Acupan
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Summary of Product characteristics
(SPC)
31-07-2008
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Active ingredient:
Nefopam hydrochloride 20 mg/mL
Available from:
iNova Pharmaceuticals (New Zealand) Limited
INN (International Name):
Nefopam hydrochloride 20 mg/mL
Dosage:
20 mg/mL
Pharmaceutical form:
Solution for injection
Composition:
Active: Nefopam hydrochloride 20 mg/mL Excipient: Dibasic sodium phosphate dodecahydrate Monobasic sodium phosphate dihydrate Water for injection
Units in package:
Ampoule, glass, 5 x 1 mL in 2ml amp, 5 mL
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
3M France
Product summary:
Package - Contents - Shelf Life: Ampoule, glass, 5 x 1 mL in 2ml amp - 5 mL - 36 months from date of manufacture stored at or below 30°C
Authorization date:
1981-02-18
Summary of Product characteristics
NEW ZEALAND DATA SHEET
ACUPAN
TM
ACUPAN
TM
Page 1 of 5
1. PRODUCT NAME
ACUPAN 30 mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains nefopam hydrochloride 30 mg.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
White, round, biconvex, film-coated tablets (7 mm diameter) engraved
APN on one face.
4. CLINICAL PARTICULARS
4.1
Therapeutic indications
ACUPAN is indicated for the relief of acute pain, including
post-operative, dental, musculoskeletal
and acute traumatic pain.
4.2
Dose and method of administration
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.
Children
ACUPAN is not recommended for children under the age of 12 years.
Elderly
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 nefopam. Some
cases of hallucination and
confusion have been reported in this age group.
4.3
Contraindications
ACUPAN is contraindicated in patients with a history of convulsive
disorders and should not be given
to patients taking monoamine oxidase (MAO) inhibitors.
ACUPAN is contraindicated in patients with known hypersensitivity to
any of the ingredients.
ACUPAN should not be used in the treatment of myocardial infarction.
This advice is based on the
lack of clinical experience for this indication.
4.4
Special warnings and precautions for use
Hepatic and renal insufficiency may interfere with the metabolism and
excretion of nefopam.
ACUPAN should be used with caution in patients with angle closure
glaucoma.
Cases of nefopam dependence and abuse have been reported with nefopam
use.
ACUPAN should be used with caution in patients with, or at risk of,
urinary retention.
NEW ZEALAND DATA SHEET
ACUPAN
TM
ACUPAN
TM
Page 2 of 5
The side effects of ACUPAN may be additive to those of other agents
with a
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