Summary of Product Characteristics (SmPC) - Paracetamol 500 mg soluble tablets
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. 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
Posology
Adults, the elderly and children aged 16 years and over:
1-2 tablets dissolved in a glass of water up to 4 times daily as required.
Paediatric population
Children aged 10-15 years:
1 tablet dissolved in water up to 4 times daily.
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 10 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
Contains paracetamol. Do not use with any other paracetamol-containing products.
Underlying liver disease increases the risk or paracetamol related liver damage. Patients who have been diagnosed with liver or kidney impairment must seek medical advice before taking this medication.
Do not exceed the stated dose.
Patients should be advised to consult their doctor if their headaches become persistent.
Patients should be advised to consult a doctor if they suffer from non-serious arthritis and need to take painkillers every day.
Cases of high anion gap metabolic acidosis (HAGMA) due to pyroglutamic acidosis have been reported. in patients with severe illness such as severe renal impairment and , sepsis, or in patients with malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin, If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring, including measurement of urinary 5-oxoproline, is recommended. The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors.
This medicinal product contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
This medicinal product contains 392 mg of sodium per tablet, equivalent to 20.05% of the WHO adult recommended maximum daily dietary intake of 2 g sodium and is considered to represent ‘high’ sodium.
For Adults, elderly and children 16 years and over:
The maximum daily dose of this product is equivalent to 160.40% of the WHO recommended maximum daily intake for sodium.
For children 12-15 years:
The maximum daily dose of this product is equivalent to 80.20% of the WHO recommended maximum daily intake for sodium.
This medicinal product is considered high in sodium. This should be particularly taken into account for those on a low salt 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.
High in sodium – see leaflet for further information.
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.
Talk to your doctor or pharmacist if you need one or more tablets daily for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet.
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.
Caution should be taken when paracetamol is used concomitantly with flucloxacillin as concurrent intake has been associated with high anion gap metabolic acidosis due to pyroglutamic acidosis, especially in patients with risks factors (see section 4.4).
4.6. Fertility, pregnancy and Lactation
Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically needed, paracetamol can be used during pregnancy however, as with any medicine it should be used at the lowest effective dose for the shortest possible time.
Paracetamol is excreted in breast milk but not in a clinically significant amount in recommended dosages. Available published data do not contraindicate breast feeding.
4.7. Effects on Ability to Drive and Use Machines
None.
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 and frequency.
The following convention has been utilised for the classification of the undesirable effects: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000) and very rare (<1/10,000), not known (cannot be estimated from available data).
Adverse event frequencies have been estimated from spontaneous reports received through post-marketing data.
Post marketing data
| Body System | Undesirable effects | Frequency |
| Blood and lymphatic | Thrombocytopenia | Very rare |
| system disorders | Agranulocytosis | |
| Immune system disorders | Anaphylaxis | Very rare |
| Cutaneous hypersensitivity reactions | ||
| including, among others, skin rashes | ||
| and angiodema. Very rare cases of | ||
| serious skin reactions have been | ||
| reported | ||
| Metabolism and nutrition | High anion gap metabolic acidosis | Not known |
| disorders | ||
| Respiratory, thoracic and | Bronchospasm* | Very rare |
| mediastinal disorders | ||
| Hepatobiliary disorders | Hepatic dysfunction | Very rare |
* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs
Description of selected adverse reactions
High anion gap metabolic acidosis
Cases of high anion gap metabolic acidosis due to pyroglutamic acidosis have been observed in patients with risk factors using paracetamol (see section 4.4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients.
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 or search for MHRA Yellow Card in the Google Play or Apple App store.
4.9 Overdose
Paracetamol overdose may cause liver failure which may require liver transplant or lead to death.
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):
Risk Factors:
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
- Regularly consumes ethanol in excess of recommended amounts.
Or
- 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 anti-inflammatory effects.
5.2. Pharmacokinetic Properties
Absorption
Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Concentration of the drug in plasma reaches a peak in 30
- 60 minutes and the plasma half-life is 1 - 4 hours.
Distribution
Paracetamol is relatively uniformly distributed throughout most body fluids. and exhibits variable protein binding.
Elimination
Excretion is almost exclusively renal in the form of conjugated metabolites.
5.3. Preclinical Safety Data
Conventional studies using the currently accepted standards for the evaluation of toxicity to reproduction and development are not available.
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 Business Park
West End Road
South Ruislip
HA4 6QD
United Kingdom
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
19/08/2026