Dihydrocodeine Tablets 30mg
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dihydrocodeine Tablets 30mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains dihydrocodeine tartrate BP 30mg.
3 PHARMACEUTICAL FORM
Tablet.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For moderate to severe pain.
4.2 Posology and method of administration
Adults and children over 12 years:
One tablet (30mg) every 4 to 6 hours when necessary after food.
Maximum dose in 24 hours 180mg (6 tablets).
Not recommended for children under 12 years old.
The dosage may have to be reduced in elderly patients. See also sub-section 4.4 Special warnings and special precautions for use.
Method of administration: oral.
4.3 Contraindications
Respiratory depression and obstructive airways disease. Hypersensitivity to dihydrocodeine or any of the excipients. Avoid use where there is a risk of paralytic ileus.
Acute alcoholism.
Head injuries or conditions in which intracranial pressure is raised.
4.4 Special warnings and precautions for use
Do not give during an attack of asthma and administer with due care to persons liable to such attacks.
Dosage should be reduced in the elderly, in hypothyroidism, in chronic hepatic disease and in renal insufficiency.
Opioid analgesics should be given in reduced doses or with caution in debilitated patients, patients with hypotension, adrenocortical insufficiency, urethral stricture, shock, inflammatory or obstructive bowel disorders, hypothyroidism, prostatic hypertrophy and convulsive disorders.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
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.
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 dihydrocodeine 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 during treatment with dihydrocodeine. The risk-benefit of continued use should be assessed regularly by the prescriber.
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 dihydrocodeine regularly for a long time can lead to addiction.
The leaflet will state in a prominent position in the ‘before taking’ section:
• Do not take for longer than directed by your prescriber
• Taking dihydrocodeine (DHC) 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.
4.5 Interaction with other medicinal products and other forms of interaction
Dihydrocodeine may cause the release of histamine; hence this product should not be administered during an asthmatic attack and should be administered with caution in patients with allergic disorders.
The depressant effects of opioid analgesics are enhanced by other CNS depressants such as;
• Anaesthetics- may increase anaesthetic and sedative effect
• Alcohol - enhanced hypotensive, sedative effect and respiratory depression
• Sedating antihistamines may enhance the CNS depressive effects when taken with opioids
• Anxiolytics or Hypnotics- may enhance CNS depressive effects when taken with opioids
• Tricyclic antidepressants- may enhance CNS depressive effects when taken with opioids
Cyclizine may counteract the haemodynamic benefits of opioids.
Dihydrocodeine tartrate causes delayed absorption of mexiletine, potentiation of hypnotics and sedatives.
MAOIs taken with pethidine have been associated with severe CNS excitation or depression (including hypertension or hypotension). Although this has not been documented with dihydrocodeine, it is possible that a similar interaction may occur and therefore the use of dihydrocodeine should be avoided while the patient is taking MAOIs and for 2 weeks after MAOI discontinuation.
When dihydrocodeine is taken concomitantly with antipsychotics there may be an increased sedative and hypotensive effect. Concomitant use of dihydrocodeine and ritonavir should be avoided due to the risk of toxicity.
Dihydrocodeine antagonises the gastro-intestinal effects of metoclopramide and domperidone.
Cimetidine inhibits metabolism of opioid analgesics.
4.6 Fertility, pregnancy and lactation
There is inadequate evidence of safety in human pregnancy, but the drug has been used for many years without apparent ill consequence and studies in animals have not yet demonstrated any hazard.. However, during labour opioids enter the fetal circulation and may cause respiratory depression in the neonate therefore administration should be avoided during the later stages of pregnancy.
Babies born to opioid-dependant mothers may suffer withdrawal symptoms.
Dihydrocodeine passes into breast milk in very small amounts which are probably insignificant, however, it is recommended that administration should be avoided if the mother is breast feeding.
4.7 Effects on ability to drive and use machines
Dihydrocodeine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.
Dihydrocodeine may cause drowsiness, hallucinations, dizziness, paraesthesia, vertigo, muscle rigidity, visual disturbances, confusion or syncope as side effects. If the patient is affected they should not drive or operate machinery.
This medicine can impair cognitive function and can affect a patient's ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients should be told:
• The medicine is likely to affect your ability to drive
• Do not drive until you know how the medicine affects you
• It is an offence to drive while under the influence of this medicine
• However, you would not be committing an offence (called 'statutory defence') if:
• The medicine has been prescribed to treat a medical or dental problem and
- You have taken it according to the instructions given by the prescriber and in the information provided with the medicine and
- It was not affecting your ability to drive safely
4.8 Undesirable effects
Side-effects are more common when the dose is greater than 30mg. May cause dependence.
Skin disorders; rash, urticaria, pruritius, sweating.
Central and peripheral nervous system disorders; paraesthesia, dizziness, headache, vertigo, respiratory depression. Muscle rigidity has been reported after high doses.
Vision disorders; visual disturbances, miosis.
Psychiatric disorders; drowsiness, changes of mood, confusion, sexual dysfunction, hallucinations, euphoria.
Gastro-intestinal system disorders; dry mouth, nausea, vomiting, abdominal pain, constipation.
Liver and biliary system disorders; biliary spasm which may be associated with alterations in liver enzyme values.
Cardiovascular disorders general; hypotension, syncope
Heart rate and rhythm disorders; bradycardia, tachycardia, palpitations.
Vascular (extracardiac) disorders; facial flushing.
Urinary systems disorders; Micturition may be difficult and there may be ureteric spasm.
Body as a whole, general; oedema.
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 pain killer for headaches can make them worse. 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 at: www.mhra.gov.uk/yellowcard
4.9 Overdose
The effects in overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs.
Symptoms
Central nervous system depression, including severe respiratory depression, may develop but is unlikely to be severe unless other sedative agents have been co-ingested, including alcohol, or the overdose is very large. The pupils may be pin-point in size; nausea and vomiting are common. Hypotension and tachycardia are possible but unlikely.
Management
This should include general symptomatic and supportive measures including a clear airway and monitoring of vital signs until stable. Gastric lavage should be carried out. Consider activated charcoal if an adult presents within one hour of ingestion of more than 350 mg or a child more than 5 mg/kg.
This may be treated with naloxone hydrochloride 0.4mg to 2mg subcutaneously, repeated as required at 2 or 3 minute intervals.
Naloxone is a competitive antagonist and has a short half-life so large and repeated doses may be required in a seriously poisoned patient. Observe for at least four hours after ingestion, or eight hours if a sustained release preparation has been taken.
5.1
5.2
5.3
6
6.1
Pharmacodynamic properties
ATC code N02A A08
Dihydrocodeine tartrate is a potent analgesic with uses similar to those of morphine but it is much less potent as an analgesic and has only mild sedative effects. It also has well-defined antitussive properties.
Pharmacokinetic properties
The pharmacokinetics of dihydrocodeine may be similar to those of codeine; they differ between subjects with normal renal function and those with chronic renal failure treated with haemodialysis.
Dihydrocodeine is well absorbed from the gastrointestinal tract following oral administration, and a small quantity is bound to plasma proteins.
Peak levels of plasma dihydrocodeine concentration are attained in an hour following ingestion. Plasma half-life has been reported to be 34 hours after oral ingestion. Dihydrocodeine is metabolised in the liver by 0- and N- demethylation.
Dihydrocodeine and its metabolites are excreted entirely by the kidneys mainly as conjugates with glucuronic acid.
Preclinical safety data
There are no preclinical safety data of relevance to the prescriber.
PHARMACEUTICAL PARTICULARS
List of excipients
Maize starch Polyvinaylpyrrolidone
Lactose
Sodium starch glycollate Magnesium stearate Colloidal silicon dioxide
6.2 Incompatibilities
None known.
6.3 Shelf life
12 months.
6.4 Special precautions for storage
Store below 25°C. Protect from light.
6.5 Nature and contents of container
Securitainers, pack sizes 25, 50, 100, 250, 500 and 1,000.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Ennogen Pharma Limited Unit G4,
Riverside Industrial Estate, Riverside Way,
Dartford DA1 5BS
| UK
Deleted: I)
8 MARKETING AUTHORISATION NUMBER(S)
PL 40147/0022
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
30 June 1992
10 DATE OF REVISION OF THE TEXT
23/07/2016