Dihydrocodeine 30mg Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dihydrocodeine 30mg Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 30mg of dihydrocodeine tartrate
Also contains 165mg lactose monohydrate For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Tablet
Round, white tablets with Sterwin on one side and S25 on the other.
4. CLNICAL PARTICULARS
4.1 Therapeutic indications
Dihydrocodeine tablets are recommended for the relief of moderate to severe pain.
They are indicated in all painful conditions where an alert patient is desired: sciatica, arthritis of the spine, peripheral vascular disease, post herpetic neuralgia, Paget’s disease, malignant disease and post-operative pain.
4.2 Posology and method of administration
Posology
Adults:
1 tablet every 4 - 6 hours or at the discretion of the physician. Dihydrocodeine tablets are best administered after food. Paediatric population:
Dihydrocodeine tablets are not recommended for children.
Elderly:
Dosage should be reduced.
Method of administration
For oral administration only
4.3 Contraindications
Hypersensitivity to dihydrocodeine or to any of the excipients listed in section 6.1
Dihydrocodeine should not be given to patients with respiratory depression, chronic obstructive airways disease, paralytic ileus, head injury, raised intracranial pressure, acute alcoholism or liver disease.
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
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 dosage should be reduced in hypothyroidism, in the elderly, in renal insufficiency and chronic hepatic disease
Alcohol should be avoided. When dihydrocodeine is prescribed for chronic use care should be taken to avoid unnecessary increase in dosage.
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 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 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.
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 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 dihydrocodeine regularly for a long time can lead to addiction.
4.5 Interactions with other medicinal products and other forms of interaction
Other central nervous system depressants, including sedatives or hypnotics, metoclopramide, 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.
4.6 Fertility, pregnancy and lactation
Pregnancy
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.
Lactation
Dihydrocodeine has not been reported to be excreted in breast milk. However it is advisable that dihydrocodeine only be administered to breastfeeding mothers if considered essential.
4.7 Effects on ability to drive and use machines
Dihydrocodeine may cause vertigo, drowsiness or headache which may affect the ability to drive or use machines.
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
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.
o
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.
The adverse experiences listed below are classified by body system according to their incidence.
Adverse effects have been ranked under headings of frequency using the following convention: common (>1/100 to <1/10); uncommon (>1/1,000 to <1/100); not known (cannot be estimated from the available data).
|
Undesirable effects |
Common (> 1/100 to <1/10) |
Uncommon (> 1/1000 to <1/100) |
|
Immune system 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 disorders |
Vertigo |
|
Vascular disorders |
Hypotension Flushing | |
|
Respiratory, thoracic and mediastinal disorders |
Dyspnoea Respiratory depression | |
|
Gastrointestinal disorders |
Abdominal pain Pancreatitis Constipation Dry mouth Nausea Vomiting |
Diarrhoea 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 or potency | |
|
General disorders and administration site conditions |
Asthenic conditions Withdrawal syndrome Drug tolerance |
Reporting of suspected adverse events
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
Symptoms
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.
Management
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.
Consider activated charcoal (50 g for adults, 10-15 g for children), if an adult presents within 1 hour of ingestion of more than 420mg or a child more than 3mg/kg.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Natural opium alkaloids ATC code: N02A A08
Dihydrocodeine is a semisynthetic narcotic analgesic with a potency between morphine and codeine. It acts on opioid receptors in the brain to reduce the patient's perception of pain and improve the psychological reaction to pain by reducing the associated anxiety.
Central Nervous System
The principal actions of therapeutic value of dihydrocodeine are analgesia and an antitussive effect (depression of the cough reflex by direct effect on the cough centre in the medulla). Antitussive effects may occur with doses lower than those usually required for analgesia.
Dihydrocodeine may produce respiratory depression by direct action on brain stem respiratory centres.
Gastrointestinal Tract and Other Smooth Muscle
Dihydrocodeine causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum. Digestion of food in the small intestine is delayed and propulsive contractions are decreased. Propulsive peristaltic waves in the colon are decreased, while tone is increased to the point of spasm resulting in constipation.
5.2 Pharmacokinetic properties
There is no information available on the pharmacokinetics of dihydrocodeine. However, the pharmacokinetics of dihydrocodeine may be similar to those of codeine, which reaches peak plasma concentrations in about one hour and is metabolised in the liver and excreted by the kidney. The plasma half-life of codeine is 3 - 4 hours after oral administration.
5.3 Preclinical safety data
There are no pre-clinical safety data of relevance to the prescriber, which are additional to that already included in the other sections of the SPC.
6. PHARMACEUTICAL PARTICULARS
6.1 List of Excipients
Lactose monohydrate Maize starch Magnesium stearate Colloidal hydrated silica
6.2 Incompatibilities
Not applicable.
Shelf life
6.3
HDPE container - 60 months.
Blister pack - 24 months.
6.4 Special Precautions for Storage
Do not store above 25°C. Store in the original container.
6.5 Nature and Contents of Container
High density polyethylene containers with tamper evident wadless, snap-on closures in low density polyethylene of pack size 100 or 500 tablets or PVC blister strips contained in cardboard cartons of pack size 30, 60 or 100 tablets.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements
7 MARKETING AUTHORISATION HOLDER
Winthrop Pharmaceuticals UK Limited
One Onslow Street
Guildford
Surrey
GU1 4YS
United Kingdom
Trading as
Winthrop Pharmaceuticals, PO Box 611, Guildford, Surrey, GU1 4YS Or
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK 8. MARKETING AUTHORISATION NUMBER
PL 17780/0174
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
1 July 2004
10 DATE OF REVISION OF THE TEXT
December 2014