Nefopam 30mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

NEFOPAM HYDROCHLORIDE

Available from:

Rivopharm Limited

ATC code:

N02BG; N02BG06

INN (International Name):

NEFOPAM HYDROCHLORIDE

Dosage:

30 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Other analgesics and antipyretics; nefopam

Authorization status:

Not marketed

Authorization date:

2016-07-08

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nefopam 30mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 30 mg of nefopam hydrochloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets
White, round, biconvex, 7.1 mm diameter tablets
4 CLINICAL PARTICULARS
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
Oral use.
_ADULTS_
Dosage may range from 1 to 3 tablets three times daily depending on
the pain severity and the patient’s response. The
recommended starting dosage is 1 or 2 tablets three times daily.
_SPECIAL POPULATIONS_
Children: Since the safety and efficacy of nefopam in children under
12 years has not yet been established, the
administration of Nefopam is not recommended in the pediatric
population.
Elderly: Dosage adjustment may be required 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.
Patients with end stage renal disease: Since these patients might
experience increased serum peak concentrations during
treatment with nefopam, the daily dose is recommended be reduced.
4.3 CONTRAINDICATIONS
Nefopam is contraindicated in patients with hypersensitivity to the
active substance or to any of the excipients listed in
section 6.1.
It is also contraindicated in patients with a history of convulsive
disorders and should not be given to patients taking
mono-amine-oxidase (MAO) inhibitors.
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 tre