Calpol Six Plus Fastmelts
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1. Trade Name of the Medicinal Product
Calpol Six Plus Fastmelts (250 mg Orodispersible Tablets)
2. Qualitative and Quantitative Composition
Paracetamol 250 mg For excipients, see 6.1.
3. Pharmaceutical Form
Orodispersible tablet
Round, white, bi-convex tablets with central concave depression.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Calpol Six Plus Fastmelts 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, sore throat, colds and influenza, aches and pains and post-immunisation fever.
4.2 Posology and method of administration
Oral:
Tablets should be placed in the mouth where they melt on the tongue. The tablet will rapidly disperse to a pleasant tasting paste that can be easily ingested. Alternatively the tablet can be dispersed in a teaspoonful of water or milk.
Adults and children
|
Child’s Age |
How Much |
How often (in 24 |
|
hours) |
|
Under 6 years |
Not recommended |
N/A |
|
6 - 9 years |
1 tablet |
4 times |
|
9 - 12 years |
2 tablets |
4 times |
|
12 - 16 years |
2 to 3 tablets |
4 times |
|
Adults and children over 16 years |
2 to 4 tablets |
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 | ||
Use in the Elderly
Normal adult dosage is appropriate. However, a reduction in dosing may be necessary in frail, elderly subjects (see Section 5.2).
4.3 Contraindications
Calpol Six Plus Fastmelts are contra-indicated in patients with known hypersensitivity to paracetamol or any other ingredient and in subjects with phenylketonuria.
4.4 Special warnings and precautions for use
Care is advised in the administration of paracetamol to patients with severe hepatic or renal dysfunction. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.
Calpol Six Plus Fastmelts contain aspartame, which is a source of phenylalanine equivalent to 0.04 mg/250 mg tablet. The phenylalanine in the tablets may be harmful to people with phenylketonuria.
Calpol Six Plus Fastmelts contain mannitol, which may have a mild laxative effect.
The label shall contain 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 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 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).
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 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 overdose with the drug.
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 10g or more of paracetamol. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested) become irreversibly bound to liver tissue. 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 carbamezepine, 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 overdose 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 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 the 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 concentrations 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 24 h from ingestion should be discussed with the NPIS or a liver unit.
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
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.
Paracetamol is distributed rapidly throughout all tissues. Protein binding is low.
The plasma half-life is in the range of 1 to 4 hours after therapeutic doses.
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 overdose there is increased N-hydroxylation followed by glutathione conjugation. When the latter is exhausted reaction with hepatic proteins is increased leading to necrosis.
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.
5.3 Preclinical Safety Data
There are no preclinical data of relevance to the prescriber which are additional to those already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Mannitol (E421)
Crospovidone
Aspartame
Strawberry flavouring E. 9620941 Magnesium stearate Polymethacrylate (Eudragit E 100) Polyacrylate dispersion 30% Colloidal anhydrous silica
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
36 months
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5. Nature and contents of container
Strip containing 24 tablets.
The blister consists of a blister complex (Polyamide/PVC/Aluminium) and either: an aluminium sealing sheet or
a paper/aluminium child resistant sealing sheet.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
McNeil Products Limited
Foundation Park
Roxborough Way
Maidenhead
Berkshire
SL6 3UG
UK
8. MARKETING AUTHORISATION NUMBER
PL 15513/0082
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
03/03/2009
10 DATE OF REVISION OF THE TEXT
06/06/2011