ACUPAN Film Coated Tablet 30 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
NEFOPAM HYDROCHLORIDE
Available from:
LTT Pharma Limited
Dosage:
30 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2010-02-05
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Acupan 30mg film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 30 mg nefopam hydrochloride.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-Coated Tablets
_Product imported from the UK_
White, circular, biconvex tablet, 7mm in diameter and marked APN on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Acupan is indicated for the relief of pain including: post-operative pain; dental pain; musculoskeletal pain; acute
traumatic pain and cancer pain. Each course of treatment should be limited to 7 days except in the case of cancer
therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS: Dosage may range from one to three tablets three times daily depending on response. The recommended
starting dose is two tablets three times daily.
ELDERLY: 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 the elderly 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.
CHILDREN: Since Acupan has not been evaluated in children no dosage recommendation can be given for patients under
12 years.
4.3 CONTRAINDICATIONS
Acupan is contra-indicated in patients with hepatic and renal failure and those hypersensitive to the active ingredient.
Since it possesses CNS stimulant effects its use is contra-indicated in patients with convulsive disorders. It should not
be given to patients taking monoamine-oxidase (MAO) inhibitors or within 14 days of their ingestion.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The side effects of Acupan may be additive to t
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