- Approval Id
- 6f1ca45f5d15c852
- Drug Approval Emc Name
- Paracetamol 80mg Suppositories
- Drug Name
- Paracetamol 80mg Suppositories
- Company Address
- Suit 12 Bunkilla Plaza, Bracetown Business Park, Meath, Ireland
- Company Website
- http://www.phoenixlabs.ie
- Company Telephone
- +353 1 574 2410
- Company Medical Info Direct Line
- +353 1 574 2410
- Company Medical Info Email
- medicalinformation@phoenixlabs.ie
- Company Medical Info Fax
- +353 1 8362271
- Atc Code
- N02BE01
- Legal Category
- Pharmacy
- Authorisation Holder
- Phoenix Labs
Suite 12, Bunkilla Plaza
Bracetown Business Park
Clonee
Co. Meath
Ireland
- Authorisation Number
- PL 35104/0003
- Authorisation Date
- 17/01/2012
- Instruction Authorisation Holder
- Phoenix Labs
Suite 12, Bunkilla Plaza
Bracetown Business Park
Clonee
Co. Meath
Ireland
- Instruction Authorisation Number
- PL 35104/0003
- Instruction Authorisation Date
- 17/01/2012
- Instruction Composition
- Each suppository contains 80mg Paracetamol
For a full list of excipients, see section 6.1
- Instruction Dosage Form
- Suppository
White, torpedo shaped, suppository
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
For the treatment of mild to moderate pain and fever in babies and children.
Paracetamol 80 mg suppositories are indicated in children from the age of 3 months.
Paracetamol suppositories may be especially useful in patients unable to take oral forms of paracetamol e.g. Post-operative patients or patients with nausea and/or vomiting.4.2 Posology and method of administration
\*\*Posology\*\*
\*Paediatric Population\*
Dosage should be based on the child's weight, with a recommended dosage of 15mg/kg per administration. Ages presented below are provided as an accompanying guide only.
3 – 12 months (5kg): One suppository
\*\*Method of administration\*\*
\*\*For rectal use only.\*\*
This dose 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. The product should not be used for more than 3 days, except on the advice of a doctor. Higher doses do not produce any increase in analgesic effect. Only whole suppositories should be administered – do not break the suppository before administration.
\*Hepatic / renal dysfunction\*
Caution should be exercised when administering the product to patients with severe hepatic or renal impairment.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
Paracetamol suppositories should not be combined with other analgesic medications that contain paracetamol.
Paracetamol suppositories should be administered with care to patients with impaired kidney or liver function.
The hazards of overdose are greater in those with non-cirrhotic liver disease.
Label and leaflet should state the following warnings:
\*\*Label\*\*
Do not exceed the stated dose.
If symptoms persist consult your doctor.
Keep out of the reach and sight of children.
Leave at least 4 hours between doses.
Immediate medical advice should be sought in the case of an overdose, even if the child seems well.
Do not give with 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.4.5 Interaction with other medicinal products and other forms of interaction
The anti-coagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding. Occasional doses have no significant effect.
Drugs which induce hepatic microsomal enzymes such as alcohol, barbiturates and other anticonvulsants, may increase the hepatotoxicity of paracetamol, particularly after over-dosage. 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)4.6 Fertility, pregnancy and lactation
\*\*Fertility\*\*
There are no data on the effects of paracetamol suppositories on human fertility.
\*\*Pregnancy\*\*
A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically needed, paracetamol can be used during pregnancy however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency.
\*\*Breast-feeding\*\*
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
Not relevant.4.8 Undesirable effects
Adverse drug reactions are rare.
| | | | |
| --- | --- | --- | --- |
| \*\*MedDRA System Organ Class (SOC)\*\* | \*\*Common\*\* \*\*≥1/100 to <1/10\*\* | \*\*Uncommon\*\* \*\*≥1/1,000 to <1/100\*\* | \*\*Rare\*\* \*\*≥1/10,000 to <1/1,000\*\* |
| Immune system disorders | | | Allergic reaction |
| Gastrointestinal disorders | Redness or soreness of the rectal mucous membrane | | |
| Hepatobiliary disorders | | | Liver damage |
| Skin and subcutaneous tissue disorders | | | Exanthema, urticaria, angioedema |
Very rare cases of serious skin reactions have been reported.
There have been reports of blood dyscrasias including thromocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.
Hepatic necrosis may occur after paracetamol overdose (see Section 4.9).
\*\*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 at: www.mhra.gov.uk/yellowcard.4.9 Overdose
\*\*Toxicity\*\*
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 carabamazepine, 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. 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 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.
\*\*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 sharply 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.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
Pharmacotherapeutic Group: Anilides, ATC Code: N02 BE01
Paracetamol is an aniline derivative with analgesic and antipyretic actions similar to those of aspirin but with no demonstrable anti-inflammatory activity. It does not affect thrombocyte aggregation or bleeding time. Paracetamol is generally well tolerated by patients hypersensitive to acetylsalicylic acid. It produces analgesia by elevation of the pain threshold and antipyresis through action on the hypothalamic heat-regulation center.5.2 Pharmacokinetic properties
\*\*Absorption\*\*
Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Peak plasma concentrations occur about 2 to 3 hours after rectal administration. Usual analgesic doses produce total serum concentrations of 5 to 20mcg/ml.
\*\*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\*\*
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.5.3 Preclinical safety data
Conventional studies using the currently accepted standards for the evaluation of toxicity to reproduction and development are not available.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Hard fat
Macrogol cetostearyl ether
Glyceryl ricinoleate6.2 Incompatibilities
Not applicable.6.3 Shelf life
2 years.6.4 Special precautions for storage
Do not store above 25°C.6.5 Nature and contents of container
Ten suppositories packed in white/opaque PVC/PE film.
Each suppository is packed separately. Due to the perforations of the welds an individual suppository can be torn out.
Two strips, each containing five suppositories, are packed into a cardboard carton.6.6 Special precautions for disposal and other handling
The suppository should only be removed from the blister packaging immediately before use.
- Instruction Content
- ## Composition
Each suppository contains 80mg Paracetamol
For a full list of excipients, see section 6.1
## Pharmaceutical Form
Suppository
White, torpedo shaped, suppository
## Clinical Particulars
4.1 Therapeutic indications
For the treatment of mild to moderate pain and fever in babies and children.
Paracetamol 80 mg suppositories are indicated in children from the age of 3 months.
Paracetamol suppositories may be especially useful in patients unable to take oral forms of paracetamol e.g. Post-operative patients or patients with nausea and/or vomiting.4.2 Posology and method of administration
\*\*Posology\*\*
\*Paediatric Population\*
Dosage should be based on the child's weight, with a recommended dosage of 15mg/kg per administration. Ages presented below are provided as an accompanying guide only.
3 – 12 months (5kg): One suppository
\*\*Method of administration\*\*
\*\*For rectal use only.\*\*
This dose 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. The product should not be used for more than 3 days, except on the advice of a doctor. Higher doses do not produce any increase in analgesic effect. Only whole suppositories should be administered – do not break the suppository before administration.
\*Hepatic / renal dysfunction\*
Caution should be exercised when administering the product to patients with severe hepatic or renal impairment.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
Paracetamol suppositories should not be combined with other analgesic medications that contain paracetamol.
Paracetamol suppositories should be administered with care to patients with impaired kidney or liver function.
The hazards of overdose are greater in those with non-cirrhotic liver disease.
Label and leaflet should state the following warnings:
\*\*Label\*\*
Do not exceed the stated dose.
If symptoms persist consult your doctor.
Keep out of the reach and sight of children.
Leave at least 4 hours between doses.
Immediate medical advice should be sought in the case of an overdose, even if the child seems well.
Do not give with 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.4.5 Interaction with other medicinal products and other forms of interaction
The anti-coagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding. Occasional doses have no significant effect.
Drugs which induce hepatic microsomal enzymes such as alcohol, barbiturates and other anticonvulsants, may increase the hepatotoxicity of paracetamol, particularly after over-dosage. 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)4.6 Fertility, pregnancy and lactation
\*\*Fertility\*\*
There are no data on the effects of paracetamol suppositories on human fertility.
\*\*Pregnancy\*\*
A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically needed, paracetamol can be used during pregnancy however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency.
\*\*Breast-feeding\*\*
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
Not relevant.4.8 Undesirable effects
Adverse drug reactions are rare.
| | | | |
| --- | --- | --- | --- |
| \*\*MedDRA System Organ Class (SOC)\*\* | \*\*Common\*\* \*\*≥1/100 to <1/10\*\* | \*\*Uncommon\*\* \*\*≥1/1,000 to <1/100\*\* | \*\*Rare\*\* \*\*≥1/10,000 to <1/1,000\*\* |
| Immune system disorders | | | Allergic reaction |
| Gastrointestinal disorders | Redness or soreness of the rectal mucous membrane | | |
| Hepatobiliary disorders | | | Liver damage |
| Skin and subcutaneous tissue disorders | | | Exanthema, urticaria, angioedema |
Very rare cases of serious skin reactions have been reported.
There have been reports of blood dyscrasias including thromocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.
Hepatic necrosis may occur after paracetamol overdose (see Section 4.9).
\*\*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 at: www.mhra.gov.uk/yellowcard.4.9 Overdose
\*\*Toxicity\*\*
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 carabamazepine, 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. 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 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.
\*\*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 sharply 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.
## Pharmacological Properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic Group: Anilides, ATC Code: N02 BE01
Paracetamol is an aniline derivative with analgesic and antipyretic actions similar to those of aspirin but with no demonstrable anti-inflammatory activity. It does not affect thrombocyte aggregation or bleeding time. Paracetamol is generally well tolerated by patients hypersensitive to acetylsalicylic acid. It produces analgesia by elevation of the pain threshold and antipyresis through action on the hypothalamic heat-regulation center.5.2 Pharmacokinetic properties
\*\*Absorption\*\*
Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Peak plasma concentrations occur about 2 to 3 hours after rectal administration. Usual analgesic doses produce total serum concentrations of 5 to 20mcg/ml.
\*\*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\*\*
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.5.3 Preclinical safety data
Conventional studies using the currently accepted standards for the evaluation of toxicity to reproduction and development are not available.
## Pharmaceutical Particulars
6.1 List of excipients
Hard fat
Macrogol cetostearyl ether
Glyceryl ricinoleate6.2 Incompatibilities
Not applicable.6.3 Shelf life
2 years.6.4 Special precautions for storage
Do not store above 25°C.6.5 Nature and contents of container
Ten suppositories packed in white/opaque PVC/PE film.
Each suppository is packed separately. Due to the perforations of the welds an individual suppository can be torn out.
Two strips, each containing five suppositories, are packed into a cardboard carton.6.6 Special precautions for disposal and other handling
The suppository should only be removed from the blister packaging immediately before use.
- Company Detail Path
- /organization/phoenix-labs
