Co-Codamol 30/500 Mg Effervescent Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Co-Codamol 30/500 mg Effervescent Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each effervescent tablet contains:
30 mg of codeine phosphate hemihydrate (codeine base 22.5 mg) and 500 mg of paracetamol.
Excipients:
Each tablet contains 410 mg sodium. Also contains sorbitol. See section 4.4 for further information.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Effervescent tablet
White, bevelled, flat, round tablets with a break-line on one side.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the relief of severe pain.
4.2 Posology and method of administration
Co-Codamol 30/500 mg Effervescent Tablets are for oral use and should be dissolved in at least half a tumbler-full of water before taking.
Adults: One or two effervescent tablets not more frequently than every 4 hours, up to a maximum of 8 tablets in any 24 hour period.
Elderly: As for adults, however a reduced dose may be required. See warnings. Children: Not recommended for children under 12 years of age.
4.3 Contraindications
Hypersensitivity to paracetamol or codeine which is rare, or hypersensitivity to any of the other constituents. Conditions where morphine and opioids are contraindicated eg, acute asthma, respiratory depression, acute alcoholism, head injuries, raised intracranial pressure and following biliary tract surgery; monoamine oxidase inhibitor therapy, concurrent or within 14 days.
4.4 Special warnings and precautions for use
Each effervescent tablet contains 410mg sodium (17.83mEquivalents). This sodium content should be taken into account when prescribing for patients in whom sodium restriction is indicated.
Care should be observed in administering the product to any patient whose condition may be exacerbated by opioids, particularly the elderly, who may be sensitive to their central and gastro-intestinal effects, those on concurrent CNS depressant drugs, those with prostatic hypertrophy and those with inflammatory or obstructive bowel disorders. Care should also be observed if prolonged therapy is contemplated.
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.
Patients should be advised not to exceed the recommended dose and not take other paracetamol containing products concurrently.
Co-codamol 30/500 mg Effervescent Tablets contain sorbitol (E420). Patients with rare hereditary problems of fructose intolerance should not take this medicine.
4.5 Interaction with other medicinal products and other forms of interaction
Paracetamol may increase the elimination half-life of chloramphenicol. Oral contraceptives may increase its rate of clearance. 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.
The effects of CNS depressants (including alcohol) may be potentiated by codeine.
4.6 Pregnancy and lactation
There is inadequate evidence of the safety of codeine in human pregnancy, but there is epidemiological evidence for the safety of paracetamol. Both substances have been used for many years without apparent ill consequences and animal studies have not shown any hazard. Nonetheless careful consideration should be given before prescribing the products for pregnant patients. Opioid analgesics may depress neonatal respiration and cause withdrawal effects in neonates of dependent mothers.
Paracetamol is excreted in breast milk but not in a clinically significant amount.
4.7 Effects on ability to drive and use machines
Patients should be advised not to drive or operate machinery if affected by dizziness or sedation.
4.8 Undesirable effects
Codeine can produce typical opioid effects including constipation, nausea, vomiting, dizziness, light-headedness, confusion, drowsiness and urinary retention. The frequency and severity are determined by dosage, duration of treatment and individual sensitivity. Tolerance and dependence can occur, especially with prolonged high dosage of codeine.
Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.
4.9 Overdose
Nausea and vomiting are prominent symptoms of codeine toxicity and if there is evidence of circulatory and respiratory depression, suggested treatment is gastric lavage and catharsis. If CNS depression is severe, assisted ventilation, oxygen and parenteral naloxone may be needed.
Patients in whom oxidative liver enzymes have been induced, including alcoholics and those receiving barbiturates and patients who are chronically malnourished, may be particularly sensitive to the toxic effects of paracetamol in 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 and pancreatitis have been reported.
Liver damage is likely in adults who have taken 10g 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 had 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
Pharmacotherapeutic group: Natural opium alkaloids ATC code: N02A A59.
Paracetamol is an analgesic which acts peripherally, probably by blocking impulse generation at the bradykinin sensitive chemo-receptors which evoke pain. Although it is a prostaglandin synthetase inhibitor, the synthetase system in the CNS rather than the periphery appears to be more sensitive to it. This may explain paracetamol's lack of appreciable anti-inflammatory activity. Paracetamol also exhibits antipyretic activity.
Codeine is a centrally acting analgesic which produces its effect by its action at opioid-binding sites (^-receptors) within the CNS. It is a full agonist.
5.2 Pharmacokinetic properties
Paracetamol is readily absorbed from the gastro-intestinal tract with peak plasma concentration occurring about 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 halflife varies from about 1 to 4 hours. Plasma-protein binding is negligible at usual therapeutic concentrations but increases with increasing concentrations.
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.
Codeine and its salts are absorbed from the gastro intestinal tract. Ingestion of codeine phosphate hemihydrate produces peak plasma codeine concentrations in about one hour. Codeine is metabolised by O- & N-demethylation in the liver to morphine and norcodeine. Codeine and its metabolites are excreted almost entirely by the kidney, mainly as conjugates with glucuronic acid.
The plasma half-life has been reported to be between 3 and 4 hours after administration by mouth or intravascular injection.
5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber, which are additional to those already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium hydrogen carbonate anhydrous sodium carbonate anhydrous citric acid sodium docusate sorbitol (E420) saccharin sodium dimeticone sodium benzoate macrogol 6000
6.2 Incompatibilities
Not applicable
6.3 Shelf life
2 years (tubes)
18 months (strips)
6.4 Special precautions for storage
Do not store above 25°C. Keep the container tightly closed.
6.5 Nature and contents of container
Polypropylene tubes with polyethylene stoppers with silica gel as desiccant, each containing 15 or 20 tablets.
The tubes are presented in packs of 30 (2 tubes of 15) and 100 (5 tubes of 20) effervescent tablets.
Aluminium/Polyethylene composite strips in packs of 30 or 100 effervescent tablets.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Consilient Health Limited,
5th floor, Beaux Lane House,
Mercer Street Lower,
Dublin 2 Ireland
8 MARKETING AUTHORISATION NUMBER(S)
PL 24837/0004
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
31/10/2008
10 DATE OF REVISION OF THE TEXT
25/03/2009