Name of the medicinal product: Dihydrocodeine 30mg Tablets
2. Qualitative and quantitative composition: Dihydrocodeine tartrate 30mg
3. Pharmaceutical form: Tablet – Oral use
4.1 Therapeutic indications
Dihydrocodeine 30mg is used to relieve moderate to severe pain.
4.2 Posology and method of administration
1 tablet (30mg) every four to six hours or at the discretion of the physician.
Dosage should be reduced
Children aged 4 to 12 years:
0.5 to 1mg/kg bodyweight every four to six hours.
Children under 4 years:
Chronic hepatic disease:
The dosage should be reduced
Moderate to severe renal impairment:
The dosage should be reduced
For concomitant illnesses/conditions where dose reduction may be appropriate see 4.4 Special Warnings and Precautions for Use.
Acute respiratory depression.
Obstructive airways disease
Known hypersensitivity to dihydrocodeine, or other opioid analgesics, or to any of the excipients
Severe hepatic dysfunction
Head injury or raised intracranial pressure (in addition to the risk of respiratory depression and increased intracranial pressure, may affect papillary and other responses vital for neurological assessment).
Children under 4 years of age.
Dihydrocodeine 30mg should not be given to comatose patients.
Dihydrocodeine 30mg is also contraindicated where there is a risk of paralytic ileus, or in acute diarrhoeal conditions such as acute ulcerative colitis or antibiotic associated colitis (e.g. pseudomembranous colitis) or diarrhoea caused by poisoning.
Dihydrocodeine 30mg should be given in reduced doses or with caution to patients with asthma and decreased respiratory reserve. Avoid use during an acute asthma attack (see 4.3 Contraindication). Dihydrocodeine should be given in reduced doses or with caution to elderly or debilitated patients (see 4.2 Posology) and in patients with adrenocortical insufficiency, prostatic hyperplasia, urethral stricture, hypotension, shock, inflammatory or obstructive bowel disorders, myasthenia gravis, hypothyroidism or convulsive disorders. It should be avoided or the dose reduced in patients with hepatic or renal impairment. However, these conditions should not necessarily be a deterrent to use in palliative care. Use in caution in those with a history of drug abuse.
Dihydrocodeine 30mg should be avoided in patients with biliary tract disorders or used in conjunction with an antispasmodic.
Administration of pethidine and possibly other opioid analgesics to patients taking a monoamine oxidase inhibitor (MAOI) has been associated with very severe and sometimes fatal reactions. If the use of codeine is considered essential then great care should be taken in patients taking MAOIs or within 14 days of stopping MAOIs (see section 4.5).
Alcohol should be avoided whilst under treatment with dihydrocodeine.
The risk-benefit of continued use should be assessed regularly by the prescriber.