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Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS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
Capsules, Hard
Oblong red and white coloured capsules.
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
‘For oral use’
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.
Contraindications
4.3
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
The patient would be informed of:
(i) Do not exceed the recommended dose.
(ii) The desirability/necessity of consulting a doctor if symptoms persist.
(iii) The need to ask the doctor or pharmacist about taking the capsules if they are already on a course of medication.
(iv) The fact that the product contains paracetamol should be stressed and a warning against taking other paracetamol containing products at the same time should be given.
(v) Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazards of' overdose are greater in those with alcoholic liver disease.
(vi) If symptoms persist, consult your doctor.
(vii) Keep out of the reach of children.
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 cholestyramine.
The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular 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.
4.9 Overdose
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.
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 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 24 h from ingestion should be discussed with the NPIS or a liver unit.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
ATC Code: N02BE01 (Analgesic and Antipyretics)
Paracetamol has analgesic and antipyretic actions but has no anti-inflammatory properties.
5.2 Pharmacokinetic properties
Paracetamol is readily absorbed from the gastro-intestinal tract with peak plasma concentrations occurring 30 minutes to 2 hours after ingestion. 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 PHARMACEUTICAL PARTICULARS
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’s or 10’s 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.
Pack sizes: 48, 60, 96 and 100 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 Tel: +44 207 419 5043 Fax: +44 207 419 5024 Email: info@relonchem.com
8 MARKETING AUTHORISATION NUMBER(S)
PL 20395/0089
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
21/08/2012
10 DATE OF REVISION OF THE TEXT
15/05/2013