Dihydrocodeine 30mg Tablets
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT
Dihydrocodeine 30mg Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Dihydrocodeine tartrate 30mg For excipients, see 6.1.
3. PHARMACEUTICAL FORM Tablet - - Oral use
4.1. Therapeutic indications
Dihydrocodeine is used to relieve moderate to severe pain.
4.2 Posology and method of administration
Adults:
1 tablet (30mg) every four to six hours or at the discretion of the physician. Elderly:
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:
Not recommended.
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.
4.3 Contraindications
Acute respiratory depression.
Obstructive airways disease
Known hypersensitivity to dihydrocodeine, or other opioid analgesics, or to
any of the excipients
Acute alcoholism
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 should not be given to comatose patients.
Dihydrocodeine 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.
4.4 Special warnings and precautions for use
Dihydrocodeine 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.
Opioid analgesics 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.
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.
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 DHC regularly for a long time can to lead to addiction.
Discontinuation should be carried out gradually in patients who may have developed physical dependence, to avoid precipitating withdrawal symptoms. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine as it contains lactose.
4.5 Interaction with other medicinal products and other forms of interaction
Alcohol: The hypotensive, sedative and respiratory depressive effects of alcohol may be enhanced; alcohol should be avoided.
Anaesthetics: concomitant administration of dihydrocodeine and anaesthetics may cause increased CNS depression and/or respiratory depression and/or hypotension.
Anti-arrhythmics: Dihydrocodeine may delay absorption of mexiletine. The analgesic activity of dihydrocodeine may be significantly impaired by quinidine which impairs codeine metabolism.
Antidepressants, anxiolytics, hypnotics and antipsychotics: Opiates potentiate the effects of CNS depressants, including anxiolytics (e.g.: chlordiazepoxide, diazepam), hypnotics, antipsychotics and tricyclic antidepressants.
Antihistamines: concomitant administration of dihydrocodeine and antihistamines with sedative properties may cause increased CNS depression and/or respiratory depression and/or hypotension.
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.
Antidiarrhoeal and antiperistaltic agents (e.g. loperamide, kaolin) ', concurrent use may increase the risk of severe constipation.
Motility stimulants: Dihydrocodeine has an antagonistic effect on cisapride, metoclopramide and domperidone.
Ulcer-healing drugs: Cimetidine may inhibit the metabolism of dihydrocodeine resulting in increased plasma concentrations.
Sodium oxybate: concomitant administration of dihydrocodeine and sodium oxybate may cause increased CNS depression and/or respiratory depression and/or hypotension.
Interference with laboratory tests: Opioid analgesics interfere with a number of laboratory tests including plasma amylase, lipase, bilirubin, alkaline phosphatase, lactate dehydrogenase, alanine aminotransferase and aspartate aminotransferase.
Opioids may interfere with gastric emptying studies as they delay gastric emptying and with hepatobiliary imaging using technetium Tc 99m disofenin as opioid treatment may cause constriction of the sphincter of Oddi and increase biliary tract pressure.
4.6 Pregnancy and lactation
A possible association with respiratory and cardiac malformations has been reported following first trimester exposure to codeine. Dihydrocodeine may cause respiratory depression in the neonate. Opioid analgesics may cause withdrawal effects in neonates of dependant mothers and gastric stasis during labour, increasing the risk of inhalation pneumonia.
It is not known if dihydrocodeine is excreted into breast milk and use should be avoided during breast-feeding unless the potential benefit outweighs the risk.
4.7 Effects on ability to drive and use machines
Dihydrocodeine produces sedation and may also cause changes in vision, including blurred or double vision. If affected, patients should not drive or operate machinery. The effects of alcohol are enhanced by opioid analgesics.
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 of 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:
o The medicine has been prescribed to treat a medical or dental problem and
o You have taken it according to the instructions given by the prescriber and in the information provided with the medicine and
o It was not affecting your ability to drive safely
4.8 Undesirable effects
Regular prolonged use of dihydrocodeine is known to lead to addiction and tolerance. Symptoms of restlessness and irritability may result when treatment is then stopped.
Prolonged use of a painkiller for headaches can make them worse.
Tolerance and some of the most common side effects - drowsiness, nausea, and vomiting, and confusion - generally develops with long term use.
Immune system disorders: maculopapular rash has been seen as part of a hypersensitivity syndrome associated with oral codeine phosphate; fever, splenomegaly and lymphadenopathy also occurred.
Endocrine disorders: hyperglycaemia.
Metabolism and nutrition disorders: anorexia.
Psychiatric disorders: mental depression, hallucinations and nightmares, restlessness, confusion, mood changes, euphoria, dysphoria.
Nervous System disorders: convulsions (especially in infants and children), dizziness, drowsiness, headache, (prolonged use of a painkiller for headaches can make them worse). Raised intracranial pressure may occur in some patients.
Eye disorders: blurred or double vision or other changes in vision. Miosis.
Ear and labyrinth disorders: vertigo.
Cardiac disorders: tachycardia, palpitations and bradycardia.
Vascular disorders: postural hypotension, facial flushing. Large doses produce hypotension.
Respiratory, thoracic and mediastinal disorders: Dyspnoea. Larger doses produce respiratory depression.
Gastrointestinal disorders: nausea, vomiting, constipation, dry mouth, stomach cramps, pancreatitis.
Hepatobiliary disorders: Biliary spasm (may be associated with altered liver enzyme values).
Skin and subcutaneous tissue disorders: allergic reactions, such as skin rash, pruritus, urticaria, sweating, facial oedema.
Musculoskeletal and connective tissue disorders: Uncontrolled muscle movements. Muscle rigidity may occur after high doses.
Renal and urinary disorders: urinary retention, difficulty with micturition, ureteric spasm, dysuria. An antidiuretic effect may also occur with codeine.
Reproductive system and breast disorders: sexual dysfunction, erectile dysfunction, decreased potency. Decreased libido.
General disorders and administration site conditions: malaise, tiredness, hypothermia.
Dose-related increased post-operative pain has been reported following dental surgery.
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
Toxic doses vary considerably with the individual and regular users may tolerate large doses. The triad of coma, pinpoint pupils and respiratory depression is considered indicative of opioid overdosage with dilatation of the pupils occurring as hypoxia develops.
Other opioid overdose symptoms include hypothermia, confusion, convulsions, severe dizziness, severe drowsiness, hypotension, nervousness or restlessness, hallucinations, slow heart beat, circulatory failure, slow or troubled breathing, severe weakness, convulsions, especially in infants and children. Rhabdomyolysis, progressing to renal failure, has been reported in overdosage with opioids.
Conservative management is recommended. In acute overdosage with respiratory depression or coma, the specific opioid antagonist naloxone is indicated, using one of the recommended dosage regimens. Patients should be observed closely.
5.1. Pharmacodynamic properties
Dihydrocodeine is a narcotic analgesic similar in potency to codeine, and is used in the relief of moderate to severe pain.
5.2. Pharmacokinetic properties
Dihydrocodeine is well absorbed after oral administration. Peak plasma levels are attained approximately 1.6 - 1.8 hours after ingestion. The half life is of the order of 3.5 hours. After oral administration the bioavailability of the drug is approximately 20%, indicating that the pre-systemic metabolism plays a substantial role in reducing the bioavailability of dihydrocodeine.
5.3. Pre-clinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to those already included in other sections.
6.1. List of excipients
Lactose Maize starch Magnesium stearate Purified water
Ethanol with 5% methanol (IMS)
Povidone
6.2. Incompatibilities
None stated.
6.3. Shelf life
Two years.
6.4. Special precautions for storage
Protect from light.
Do not store above 25°C.
6.5. Nature and content of container
Polypropylene or polyethylene tablet containers of 30 or 100 tablets. Strip packs of 10 or 14 tablets in multiple pack sizes.
6.6. Instructions for use/handling
None.
7 MARKETING AUTHORISATION HOLDER
Wockhardt UK Ltd Ash Road North Wrexham
LL13 9UF United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 29831/0069
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
01 / 11 / 2006
10 DATE OF REVISION OF THE TEXT
27/08/2015