This information is intended for use by health professionals

1. Name of the medicinal product

Nefopam hydrochloride 30mg film-coated tablets.

2. Qualitative and quantitative composition

Nefopam hydrochloride 30mg per tablet.

Excipients with known effect: lactose monohydrate.

For the full list of excipients, see Section 6.1.

3. Pharmaceutical form

Film-coated tablet.

Round, normal convex shaped, white tablets debossed with 'N30' on one side and plain on the other.

4. Clinical particulars
4.1 Therapeutic indications

For the relief of acute and chronic pain, including post-operative pain, dental pain, musculo-skeletal pain, acute traumatic pain and cancer pain.

Nefopam hydrochloride 30mg film-coated tablets are indicated in adults, including the elderly, and children aged 12 years and older.

4.2 Posology and method of administration

Posology

Adults and children aged 12 years and older:

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 population:

Elderly patients may require reduced dosage due to slower metabolism.

It is strongly recommended that the starting dose does not exceed 1 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.

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 that the daily dose should be reduced, not only for the elderly, but also for patients with terminal renal insufficiency.

Method of administration

For oral use.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Nefopam is contraindicated in patients with a history of convulsive disorders and should not be given to patients taking monoamine oxidase inhibitors (see Section 4.5).

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.

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Nefopam should be used with caution in patients with angle closure glaucoma. Cases of nefopam dependence and abuse have been reported with nefopam use.

4.5 Interaction with other medicinal products and other forms of interaction

Nefopam hydrochloride 30mg film-coated tablets are contraindicated in patients receiving monoamine oxidase inhibitors (see section 4.3).

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 hydrochloride 30mg film-coated tablets may cause drowsiness. If affected do not drive and use machines.

4.8 Undesirable effects

Nausea, nervousness, dry mouth and light-headedness, urinary retention, hypotension, syncope, palpitations, gastro-intestinal disturbances (including abdominal pain and diarrhoea), dizziness, paraesthesia, convulsions, tremor, confusion, hallucination, angioedema and allergic reactions 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 professional 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 (coma, 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 (e.g. with intravenously or rectally administered diazepam). Beta-adrenergic blockers may help control the cardiovascular complications.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Other analgesics and antipyretics.

ATC code: N02BG06.

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

There are no findings of relevance to the prescriber other than those already mentioned elsewhere in the SPC.

6. Pharmaceutical particulars
6.1 List of excipients

Tablet core constituents:

Calcium hydrogen phosphate dihydrate

Microcrystalline cellulose

Starch, pregelatinised

Magnesium stearate

Hydrogenated vegetable oil

Silica, colloidal anhydrous

Film-coat constituents:

Hypromellose (E464)

Titanium dioxide (E171)

Lactose monohydrate

Macrogol 3000

Triacetin

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 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/aluminium blisters.

Pack size: 90 tablets.

6.6 Special precautions for disposal and other handling

No special requirements.

7. Marketing authorisation holder

Galen Limited

Seagoe Industrial Estate

Craigavon

BT63 5UA

UK

8. Marketing authorisation number(s)

PL 27827/0038

9. Date of first authorisation/renewal of the authorisation

20/07/2017.

10. Date of revision of the text

30 04 2020.