Paracetamol 500mg Soluble Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Paracetamol 500mg Soluble Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Soluble tablet contains paracetamol 500mg Each soluble tablet contains approximately 392 mg sodium.
Excipients with known effect: lactose monohydrate.
For full list of excipients, see 6.1
3. PHARMACEUTICAL FORM
Soluble Tablet
4 CLINICAL PARTICULARS
4.1. Therap euti c Indi cati ons
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
Posology:
Adults, elderly and children 16 years and over:
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.
Children 12-15 years:
One tablet every 4-6 hours when necessary to a maximum of 4 doses in 24 hours.
Doses of Paracetamol should not be repeated more frequently than every 4 hours and not more than 4 doses should be given in any 24hour period.
Children should not be given paracetamol for more than 3 days without consulting a doctor.
Children under 12 years of age:
Not recommended.
Method of administration:
Oral administration only
4.3. Contra-indications
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 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.
This medicinal product contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
This medicinal product contains 392 mg of sodium per tablet and should not be taken by patients on a low sodium diet.
If symptoms persist, consult your doctor.
Keep out of the sight and reach 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 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. Interactions with other Medicaments 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. 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 reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.
Adverse events of paracetamol from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive postmarketing 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 postmarketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare.
Post marketing data
Undesirable effects
Body System
|
Skin and subcutaneous disorders |
Very rare cases of serious skin reactions have been reported |
|
Blood and lymphatic system disorders |
Thrombocytopenia Agranulocytosis |
|
Immune system disorders |
Anaphylaxis |
|
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
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, website www.mhra.gov.uk/yellowcard.
4.9 Overdose
Liver damage is possible in adults who have taken 10 g or more of paracetamol.
Ingestion of 5 g or more of paracetamol may lead to liver damage if the patient has
risk factors (see below):
• If the patient is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John’s Wort or other drugs that induce liver enzymes.
Or
• If the patient regularly consumes ethanol in excess of recommended amounts.
Or
• If the patient 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, anorexia, nausea, vomiting 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.
5 PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic Properties
ATC Name. Analgesics ATC Code. N02
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.
Preclinical Safety Data
5.3.
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
Citric acid
Sodium sulphate
Lactose monohydrate
Sodium hydrogen carbonate
Povidone
Simethicone
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
None known
6.3. Shelf Life
3 years
6.4. Special Precautions for Storage
Do not store above 25°C. Store in the original container. Keep the container tightly closed at dry place.
6.5. Nature and Contents of Container
Polypropylene tube with polyethylene stopper containing silica gel as desiccant. The tubes are packed into an outer carton.
Pack sizes: 6, 12 and 16 tablets
6.6 Special precautions for disposal
Dissolve tablets in a glass of water prior to intake.
7 MARKETING AUTHORISATION HOLDER
Milpharm Limited
Ares, Odyssey Busines Park
West End Road
South Ruislip
HA4 6QD
UK
8 MARKETING AUTHORISATION NUMBER
PL 16363/0127
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
02/03/2011
10 DATE OF REVISION OF THE TEXT
04/10/2016