Nefopam hydrochloride 30 mg Film-coated Tablets

Film-coated Tablet White to off white, round, film-coated biconvex tablets engraved with “20” on one side and “G” on the other side.

4.1 Therapeutic indications Nefopam is 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 **Posology** Adults: 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 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. 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 use4.3 Contraindications Nefopam is contra-indicated in patients with a history of convulsive disorders and should not be given to patients taking mono-amine-oxidase (MAO) inhibitors. Nefopam is contraindicated in patients with known hypersensitivity to any of the ingredients.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 angle closure glaucoma. Cases of nefopam dependence and abuse have been reported with nefopam use. 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.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.4.6 Fertility, pregnancy and lactation There is no evidence as to the drug safety in human pregnancy, nor is the 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 Not applicable4.8 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, 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 Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.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 (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 and compound analgesic preparations 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 Not applicable

6.1 List of excipients **Tablet core:** Calcium hydrogen phosphate, dihydrate Microcrystalline cellulose Pregelatinised starch Colloidal anhydrous silica Magnesium stearate **Film-coating material:** Hydroxypropyl methylcellulose Polyethylene glycol 6000 & 400 Titanium dioxide E1716.2 Incompatibilities Not Applicable6.3 Shelf life 2 years6.4 Special precautions for storage This medicinal product does not require any special storage conditions.6.5 Nature and contents of container Tablets are packed in either an Alu-Alu blister pack (consisting of 60µ PVC/50µ Alu/25µ OPA and aluminium foil). Each pack contains 90 film-coated tablets (9 blisters of 10 film-coated tablets)6.6 Special precautions for disposal and other handling No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.