SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Nefopam Hydrochloride 30 mg Film-coated tablets

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 30 mg of nefopam hydrochloride.

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Film-coated tablets

White, round, biconvex, 7.1 mm diameter tablets

4    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, 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 (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.

5.1 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.

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 dioxide

6.2 Incompatibilities

Not applicable

6.3 Shelf life

2 years

6.4 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

No special requirements.

7    MARKETING AUTHORISATION HOLDER

Rivopharm UK Ltd 30^th Floor 40 Bank Street Canary Wharf London E14 5NR United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

PL 33155/0037

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

13/06/2016

10    DATE OF REVISION OF THE TEXT

13/06/2016