1. Name Of The Medicinal Product
CALPOL Sugar Free Infant suspension
2. Qualitative And Quantitative Composition
CALPOL Sugar Free Infant suspension contains 120 mg Paracetamol in each 5 ml.
Excipients: maltitol liquid (E965), sorbitol liquid (E420), methyl parahydroxybenzoate (E218), ethyl parahydroxybenzoate (E214), propyl parahydroxybenzoate (E216) and carmoisine (E122). See section 4.4 for further information.
For full list of excipients, see section 6.1.
3. Pharmaceutical Form
Oral Suspension.
A pink strawberry flavoured suspension.
4. Clinical Particulars
4.1 Therapeutic Indications
CALPOL Sugar Free Infant 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
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Children aged 3 months – 6 years:
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• Do not give more than 4 doses in any 24 hour period
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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
CALPOL Sugar Free Infant suspension is contra-indicated in patients with known hypersensitivity to paracetamol, or any of the other components.
4.4 Special Warnings And Precautions For Use
Care is advised in the administration of paracetamol to patients with severe renal impairment or severe hepatic impairment.
The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.
Concomitant use of other paracetamol-containing products should be avoided.
Due to the presence of maltitol liquid (E965) and sorbitol liquid (E420), patients with rare hereditary problems of fructose intolerance should not take this medicine.
Ethyl (E214), Propyl (E216) and Methyl (E218) parahydroxybenzoate may cause allergic reactions (possibly delayed).
Carmoisine (E122) may cause allergic reactions.
The label contains the following statements:
Contains paracetamol.
Do not give this medicine with any other paracetamol containing products.
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 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 reach and sight of children.
Do not store above 25°C. Keep bottle in the outer carton.
Shake the bottle for at least 10 seconds before use. (bottle only)
Do not exceed the stated dose.
If symptoms persist consult your doctor.
Immediate medical advice should be sought in the event of an overdose, even if the child seems well. (label)
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. (leaflet)
Talk to your doctor: If your child has an inherited intolerance to fructose or been diagnosed with an intolerance to some other sugars. (leaflet)
The sorbitol (E420) and maltitol (E965) content of this product means that this product is unsuitable for people with inherited intolerance to fructose. (leaflet)
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
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.
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 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.
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 known.
4.8 Undesirable Effects
Adverse effects of paracetamol are rare. Very rarely hypersensitivity and anaphylatic 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 overdose 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 their disease improved after paracetamol withdrawal.
Nephrotoxicity following therapeutic doses of paracetamol is uncommon, but papillary necrosis has been reported after prolonged administration.
4.9 Overdose
Liver damage is possible in adults who have taken 10 g 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 carbamezipine, 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 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 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
Paracetamol has analgesic and antipyretic effects similar to those of aspirin and is useful in the treatment of mild to moderate pain. It has only weak anti-inflammatory effects.
5.2 Pharmacokinetic Properties
Paracetamol 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. Drug is widely distributed throughout most body fluids. Following therapeutic doses 90-100% of the drug is recovered in the urine within 24 hours almost entirely following 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.
5.3 Preclinical Safety Data
The active ingredient of this product is a well known constituent of medicinal products and its safety profile is well documented.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Maltitol liquid
Sorbitol solution (70% non crystallising) (E420)Glycerol
Dispersible cellulose
Xanthan gum
Ethyl parahydroxybenzoate (E214)
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
Polysorbate 80
Strawberry flavour
Carmoisine (E122)
Purified water
6.2 Incompatibilities
None known
6.3 Shelf Life
36 months.
6.4 Special Precautions For Storage
Do not store above 25°C. Keep bottle in the outer carton.
6.5 Nature And Contents Of Container
Amber glass bottle with plastic screw cap, a polyethylene or polyvinylidene chloride (PVDC) laminate faced wad.
or
Amber glass bottle with a two-piece plastic child resistant, tamper evident closure fitted with a polyethylene or polyvinylidene chloride (PVDC) laminate faced wad.
or
Amber glass bottle with a three-piece plastic child resistant, tamper evident closure fitted with a polyethylene or polyvinylidene chloride (PVDC) laminate faced wad.
Pack sizes
140 ml, 200 ml and 1000 ml. A spoon with a 5 ml and 2.5 ml measure is supplied with this pack.
1000 ml amber glass bottle with an aluminium cap fitted with a polyethylene wad.
6.6 Special Precautions For Disposal And Other Handling
No special requirements.
7. Marketing Authorisation Holder
McNeil Products Limited
Foundation Park
Roxborough Way
Maidenhead
Berkshire
SL6 3UG
UK
8. Marketing Authorisation Number(S)
PL 15513/0006
9. Date Of First Authorisation/Renewal Of The Authorisation
28 April 1997 / 13th September 2004
10. Date Of Revision Of The Text
6th June 2011
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