Co-Codamol 8/500 Mg Effervescent Tablets
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT
Co-Codamol 8/500 mg Effervescent Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Co-Codamol 8/500 mg Effervescent Tablets contain:
Paracetamol BP 500mg Codeine Phosphate BP 8mg
3 PHARMACEUTICAL FORM
Effervescent Tablets
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the relief of mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, muscular and periods pains.
The symptomatic relief of influenza, feverishness and colds.
4.2 Posology and method of administration
For oral administration.
Adults and Children Aged Over 12 Years
One to two tablets to be taken every four hours if necessary. Do not exceed 8 tablets in 24 hours.
The Elderly
Normal dose unless there is impaired kidney or liver function.
Children Under 12 Years Not recommended
The tablets must be dissolved in half glass of water (100ml). The tablet dissolves more quickly in warm water, or if stirred.
4.3 Contraindications
Caution should be taken in patients with impaired kidney or liver function. Each tablet contains 430.1 mg (18.7 mmols) of Na+. This sodium should be taken into account when prescribing for patients on a sodium restricted diet. Hypersensitivity to Paracetamol and/or other constituents.
4.4 Special warnings and precautions for use
Do not exceed the recommended dose. This product contains Paracetamol. If you are pregnant or breastfeeding consult your doctor before taking this preparation. Keep out of the reach of children. Care is advised in the administration of Paracetamol to patients with severe renal or severe hepatic impairment and in those with noncirrhotic alcoholic liver disease. The hazards of overdose are greater in those with alcoholic disease. Do not take with any other paracetamol-containing products. 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.
The risk-benefit of continued use should be assessed regularly by the prescriber.
The leaflet will state in a prominent position in the ‘before taking’ section:
• Do not take for longer than directed by your prescriber
• Taking codeine regularly for a long time can lead to addiction, which might cause you to feel restless and irritable when you stop the tablets.
• Taking a painkiller for headaches too often or for too long can make them worse.
The label will state (To be displayed prominently on outer pack - not boxed):
• Do not take for longer than directed by your prescriber as taking codeine regularly for a long time can lead to addiction.
Interaction with other medicinal products and other forms of interaction
4.5
Alcohol, barbiturates, anticonvulsants and tricyclic antidepressants may increase the hepatotoxicity of Paracetamol, particularly after an overdose.
Chloramphenicol - Paracetamol may increase the half-life of Chloramphenicol.
Cholestyramine - may reduce absorption of Paracetamol.
Metoclopramide, Domperidone - may potentiate the effect of Paracetamol.
Warfarin and other coumarins - The anticoagulant effect may be enhanced by prolonged regular use or Paracetamol with increased bleeding.
4.6 Pregnancy and lactation
There is inadequate evidence for the safety of codeine in pregnancy.
Epidemiological studies in human pregnancy have shown no effects due to Paracetamol used in the recommended dosage. Both substances have been used for many years without apparent ill consequences and animal studies have not shown any hazard. However, these tablets should be avoided in pregnancy unless considered essential by the physician. Paracetamol has been detected in breast milk, although it is estimated that less than 0.1% of the material dose appears in 100ml of breast milk. Codeine has also been shown to be excreted in breast milk, although the quantity was not determined. Available published data do not contraindicate breastfeeding.
4.7 Effects on ability to drive and use machines
Codeine can occasionally cause drowsiness. If affected the patient should not drive or operate machinery.
4.8 Undesirable effects
If given in therapeutic doses side effects are very rare. Hypersensitivity including skin rashes and other allergic reactions may occur occasionally. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, and of acute pancreatitis. Most reports of adverse reactions to Paracetamol relate to overdose with the drug. Codeine can cause constipation, nausea, drowsiness and confusion.
• Regular prolonged use of codeine is known to lead to addiction and tolerance. Symptoms of restlessness and irritability may result when treatment is then stopped.
• Prolonged use of a painkiller for headaches can make them worse.
4.9 Overdose
Symptoms - due to Paracetamol in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent after 12 to 48 hours. Abnormalities of glucose metabolism (usually transient hypoglycaemia 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, gastrointestinal haemorrhage and jaundice may occur.
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.
Due to codeine - respiratory depression and hypotension with circulatory failure and deepening coma. Convulsion may occur in infants and children.
Treatment:
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 four hours should undergo gastric lavage. When over 4 hours have elapsed after overdosing, plasma paracetamol concentration should be measured. Specific treatment is required if the concentration falls above a line drawn between the A point S200mg per litre at 4 hours and 30mg per litre at 1.5 hours after the overdose. Acetylcysteine should be given intravenously, or alternatively, Methionine may be given by mouth unless the patient is vomiting or unconscious; both agent are of little value more than 15 hours after the overdose.
Patients at risk of renal or hepatic failure should receive a glucose infusion intravenously to prevent hypoglycaemia and established hepatic or renal failure should be managed conventionally. Naxolone Hydrochloride 400 pg is given intravenously repeated at intervals of 2 to 3 minutes if necessary. In children doses of 5 to 10pm per kg body weight may be given.
PHARMACOLOGICAL PROPERTIES
5
5.1 Pharmacodynamic properties
Analgesic and anti-pyretic properties.
5.2 Pharmacokinetic properties
None stated.
5.3 Preclinical safety data
None stated.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Citric Acid BP
Povidone BP Sodium Saccharin BP Sodium Cyclamate 1968 BP Sodium Bicarbonate BP Sodium Carbonate (Anhydrous) BP Polyethylene Glycol USNF
6.2 Incompatibilities
None stated.
6.3 Shelf life
Two years.
6.4 Special precautions for storage
Store in a cool dry place at or below 25°C.
6.5 Nature and contents of container
Cartonned strip packs using PPFM laminate, constructed of: 40gsm MGBK paper, 12gsm LDPE, 8micron aluminium foil, 23gsm LDPE, containing either 10, 12, 16, 24, 30, 32, 36, 50, 56, 60, 100 or 112 tablets.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Consilient Health Ltd.,
5th Floor, Beaux Lane House,
Mercer Street Lower,
Dublin 2,
Ireland.
8 MARKETING AUTHORISATION NUMBER(S)
PL 24837/0026
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 24/03/2009
10 DATE OF REVISION OF THE TEXT
24/11/2010