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
Each 5ml of the oral suspension contains Paracetamol 120mg
Excipients with known effect:
Maltitol liquid (E965) 1 ml
Sodium methyl parahydroxybenzoate (E219) 9 mg
Sodium propyl parahydroxybenzoate (E217) 1 mg
Strawberry flavour contains propylene glycol which amounts to 0.00768mg of propylene glycol in 5ml see section 4.4
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Oral Suspension White uniform suspension.
4.1 Therapeutic indications
Paracetamol 120mg/5ml Oral Suspension is indicated for the treatment of mild to moderate pain and as an antipyretic. It can be used in many conditions including headache, toothache, earache, teething, sore throat, colds & influenza, aches and pains and post-immunisation fever.
4.2 Posology and method of administration
For the relief of fever after vaccinations at 2,3 and 4 months:
One 2.5ml 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 4kg and was born after 37 weeks (not premature) |
One 2.5 mL spoonful (small end). If necessary, after 4-6 hours, give a second 2.5 mL dose |
|
• 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. | |
|
Child’s Age |
How Much |
How often (in 24 hours) |
|
3 - 6 months |
One 2.5 mL spoonful (small end) |
4 times |
|
6 - 24 months |
One 5 mL spoonful (large end) |
4 times |
|
2 - 4 years |
One 5.0 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 |
|
• 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 | ||
It is important to shake the bottle for at least 10 seconds before use.
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.
4.3 Contraindications
Paracetamol Oral Suspension is contra-indicated in patients with known 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.
Patients should be informed about the signs of serious skin reactions and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
This product contains sodium methyl parahydroxybenzoate (E219) and sodium propyl parahydroxybenzoate (E217). These may cause allergic reactions (possibly delayed).
It also contains maltitol liquid (E965). Patients with rare hereditary problems of fructose intolerance should not take this medicine.
The strawberry flavour contains propylene glycol in very small amounts of 0.00768mg of propylene glycol in 5ml. This may be of significance when using the product for neonates.
The label will include:
• Contains paracetamol.
• Do not give anything else containing paracetamol while giving this medicine.
• For oral use only.
• Do not give more medicine than the label tells you to. If your child does not get better, talk to your doctor.
• Do not overfill the spoon.
• Always use the spoon supplied with the pack.
• 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.
• Keep 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).
• Shake the bottle for at least 10 seconds before use.
• Very rare cases of serious skin reactions have been reported. Symptoms may include:
- Skin reddening
- Blisters
- Rash
If skin reactions occur or existing skin symptoms worsen, stop use and seek medical help right away (leaflet).
4.5. Interaction with other medical products and other forms of interaction
The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine.
The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with risk of bleeding; occasional doses have no significant effect.
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. Acute 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.
4.6 Fertility, pregnancy and lactation Fertility
There is no information relating to the effects of Paracetamol Oral Suspension on fertility (see section 5.3)
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 the doctor regarding its use.
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
No adverse effects known.
4.8 Undesirable effects
Adverse effects of paracetamol are rare. Very rare cases of serious skin reactions have been reported. Very rarely 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 causality related to paracetamol.
Most reports of adverse reactions to paracetamol relate to overdosage with the drug.
Chronic hepatic necrosis has been reported in a patient who took daily therapeutic doses of paracetamol for about a year and liver damage has been reported after daily ingestion of excessive amounts for shorter periods. A review of a group of patients with chronic active hepatitis failed to reveal differences in the abnormalities of liver function in those who were long-term users of paracetamol nor was the control of the disease improved after paracetamol withdrawal.
Nephrotoxic effects following therapeutic doses of paracetamol are uncommon. Papillary necrosis has been reported after prolonged administration.
Low level transaminase elevations may occur in some patients taking therapeutic doses of paracetamol; these are not accompanied with liver failure and usually resolve with continued therapy or discontinuation of paracetamol.
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
Children who have ingested 75mg/kg or more of paracetamol in less than 1 hour should be referred to hospital. Administration of activated charcoal should be considered if paracetamol in excess of 150mg/kg is thought to have been ingested within the previous hour.
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, 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, hyperhidrosis, malaise, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. This may include hepatomegaly, liver tenderness, jaundice, acute hepatic failure and hepatic necrosis. Abnormalities of glucose metabolism and metabolic acidosis may occur. Blood bilirubin, hepatic enzymes, INR, prothrombin time, blood phosphate and blood lactate may be increased. 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.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Non-Opioid Analgesic ATC CODE: N02B E01
Paracetamol has analgesic and antipyretic effects similar to those of aspirin and is useful in the treatment of mild to moderate pain. It has weak antiinflammatory effects. It is only a weak inhibitor of prostaglandin biosynthesis although there is some evidence to suggest it may be more effective against enzymes in the central nervous system than in the periphery. This may in part account for its activity profile.
5.2. Pharmacokinetic properties
Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract with peak plasma concentrations occurring 0.5-2 hours. The plasma half-life is approximately 2 hours after therapeutic doses in adults but is increased in neonates to about 5 hours. It is widely distributed through the body. Metabolism is principally by the hepatic microsomal enzymes and urinary excretion accounts for over 90% of the dose within 1 day. Virtually no paracetamol is excreted unchanged, the bulk being conjugated with glucuronic acid (60%), sulphuric acid (35%) or cysteine (3%). Children have less capacity for glucuronidation of the drug than adults.
5.3 Preclinical safety data
Mutagenicity
There are no studies relating to the mutagenic potential of Paracetamol Oral Suspension.
In vivo mutagenicity tests of paracetamol in mammals are limited and show conflicting results. Therefore, there is insufficient information to determine whether paracetamol poses a mutagenic risk to man.
Paracetamol has been found to be non-mutagenic in bacterial mutagenicity assays, although a clear clastogenic effect has been observed in mammalian cells in vitro following exposure to paracetamol (3 and 10mM for 2h).
Carcinogenicity
There are no studies to the carcinogenic potential of Paracetamol Oral Suspension.
There is inadequate evidence to determine the carcinogenic potential of paracetamol in humans. A positive association between the use of paracetamol and cancer of the ureter (but not of other sites in the urinary tract) was observed in a case-control study in which approximate lifetime consumption of paracetamol (whether acute or chronic) was estimated. However, other similar studies have failed to demonstrate a statistically significant association between paracetamol and cancer of the urinary tract or paracetamol and renal cell carcinoma.
There is limited evidence for the carcinogenicity of paracetamol in experimental animals. Liver cell tumours can be detected in rats following chronic feeding of 500mg/kg/day paracetamol.
Teratogenicity
There is no information relating to the teratogenic potential of Paracetamol Oral Suspension. In humans, paracetamol crosses the placenta and attains concentrations in the foetal circulation similar to those in the maternal circulation. Intermittant maternal ingestion of therapeutic doses of paracetamol are not associated with teratogenic effects in humans.
Paracetamol has been found to be foetotoxic to cultured rate embryo.
Fertility
There is no information relating to the effects of Paracetamol oral suspension on fertility. A significant decrease in testicular weight was observed when male Sprague-Dawley rats were given daily high doses of paracetamol (500 mg/kg/body weight/day) orally for 70 days.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Glycerol
Polysorbate 80
Xanthan gum
Maltitol liquid
Saccharin sodium
Citric acid monohydrate
Sodium methyl parahydroxybenzoate
Sodium propyl parahydroxybenzoate
Strawberry flavour (containing propylene glycol)
Purified water
6.2 Incompatibilities
None Known
6.3 Shelf life
24 months.
6.4 Special precautions for storage
Do not store above 25°C. Store the container in the outer carton. Discard after 2 months of first opening.
6.5. Nature and contents of containers
Amber Type III Glass
Child Resistant Tamper Evident Cap- High density polypropylene cap with a polyethylene lining
A spoon with a 2.5 ml and 5 ml measure is supplied with all packs of this product
Pack sizes available: 100ml, 200ml
6.6. Special precaution for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Edict Consulting Ltd 49 Ivinghoe Road Bushey Herts
WD23 4SW
8 MARKETING AUTHORISATION NUMBER(S)
PL 20941/0001 Legal status - P
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
03/03/2009
10 DATE OF REVISION OF THE TEXT
06/11/2015