Paracetamol 500mg Soluble Tablets
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol 500mg Soluble Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Soluble tablet contains Paracetamol 500mg
Also contains lactose monohydrate, sodium; For excipients, see 6.1
3 PHARMACEUTICAL FORM
Soluble Tablets
Round, biplane, white or off-white tablets with facets on both sides
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Paracetamol 500mg Tablets is a mild analgesic and antipyretic and is recommended for the treatment of most painful and febrile conditions, for example, headache including migraine and tension headaches, toothache, neuralgia, backache, rheumatic and muscle pains, dysmenorrhoea, sore throat and for relieving the fever, aches and pains of colds and flu.
4.2 Posology and method of administration
Adults and elderly:
1-2 tablets dissolved in a glass of water up to 4 times a day.
These doses should not be repeated more frequently than every 4 hours and not more than 4 doses should be given in any 24hour period.
Not recommended for children under 12 years of age.
Oral administration only.
Contraindications
4.3
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 hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.
Do not exceed the stated dose.
Patients should be advised to consult their doctor if their headaches become persistent.
Patients should be advised not to take other paracetamol-containing products concurrently.
If symptoms persist, consult your doctor.
Keep out of the reach and sight of children.
Sodium content: approximately 392 mg per tablet.
This product contains lactose; patient with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Pack Label:
Immediate medical advice should be sought in the event of an overdose, even if you feel well.
Do not take with other paracetamol-containing products.
Patient Information Leaflet:
Immediate medical advice should be sought in the event of an overdose even if you feel well, because of the risk of delayed, serious liver damage.
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 cholestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.
4.6 Fertility, 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 the 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
No special comment. Unlikely to produce an effect.
4.8 Undesirable effects
Adverse effects of paracetamol are rare but hypersensitivity, including skin rash, may occur. There have been very rare reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these were not necessarily causally related to paracetamol.
4.9 Overdose
Symptoms of overdosage:
Pallor, anorexia, nausea, vomiting and abdominal pain are frequent early symptoms of paracetamol overdosage.
Hepatic necrosis is a dose-related complication of paracetamol overdose. Hepatic enzymes may become elevated and prothrombin time prolonged within 12 to 48 hours but clinical symptoms may not be apparent for 1 to 6 days after ingestion. Toxicity is likely in subjects who have taken single doses of 10 g (150 mg/kg) or more. It is considered that excess quantities of toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested) become irreversibly bound to liver tissue. Paracetamol hepatotoxicity is directly dependent on the plasma concentration related to time. Plasma concentrations above 1.2 mmol/l at 4 hours, 0.6 mmol/l at 8 hours and 0.3 mmol/l at 12 hours are criteria for treatment with acetylcysteine to prevent irreversible liver damage.
Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.
In paracetamol overdosage with liver cell damage, paracetamol half-life is often prolonged from around 2 hours in normal adults to 4 hours or longer. However liver cell damage has been found in patients with a paracetamol half life less than 4 hours. Renal failure due to acute tubular necrosis may follow paracetamol-induced fulminant hepatic failure. The incidence of this is, however, no more frequent in these patients than in others with fulminant hepatic failure from other causes.
Therapeutic measures in overdosage:
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 and any patient who had ingested around 7.5 g or more of paracetamol in the preceding 4 hours should undergo gastric lavage.
Administration of oral methionine or intravenous N-acetylcysteine which may have beneficial effect up to at least 48 hours after overdose, may be required. General supportive measures must be available.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Anilides 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.
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 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
There are no pre-clinical 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
Anhydrous citric acid
Anhydrous sodium sulphate Lactose monohydrate Sodium bicarbonate Povidone k-25 Simethicone emulsion (dry)
Saccharin sodium
Lemon flavour; containing citral, citric acid, ethyl alcohol, lemon oil, lime oil, alpha-tocopherol, triacetine, maltodextrin, gum arabic and sucrose Macrogol 6000
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years
6.4 Special precautions for storage
Do not store above 25°C. Store in the original package. Keep the tablet container tightly closed.
6.5 Nature and contents of container
Polypropylene tablet container with polyethylene stopper containing silica gel as desiccant. 16 Soluble tablets are packed in one tablet container. Two such tablet containers are packed into an outer carton.
Pack size: 32 tablets
6.6 Special precautions for disposal
Dissolve tablet in a glass of water prior to intake.
7 MARKETING AUTHORISATION HOLDER
Activase Pharmaceuticals Limited,
C/O Genesis Pharmaceuticals Limited
4-5 Grosvenor Place
London
SW1X 7HJ UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 28444/0096
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
02/03/2011
10 DATE OF REVISION OF THE TEXT
01/12/2011