SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Dihydrocodeine Tablets BP 30mg

2.    Qualitative and Quantitative Composition

Each tablet contains 30mg Dihydrocodeine Tartrate

3.    Pharmaceutical Form

Tablet

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Dihydrocodeine tablets are indicated for the relief of moderate to severe pain.

4.2    Posology and method of administration

For oral administration.

The analgesic effect is not materially enhanced by increasing the dose above that recommended below; in severe cases the interval between doses should be reduced to obtain the requisite analgesic cover.

Dihydrocodeine tablets are best taken with or after food.

Adults

1 tablet (30mg) every 4 to 6 hours or at the discretion of the physician.

Elderly

A reduced adult dose is recommended, at the advice of the physician.

Children 4 to 12 years of age

0.5 to 1 mg/kg body weight, every 4 to 6 hours.

Children under 4 years of age Dihydrocodeine is not recommended

4.3 Contraindications

•    Hypersensitivity to dihydrocodeine or any of the excipients

•    Respiratory depression

•    Obstructive airways disease

•    Acute alcoholism

•    Risk of paralytic ileus

•    Head injuries or conditions in which intracranial pressure is raised.

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.

Dihydrocodeine should be avoided, or the dose reduced in patients with hepatic or renal impairment.

Dihydrocodeine should be given in reduced doses or with caution to; debilitated patients, adrenocortical insufficiency, prostatic hyperplasia, urethral stricture, hypotension, shock, inflammatory or obstructive bowel disorders, hypothyroidism or convulsive disorders.

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.

Alcohol should be avoided whilst under treatment with these tablets.

Contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine.

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 lead to addiction

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:

•    Alcohol - enhanced hypotensive, sedative effect and respiratory depression

•    Anaesthetics - may increase anaesthetic and sedative effect

•    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

•    Antipsychotics - enhanced hypotensive, sedative effect

•    MAOIs taken with pethidine have been associated with severe CNS excitation or depression. Although this has not been documented with dihydrocodeine, it is possible that a similar interaction may occur with other opioid analgesics.

Dihydrocodeine may antagonise the gastrointestinal effects metoclopramide and domperidone.

Cyclizine may counteract the haemodynamic benefits of opioids. Dihydrocodeine may delay absorption of mexiletine.

Cimetidine may inhibit the metabolism of opioids

4.6 Pregnancy and lactation

Whilst there is no adequate evidence of safety in human pregnancy, dihydrocodeine has been widely used without apparent ill-effect for many years and studies in animals have not yet demonstrated any hazard. The administration of opioid analgesics during labour may cause respiratory depression in the new-born infant, 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.

Effects such as paraesthesia, dizziness, vertigo, muscle rigidity, visual disturbances, drowsiness, confusion and hallucinations may occur. Do not drive or operate machinery if affected.

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

Skin disorders; rash, urticaria, pruritus, 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.

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 DHC 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.

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 respiratory depression, may develop but is unlikely to be severe unless other sedative agents have been coingested, 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. 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.

Give naloxone if coma or respiratory depression is present. 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 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

ATC code N02A A08

Dihydrocodeine tartrate is an analgesic with uses similar to those of morphine but it is much less potent as an analgesic and has only mild sedative effects.

5.2 Pharmacokinetic properties

Dihydrocodeine is well absorbed after oral administration. Peak plasma levels occur 1.6 - 1.8 hours after ingestion. 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. Dihydrocodeine is excreted in the urine as unchanged drug and metabolites. The mean elimination half life ranges between 3.5 - 5 hours.

5.3 Preclinical safety data

Not applicable.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

The tablet contains Maize Starch, Lactose Monohydrate, Polyvinylpyrrolidone, Sodium Starch Glycollate (Type A), Magnesium Stearate and Colloidal Silicon Dioxide.

6.2. Incompatibilities

None stated

6.3. Shelf Life

36 months

Special Precautions for Storage

Do not store above 25°C. For containers, keep tightly closed, store in the original container. For strip packaging, store in the original package, keep in the outer carton.

6.5. Nature and Contents of Container

HDPE containers with LDPE lids or polypropylene containers with polyethylene lids (Securitainers) in packs of 25, 50, 100, 250, 500 and 1000 tablets.

PVDC coated PVC film with hard temper aluminium foil (strips) in packs of 7, 10, 14, 21, 28, 30, 56, 60, 84, 90, 100, 110, 112, 120, 150, 160 and 168 tablets.

6.6. Instruction for Use/Handling

Not applicable

Administrative Data

7 MARKETING AUTHORISATION HOLDER

M & A Pharmachem Ltd Wigan Road Westhoughton Bolton BL5 2AL United Kingdom

8. Marketing Authorization Number

PL 04077/0183

9    Date of the first authorisation or renewal

27/09/2005

10 DATE OF REVISION OF THE TEXT

24/09/2015