to glucuronide and sulphate. A small amount (about 3-10% of a therapeutic dose) is metabolised by oxidation and the reactive intermediate metabolite thus formed is bound preferentially to the liver glutathione and excreted as cystein and mercapturic acid conjugates.

Elimination

Excretion occurs via the kidneys. 2-3% of a therapeutic dose is excreted unchanged; 80-90% as glucuronide and sulphate and a smaller amount as cystein and mercapturic acid derivatives.

5.3 Preclinical safety data

Not applicable

6. Pharmaceutical particulars
6.1 List of excipients

Hard fat (Witepsol H12)

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

PVC/polyethylene blister strips each containing 5 suppositories. Packs of 5 or 10 suppositories.

PVC/polyethylene blister strips each containing 1 suppository. Packs of 10 suppositories.

PVC/polyethylene blister strips each containing 1 suppository packed in high density polyethylene (HDPE) bottles with child resistant, polypropylene (PP) lids. Packs of 10 suppositories.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

Peel the wrapper apart to remove the suppository, gently push into the rectum pointed end first.

7. Marketing authorisation holder

AstraZeneca UK Ltd.,

600 Capability Green,

Luton,

LU1 3LU,

UK

8. Marketing authorisation number(s)

60 mg Suppositories

PL 17901/0098

125 mg Suppositories

PL 17901/0096

250 mg Suppositories

PL 17901/0097

9. Date of first authorisation/renewal of the authorisation

16th June 2002

10. Date of revision of the text

10th October 2014

Company contact details

AstraZeneca UK Limited

Company image
Address

Horizon Place, 600 Capability Green, Luton, Bedfordshire, LU1 3LU

Fax

+44 (0)1582 838 000

Medical Information e-mail
Medical Information Fax

+44 (0)1582 838 003

Telephone

+44 (0)1582 836 000

Medical Information Direct Line

0800 783 0033

Customer Care direct line

+44 (0)1582 837 837

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Active ingredients

paracetamol

Legal categories

P - Pharmacy

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