Dihydrocodeine 30mg Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dihydrocodeine 30mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Dihydrocodeine Tartrate BP 30.0 mg.
3. PHARMACEUTICAL FORM
Tablet.
4. CLINICAL PARTICULARS
4.1. Therapeutic Indications
For moderate to severe pain.
4.2. Posology and Method of Administration
Adults:One tablet every 4-6 hours when necessary after food. Maximum dose in 24 hours 180mg (6 tablets).
Not recommended for children under 12 years.
Dosage should be reduced for the elderly.
For oral administration.
4.3 Contraindications
Hypersensitivity to dihydrocodeine or any of the tablet constituents; respiratory depression; obstructive airways disease; paralytic ileus; head injury; raised intracranial pressure; acute alcoholism. As dihydrocodeine may cause the release of histamine, it should not be given during an asthma attack and should be given with caution to asthmatics.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
4.4 Special warnings and precautions for use
Dosage should be reduced in the elderly, in hypothyroidism, chronic hepatic disease and renal insufficiency.
Dihydrocodeine should be administered with caution to patients with a history of opioid abuse, biliary tract disorders, prostatic hypertrophy, pancreatitis, constipation, obstructive bowel disorder and severe cor pulmonale.
The patient may develop tolerance to the drug with chronic use and require progressively higher doses to maintain pain control. Prolonged use of this product may lead to addiction, physical dependence and a withdrawal syndrome may occur upon abrupt cessation of therapy. When a patient no longer requires therapy with dihydrocodeine, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.
For treatment of headaches, dihydrocodeine should not be prescribed too often or for too long as this could make them worse.
Dihydrocodeine has an abuse profile similar to other agonist opioids. Dihydrocodeine tablets may be sought and abused by people with latent or manifest addiction disorders. The product should be used with particular care in patients with a history of alcohol and drug abuse.
The risk-benefit of continued use should be assessed regularly by the prescriber, and in particular the prescriber should take care to avoid any unnecessary increase in dosage especially where there is evidence of a previous history of drug dependence or 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 codeine [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).
Dihydrocodeine tablets must be swallowed whole, and not broken, chewed or crushed. The administration of broken, chewed or crushed tablets may lead to a rapid release and absorption of a potential overdose of dihydrocodeine (see Section 4.9).
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 lead to addiction.
4.5 Interaction with other medicinal products and other forms of interaction
Dihydrocodeine tartrate causes delayed absorption of mexiletine, potentiates the action of hypnotics and sedatives, causes CNS excitation and hypertension by interaction with MAOIs. Opioid analgesics should be avoided in patients with raised intracranial pressure or head injury.
Other central nervous system depressants, including phenothiazines, other tranquillisers and alcohol, may result in respiratory depression or sedation. Dihydrocodeine should be used with caution in patients taking monoamine oxidase inhibitors or within two weeks of such therapy.
MAOIs taken with pethidine have been associated with severe CNS excitation or depression (including hypertension or hypotension). Although this has not been documented with codeine [dihydrocodeine], it is possible that a similar interaction may occur and therefore the use of codeine [dihydrocodeine] should be avoided while the patient is taking MAOIs and for 2 weeks after MAOI discontinuation.
4.6 Fertility, pregnancy and lactation
There are no or limited amount of data from the use of dihydrocodeine in pregnant women. Dihydrocodeine should not be used during pregnancy and labour due to the risk of neonatal respiratory depression. Infants born to mothers who have received opioids during pregnancy should be monitored for respiratory depression. Withdrawal symptoms may be observed in the newborn of mothers undergoing treatment with dihydrocodeine.
Dihydrocodeine has not been reported to be excreted in breast milk. However, it is advisable that dihydrocodeine only be administered to breast-feeding mothers if considered essential.
4.7 Effects on ability to drive and use machines
Dihydrocodeine may cause drowsiness and if patients are 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:
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
The adverse experiences listed below are classified by body system according to their incidence (common or uncommon). Common adverse drug experiences have an incidence of ^ 1 % and uncommon adverse drug experiences have an incidence of < 1%.
|
Undesirable Effects |
Common (* 1%) |
Uncommon (< 1%) |
|
Immunesystem disorders |
Angioedema | |
|
Psychiatric disorders |
Confusional state Drug dependence Hallucination Mood altered | |
|
Nervous system disorders |
Somnolence |
Convulsions Dizziness Headache Paraesthesia |
|
Eye disorders |
Blurred vision | |
|
Ear and labyrinth |
Vertigo |
|
disorders | ||
|
Vascular disorders |
Hypotension Flushing | |
|
Respiratory, thoracic and mediastinal |
Dyspnoea | |
|
disorders |
Respiratory depression | |
|
Gastrointestinal disorders |
Abdominal pain |
Diarrhoea |
|
Constipation Dry mouth Nausea Vomiting |
Ileus paralytic | |
|
Hepato-biliary disorders |
Biliary colic Hepatic enzymes increased | |
|
Skin and subcutaneous tissue disorders |
Hyperhidrosis Pruritus Rash Urticaria | |
|
Renal and urinary disorders |
Urinary retention Ureteric spasm | |
|
Reproductive system and breast disorders |
Decreased libido | |
|
General disorders and administration site |
Asthenic conditions | |
|
conditions |
Withdrawal syndrome Drug tolerance |
Dependence may occur. 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 pain killer for headaches can make them worse
Paediatric population
Neonatal respiratory depression and withdrawl symptoms may occur in the newborn of mothers undergoing treatment with dihydrocodeine (see Section 4.6).
4.9 Overdose
Acute overdosage with dihydrocodeine can be manifested by somnolence progressing to stupor or coma, miotic pupils, rhabdomyolysis, non-cardiac pulmonary oedema, bradycardia, hypotension and respiratory depression or apnoea, which may in severe cases result in a fatal outcome.
Primary attention should be given to the establishment of a patent airway and institution of assisted or controlled ventilation.
In the case of massive overdosage, administer naloxone intravenously (0.4 to 2 mg for an adult and 0.01 mg/kg body weight for children) if the patient is in a coma or respiratory depression is present. Repeat the dose at 2 minute intervals if there is no response, or by an infusion. An infusion of 60% of the initial dose per hour is a useful starting point. A solution of 10 mg made up in 50 ml dextrose will produce 200 micrograms/ml for infusion using an IV pump (dose adjusted to the clinical response). Infusions are not a substitute for frequent review of the patient's clinical state. Intramuscular naloxone is an alternative in the event that IV access is not possible.
As the duration of action of naloxone is relatively short, the patient must be carefully monitored until spontaneous respiration is reliably re-established. Naloxone is a competitive antagonist and large doses (4 mg) may be required in seriously poisoned patients. For less severe overdosage, administer naloxone 0.2 mg intravenously followed by increments of 0.1 mg every 2 minutes if required.
Naloxone should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to dihydrocodeine overdosage. Naloxone should be administered cautiously to persons who are known, or suspected, to be physically dependent on dihydrocodeine. In such cases, an abrupt or complete reversal of opioid effects may precipitate pain and an acute withdrawal syndrome.
Additional/other considerations:
• Consider activated charcoal (50 g for adults, 10-15 g for children), if a substantial amount has been ingested within 1 hour, provided the airway can be protected. It may be reasonable to assume that late administration of activated charcoal may be beneficial for prolonged release preparations but there is no evidence to support this.
• Dihydrocodeine tablets will continue to release and add to the dihydrocodeine load for up to 12 hours after administration and the management of overdosage should be modified accordingly. Gastric contents may therefore need to be emptied, as this can be useful in removing unabsorbed drug, particularly when a prolonged release formulation has been taken.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic Properties
Dihydrocodeine tartrate is a potent analgesic with well defined anti-tussive properties
5.2. 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.
5.3. Pre-clinical Safety Data
Not applicable
6. PHARMACEUTICAL PARTICULARS 6.1. List of Excipients
Starch, povidone (K= 29/32), Lactose, Sodium starch glycollate, Magnesium stearate, Colloidal.
6.2.
Incompatibilities
None stated.
6.3. Shelf-Life
3 years
6.4. Special Precautions for Storage
Store in a cool dry place protected from light below 25°C.
6.5. Nature and Content of Container
Securitainers containing 25, 50, 100, 250, 500 or 1000 tablets. Blister packs in cartons of 28 or 30 tablets
6.6. Instruction for Use, Handling and Disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Mercury Pharma (Generics) Ltd Capital House, 85 King William Street,
London EC4N 7BL, UK
8. MARKETING AUTHORISATION NUMBER
PL 16201/0007
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
22 July 1999.
10 DATE OF REVISION OF THE TEXT
27/11/2014