- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Fertility, pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
Nefopam Hydrochloride 30mg Film-coated Tablets
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.
Film-coated, white, round biconvex and marked 55 on one side.
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.
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 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.
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.
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
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.
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.
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.
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.
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.
Nefopam is excreted in human milk but there is insufficient information on the effect of Nefopam in newborns/infants.
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.
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.
Nausea, nervousness, dry mouth and light-headedness, urinary retention, hypotension, syncope, palpitations, gastrointestinal disturbances (including abdominal pain and diarrhoea), dizziness, paraesthesia, convulsions, tremor, hallucination, angioedema, and allergic reactions may occur.
Less frequently, anaphylactic reactions, vomiting, blurred vision, drowsiness, sweating, insomnia, headache, tachycardia, confusional state and coma 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
Symptoms of nefopam toxicity in overdose are from anticholinergic origin: convulsions, hallucinations, agitation, coma (neurological system) and tachycardia with a hyperdynamic circulation (cardiovascular system). 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.
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.
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.
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.
Silica, colloidal anhydrous
Sodium starch glycolate (type A)
Opadry II white 85F184221
- Polyvinyl alcohol (E1203)
- Titanium dioxide (E171)
- Macrogol/PEG 3350 (E1521)
- Talc (E553b)
This medicinal product does not require any special storage conditions
Blister pack of 90 film-coated tablets
No special requirements
Actavis Group PTC ehf.
Actavis UK Ltd
Actavis UK Ltd, a subsidiary of Accord Healthcare Ltd, Whiddon Valley, Barnstaple, Devon, EX32 8NS, UK
+44 (0)1271 346 106
+44 (0)1271 385 200
+44 (0)1271 385 257