Paracetamol 500mg Capsules
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol 500mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: Paracetamol 500mg.
‘For full list of excipients, see section 6.1’
3 PHARMACEUTICAL FORM
Capsule For oral administration.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment of mild to moderate pain, including rheumatic and muscular pain, backache, neuralgia, migraine, headache, toothache and period pains and for the symptomatic relief of feverishness, colds and flu.
4.2 Posology and method of administration
The capsules are taken by mouth. Adults: one or two capsules.
The dose should not be repeated more than four times in 24 hours. The dosage should not be continued for more than 3 days without consulting a doctor.
4.3 Contraindications
Hypersensitivity to paracetamol and/or other constituents. Patients with impaired liver or kidney function and alcoholics could be at risk in taking paracetamol. The hazard of overdose is greater in those with non-cirrhotic liver disease.
4.4 Special warnings and precautions for use
Care is advised in the administration of paracetamol to patients with severe renal or hepatic impairment. The hazard of overdosage is greater in those with non-cirrhotic alcoholic liver disease.
Do not exceed the recommended dose.
If symptoms persist for more than 3 days or get worse consult your doctor.
Patients should be advised not to take other paracetamol-containing products concurrently.
Patients should be advised to consult a doctor if they suffer from non-serious arthritis and need to take painkillers every day.
If symptoms persist, consult your doctor.
Keep out of 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 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
Colestyramine: The speed of absorption of paracetamol is reduced by colestyramine. Therefore, the colestyramine should not be taken within one hour if maximal analgesia is required.
Metoclopramide and domperidone: The speed of absorption of paracetamol may be increased by metoclopramide and domperidone. However, concurrent use need not be avoided.
Warfarin: 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 being 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.
4.8 Undesirable effects
Allergic reactions and sensitivity are rare but may include skin rashes, drug fever and mucosal lesions.
There have been reports of blood dyscrasias, including thrombocytopenia and agranulocytosis and/or acute pancreatitis, but these were not necessarily causality related to paracetamol. At the recommended dosages, drowsiness, impairment of mental function and methaemoglobinaemia have been seen.
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 at: www.mhra.gov.uk/yellowcard.
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, phenobarbitone, 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 Nacetylcysteine 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 24 h from ingestion should be discussed with the NPIS or a liver unit.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Pharmacotherapeutic group: Anilides ATC code: N02BE01
Mechanisms of action/Effect
Analgesic- the mechanism of analgesic action has not been fully determined. Paracetamol may act predominantly by inhibiting prostaglandin synthesis in the central nervous system and to a lesser extent, through a peripheral action by blocking pain-impulse generation.
The peripheral action may also be due to inhibition of prostaglandin synthesis or to the synthesis or actions of other substances that sensitise pain receptors to mechanical or chemical stimulation.
Antipyretic- paracetamol probably produces antipyresis by acting centrally on the hypothalamic heat-regulation centre to produce peripheral vasodilation resulting in increased blood flow through the skin, sweating and heat loss. The central action probably involves inhibition of prostaglandin synthesis in the hypothalamus.
5.2 Pharmacokinetic properties
Absorption and Fate
Paracetamol is rapidly absorbed from the gastrointestinal tract. The concentration in plasma reaches a peak in 30 to 60 minutes and the plasma half-life is 1 to 4 hours after therapeutic doses.
It is metabolised in the liver and excreted in the urine mainly as the glucuronide and sulphate conjugates. Less than 5 % is excreted as unchanged paracetamol. The elimination half life varies from about 1-4 hours. Plasma-protein binding is negligible at usual therapeutic concentrations but increases with increased concentration.
A minor hydroxylated metabolite which is usually produced in very small amounts by mixed-function oxidases in the liver and which is usually detoxified by conjugation with liver glutathione may accumulate following paracetamol overdosage and cause liver damage.
5.3 Preclinical safety data
There is no pre-clinical data of relevance to a prescriber which is additional to that already included in other sections of the SPC.
6.1 List of excipients
Starch 1500 , Magnesium Stearate , Sodium Lauryl Sulphate . The capsule shell is opaque red/white gelatin 100 mg, containing as colours Erythrosine (E127), Patent Blue V (E131), Titanium Dioxide (E171), and Quinoline Yellow (E104).
6.2 Incompatibilities
None known
6.3 Shelf life
36 months
6.4 Special precautions for storage
Store in original blister in order to protect from moisture. Do not store above 25°C. Store in original package- for blister pack.
6.5 Nature and contents of container
Strips of 8, 16, 32 blisters in a carton. The blisters are white opaque rigid PVC film unplasticised 250 pm, with hard tempered aluminium foil.
Glassine paper 35g/sqm/ Adhesive lacquer 2.5g/sqm/ Aluminium foil (9 micron)/Heatseal coating 7.0g/sgm/ PVC 250 micron with 8, 16, 32 capsules.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special precautions required.
7 MARKETING AUTHORISATION HOLDER
Relonchem Limited Cheshire House
Gorsey Lane, Widnes, Cheshire WA8 0RP, UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 20395/0081
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
11/08/2011
10 DATE OF REVISION OF THE TEXT
09/09/2013