Summary of medicine characteristics - PARACETAMOL 120 MG / 5 ML ORAL SUSPENSION
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol 120mg/5 ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml spoonful contains Paracetamol Ph. Eur 120mg.
For excipients, see 6.1
3 PHARMACEUTICAL FORM
Oral Suspension.
Cream to brown oral suspension with cherry odour andtaste.
4 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.
4.2Posology and method of administration
Children aged 3months– 12years :
| Child’sAge | How Much | How often (in 24hours) |
| 3– 6months | 2.5ml | 4times |
| 6– 24months | 5ml | 4times |
| 2– 4years | 7.5ml ( (5ml+ 2.5ml) | 4times |
| 4– 8years | 10ml (5ml+ 5ml) | 4times |
| 8– 10years | 15ml (5ml+5ml+5ml) | 4times |
| 10– 12years | 20ml(5ml+5ml+5ml+5ml) | 4times |
| Do not give more than 4doses in any 24hour period Leave at least 4hours between doses Do not give this medicine to your child for more than 3days without speaking to your doctor or pharmacist | ||
Babies over 2months in age
For the relief of fever after vaccination at 2, 3and 4months
2.5ml. This dose may be given up to 4times a day at the time of vaccination. Do not give more than 4doses in any 24hour period. Leave at least 4hours between doses. If your baby still needs this medicine two days after receiving the vaccine talk to your doctor or pharmacist.
4.3 Contraindications
Hypersensitivity to Paracetamol or any of the other constituents.
4.4Special 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.
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 4doses in any 24hour period.
Leave at least 4hours between doses.
Do not give this medicine to your child for more than 3days 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 25°C. 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. Anticonvulsant 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.
4.6Pregnancy 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. Alarge 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.
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
4.8Undesirable 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 causually related to Paracetamol. With prolonged use or overdosage, hepatic necrosis, acute pancreatitis and nephrotoxicity have been reported.
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
4.9Overdose
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.
Risk Factors
If the patient:
a, Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St. John’sWort 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 24hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12to 48hours 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 1hour. Plasma Paracetamol concentration should be measured at 4hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24hours after ingestion of Paracetamol, however, the maximum protective effect is obtained up to 8hours postingestion. 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 liverunit.
5 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 selectivebasis.
5.2 Pharmacokinetic properties
Paracetamol is rapidly and almost completely absorbed from the gastro-intestinal tract. The concentration in plasma reaches a peak in 30to 60minutes and the half-life in plasma is 1to 4hours after therapeutic doses. Paracetamol is relatively uniformly distributed throughout most body fluids. Binding of the drug to plasma proteins is variable; 20to 50% may be bound at the concentrations encountered during acute intoxication. Following therapeutic doses 90to 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
5.3Preclinical 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.
6 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 water
6.2 Incompatibilities
None known
6.3 Shelf life
Amber glass bottles– 5years
High density polyethylene– 5years.
6.4 Special precautions for storage
Do not store above 25°C. 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 screwcaps.
Pack sizes: 70ml, 100ml, 150ml, 200ml, 500ml, 1Litre and 2litre.
High density polyethylene bottles with tamper evident plasticcap.
Pack sizes: 500ml, 1Litre and 2Litre.
6.6 Special precautions for disposal
6.6Special precautions for disposal
As for all medicines– no special requirements.
MARKETING AUTHORISATION HOLDER
Pinewood Laboratories Limited
Ballymacarbry
Clonmel
Co Tipperary
Ireland
8 MARKETING AUTHORISATION NUMBER(S)
PL 04917/0028
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION
23/03/2007
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