Summary of Product Characteristics (SmPC) - Co-codamol tablets
1 NAME OF THE MEDICINAL PRODUCT
Co-Codamol Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Paracetamol 500.0mg
Codeine phosphate 8.0mg
Excipient with knon effects
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
An analgesic for the treatment of mild to moderate pain including headache, neuralgia, toothache, sore throat, period pains and the symptomatic relief of influenza, feverishness and feverish colds, especially where aches and pains are present.
4.2 Posology and method of administration
Route of administration: Oral
To be taken every three or four hours when needed.
Adults and Children over 15 years of age
One or two tablets – Maximum of eight tablets per 24 hours
Children 6 – 15 years
| Age | Recommended Paracetamol Dose | Co-codamol tablet dose | How Often |
| 6-8 years | 240-250mg | Half | Every 4-6 hours when necessary |
| to a maximum of 4 doses in 24 hours | |||
| 8-10 years | 360-375mg | Half – three quarters | Every 4-6 hours when necessary to a maximum of 4 doses in 24 hours |
| 10-12 years | 480-500mg | One | Every 4-6 hours when necessary to a maximum of 4 doses in 24 hours |
| 12-15 years | 480-750mg | One – One & half | Every 4-6 hours when necessary to a maximum of 4 doses in |
Not suitable for children under six years of age.
Do not take more than 3 days continuously without medical review.
4.3 Contraindications
Hypersensitivity to paracetamol and/or to any of the excipients listed in section 6.1 .
Impaired kidney or liver function.
Monoamine oxidase inhibitor therapy, concurrent or within 14 days.
4.4 Special warnings and precautions for use
Do
not exceed the recommended dose
Contains paracetamol. Do not take with any other paracetamol-containing products. Immediate medical advise should be sought in the event of an overdose, because of the risk of delayed serious liver damage. If symptoms persist, consult your doctor.
If you are pregnant consult your doctor before taking this product. Keep out of the reach of children.
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 non-cirrhotic alcoholic liver disease.
Cases of high anion gap metabolic acidosis (HAGMA) due to pyroglutamic acidosis have been reported in patients with severe illness such as severe renal impairment and sepsis, or in patients with malnutrition or other sources of glutathione deficiency (e.g. chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin. If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended. The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors.
Care should be observed in administering the product to any patient whose condition may be exacerbated by opioids, including the elderly, who may be sensitive to their central and gastro-intestinal effects, those on concurrent CNS depressant drugs, those with prostatic hypertrophy, hypothyroidism and those with inflammatory or obstructive bowel disorders. Addison’s disease or myasthenia gravis. Care should also be observed if prolonged therapy is contemplated.
For product in packs of 32 tablets or fewer the label and leaflet will state: Patient Information Leaflet (in ‘before taking’ section)
If you need to use this medicine for more than three days at a time, see your doctor, pharmacist or healthcare professional.
Taking codeine regularly for a long time can lead to addiction, which might cause you to feel restless and irritable when you stop taking the tablets.
Taking a painkiller for headaches too often or for too long can make them worse. Packaging (to be displayed prominently on outer pack – not boxed)
If you need to use this medicine for more than three days at a time, see your doctor or pharmacist.
Taking codeine regularly for a long time can lead to addiction.
Taking a painkiller for headaches too often or for too long can make them worse. Packs containing more than 32 dosage units should be labelled as dispensing and should make reference to the necessary indications, dosage instructions, Warnings and precautions for an over the counter presentation (as above).
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 warfin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.
Caution should be taken when paracetamol is used concomitantly with flucloxacillin as concurrent intake has been associated with high anion gap metabolic acidosis due to pyroglutamic acidosis, especially in patients with risks factors (see section 4.4).
Concomitant administration of MAOI (e.g. tranylcypromine) can potentiate the central nervous effects and other side effects of unpredictable severity, Co-codamol should not be used within two weeks after the discontinuation of MAOI treatment.
4.6 Fertility, Pregnancy and lactation
There is inadequate evidence for the safety of codeine in pregnancy, but there is epidemiological evidence for the safety of paracetamol.
Epidemiological studies inn human pregnancy have shown no ill effects due to paracetamol 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.
Both substances have been used for many years without apparent ill consequence and animal studies have not shown any hazard. Nonetheless, careful consideration should be given before giving Co-Codamol Tablets to pregnant mothers, particularly in the first trimester.
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
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 causality related to paracetamol.
Codeine can cause constipation, nausea, drowsiness and confusion.
Regular prolonged use of codeine is known to lead to addiction and symptoms of restlessness and irritability may result when the treatment is stopped. Prolonged use of a painkiller for headaches can make them worse.
Metabolism and nutrition disorders
“High anion gap metabolic acidosis’’ with frequency ‘’Not known’’ (cannot be estimated from the available data)
Description of selected adverse reactions
High anion gap metabolic acidosis
Cases of high anion gap metabolic acidosis due to pyroglutamic acidosis have been observed in patients with risk factors using paracetamol (see section 4.4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
- i) Symptoms
Due to paracetamol – in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain, liver damage may become apparent 12 to 48 hours after indigestion. 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 possible in adults who have taken 10g or more of paracetamol. Due to codeine – respiratory depression and hypotension with circulatory failure and deepening coma. Convulsion may occur in infants and children.
ii) Treatment
The stomach should be emptied by aspiration and lavage. Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to a 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 Nacetylcysteine which may have a beneficial effect up to at least 48 hours after the overdose, may be required. General supportive measures must be available.The antidote for codeine is naloxone hydrochloride. This should be given as follows:
Naloxone Hydrochloride: 400mg is given IV repeated at intervals of 2 to 3 minutes if necessary. In children a dose of 5 to 10μg/kg body weight may be given.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Analgesic, antipyretic
5.2 Pharmacokinetic properties
Not applicable
5.3 Preclinical safety data
None stated
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Starch (maize)
Potassium sorbate
Sodium starch glycolate
Magnesium stearate
Pregelatinised maize starch
6.2 Incompatibilities
None stated
6.3 Shelf life
Three years
6.4 Special precautions for storage
None
6.5 Nature and contents of container
Round white, polypropylene containers, tamper evident and child-resistant, containing 25, 30 and 32 tablets
6.6 Special precautions for disposal
None stated
7 MARKETING AUTHORISATION HOLDER
Activase Pharmaceuticals Limited
11 Boumpoulinas, 3rd floor
P.C. 1060 Nicosia,
Cyprus
8 MARKETING AUTHORISATION NUMBER(S)
PL 28444/0160
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
06/11/1978 / 08/07/2008
10 DATE OF REVISION OF THE TEXT
21/01/2026