Paracetamol 500mg Tablets
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Doans Tablets 500mg Paracetamol Tablets 500mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient : Paracetamol 500mg.
3 PHARMACEUTICAL FORM
Tablet.
White to off-white caplets plain on both sides. These tablets are for oral administration.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment of mild to moderate pain, including headache, migraine, neuralgia. toothache, sore throat, period pains, aches and pains.
Symptomatic relief of rheumatic aches and pains.
Symptomatic relief of influenza, feverishness, feverish colds.
4.2 Posology and method of administration
Adults, the elderly and children over 12 years:
Single dose 0.5 g - 1 g (1 to 2 tablets).
Maximum daily dose 4 g (8 tablets) in divided closes.
Children:
Age 6 years to under 12 years : half tablet to one tablet. Age under 6 years: this formulation is not appropriate.
Dosage instruction
1 - Dose should not be repeated more frequently than 4 hour intervals.
2 - Not more than 4 doses should be administered in any 24 hour period.
3 - Dosage should not be continued for more than 3 days without consulting a doctor.
4.3 Contraindications
Hypersensitivity to paracetamol or any other ingredients. Patients with impaired liver or kidney function and patients taking other drugs that affect the liver. 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
(i) Do not exceed the stated dose.
(ii) Consult a doctor if symptoms persist.
(iii) Ask the doctor or pharmacist about taking the capsules if they are already on a course of medication.
(iv) This product contains paracetamol.
(v) Do not take with other paracetamol- containing products.
(vi) 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.
(vii) 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.
(viii) Keep out of the reach of children.
4.5 Interaction with other medicinal products and other forms of interaction
Alcohol reduces liver capacity to deal with paracetamol. Chronic use of paracetamol enhances effect of warfarin and other coumarins with increased risk of bleeding; occasional doses have no significant effect. Cholestyramine reduces absorption of paracetamol. Metoclopramide and domperidone accelerate absorption of paracetamol.
May interact with chloramphenicol causing increased plasma levels.
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 clinically significant quantities. 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 causally related to paracetamol. At the recommended dosages drowsiness, impairment of mental function and methaemoglobinaemia have been seen.
4.9 Overdose
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 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 employed) become irreversibly bound to liver tissue.
Prompt treatment is essential in the management of paracetamol overdosage.
Any patient who has ingested about 7.5 g or more of paracetamol in the preceding 4 hours should undergo gastric lavage. Specific therapy with an antidote such as acetylcysteine or methionine may be necessary.
Acetylcysteine may be given either intravenously or by mouth or methionine may be given by mouth within 10 - 12 hours of ingestion of the overdose.
Cysteamine was also formerly used.
Generally, treatment is required if the blood-paracetamol concentration is higher than a line (the ‘200' line) drawn on semi-log/linear paper joining the
points 200 mg per litre (1.32 mmol. per litre) at 4 hours and 30 mg per litre (0.20 mmol. per litre) at 15 hours.
Determination of the concentration before 4 hours is not considered to give a reliable measurement and administration of acetylcysteine or methionine more than 15 hours after overdose is generally ineffective and may be associated with an exacerbation of any liver abnormality.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Paracetamol is an effective analgesic and antipyretic agent but has only weak anti-inflammatory properties. Its mechanism of action is not fully understood, as it is only a weak inhibitor of prostaglandin bio-synthesis, but it has been suggested that it is more effective against enzymes in the CNS than those in the periphery. The drug has no effect on the cardiovascular and respiratory systems, and it does not cause gastric irritation or bleeding like salicylates.
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 increasing 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
Maize starch, Povidone K-30, Sodium metabisulphite, Sodium Starch Glycollate, Colloidal Anhydrous Silica, Magnesium stearate.
6.2 Incompatibilities
None stated.
6.3 Shelf life
3 years.
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
Child resistant blister packs of 4, 8, 16, 24, 32, 50, 60, 84, 96 and 100 tablets. Tamper evident bottle 4, 8, 16, 100, 250, 500 and 1000 tablets.
Specification details of blister packs:
- PVC (white, rigid, opaque): 250 microns
- PVC/Aluminium foil (hard tempered): 15/20 microns
- Primer (nitrocellulose): 1.5-2.5 gsm
- Heat seal lacquer: 6.5 - 8.5 gsm
6.6 Special precautions for disposal
No special precautions required.
7 MARKETING AUTHORISATION HOLDER
Activase Pharmaceuticals Limited,
11 Boumpoulinas, 3 Floor,
PC. 1060 Nicosia.
Cyprus
8 MARKETING AUTHORISATION NUMBER(S)
PL 28444/0093
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
2nd February 2005
10 DATE OF REVISION OF THE TEXT
11/01/2012