CO-CODAMOL TABLETS - summary of medicine characteristics

Co-Codamol Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Paracetamol 500.0mg

Codeine phosphate 8.0mg

Tablet

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 12 years of age

One or two tablets – Maximum of eight tablets per 24 hours

Children 6 – 12 years

Half to One tablet – Maximum of four tablets per 24 hours.

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 other constituents.

Impaired kidney or liver function.

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.

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.

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.

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 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.

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 10jrg/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

50, 100, 250 and 500 tablets

6.6 Special precautions for disposal

Round white, polypropylene containers, tamper evident and child-resistant, containing 50 or 100 tablets

Polypropylene screw cap bottles containing 250 or 500 tablets

7 MARKETING AUTHORISATION HOLDER

Activase Pharmaceuticals Limited

11 Boumpoulinas, 3rd floor

P.C. 1060 Nicosia,

Cyprus

8 MARKETING AUTHORISATION NUMBER(S)

PL 28444/0161