Paracetamol Capsules 500mg
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Doans Capsules 500mg Paracetamol Capsules 500mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient : Paracetamol 500mg.
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
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 metoclopramine 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 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.
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, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.
Liver damage is likely in adults who have taken 10 g or more of paracetamol.
It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested) become irreversibly bound to liver tissue.
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 and any patient who has ingested around 7.5g or more of paracetamol in the preceding 4 hours should undergo gastric lavage. Administration of oral methionine or intravenous N-acetylcysteine which may have a beneficial effect up to at least 48 hours after the overdose, may be required. General supportive measures must be available.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
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 a dry place. Do not store above 25°C. Store in original package- for blister pack.
6.5 Nature and contents of container
Strips of 8, 12, 16, 24, 32, 50, 60, 84, 96 or 100 blisters in a carton. The blisters are white opaque rigid PVC film unplasticised 250 pm, with hard tempered aluminium foil.
Bottles -16, 25, 50, 60,100 capsules.
Securitainers -250, 500, 1000 capsules.
Glassine paper 35g/sqm/ Adhesive lacquer 2.5g/sqm/ Aluminium foil (9 micron)/Heatseal coating 7.0g/sgm/ PVC 250 micron with 8, 12, 16, 24, 32, 50, 60, 84, 96 or 100 capsules.
6.6 Special precautions for disposal
No special precautions required.
7 MARKETING AUTHORISATION HOLDER
Fourrts (Uk) Pharmacare Ltd First Floor,
2 Victoria Road,
Harpenden,
Hertfordshire,
A15 4EA,
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 39484/0037
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
2nd February 2005
10 DATE OF REVISION OF THE TEXT
27/06/2011