Paracetamol 120mg/5ml Oral Suspension
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol 120mg/5ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Paracetamol 120mg/5ml
Excipients with known effect:
Methyl hydroxybenzoate (E218)
Propyl hydroxybenzoate (E216)
Sucrose 3g/5ml Sorbitol (E420)
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Oral Suspension
Off white/cream suspension
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment of mild to moderate pain and to reduce fever in many conditions including headache, toothache or teething, earache, sore throat, colds and influenza, aches and pains and post-immunisation fever.
4.2 Posology and method of administration
Posology
For the relief of fever after vaccinations at 2, 3 and 4 months
One 2.5 mL spoonful (small end). This dose may be given up to 4 times a day starting at the time of vaccination. Do not give more than 4 doses in any 24 hour 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._
|
Age: 2 - 3 months |
Dose |
|
Pain and other causes of fever - if your baby weighs over 4 kg and was born after 37 weeks |
One 2.5 mL spoonful (small end). If necessary, after 4-6 hours, give a second 2.5 mL spoonful |
|
• Do not give to babies less than 2 months of age • Leave at least 4 hours between doses • Do not give more than 2 doses. This is to ensure that fever that may be due to a serious infection is quickly diagnosed. If your child is still feverish after two doses, talk to your doctor or pharmacist. | |
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Child’s Age |
How Much |
How often (in 24 hours) |
|
3 - 6 months |
One 2.5 mL spoonful (small end) |
4 times |
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6 - 24 months |
One 5 mL spoonful (large end) |
4 times |
|
2 - 4 years |
One 5 mL spoonful (large end) and one 2.5 mL spoonful (small end) |
4 times |
|
4 - 6 years |
Two 5 mL spoonfuls (large end) |
4 times |
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• 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 | ||
The Elderly:
In the elderly, the rate and extent of paracetamol absorption is normal but plasma half-life is longer and paracetamol clearance is lower than in young adults.
Method of administration For oral administration only.
It is important to shake the bottle for at least 10 seconds before use.
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
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 with any other paracetamol-containing products.
• For oral use only.
• Never give more medicine than shown in the table.
• Always use the spoon supplied with the pack. Do not overfill the spoon.
• Do not give to babies less than 2 months of age.
• For infants 2-3 months no more than 2 doses should be given.
• 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.
• 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.
• 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.
• If symptoms persist consult your doctor.
• Keep out of the reach and sight of children.
Excipients in the formulation
This product contains parahydroxybenzoates. These may cause allergic reactions (possibly delayed). The product also contains sucrose (3g per 5ml dose) and sorbitol. This should be taken into account in patients with diabetes mellitus. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
4.5 Interaction with other medicinal products and other forms of interaction
Chronic alcohol intake can increase the hepatotoxicity of paracetamol overdose and may have contributed to the acute pancreatitis reported in one patient who had taken an overdose of paracetamol. Barbiturates, tricyclic antidepressants and alcohol intake may diminish an individual's ability to metabolise large doses of paracetamol, the plasma half-life of which can be prolonged.
The use of drugs that induce hepatic microsomal enzymes, such as anticonvulsants and oral contraceptives, may increase the extent of metabolism of paracetamol, resulting in reduced plasma concentrations of the drug and a faster elimination rate.
The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine.
The anticoagulant 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.
Antivirals: Regular use of paracetamol possibly reduces metabolism of zidovudine (increased risk of neutropenia).
4.6 Fertility, pregnancy and lactation
Pregnancy
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.
Breast-feeding
Paracetamol is excreted in breast milk but not in clinically significant quantities. Available published data do not contraindicate breast feeding.
4.7 Effects on ability to drive and use machines
None.
4.8 Undesirable effects
Adverse effects of paracetamol are rare but hypersensitivity and anaphylactic reactions including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.
Very rare cases of serious skin reactions have been reported.
Cases of acute pancreatitis and chronic hepatic necrosis with prolonged use or overdoage have been reported.
Paracetamol has been widely used and reports of adverse reactions are rare, and are generally associated with overdosage.
Nephrotoxic effects are uncommon and have not been reported in association with therapeutic doses, except after prolonged administration.
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 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 carbamazepine, phenobarbital, 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 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 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 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.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
The mechanism of analgesic action has not been fully determined.
Paracetamol may act predominantly by inhibiting prostaglandin synthesis in the central nervous system (CNS) and, to a lesser extent, through a peripheral action by blocking pain impulse generation. The peripheral action may also be due to inhibition of prostaglandin synthesis or to inhibition of the synthesis or actions of other substances that sensitise pain receptors to mechanical or chemical stimulation.
Paracetamol probably produces antipyresis by acting centrally on the hypothalamic heat regulating centre to produce peripheral vaso-dilation resulting in increased blood flow through the skin, sweating and heat loss. The central action probably involves inhibition of prostaglandin synthesis in the hypothalamus.
5.2 Pharmacokinetic properties
Oral absorption is rapid and almost complete, it may be decreased if paracetamol is taken following a high carbohydrate meal.
There is no significant protein binding with doses producing plasma concentrations of below 60mcg (pg)/ml, but may reach moderate levels with high or toxic doses.
Approximately 90 - 95% of a dose is metabolised in the liver, primarily by conjugation with glucuronic acid, sulphuric acid and cysteine. An intermediate metabolite, which may accumulate in overdosage after primary metabolic pathways become saturated, is hepatotoxic and possibly nephrotoxic.
Half life is 1 to 4 hours; does not change with renal failure but may be prolonged in acute overdosage, in some forms of hepatic disease, in the elderly, and in the neonate; may be somewhat shortened in children.
Time to peak concentration, 0.5 - 2 hours; peak plasma concentrations, 5 -20mcg (pg)/ml (with doses up to 650mg); time to peak effect, 1- 3 hours; duration of action, 3- 4 hours.
Elimination is by the renal route, as metabolites, primarily conjugates, 3% of a dose may be excreted unchanged.
Peak concentration of 10 - 15mcg(gg)/ml have been measured in breast milk, 1 - 2 hours following maternal ingestion of a single 650mg dose. Half life in breast milk is 1.35 - 3.5 hours.
5.3 Preclinical safety data
None stated
6. PHARMACEUTICAL PARTICULARS
6.1 List of Excipients
Propylene glycol Methyl parahydroxybenzoate Propyl parahydroxybenzoate Xanthan gum
Sorbitol liquid non-crystallising Sucrose Mango flavour Purified water
6.2 Incompatibilities
None stated.
6.3 Shelf life
24 months
6.4 Special precautions for storage
Store below 25°C. Keep the bottle in the outer carton. 6.5. Nature and Contents of Container
Bottles: Amber (Type III) glass bottle
Closure: HDPE, child resistant, tamper evident, EPE wadded closure
Capacities: 60ml and 100ml
Dosing device: 2.5/5ml double ended polypropylene spoon.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 00427/0140
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
07/03/2007
10 DATE OF REVISION OF THE TEXT
27/06/2016