CO-DYDRAMOL TABLETS - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Co-Dydramol Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Tablets containing 10mg of Dihydrocodeine tartrate BP and 500mg Paracetamol BP

3 PHARMACEUTICAL FORM

White, flat circular plain tablets with a bevel edge and breakline.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

1. An analgesic

2. An antitussive

4.2 Posology and method of administration

Co-Dydramol tablets should be taken if possible, during or after meals.

As an analgesic:

Adults and children over 12 years:

1 tablet every four hours. This may if necessary be increased to 2 tablets four times daily.

As an antitussive:

Adults and children over 12 years:

1 tablet every four hours.

Not recommended for children under 12 years.

Dosage should be reduced in the elderly.

Not more than 8 tablets in 24 hours.

Oral.

4.3 Contraindications

Respiratory depression, obstructive airway disease, allergic disorders or during an attack of asthma. Hypersensitivity to Paracetamol and /or other constituents.

4.4 Special warnings and precautions for use

The risk-benefit of continued use should be assessed regularly by the prescriber. Use with caution in impaired liver function or renal disease. Reduce dosage in hypothyroidism and in chronic hepatic disease. May cause constipation, nausea, headache, vertigo & giddiness in some patients. Care is advised in the administration if paracetamol to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with (non-cirrhotic) alcoholic liver disease. Do not exceed the recommended dose.

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 warfarin 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

Epidemiological studies in 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 on paracetamol do not contraindicate breast-feeding.

4.7 Effects on ability to drive and use machines

None stated

4.8 Undesirable effects

Regular prolonged use of dihydrocodeine is known to lead to addiction, and symptoms of restlessness and irritability may result when treatment is then stopped. Prolonged use of a painkiller for headaches can make them worse. 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 casually related to paracetamol.

4.9 Overdose

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.

Symptoms of paracetamol overdose 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.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Peak levels of plasma dihydrocodeine concentration are attained in an hour, following ingestion. Plasma half-life has been reported to be between 3–4 hours after oral ingestion. Dihydrocodeine is metabolised in the liver by O-and N- demethylation. Dihydrocodeine and its metabolites are excreted entirely by the kidneys mainly as conjugates with glucuronic acid.

Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentration occurring 30 minutes to 2 hours after ingestion. It is metabolised in the liver and excreted in the urine mainly as the glucuronide and the sulphate conjugates. Less than 5% is excreted as unchanged paracetamol. The elimination half – life varies from 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 small amounts by mixed-function oxidases in the liver and which is usually de-toxified by conjugation with liver glutathione may accumulate following paracetamol overdosage and may cause liver damage.

5.2 Pharmacokinetic properties

The pharmacokinetics of dihydrocodeine may be similar to codeine: they differ between subjects with normal renal function and those with chronic renal failure treated with haemodialysis. Dihydrocodiene is well absorbed from the gastrointestinal tract following oral administration. Plasma half-life has been reported to between 3–4 hours after oral ingestion.

5.3 Preclinical safety data

Not applicable

6.1

6.2

Maize Starch

Povidone (K= 29/32) Sodium Starch Glycollate Stearic Acid

Colloidal Silicone Dioxide Talc

None Stated

6.3 Shelf life

12 Months

6.4 Special precautions for storage

Store in a cool dry place below 25°C. Protect from light.

6.5 Nature and contents of container

Securitainers in pack sizes if 16, 25, 30, 32, 50, 100, 250, 500 and 1000.

PVC blisters of 16, 32 and 100.

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 28444/0159

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION

26th September 1994