SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Dihydrocodeine Elixir BP 10mg/5ml

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Dihydrocodeine Tartrate BP 10mg/5ml

3.    PHARMACEUTICAL FORM

Elixir

4.    CLINICAL PARTICULARS

4.1.    Therapeutic indications

Relief of moderate to severe pain in all painful conditions where an alert patient is desired, e.g. sciatica, osteoarthritis, chronic rheumatoid arthritis, arthritis of the spine, peripheral vascular disease, post hepatic neuralgia, Paget’s disease, malignant disease and post operative pain. Also used as an anti-tussive.

4.2.    Posology and method of administration

Route of Administration

Oral

Dihydrocodeine Elixir BP is best administered with or after food. It is not recommended for administration to children under 4 years. Dosage should be reduced in the elderly.

Dosage Analgesia

Adults

One to three 5ml spoonfuls (10 to 30mg) every four to six hours at the discretion of the physician.

Children aged 4 to 12 years

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

Dosage anti-tussive

Adult

One 5ml spoonful (10mg) every four to six hours at the discretion of the physician.

Children aged 4 to 12 years 0.2mg/kg body weight every 4 to 6 hours.

4.3 Contra-indications

Respiratory depression, obstructive airways disease or hepatic failure.

As dihydrocodeine may bring about histamine release, Dihydrocodeine Elixir BP should not be given during an attack of asthma and should be administered with due care to persons liable to such attacks.

Dihydrocodeine should not be used where an infective bronchial condition exists. Where an infection is diagnosed during the use of the product its use should be discontinued.

Known hypersensitivity to any of the ingredients of the product.

4.4. Special warnings and special precautions for use

Dosage should be reduced in the elderly, in hypothyroidism, in chronic hepatic disease and in renal insufficiency. Opioid analgesics should be avoided in those patients with raised intracranial pressure or head injury.

Where the dose used exceeds 10mg three times a day mucociliary transport and the cough reflex may be impaired.

Dihydrocodeine should be avoided in patients with decreased respiratory reserve, prostatic hypertrophy, a history of convulsive disorders and where there is a risk of paralytic ileus.

No Data Held

4.5. Interactions with other medicinal products and other forms of interaction

Alcohol should be avoided whilst under treatment with Dihydrocodeine Elixir BP.

Antidepressants: Dihydrocodeine Elixir should not be administered to patients receiving monoamine oxidase inhibitors, or within two weeks of their withdrawal.

Anxiolytics, Hypnotics and other CNS Depressants: Sedative effects may be enhanced by simultaneous use of dihydrocodeine.

4.6. Pregnancy and lactation

There is no, or inadequate evidence of safety in human pregnancy but the drug has been used for many years without apparent ill consequence.

Administration during labour may cause respiratory depression in the newborn infant. It is likely that dihydrocodeine is excreted in breast milk. As with all drugs during pregnancy and lactation care should be taken in assessing the risk to benefit ratio.

4.7 Effects on ability to drive and use machines

Dihydrocodeine may cause drowsiness. If affected patients 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

Adverse effects may include drowsiness, dependence, headache, vertigo, dysphoria, hallucinations and mood changes.

Miosis may be experienced.

Sweating, postural hypotension and facial flushing have been reported.

Where the dose of the elixir used exceeds 5ml three times a day mucociliary transport and the cough reflex may be impaired.

Constipation, nausea, vomiting may occur and are relatively more common when the dose is increased above 30mg. If constipation occurs, it can be treated with a gentle laxative.

Rashes and pruritis may occur.

Patients may experience difficulty with micturation.

4.9. Overdose

Conservative management is recommended, gastric lavage should be carried out. Severe respiratory depression can be treated with naloxone hydrochloride 0.8mg intravenously repeated as required at 2 or 3 minute intervals

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

Dihydrocodeine is a narcotic analgesic which possesses pharmacological properties similar to those of morphine. 30mg given parenterally has been shown to have an analgesic potency equivalent to that of 10mg morphine. In a study of oral analgesics for the relief of chronic pain, the same dose was found to be equivalent to 100mg of pethidine. The duration of action of dihydrocodeine is about 4-5 hours, similar to morphine and codeine.

5.2. Pharmacokinetic properties

Dihydrocodeine Elixir has been shown to have a satisfactory pharmacokinetic profile by many years of successful clinical experience.

5.3. Pre-clinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Glycerol Ph Eur Sugar Syrup BP

Citric acid Monohydrate Ph Eur Alcohol 96%BP Oxymel BPC Sodium Chloride Ph Eur Essence of limes soluble Essence of bitter orange soluble Strong tincture of ginger BP E150 (c)

Methyl-4-hydroxybenzoate BP Ethyl-4-hydroxybenzoate BP Propyl-4-hydroxybenzoate BP Purified Water Ph Eur 6.2. Incompatibilities

None known.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

None.

Nature and content of container

150ml amber glass bottle with either a plastic tamper evident child resistant closure or a ROPP aluminium closure, lacquered internally and externally with either PVdC faced EPE wads or LDPE faced PVdC/EPE wads.

1 litre amber glass bottle with black plastic cap.

6.6. Instructions for use, handling and disposal

None.

ADMINISTRATIVE DATA

7. MARKETING AUTHORISATION HOLDER

Martindale Pharmaceuticals Ltd.

Bampton Road Romford Essex RM3 8UG England

8. MARKETING AUTHORISATION NUMBER

PL 0156/0092

9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

First Authorised: 11 January 1999

10 DATE OF REVISION OF THE TEXT

27/02/2015