- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Fertility, pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
For the relief of fever after vaccinations at 2, 3 and 4 months2.5ml. 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||2.5 ml 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.|
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|
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.
The label contains the following statements:Contains paracetamol.Do not give anything else containing paracetamol while giving this medicine.Do not give more medicine than the label tells you to. If your child does not get better, talk to your doctorFor oral use only.Always use the syringe 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 other medicine consult your doctor or pharmacist before using this product.Keep out of the sight and reach of children.Do not store above 25°C. Keep bottle in the outer carton.It is important to shake the bottle for at least 10 seconds before use.Talk to a doctor at once if your child takes too much of this medicine, even if they seem well.
The leaflet contains the following statements: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. Talk to your doctor: If your child has an inherited intolerance to fructose or been diagnosed with an intolerance to some other sugars. The sorbitol (E420) and maltitol (E965) content of this product means that this product is unsuitable for people with inherited intolerance to fructose. Very rare cases of serious skin reactions have been reported. Symptoms may include:- Skin reddening- Blisters- RashIf skin reactions occur or existing skin symptoms worsen, stop use and seek medical help right away.
PregnancyEpidemiological 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-feedingParacetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding.
FertilityThere is no information relating to the effects of Calpol Sugar Free Infant Suspension on fertility.
Risk Factors:If the patienta) Is on long term treatment with carbamezipine, phenobarbital, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.Orb) Regularly consumes ethanol in excess of recommended amounts.Orc) Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
SymptomsSymptoms 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.
ManagementImmediate 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.
AbsorptionParacetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Peak plasma concentrations are reached 30-90 minutes post dose and the plasma half-life is in the range of 1 to 3 hours after therapeutic doses.
DistributionDrug is widely distributed throughout most body fluids.
BiotransformationMetabolism occurs almost entirely via hepatic conjugation with glucuronic acid (about 60%), sulphuric acid (about 35%) or cysteine (about 3%). Small amounts of hydroxylated and deacetylated metabolites have also been detected. Children have less capacity for glucuronidation of the drug than do adults. In overdosage there is increased N-hydroxylation followed by glutathione conjugation. When the latter is exhausted, reaction with hepatic proteins is increased leading to necrosis.
EliminationFollowing therapeutic doses 90-100% of the drug is recovered in the urine within 24 hours.
MutagenicityThere are no studies relating to the mutagenic potential of Calpol Sugar Free Infant 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 10 mM for 2h).
CarcinogenicityThere are no studies to the carcinogenic potential of Calpol Sugar Free Infant 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 500 mg/kg/day paracetamol.
TeratogenicityThere is no information relating to the teratogenic potential of Calpol Sugar Free Infant Suspension. In humans, paracetamol crosses the placenta and attains concentrations in the foetal circulation similar to those in the maternal circulation. Intermittent maternal ingestion of therapeutic doses of paracetamol are not associated with teratogenic effects in humans.Paracetamol has been found to be foetotoxic to cultured rat embryo.
FertilityA 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.
McNeil Products Ltd
Foundation Park, Roxborough Way, Maidenhead, Berks, SL6 3UG