- Approval Id
- 05a4fd62e3dfae87
- Drug Approval Emc Name
- Nefopam Hydrochloride 30 mg film-coated tablets
- Drug Name
- Nefopam Hydrochloride 30 mg film-coated tablets
- Company Name
- Rivopharm UK Ltd
- Company Address
- Rivopharm UK Ltd, 100 Bishopsgate, London, EC2N 4AG
- Company Website
- https://www.rivopharm.co.uk
- Company Telephone
- +44 (0)207 864 1677
- Company Medical Info Direct Line
- +44 (0)2034328085
- Company Medical Info Email
- pv.sanoswiss@biomapas.com
- Company Stock Availability
- +44 (0)7831 690 243
- Atc Code
- N02BG06
- Legal Category
- Prescription only medicine
- Authorisation Holder
- Rivopharm UK Ltd
100 Bishopsgate
London
EC2N 4AG
United Kingdom
- Authorisation Number
- PL 33155/0037
- Authorisation Date
- 13/06/2016
- Instruction Authorisation Holder
- Rivopharm UK Ltd
100 Bishopsgate
London
EC2N 4AG
United Kingdom
- Instruction Authorisation Number
- PL 33155/0037
- Instruction Authorisation Date
- 13/06/2016
- Instruction Composition
- Each tablet contains 30 mg of nefopam hydrochloride.
For the full list of excipients, see section 6.1.
- Instruction Dosage Form
- Film-coated tablets
White, round, biconvex, 7.1 mm diameter tablets
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
Nefopam 30 mg tablets are 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
Oral use.
\*\*\*Adults\*\*\*
Dosage may range from 1 to 3 tablets three times daily depending on the pain severity and the patient's response. The recommended starting dosage is 1 or 2 tablets three times daily.
\*\*\*Special populations\*\*\*
\*\*Children\*\*: Since the safety and efficacy of nefopam in children under 12 years has not yet been established, the administration of Nefopam 30 mg tablets is not recommended in the pediatric population.
\*\*Elderly:\*\* Dosage adjustment may be required 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 30 mg tablets and some cases of hallucinations and confusion have been reported in this age group.
\*\*Patients with end stage renal disease\*\*: Since these patients might experience increased serum peak concentrations during treatment with nefopam, the daily dose is recommended be reduced.4.3 Contraindications
Nefopam 30 mg tablets are contraindicated in patients with hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
It is also contraindicated 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 Nefopam 30 mg tablets 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 30 mg tablets 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 30 mg tablets.4.6 Fertility, pregnancy and lactation
\*\*Pregnancy\*\*
There is no evidence of safety of use during pregnancy nor is there evidence from animal studies that is free from hazard. Therefore Nefopam 30 mg tablets should not be used in pregnancy unless considered absolutely essential by the physician.
\*\*Lactation\*\*
Nefopam is excreted in human milk. Concentrations are approximately the same as those in maternal plasma. Since there is a risk of adverse effects in the nursing infant, breast-feeding should be discontinued during treatment with Nefopam 30 mg tablets.
\*\*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.4.7 Effects on ability to drive and use machines
Nefopam 30 mg tablets may cause drowsiness. Patients should be warned not to drive or operate machinery during the treatment.4.8 Undesirable effects
Nausea, nervousness, dry mouth and light-headedness, urinary retention, hypotension, syncope, palpitations, gastrointestinal disturbances (including abdominal pain and diarrhea), dizziness, paraesthesia, convulsions, tremor, confusion, hallucination, angioedema, and allergic reaction may occur. Less frequently, anaphylactic reactions, coma, 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, hallucination and agitation) and cardiovascular systems (coma, 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.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
Pharmacotherapeutic group\*\*:\*\* Non-opioid analgesics with central stimulant and sympathomimetic properties.
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 or habituation occurring with Nefopam hydrochloride 30 mg Film-coated tablets.5.2 Pharmacokinetic properties
\*\*\*\*Absorption\*\*\*\*
Nefopam hydrochloride is absorbed from the gastro-intestinal tract. Peak plasma concentrations occur about 1-3 hours after oral administration.
\*\*\*\*Distribution\*\*\*\*
Approximately 73% is bound to plasma proteins.
\*\*\*\*Biotransformation\*\*\*\*
Nefopam hydrochloride is extensively metabolised
\*\*\*\*Elimination\*\*\*\*
Nefopam hydrochloride is excreted mainly in urine. Less than 5% of a dose is excreted unchanged in the urine. Approximately 8% of a dose is excreted via the faeces.5.3 Preclinical safety data
Non-clinical data reveal special hazards for humans based on conventional studies of safety pharmacology, repeated dose toxicity, carcinogenic potential, and toxicity to reproduction.
Non-clinical data on genotoxicity are not available.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
\*\*Tablet core\*\*
Cellulose microcrystalline
Povidone (K30)
Calcium hydrogen phosphate, anhydrous
Copovidone (VA64)
Pregelatinised starch
Silica colloidal anhydrous
Magnesium stearate
\*\*Film-coating\*\*
Opadry OY-S-7335:
HPMC 2910/Hypromellose
Titanium dioxide6.2 Incompatibilities
Not applicable6.3 Shelf life
2 years6.4 Special precautions for storage
Do not store above 30°C.6.5 Nature and contents of container
Aluminium/ PVC-PE-PVDC blister.
Packs containing 30 and 90 tablets.
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
No special requirements.
- Instruction Content
- ## Composition
Each tablet contains 30 mg of nefopam hydrochloride.
For the full list of excipients, see section 6.1.
## Pharmaceutical Form
Film-coated tablets
White, round, biconvex, 7.1 mm diameter tablets
## Clinical Particulars
4.1 Therapeutic indications
Nefopam 30 mg tablets are 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
Oral use.
\*\*\*Adults\*\*\*
Dosage may range from 1 to 3 tablets three times daily depending on the pain severity and the patient's response. The recommended starting dosage is 1 or 2 tablets three times daily.
\*\*\*Special populations\*\*\*
\*\*Children\*\*: Since the safety and efficacy of nefopam in children under 12 years has not yet been established, the administration of Nefopam 30 mg tablets is not recommended in the pediatric population.
\*\*Elderly:\*\* Dosage adjustment may be required 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 30 mg tablets and some cases of hallucinations and confusion have been reported in this age group.
\*\*Patients with end stage renal disease\*\*: Since these patients might experience increased serum peak concentrations during treatment with nefopam, the daily dose is recommended be reduced.4.3 Contraindications
Nefopam 30 mg tablets are contraindicated in patients with hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
It is also contraindicated 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 Nefopam 30 mg tablets 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 30 mg tablets 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 30 mg tablets.4.6 Fertility, pregnancy and lactation
\*\*Pregnancy\*\*
There is no evidence of safety of use during pregnancy nor is there evidence from animal studies that is free from hazard. Therefore Nefopam 30 mg tablets should not be used in pregnancy unless considered absolutely essential by the physician.
\*\*Lactation\*\*
Nefopam is excreted in human milk. Concentrations are approximately the same as those in maternal plasma. Since there is a risk of adverse effects in the nursing infant, breast-feeding should be discontinued during treatment with Nefopam 30 mg tablets.
\*\*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.4.7 Effects on ability to drive and use machines
Nefopam 30 mg tablets may cause drowsiness. Patients should be warned not to drive or operate machinery during the treatment.4.8 Undesirable effects
Nausea, nervousness, dry mouth and light-headedness, urinary retention, hypotension, syncope, palpitations, gastrointestinal disturbances (including abdominal pain and diarrhea), dizziness, paraesthesia, convulsions, tremor, confusion, hallucination, angioedema, and allergic reaction may occur. Less frequently, anaphylactic reactions, coma, 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, hallucination and agitation) and cardiovascular systems (coma, 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.
## Pharmacological Properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group\*\*:\*\* Non-opioid analgesics with central stimulant and sympathomimetic properties.
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 or habituation occurring with Nefopam hydrochloride 30 mg Film-coated tablets.5.2 Pharmacokinetic properties
\*\*\*\*Absorption\*\*\*\*
Nefopam hydrochloride is absorbed from the gastro-intestinal tract. Peak plasma concentrations occur about 1-3 hours after oral administration.
\*\*\*\*Distribution\*\*\*\*
Approximately 73% is bound to plasma proteins.
\*\*\*\*Biotransformation\*\*\*\*
Nefopam hydrochloride is extensively metabolised
\*\*\*\*Elimination\*\*\*\*
Nefopam hydrochloride is excreted mainly in urine. Less than 5% of a dose is excreted unchanged in the urine. Approximately 8% of a dose is excreted via the faeces.5.3 Preclinical safety data
Non-clinical data reveal special hazards for humans based on conventional studies of safety pharmacology, repeated dose toxicity, carcinogenic potential, and toxicity to reproduction.
Non-clinical data on genotoxicity are not available.
## Pharmaceutical Particulars
6.1 List of excipients
\*\*Tablet core\*\*
Cellulose microcrystalline
Povidone (K30)
Calcium hydrogen phosphate, anhydrous
Copovidone (VA64)
Pregelatinised starch
Silica colloidal anhydrous
Magnesium stearate
\*\*Film-coating\*\*
Opadry OY-S-7335:
HPMC 2910/Hypromellose
Titanium dioxide6.2 Incompatibilities
Not applicable6.3 Shelf life
2 years6.4 Special precautions for storage
Do not store above 30°C.6.5 Nature and contents of container
Aluminium/ PVC-PE-PVDC blister.
Packs containing 30 and 90 tablets.
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
No special requirements.
