Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
NEFOPAM HYDROCHLORIDE
LTT Pharma Limited
30 Milligram
Film Coated Tablet
2010-02-05
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 Soma hati kamili