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
Nefopam hydrochloride 30 mg.
Excipient with known effect: 50.0 mg lactose anhydrous per tablet For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated, white, round biconvex and marked 55 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, musculoskeletal pain, acute traumatic pain and cancer pain.
4.2 Posology and method of administration
Posology
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
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 in children under 12 years has not yet been established. No dosage recommendation can be given for patients under 12 years.
Renal impairment
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.
Method of administration
Oral use.
4.3 Contraindications
Nefopam Hydrochloride is contra-indicated in:
- patients with a history of convulsive disorders
- patients taking mono-amine-oxidase (MAO) inhibitors.
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
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.
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 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 Hydrochloride.
Lactose
Nefopam Hydrochloride film-coated tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
4.6 Fertility, pregnancy and lactation
Pregnancy
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.
Breast-feeding
Nefopam is excreted in human milk but there is insufficient information on the effect of Nefopam in newborns/infants.
Fertility
In animal studies no adverse effects on fertility were observed (see Section 5.3). Whether or not nefopam affects the fertility in humans is unknown.
Effects on ability to drive and use machines
4.7
Nefopam Hydrochloride has moderate influence on the ability to drive and use machines. Nefopam Hydrochloride may cause drowsiness. Patients should be warned not to drive or operate machinery until they know how Nefopam Hydrochloride affects them.
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 Yellow Card Scheme Website: 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). Betaadrenergic blockers may help control the cardiovascular complications.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: 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 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
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Tablet Core:
Lactose, anhydrous Silica, colloidal anhydrous Cellulose, microcrystalline
Sodium starch glycolate (type A) Magnesium stearate
Film-coating:
Opadry II white 85F184221
- Polyvinyl alcohol (E1203)
- Titanium dioxide (E171)
- Macrogol/PEG 3350 (E1521)
- Talc (E553b)
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
2 years
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions
6.5 Nature and contents of container
PVC/PE/PVDC/Alu blister Blister pack of 90 film-coated tablets
6.6 Special precautions for disposal
No special requirements
MARKETING AUTHORISATION HOLDER
7
Actavis Group PTC ehf. Reykjavikurvegi 76-78 220 Hafnarfjordur Iceland
8 MARKETING AUTHORISATION NUMBER(S)
PL 30306/0774
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
30/08/2016
10 DATE OF REVISION OF THE TEXT
30/08/2016