- 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
1. Name of the medicinal product
Calpol Six Plus Fastmelts (250 mg Orodispersible Tablets)
2. Qualitative and quantitative composition
Paracetamol 250 mgExcipients: also contains mannitol (E421) and aspartame (E951).For the full list of excipients, see section 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 ElderlyNormal adult dosage is appropriate. However, a reduction in dosing may be necessary in frail, elderly subjects (see Section 5.2).
Hypersensitivity to paracetamol or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help straight away. Quick medical attention is critical for adults as well as children even if signs or symptoms are not noticed.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. Chronic alcohol abusers should consult a doctor before use. 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.Serious skin reactions have been reported very rarely in patients receiving paracetamol. The use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.The label shall contain 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 doctor.For oral use onlyDo 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.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. Very rare cases of serious skin reactions have been reported. Symptoms may include:Skin reddeningBlistersRashIf skin reactions occur or existing skin symptoms worsen, stop use and seek medical help right away.
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 Fertility, pregnancy and lactation
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 Six Plus Fastmelts on fertility.
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
Adverse effects of paracetamol are rare. Very rarely hypersensitivity and anaphylactic reactions including skin rash may occur. Very rare cases of serious skin reactions have been reported. 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.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
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 patienta, Is on long term treatment with carbamezepine, 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 overdose 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 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 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
Pharmacotherapeutic group: Other Analgesics and Antipyretics (Anilides)ATC Code: N02 BE01Paracetamol 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 gastro-intestinal 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)CrospovidoneAspartame (E951)Strawberry flavouring E. 9620941Magnesium stearateBasic butylated methacrylate copolymerPolyacrylate dispersion 30%Colloidal anhydrous silica
6.3 Shelf life
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 sheetor a paper/aluminium child resistant sealing sheet.
6.6 Special precautions for disposal and other handling
No special requirements for disposal.
7. Marketing authorisation holder
McNeil Products Limited Foundation ParkRoxborough WayMaidenheadBerkshireSL6 3UG
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
19th March 2001/03 March 2009
10. Date of revision of the text
McNeil Products Ltd
Foundation Park, Roxborough Way, Maidenhead, Berks, SL6 3UG
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