Informations for option: Acupan Tablets, show other option

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1. Acupan Tablets
2. Acupan Tablets

1    NAME OF THE MEDICINAL PRODUCT

Acupan 30 mg Tablets

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Nefopam Hydrochloride 30 mg.

For the full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Film coated, white, round tablet and marked APN on one side

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Acupan 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.

OLDER PEOPLE: 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 Acupan and some cases of hallucinations and confusion have been reported in this age group.

PAEDIATRIC POPULATION: The safety and efficacy of Acupan 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 use.

4.3    Contraindications

Acupan is contra-indicated in patients with a history of convulsive disorders and should not be given to patients taking mono-amine-oxidase (MAO) inhibitors. Acupan is contraindicated in patients with known hypersensitivity to any of the ingredients.

4.4    Special warnings and precautions for use

The side effects of Acupan 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. Acupan 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 Acupan.

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

Not applicable

4.8 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, 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, 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    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Pharmacotherapeutic group: 4.7.1 Non-opioid analgesics and compound analgesic

preparations

ACT code: N02BG06

Acupan 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, Acupan has been shown not to cause respiratory depression. There is no evidence from pre-clinical research of habituation occurring with Acupan.

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

5.3 Preclinical safety data

Not applicable

6    PHARMACEUTICAL    PARTICULARS

6.1    List of excipients

Dibasic calcium phosphate dihydrate Microcrystalline cellulose Pregelatinised maize starch Magnesium stearate Hydrogenated vegetable oil Colloidal silicon dioxide

These tablets are film coated using an aqueous solution containing: hydroxypropyl methylcellulose    2910, titanium dioxide E171.

6.2    Incompatibilities

None known

6.3 Shelf life

5 years

6.4 Special precautions for storage

Store below 30°C.

6.5 Nature and contents of container

20 micron aluminium foil and 250 micron UPVC.

Blister pack of 90 tablets

6.6 Special precautions for disposal

None

7    MARKETING AUTHORISATION HOLDER

Meda Pharmacuticals Ltd Skyway House Parsonage Road Takeley

Bishop’s Stortford CM22 6PU

8 MARKETING AUTHORISATION NUMBER(S)

PL 15142/0109

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

2^nd March 1978 / 1^st October 2005

10 DATE OF REVISION OF THE TEXT

01/05/2015