Nefopam Hydrochloride 30mg Film-Coated Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nefopam Hydrochloride 30mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains Nefopam Hydrochloride 30 mg. For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
White to off white, round, biconvex film coated tablets with 'NFP' debossed on one side and plain on other side.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Nefopam 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 nefopam and some cases of hallucinations and confusion have been reported in this age group.
CHILDREN: The safety and efficacy of nefopam has not been evaluated in children under 12 years, 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. 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.
4.3 Contraindications
Nefopam 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 is contraindicated in patient with Known hypersensitivity to any of the ingredients.
4.4 Special warnings and precautions for use
The side effects of Nefopam 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. Nefopam 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.
It should be noted that nefopam 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.
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
Nefopam may cause drowsiness. If affected do not drive or operate machinery.
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 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
ATC code: N02BG06
Pharmacotherapeutic group: Other Analgesics and antipyretics
Nefopam 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 has been shown not to cause respiratory depression. There is no evidence from pre-clinical research of habituation occurring with Nefopam.
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
Core Tablet
Calcium Hydrogen Phosphate Dihydrate
Cellulose Microcrystalline
Starch Pregelatinized
Hydrogenated Vegetable Oil
Silica, Colloidal anhydrous
Magnesium Stearate
Coating
Hypromellose (HPMC 2910),
Titanium Dioxide (E171),
Macrogol/PEG
6.2 Incompatibilities
None known
6.3 Shelf life
24 Months
6.4 Special precautions for storage
Not applicable
6.5 Nature and contents of container
Tablets are packed in either an ALU-ALU blister pack (consisting of ALU/ OPA/PVC (50/25 /60 microns) and Aluminium Foil 25 microns) or PVC - ALU blister pack (consisting of PVC 250 micron and Aluminium Foil 20 microns).
Each pack contains 3 blisters of 30 tablets hence a total pack size of 90 tablets.
6.6 Special precautions for disposal
None
7 MARKETING AUTHORISATION HOLDER
Focus Pharmaceuticals Limited
Capital House
85 King William Street
London
EC4N 7BL
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 20046/0297
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
09/02/2015
10 DATE OF REVISION OF THE TEXT
01/10/2015