Paracetamol 120mg/5ml Oral Suspension (04917/0028)

Pinewood Healthcare🇬🇧 Electronic Medicines Compendium

Approval Date: N/A
Approval ID: ce697ad3c7866efb
Company: Pinewood Healthcare
Type: Standard

Approval Details

Approval Id: ce697ad3c7866efb
Drug Approval Emc Name: Paracetamol 120mg/5ml Oral Suspension (04917/0028)
Drug Name: Paracetamol 120mg/5ml Oral Suspension (04917/0028)
Company Name: Pinewood Healthcare
Company Address: Ballymacarby, Clonmel, Co. Tipperary, Co. Tipperary, Ireland
Company Website: http://www.pinewood.ie
Company Telephone: +353 52 6186000
Company Medical Info Direct Line: +353 52 6186000
Company Medical Info Email: drug.safety@pinewood.ie
Company Medical Info Fax: +353 52 6136311
Legal Category: Pharmacy
Authorisation Holder: Pinewood Laboratories Limited Ballymacarbry Clonmel Co Tipperary Ireland
Authorisation Number: PL 04917/0028
Authorisation Date: 23/03/2007
Instruction Authorisation Holder: Pinewood Laboratories Limited Ballymacarbry Clonmel Co Tipperary Ireland
Instruction Authorisation Number: PL 04917/0028
Instruction Authorisation Date: 23/03/2007
Instruction Composition: Each 5 ml spoonful contains Paracetamol Ph. Eur 120 mg. For excipients, see 6.1
Instruction Dosage Form: Oral Suspension. Cream to brown oral suspension with cherry odour and taste.
Instruction Clinical Particulars: 4.1 Therapeutic indications For the treatment of mild to moderate pain and as an anti-pyretic. Used for the relief of pain and feverishness associated with teething, toothache, headache, colds, flu and post-immunisation pyrexia.4.2 Posology and method of administration \*\*Children aged 3 months – 6 years:\*\* | | | | | --- | --- | --- | | Child's Age | How Much | How often (in 24 hours) | | 3 – 6 months | 2.5 ml | 4 times | | 6 – 24 months | 5 ml | 4 times | | 2 – 4 years | 7.5 ml (5 ml + 2.5 ml) | 4 times | | 4 – 6 years | 10 ml (5 ml + 5 ml) | 4 times | | • Do not give more than 4 doses in any 24-hour period • Leave at least 4 hours between doses • Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist | | | | | | --- | | \*\*Babies over 2 months in age\*\* \*\*For the relief of fever after vaccination at 2, 3 and 4 months\*\* 2.5ml. This dose may be given up to 4 times a day at the time of vaccination. Do not give more than 4 doses in any 24hour period. Leave at least 4 hours between doses. If your baby still needs this medicine two days after receiving the vaccine talk to your doctor or pharmacist. | \*\*`\*\* It is important to \*\*shake the bottle\*\* for at least 10 seconds before use.4.3 Contraindications Hypersensitivity to Paracetamol or any of the other constituents.4.4 Special warnings and precautions for use Care is advised in the administration of Paracetamol to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with (non-cirrhotic) alcoholic liver disease. Cases of high anion gap metabolic acidosis (HAGMA) due to pyroglutamic acidosis have been reported in patients with severe illness such as severe renal impairment and sepsis, or in patients with malnutrition and other sources of glutathione deficiency (e.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. The label should contain the following statements: • Contains paracetamol. • Do not give this medicine with any other paracetamol-containing product. • For oral use only. • Never give more medicine than shown in the table. • Do not overfill the spoon. • Always use the spoon supplied with the pack. • Do not give more than 4 doses in any 24hour period. • Leave at least 4 hours between doses. • Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist. • If your baby still needs this medicine two days after receiving the vaccine talk to you doctor or pharmacist. (leaflet). • As with all medicines, if your child is currently taking any medicine consult your doctor or pharmacist before taking this product. • Do not store above 25ºC. Store in the original package. • Keep all medicines out of the sight and reach of children • Talk to a doctor at once if your child takes too much of this medicine, even if they seem well (label). • 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. (leaflet) Patients with rare hereditary problems of fructose intolerance should not take this medicine.4.5 Interaction with other medicinal products and other forms of interaction Drugs which induce hepatic microsomal enzymes such as alcohol. Concomitant barbiturates and tricyclic antidepressants may increase the hepatoxicity of Paracetamol particularly after overdose. Anti-convulsant or oral steroid contraceptives have the ability to reduce serum levels of Paracetamol by liver enzyme induction. The speed of absorption of Paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. 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. Caution should be taken when paracetamol is used concomitantly with flucloxacillin as concurrent intake has been associated with high anion gap metabolic acidosis due to pyroglutamic acidosis, especially in patients with risks factors (see section 4.4)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. A large amount of data on pregnant women indicates 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. 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.4.8 Undesirable effects Very rare cases of serious skin reactions have been reported. Adverse effects of Paracetamol are rare but hypersensitivity including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily casually related to Paracetamol. With prolonged use or overdosage, hepatic necrosis, acute pancreatitis and nephrotoxicity have been reported. SOC: Metabolism and nutrition disorders “High anion gap metabolic acidosis'' with frequency ''Not known'' (cannot be estimated from the available data) Description of selected adverse reactions High anion gap metabolic acidosis Cases of high anion gap metabolic acidosis due to pyroglutamic acidosis have been observed in patients with risk factors using paracetamol (see section 4.4). 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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.4.9 Overdose 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. \*\*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, 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, 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 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, see BNF overdose section. Treatment with activated charcoal should be considered if the overdose has been taken within one 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 24 h from ingestion should be discussed with the NPIS or a liver unit.
Instruction Pharmacology: 5.1 Pharmacodynamic properties Paracetamol is an antipyretic analgesic. The mechanism of action is probably similar to that of aspirin and dependent on the inhibition of prostaglandin synthesis. This inhibition appears, however, to be on a selective basis.5.2 Pharmacokinetic properties Paracetamol is rapidly and almost completely absorbed from the gastro-intestinal tract. The concentration in plasma reaches a peak in 30 to 60 minutes and the half-life in plasma is 1 to 4 hours after therapeutic doses. Paracetamol is relatively uniformly distributed throughout most body fluids. Binding of the drug to plasma proteins is variable; 20 to 50% may be bound at the concentrations encountered during acute intoxication. Following therapeutic doses 90 to 100% of the drug may be recovered in the urine within the first day. However, practically no Paracetamol is excreted unchanged, and the bulk is excreted after hepatic conjugation.5.3 Preclinical safety data There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC. 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 Ethanol 96% Sorbitan Monooleate Glycerol (E422) Magnesium Aluminium Silicate Liquid Maltitol (E965) Saccharin Sodium (E954) Xanthan Gum Cherry Flavour Sodium Benzoate (E211) Citric Acid (monohydrate) Polysorbate 80 Purified water6.2 Incompatibilities None known.6.3 Shelf life Amber glass bottles – 5 years High density polyethylene – 5 years.6.4 Special precautions for storage Do not store above 25ºC. Store in the original container. Keep container in the outer carton.6.5 Nature and contents of container Pharmaceutical grade III amber glass bottles with pilfer proof screw caps. Pack sizes: 70 ml, 100 ml, 150 ml, 200 ml, 500 ml, 1 Litre and 2 litre. High density polyethylene bottles with tamper evident plastic cap. Pack sizes: 500 ml, 1 Litre and 2 Litre.6.6 Special precautions for disposal and other handling As for all medicines – no special requirements.
Instruction Content: ## Composition Each 5 ml spoonful contains Paracetamol Ph. Eur 120 mg. For excipients, see 6.1 ## Pharmaceutical Form Oral Suspension. Cream to brown oral suspension with cherry odour and taste. ## Clinical Particulars 4.1 Therapeutic indications For the treatment of mild to moderate pain and as an anti-pyretic. Used for the relief of pain and feverishness associated with teething, toothache, headache, colds, flu and post-immunisation pyrexia.4.2 Posology and method of administration \*\*Children aged 3 months – 6 years:\*\* | | | | | --- | --- | --- | | Child's Age | How Much | How often (in 24 hours) | | 3 – 6 months | 2.5 ml | 4 times | | 6 – 24 months | 5 ml | 4 times | | 2 – 4 years | 7.5 ml (5 ml + 2.5 ml) | 4 times | | 4 – 6 years | 10 ml (5 ml + 5 ml) | 4 times | | • Do not give more than 4 doses in any 24-hour period • Leave at least 4 hours between doses • Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist | | | | | | --- | | \*\*Babies over 2 months in age\*\* \*\*For the relief of fever after vaccination at 2, 3 and 4 months\*\* 2.5ml. This dose may be given up to 4 times a day at the time of vaccination. Do not give more than 4 doses in any 24hour period. Leave at least 4 hours between doses. If your baby still needs this medicine two days after receiving the vaccine talk to your doctor or pharmacist. | \*\*`\*\* It is important to \*\*shake the bottle\*\* for at least 10 seconds before use.4.3 Contraindications Hypersensitivity to Paracetamol or any of the other constituents.4.4 Special warnings and precautions for use Care is advised in the administration of Paracetamol to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with (non-cirrhotic) alcoholic liver disease. Cases of high anion gap metabolic acidosis (HAGMA) due to pyroglutamic acidosis have been reported in patients with severe illness such as severe renal impairment and sepsis, or in patients with malnutrition and other sources of glutathione deficiency (e.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. The label should contain the following statements: • Contains paracetamol. • Do not give this medicine with any other paracetamol-containing product. • For oral use only. • Never give more medicine than shown in the table. • Do not overfill the spoon. • Always use the spoon supplied with the pack. • Do not give more than 4 doses in any 24hour period. • Leave at least 4 hours between doses. • Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist. • If your baby still needs this medicine two days after receiving the vaccine talk to you doctor or pharmacist. (leaflet). • As with all medicines, if your child is currently taking any medicine consult your doctor or pharmacist before taking this product. • Do not store above 25ºC. Store in the original package. • Keep all medicines out of the sight and reach of children • Talk to a doctor at once if your child takes too much of this medicine, even if they seem well (label). • 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. (leaflet) Patients with rare hereditary problems of fructose intolerance should not take this medicine.4.5 Interaction with other medicinal products and other forms of interaction Drugs which induce hepatic microsomal enzymes such as alcohol. Concomitant barbiturates and tricyclic antidepressants may increase the hepatoxicity of Paracetamol particularly after overdose. Anti-convulsant or oral steroid contraceptives have the ability to reduce serum levels of Paracetamol by liver enzyme induction. The speed of absorption of Paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. 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. Caution should be taken when paracetamol is used concomitantly with flucloxacillin as concurrent intake has been associated with high anion gap metabolic acidosis due to pyroglutamic acidosis, especially in patients with risks factors (see section 4.4)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. A large amount of data on pregnant women indicates 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. 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.4.8 Undesirable effects Very rare cases of serious skin reactions have been reported. Adverse effects of Paracetamol are rare but hypersensitivity including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily casually related to Paracetamol. With prolonged use or overdosage, hepatic necrosis, acute pancreatitis and nephrotoxicity have been reported. SOC: Metabolism and nutrition disorders “High anion gap metabolic acidosis'' with frequency ''Not known'' (cannot be estimated from the available data) Description of selected adverse reactions High anion gap metabolic acidosis Cases of high anion gap metabolic acidosis due to pyroglutamic acidosis have been observed in patients with risk factors using paracetamol (see section 4.4). 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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.4.9 Overdose 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. \*\*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, 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, 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 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, see BNF overdose section. Treatment with activated charcoal should be considered if the overdose has been taken within one 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 24 h from ingestion should be discussed with the NPIS or a liver unit. ## Pharmacological Properties 5.1 Pharmacodynamic properties Paracetamol is an antipyretic analgesic. The mechanism of action is probably similar to that of aspirin and dependent on the inhibition of prostaglandin synthesis. This inhibition appears, however, to be on a selective basis.5.2 Pharmacokinetic properties Paracetamol is rapidly and almost completely absorbed from the gastro-intestinal tract. The concentration in plasma reaches a peak in 30 to 60 minutes and the half-life in plasma is 1 to 4 hours after therapeutic doses. Paracetamol is relatively uniformly distributed throughout most body fluids. Binding of the drug to plasma proteins is variable; 20 to 50% may be bound at the concentrations encountered during acute intoxication. Following therapeutic doses 90 to 100% of the drug may be recovered in the urine within the first day. However, practically no Paracetamol is excreted unchanged, and the bulk is excreted after hepatic conjugation.5.3 Preclinical safety data There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC. 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 Ethanol 96% Sorbitan Monooleate Glycerol (E422) Magnesium Aluminium Silicate Liquid Maltitol (E965) Saccharin Sodium (E954) Xanthan Gum Cherry Flavour Sodium Benzoate (E211) Citric Acid (monohydrate) Polysorbate 80 Purified water6.2 Incompatibilities None known.6.3 Shelf life Amber glass bottles – 5 years High density polyethylene – 5 years.6.4 Special precautions for storage Do not store above 25ºC. Store in the original container. Keep container in the outer carton.6.5 Nature and contents of container Pharmaceutical grade III amber glass bottles with pilfer proof screw caps. Pack sizes: 70 ml, 100 ml, 150 ml, 200 ml, 500 ml, 1 Litre and 2 litre. High density polyethylene bottles with tamper evident plastic cap. Pack sizes: 500 ml, 1 Litre and 2 Litre.6.6 Special precautions for disposal and other handling As for all medicines – no special requirements.

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