Paracetamol 500mg Effervescent Tablets.
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol 500mg Effervescent Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Paracetamol 500mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Effervescent Tablet
4.1 Therapeutic indications
Paracetamol 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, 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
Route of administration: Oral administration only.
Adults and the elderly:
1 -2 tablets in at least half a tumbler of water, up to 4 times daily as required. Children:
6 - 12 years: ^ - 1 tablet dissolved in water up to 4 times daily. Not recommended
for children under the age of 6 years.
Doses of paracetamol should not be given more frequently than every 4 hours, and
not more than 4 doses should be given in any 24 hour period.
Children should not be given paracetamol for more than 3 days without consulting a doctor.
4.3 Contraindications
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 renal or hepatic impairment. The hazard of overdose is greater in those with noncirrhotic 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.
CAUTION: Each tablet contains 466.3mg (18.9 mill mole) of Na+' This Sodium should be taken into account when prescribing for patients on a sodium restricted diet.
If symptoms persist consult your doctor.
Keep out of the reach and sight of children.
Pack Label:
Immediate medical advice should be sought in the event of an overdose, even if you feel well.
Do not take with any 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 colestyramine. 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 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 stated.
4.8 Undesirable effects
Adverse events of paracetamol from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system class. Due to limited clinical trial data, the frequency of these adverse events is not known (cannot be estimated from available data), but post-marketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare.
Post marketing data
|
Body System |
Undesirable effect |
|
Blood and lymphatic system disorders |
Thrombocytopenia |
|
Agranulocytosis | |
|
Immune system disorders |
Anaphylaxis |
|
Cutaneous hypersensitivity reactions including skin rashes and angiodema | |
|
Respiratory, thoracic and mediastinal disorders |
Bronchospasm* |
|
Hepatobiliary disorders |
Hepatic dysfunction |
* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.
Very rare cases of serious skin reactions have been reported.
4.9 Overdose
Liver damage is possible in adults who have taken 10g 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 carbamazepine, 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.
High doses of sodium bicarbonate may be expected to induce gastrointestinal symptoms including belching and nausea. In addition, high doses of sodium bicarbonate may cause hypernatraemia; electrolytes should be monitored and patients managed accordingly.
Pharmacodynamic properties
5.1
Paracetamol is an antipyretic analgesic. The mechanism of action is probably similar to that of aspirin and dependant on the inhibition of prostaglandin synthesis. This inhibition appears, however to be on a selective basis.
5.2 Pharmacokinetic Properties:
Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. The concentration in plasma reaches a peak in 30 to 60 minutes and the plasma half-life is 1 - 4 hours after therapeutic doses. Paracetamol is relatively uniformly distributed throughout most body fluids and exhibits variable protein binding. Excretion is almost entirely renal in the form of conjugated metabolites.
5.3 Preclinical safety data
There are no clinically relevant preclinical safety data in addition to that already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Citric Acid, Anhydrous
Povidone
Sodium Cyclamate
Polyethylene Glycol 6000
Sodium Bicarbonate
Sodium Carbonate Anhydrous
Sodium Saccharin
Water
IMS
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
Three years.
6.4 Special precautions for storage
Store at or below 25 °C in a dry place.
6.5 Nature and contents of container
Trip pack using PPFM laminate comprising: 40 gsm MGBK paper/ 12gsm LDPE/8 p
Aluminium foil/23 gsm LDPE. Strips are packed in an outer carton containing 16, 20, 24, 56, 60 or 100 tablets.
6.6 Special precautions for disposal
Not applicable
7 MARKETING AUTHORISATION HOLDER
Aspar Pharmaceuticals Limited 29-30 Capitol Way
Capitol Way Industrial Park, Colindale London NW9 0EQ United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 08977/0045
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
23/4/96
10 DATE OF REVISION OF THE TEXT
14/08/2014