1. Name Of The Medicinal Product
Acupan Tablets
2. Qualitative And Quantitative Composition
Nefopam Hydrochloride 30 mg.
3. Pharmaceutical Form
Tablet
4. Clinical Particulars
4.1 Therapeutic Indications
Acupan is indicated for the relief of acute and chronic pain, including post-operative pain, dental pain, musculo-skeletal pain, acute traumatic pain and cancer pain.
4.2 Posology And Method Of Administration
ADULTS: Dosage may range from 1 to 3 tablets three times daily depending on response. The recommended starting dosage is 2 tablets three times daily.
ELDERLY: Elderly patients may require reduced dosage due to slower metabolism. It is strongly recommended that the starting dose does not exceed one tablet three times daily as the elderly appear more susceptible to, in particular, the CNS side effects of Acupan and some cases of hallucinations and confusion have been reported in this age group.
CHILDREN: Since Acupan has not been evaluated in children, no dosage recommendation can be given for patients under 12 years.
4.3 Contraindications
Acupan is contra-indicated in patients with a history of convulsive disorders and should not be given to patients taking mono-amine-oxidase (MAO) inhibitors.
4.4 Special Warnings And Precautions For Use
The side effects of Acupan may be additive to those of other agents with anticholinergic or sympathomimetic activity. It should not be used in the treatment of myocardial infarction since there is no clinical experience in this indication. Hepatic and renal insufficiency may interfere with the metabolism and excretion of nefopam. Acupan should be used with caution in patients with, or at risk of, urinary retention. Rarely a temporary, harmless pink discolouration of the urine has occurred.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Caution should be exercised when nefopam is administered concurrently with tricyclic antidepressants.
4.6 Pregnancy And Lactation
There is no evidence as to the drug safety in human pregnancy, nor is there evidence from animal work that it is free from hazard. Avoid in pregnancy unless there is no safer treatment.
4.7 Effects On Ability To Drive And Use Machines
Not applicable
4.8 Undesirable Effects
Nausea, nervousness, dry mouth and light-headedness, urinary retention, hypotension, syncope, palpitations, gastrointestinal disturbances (including abdominal pain and diarrhoea), dizziness, paraesthesia, convulsions, tremor, confusion, hallucination, angioedema, and allergic reactions may occur. Less frequently, vomiting, blurred vision, drowsiness, sweating, insomnia, headache and tachycardia have been reported.
4.9 Overdose
The clinical pattern of nefopam toxicity in overdose is on the neurological (convulsions, hallucinations and agitation) and cardiovascular systems (tachycardia with a hyperdynamic circulation). Routine supportive measures should be taken and prompt removal of ingested drug by gastric Lavage or induced vomiting with Syrup of Ipecacuanha should be carried out. Oral administration of activated charcoal may help prevent absorption.
Convulsions and hallucinations should be controlled (eg with intravenously or rectally administered diazepam). Beta-adrenergic blockers may help control the cardiovascular complications.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Acupan is a potent and rapidly-acting analgesic. It is totally distinct from other centrally-acting analgesics such as morphine, codeine, pentazocine and propoxyphene.
Unlike the narcotic agents, Acupan has been shown not to cause respiratory depression. There is no evidence from pre-clinical research of habituation occurring with Acupan.
5.2 Pharmacokinetic Properties
Nefopam is absorbed from the gastro-intestinal tract. Peak plasma concentrations occur about 1-3 hours after oral administration. About 73% is bound to plasma proteins. It has an elimination half-life of about 4 hours. It is extensively metabolised and excreted mainly in urine. Less than 5% of a dose is excreted unchanged in the urine. About 8% of a dose is excreted via the faeces.
5.3 Preclinical Safety Data
Not applicable
6. Pharmaceutical Particulars
6.1 List Of Excipients
Dibasic calcium phosphate dihydrate
Microcrystalline cellulose
Pregelatinised maize starch
Magnesium stearate
Hydrogenated vegetable oil
Colloidal silicon dioxide
These tablets are film coated using an aqueous solution containing:
hydroxypropyl methylcellulose 2910, titanium dioxide.
6.2 Incompatibilities
None known
6.3 Shelf Life
5 years
6.4 Special Precautions For Storage
Store below 30ºC.
6.5 Nature And Contents Of Container
20 micron aluminium foil and 250 micron UPVC.
Blister pack of 90 tablets
6.6 Special Precautions For Disposal And Other Handling
None
7. Marketing Authorisation Holder
Meda Pharmaceuticals Ltd
249 West George Street
Glasgow
G2 4RB
Trading as:
Meda Pharmaceuticals Ltd
Skyway House
Parsonage Road
Takeley
Bishop's Stortford
CM22 6PU
8. Marketing Authorisation Number(S)
PL 15142/0109
9. Date Of First Authorisation/Renewal Of The Authorisation
2nd March 1978 / 1st October 2005
10. Date Of Revision Of The Text
2nd February 2010
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