Df 118 Forte 40mg
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
DF118 FORTE 40mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Dihydrocodeine Tartrate BP 40mg
3 PHARMACEUTICAL FORM
White circular biconvex tablets engraved DF118 on one side and Forte on the other.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the relief of severe and chronic pain
4.2 Posology and method of administration
Route of Administration
Oral
DF118 tablets should be administered with or after food.
Adults and elderly
One or two tablets three times daily. The maximum daily dose is 240mg.
Children under 12 years
Not recommended.
4.3 Contraindications
• Hypersensitivity to any of the products ingredients.
• Acute respiratory depression or Chronic Obstructive Airways Disease.
• Asthma attack.
• Acute alcoholism.
• Biliary colic.
• Head injuries or increased intracranial pressure.
• Heart failure secondary to lung disease.
• Concurrent use with Monoamine Oxidase Inhibitors (including moclobemide), or within two weeks of their withdrawal.
• Risk of paralytic ileus.
• Phaeochromocytoma.
4.4 Special warnings and precautions for use
As dihydrocodeine may cause the release of histamine it should be given with caution to asthmatics.
Repeated use can cause tolerance and dependence. Caution in use should be exercised and a reduction in dose may be advisable in the elderly and in the following cases.
• Hypotension.
• Hypothyroidism.
• Depressed respiratory reserve.
• Prostatic hypertrophy.
• Hepatic or renal impairment or chronic hepatic disease.
• Convulsive disorders.
4.5 Interaction with other medicinal products and other forms of interaction Alcohol: Enhanced sedative and hypertensive effects.
Antidepressants: The use of dihydrocodeine should be avoided or used with caution in patients receiving monoamine oxidase inhibitors (including moclobemide), or within two weeks of their withdrawal.
Anxiolytics, Hypnotics and other CNS Depressants: Sedative effects may be enhanced by simultaneous use with dihydrocodeine.
Ciprofloxacin: If dihydrocodeine is used prior to surgery and ciprofloxacin is used for surgical prophylaxis then serum levels of ciprofloxacin are reduced and adequate cover may not be obtained during surgery.
4.6 Pregnancy and lactation
There is little published evidence on safety in human pregnancy but dihydrocodeine has been used for many years without apparent ill effects. Dihydrocodeine has not been reported to be excreted in breast milk. However, it is advisable that dihydrocodeine be administered to breast feeding mothers only if considered essential. Risk is dose and duration of treatment related.
4.7 Effects on ability to drive and use machines
Dihydrocodeine may cause drowsiness, and, 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
• Hallucinations, confusion, mood changes, dysphoria and dependence.
• Headache, vertigo, dizziness and drowsiness.
• Sweating and postural hypotension.
• Miosis.
• Bradycardia, palpitations, tachycardia and facial flushing.
• Respiratory depression.
• Constipation, nausea, vomiting and a dry mouth.
• Ureteric or biliary spasm.
• Rashes, pruritus and urticaria.
• Anaphylaxis and bronchospasm.
• Decrease in libido or potency.
• Difficulty with micturition.
• Hypothermia.
If constipation occurs, it can be treated with a gentle laxative.
4.9 Overdose
Symptoms: Pin point pupils, respiratory depression and hypotension.
Convulsions, especially in children and rhabdomyolysis leading to renal failure. Circulatory failure and coma may occur in severe cases.
Treatment: Administer naloxone 0.8mg intravenously. Repeat at 2 - 3 minute intervals as necessary, or by an infusion of 2mg in 500ml of normal saline or 5% dextrose (0.004mg/ml). The infusion should be run at a rate related to the previous bolus doses administered and should be in accordance with the patient’s response. Empty the stomach. Assist respiration if necessary. Maintain fluid and electrolyte levels.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Dihydrocodeine is a semi-synthetic 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.
5.2 Pharmacokinetic properties
Dihydrocodeine is mainly metabolised in the liver with the resultant metabolites being excreted mainly in the urine. Metabolism of dihydrocodeine includes O-demethylation, N-demethylation and 6-keto reduction.
5.3 Preclinical 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
Lactose Maize Starch
Pregelatinised Maize Starch Magnesium Stearate
6.2 Incompatibilities
None known
6.3 Shelf life
Three years
6.4 Special precautions for storage
Store at or below 25°C
Store in a dry place and protect from light
6.5 Nature and contents of container 28, 56, 100 and 500 tablet packs
Polypropylene container fitted with polyethylene lid or PVdC coated PVC blister packs with aluminium backing foil.
10, 28 and 56 tablet pack
Polypropylene container fitted with polyethylene lid.
6.6 Special precautions for disposal
None stated
7 MARKETING AUTHORISATION HOLDER
Martindale Pharmaceuticals Ltd.
Bampton Road,
Romford Essex RM3 8UG England
8 MARKETING AUTHORISATION NUMBER(S)
PL 00156/0093
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
06/09/1993 / 13/09/2005
10 DATE OF REVISION OF THE TEXT
25/03/2014