Summary of Product Characteristics (SmPC) - Dihydrocodeine tablets 30 mg
1 NAME OF THE MEDICINAL PRODUCT
Dihydrocodeine Tablets 30mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Dihydrocodeine Tartrate BP 30mg
3 PHARMACEUTICAL FORM
Dihydrocodeine Tablets are white, flat, circular tablets with a bevel edge and a break-line on one side for oral administration.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Dihydrocodeine is indicated for the relief of moderate to severe pain in all painful conditions where an alert patient is required, e.g. Sciatica, osteoarthritis, chronic rheumatoid arthritis, arthritis of the spine, peripheral vascular disease, post herpetic neuralgia, Paget’s disease of the bone, malignant disease and post-operative pain.
4.2 Posology and method of administration
Dihydrocodeine tablets should be taken after food.
Treatment goals and discontinuation
Before initiating treatment with Dihydrocodeine, treatment duration and treatment goals, should be agreed together with the patient, in accordance with pain management guidelines. During treatment, there should be frequent contact between the physician and the patient to evaluate the need for continued treatment, consider discontinuation and to adjust dosages if needed. When a patient no longer requires therapy with codeine, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal. In absence of adequate pain control, the possibility of hyperalgesia, tolerance and progression of underlying disease should be considered (see section 4.4)
Adults: One tablet to be taken every four to six hours when necessary.
Elderly: Dosage should be reduced in the elderly.
Children under 12 years of age: Not recommended.
A maximum dose of not more than 6 tablets should be taken in any 24 hour period.
Duration of treatment
The duration of treatment should be as short as possible, and if no effective pain relief is achieved the patients/carers should be advised to seek the views of a healthcare professional.
Dosage should be reduced in patients with hypothyroidism chronic hepatic disease and in patients with renal insufficiency.
4.3 Contraindications
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
Acute respiratory depression, obstructive airways disease; acute alcoholism; raised intracranial pressure or head injury, as it can affect papillary responses vial for neurological assessment, and respiration; where there is a risk of paralytic ileus; hypersensitivity to the product. It is not indicated for acute abdomen.
4.4 Special warnings and precautions for use
Tolerance and opioid use disorder (abuse and dependence) Tolerance, physical and psychological dependence, and opioid use disorder (OUD) may develop upon repeated administration of opioids such as Dihydrocodeine. Repeated use of Dihydrocodeine can lead to OUD. A higher dose and longer duration of opioid treatment can increase the risk of developing OUD. Abuse or intentional misuse of Dihydrocodeine may result in overdose and/or death. The risk of developing OUD is increased in patients with a personal or a family history (parents or siblings) of substance use disorders (including alcohol use disorder), in current tobacco users or in patients with a personal history of other mental health disorders (e.g. major depression, anxiety and personality disorders).
Before initiating treatment with [product name] and during the treatment, treatment goals and a discontinuation plan should be agreed with the patient (see section 4.2). Before and during treatment the patient should also be informed about the risks and signs of OUD. If these signs occur, patients should contact their physician.
Patients will require monitoring for signs of drug-seeking behaviour (e.g. too early requests for refills). This includes the review of concomitant opioids and psycho-active drugs (like benzodiazepines). For patients with signs and symptoms of OUD, consultation with an addiction specialist should be considered.
The patient should be made aware of the risks and signs of OUD as set out in the package leaflet. If these signs occur, patients should contact their physician.
For patients who experience signs and symptoms of OUD, and/or exibit drug seeking behaviours, review of concomitant opioids and psycho-active drugs (like benzodiazepines) and consultation with an addiction specialist may be required.
Hyperalgesia
As with other opioids, in case of insufficient pain control in response to an increased dose of codeine, the possibility of opioid-induced hyperalgesia should be considered. A dose reduction or treatment review may be indicated.
Hepatobiliary disorders
Dihydrocodeine may cause dysfunction and spasm of the sphincter of Oddi, thus increasing the risk of biliary tract symptoms and pancreatitis. Therefore, Dihydrocodeine has to be administered with caution in patients with pancreatitis and diseases of the biliary tract.
Risks from concomitant use of sedative medicines such as benzodiazepines or related drugs:
Sleep-related breathing disorders
Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage.
Dihydrocodeine should not be taken during an attack of asthma, and should be administered with caution to patients liable to such attacks, as dihydrocodeine may bring about histamine releases. It should also be avoided in patients with decreased respiratory reserve.
Monoamine oxidase inhibitors including moclobemide should not be given with dihydrocodeine or other narcotic analgesics. Monoamine oxidase inhibitors should be stopped for at least two to three weeks before dihydrocodeine treatment is initiated.
The dosage should be reduced in the elderly or debilitated. The dosage should also be reduced or avoided in patients with chronic hepatic disease (may precipitate coma), and in renal insufficiency.
Caution should be exercised, or reduced doses given, in patients with hypotension, hypothyroidism, prostatic hypertrophy, convulsive disorders, shock, inflammatory or obstructive bowel disorders, myasthenia gravis, or adrenocortical insufficiency.
Prolonged administration may cause dependence, and severe withdrawal symptoms if it is withdrawn abruptly. Tolerance may develop in repeated use. Alcohol should be avoided during treatment with dihydrocodeine.
4.5 Interaction with other medicinal products and other forms of interaction
Alcohol: Enhanced sedative and hypotensive effect.
Anti-arrhythmics: Dihydrocodeine tartrate causes delayed absorption of mexiletine.
Anti-bacterial: Avoid opoid analgesics as premedication when patient is treated with ciprofloxacin as it reduces the plasma-ciprofloxacin concentration.
Anti-virals: The plasma concentration of dihydrocodeine is possible increased by ritonavir.
Anti-depressants: Monoamine oxidase inhibitors include moclobemide: The interaction can cause serious CNS excitation or depression (hypertension or hypotension). Dihydrocodeine should not be given concomitantly or till at least two weeks after discontinuing the treatment.
Tricyclics: Possible increased sedation.
Anti-psychotics: Enhanced sedative and hypotensive effect. Anxiolytics and hyponotics and sedative: Enhanced sedative effect. Cisapride: Possible antagonism of gastro-intestinal effects
Cyclizine: May counteract the haemodynamic effects of opioids. Metoclopramide and Donperidone: Antagonism of gastro-intestinal effects. Ulcer-healing drugs: Cimetidine inhibits the metabolism of opioid analgesics. Concomitant use of Dihydrocodeine with gabapentinoids (gabapentin and pregabalin) may result in respiratory depression, hypotension, profound sedation, coma or death (see section 4.4).
4.6 Fertility, pregnancy and lactation
Inadequate evidence of safety in human pregnancy, but the drug has been used for many years without apparent ill consequences. Dihydrocodeine should only be administered during pregnancy and to nursing mothers if considered essential.
4.7 Effects on ability to drive and use machines
Dihydrocodeine may cause drowsiness, and if affected, patients should not drive or operate machinery.
4.8 Undesirable effects
The most common side-effects are constipation, drowsiness, nausea and vomiting (particularly in the initial stages of treatment), headache, vertigo, urinary retention and ureteric and biliary spasm may occur. Constipation can be treated with a simple laxative.
Larger doses can produce respiratory depression and hypotension.
Other side-effects are dry mouth, sweating, headache, miosis, facial flushing, vertigo, bradycardia, tachycardia, palpitations, postural hypotension and hypothermia.
Patients have experienced hallucinations, mood changes, dysphoria, and decreased libido and potency. Skin reactions are rashes, urticaria and pruritis.
Gastrointestinal disorders
Not known: pancreatitis
Hepatobiliary disorders
Not known: sphincter of Oddi dysfunction
May cause dependence. Side-effects are more common when the dose exceeds 30mg.
Drug dependence
Repeated use of Dihydrocodeine can lead to drug dependence, even at therapeutic doses. The risk of drug dependence may vary depending on a patient's individual risk factors, dosage, and duration of opioid treatment (see section 4.4).
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
Opioids cause varying degrees of coma, respiratory depression, and pinpoint pupils. The specific antidote naloxone is indicated if there is coma or bradypnoea. Respiratory depression is a major concern and it maybe treated by artificial ventilation or naloxone. Naloxone will immediately reverse the respiratory depression as well as antagonising the analgesic effect. Since naloxone has a shorter duration of action than many opioids, close monitoring and repeated injections are necessary according to the respiratory rate and depth of coma. Alternatively, it maybe given by continuous intravenous infusion, the rate of administration being adjusted according to response.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Dihydrocodeine Tartrate is used for the relief of mild to moderate pain. It has also been used as a cough suppressant.
Dihydrocodeine is a narcotic analgesic with similar but more addictive than codeine.
Dihydrocodeine possess some of the properties of naturally occurring or endogenous opioid peptides. Pharmacologically the opioid analgesics are broadly similar, dihydrocodeine is considered to produce its effects by action on specific opiate receptors in the central nervous system.
There are several types of opioid receptor, dihydrocodeine is thought to act mainly at the mu receptor which is distributed throughout the body especially at supra-spinal sites. It is at this receptor that dihydrocodeine is thought to exert its analgesic effect.
5.2 Pharmacokinetic properties
The pharmacokinetics of dihydrocodeine may be similar to those of codeine; they differ between subjects of 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 about one hour following ingestion. Plasma half-life has been reported to be between 3-4 hours after oral ingestion. The rate of absorption is independent of dose and oral bioavailability is only 20%, possibly because of substantial first-pass metabolism in the gut wall or liver.
Dihydrocodeine is metabolised in the liver by O- and N- demethylation to morphine, norcodeine and hydrocodone.
Dihydrocodeine and its metabolites are excreted entirely by the kidneys mainly as conjugates with glucuronic acid.
5.3 Preclinical safety data
Dihydrocodeine Tartrate has been in use for many years and has an established safety profile. Reproductive studies have been carried out in the hamster and they show that doses of 153mg/kg show abnormalities to the central nervous system and other developmental abnormalities. Oral toxicity has been studied in rats and the LD50 was found to be 250mg/kg.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Maize Starch
Polyvinylpyrrolidone
Lactose
Sodium Starch Glycollate
Magnesium Stearate
Colloidal Anhydrous Silica
6.2 Incompatibilities
None reported
6.3 Shelf life
Shelf-life of the unopened final container is one year
6.4 Special precautions for storage
In a dry place protected from light store at a temperature below 25°C.
6.5 Nature and contents of container
In securitainers of 25, 50, 100, 250, 500 and 1000 tablets.
6.6 Special precautions for disposal
No special requirements
7. MARKETING AUTHORISATION HOLDER
Activase Pharmaceuticals Limited
11 Boumpoulinas, 3rd floor
P.C. 1060 Nicosia,
Cyprus
8. MARKETING AUTHORISATION NUMBER(S)
PL 28444/0162
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
06/03/2009
10 DATE OF REVISION OF THE TEXT
16/04/2026