Paracetamol ........................... 325 mg
Excipients q.s …………………….. 1 tablet
Tablet.
Product description: A capsule-shaped, orange tablet, scored on one side, plain on the other side, undamaged edges.
Box of 10 blisters x 10 tablets.
Box of 1 bottle x 100 tablets.
Bottle of 400 tablets.
Pharmacotherapeutic group: Other analgesics and antipyretics ATC code: N02BE01
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.
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. Binding of the drug to plasma proteins is variable; 20 to 30% may be bound at the concentrations encountered during acute intoxication. Following therapeutic doses 90 - 100% of the drug may be recovered in the urine within the first day. However, practically no paracetamol is excreted unchanged and the bulk is excreted after hepatic conjugation.
The medicinal product does not affect the ability to drive and use machines.
Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically needed, paracetamol can be used during pregnancy if clinically needed, 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 breastfeeding.
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.
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.
Blood and lymphatic system disorders:
Very rare: Thrombocytopenia, agranulocytosis
Immune system disorders:
Very rare: Anaphylaxis, cutaneous hypersensitivity reactions including skin rashes, angioedema. Very rare cases of serious skin reactions have been reported.
Respiratory, thoracic and mediastinal disorders:
Very rare: Bronchospasm (There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs).
Hepatobiliary disorders:
Very rare: Hepatic dysfunction.
Please inform your doctor of all undesirable effects upon drug administration.
Paracetamol overdose may cause liver failure which may require liver transplant or lead to death.
Liver damage is possible in adults who have taken 10g 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
- If the patient regularly consumes ethanol in excess of recommended amounts. Or
- If the patient is likely to be glutathione depleted 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.
Store in dry places, not exceeding 30oC, protect from light.
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.
Caution should be exercised in patients with glutathione depleted states, as the use of paracetamol may increase the risk of metabolic acidosis.
Use with caution in patients with glutathione depletion due to metabolic deficiencies.
If symptoms persist, medical advice must be sought.
Keep out of the sight and reach of children.
The physician should warn patients of serious signs of skin reactions such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) or Lyell's syndrome, acute generalized exanthematous pustulosis (AGEP).
Excipients
Wheat starch in this medicine contains only very low levels of gluten and is very unlikely to cause problems if you have coeliac disease. If you have wheat allergy, you should not take this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium-free”.
This medicine contains 2 mg of sodium benzoate per tablet.
Orange E110 may cause allergic reactions.
Temporarily relieves the symptoms: flu, headache, backache, minor pain of arthritis, toothache, muscular aches, premenstrual and menstrual cramps.
Temporarily reduces fever.
Hypersensitivity to paracetamol or any of the ingredients of the drug.
For oral administration.
Do not exceed the recommended dose.
Adults and children aged > 12 years: oral dose of 2 tablets every 4 - 6 hours.
Do not take more than 10 tablets in 24 hours, unless directed by the physician.
Do not administer for more than 10 days unless directed by the physician.
Children aged 6 to 12 years: oral dose of 1 tablet every 4 - 6 hours.
Do not take more than 5 tablets in 24 hours.
Do not administer for more than 5 days unless directed by the physician.
Children aged less than 6 years: not applicable.
Or as directed by the physician.
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