Nefopam Hydrochloride 30mg Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nefopam Hydrochloride 30 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Nefopam Hydrochloride 30 mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film coated, white, round tablet and marked APN on one side
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Nefopam Hydrochloride 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
Posology
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.
OLDER PEOPLE: Older 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 older people appear more susceptible to, in particular, the CNS side effects of Nefopam Hydrochloride and some cases of hallucinations and confusion have been reported in this age group.
PAEDIATRIC POPULATION: The safety and efficacy of Nefopam Hydrochloride in children under 12 years has not yet been established. No dosage recommendation can be given for patients under 12 years.
Patients with end stage renal disease might experience increased serum peak concentrations during treatment with Nefopam Hydrochloride. In order to avoid that, it is recommended the daily dose should be reduced not only for the elderly, but also for patients with terminal renal insufficiency.
Method of administration Oral use.
4.3 Contraindications
Nefopam Hydrochloride is contra-indicated in patients with a history of convulsive disorders and should not be given to patients taking mono-amine-oxidase (MAO) inhibitors. Nefopam Hydrochloride is contraindicated in patients with known hypersensitivity to any of the ingredients.
4.4 Special warnings and precautions for use
The side effects of Nefopam Hydrochloride 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 Hydrochloride.
Nefopam Hydrochloride 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 Hydrochloride is administered concurrently with tricyclic antidepressants.
It should be noted that Nefopam Hydrochloride may interfere with some screening tests for benzodiazepines and opioids. These tests for benzodiazepines and opioids may give false positive results for patients taking Nefopam Hydrochloride.
4.6 Fertility, 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, anaphylactic reactions, vomiting, blurred vision, drowsiness, sweating, insomnia, headache and tachycardia have been reported.
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 clinical pattern of Nefopam Hydrochloride 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
Pharmacotherapeutic group: 4.7.1 Non-opioid analgesics and compound analgesic preparations ATC code: N02BG06
Nefopam Hydrochloride 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, Nefopam Hydrochloride has been shown not to cause respiratory depression. There is no evidence from pre-clinical research of habituation occurring with Nefopam Hydrochloride.
5.2 Pharmacokinetic properties
Nefopam Hydrochloride 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 E171.
6.2 Incompatibilities
None known
6.3 Shelf life
5 years
6.4 Special precautions for storage
Store below 30°C.
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
None
7 MARKETING AUTHORISATION HOLDER
Meda Pharmaceuticals Ltd Skyway House Parsonage Road Takeley
Bishop's Stortford CM22 6PU United Kingdom
Trading as:
Beechmere Pharmaceuticals Merlin Place Milton Road Cambridge CB40DP UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 15142/0268
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
29/09/2015
10 DATE OF REVISION OF THE TEXT
29/09/2015