Nefopam Hydrochloride 30 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Nefopam hydrochloride

Available from:

Brown & Burk IR Limited

ATC code:

N02BG; N02BG06

INN (International Name):

Nefopam hydrochloride

Dosage:

30 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Other analgesics and antipyretics; nefopam

Authorization status:

Marketed

Authorization date:

2018-04-13

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
NEFOPAM HYDROCHLORIDE 30 MG FILM-COATED TABLETS
(NEFOPAM HYDROCHLORIDE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
The name of your medicine is Nefopam Hydrochloride 30mg Film-coated
tablets
(referred to as
Nefopam Hydrochloride throughout this leaflet).
WHAT IS IN THIS LEAFLET
1.
What Nefopam Hydrochloride is and what it is used for
2.
What you need to know before you take Nefopam Hydrochloride
3.
How to take Nefopam Hydrochloride
4.
Possible side effects
5.
How to store Nefopam Hydrochloride
6.
Contents of the pack and other information
1.
WHAT NEFOPAM HYDROCHLORIDE IS AND WHAT IT IS USED FOR
Nefopam Hydrochloride belongs to a group of medicines called
analgesics, commonly known as pain
killers or pain relievers. The active substance, nefopam
hydrochloride, interrupts the pain messages
being sent to your brain, and it also acts in your brain to stop pain
messages being felt.
This means that Nefopam Hydrochloride does not stop the pain from
happening, but you will not be
able to feel the pain as much.
Nefopam Hydrochloride is used to relieve acute and chronic pain (for
example pain after an operation,
dental pain, joint or muscle pain, after an injury, or pain caused by
cancer). Nefopam Hydrochloride
should not be used to treat the pain from a heart attack.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEFOPAM HYDROCHLORIDE
DO NOT TAKE NEFOPAM HYDROCHLORIDE IF:
•
you are a child under 12 years old
•
you have ever had an allergic reaction to nefopam hydrochloride or any
of t

Summary of Product characteristics

Health Products Regulatory Authority
20 June 2023
CRN00DMPD
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nefopam Hydrochloride 30 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 30 mg nefopam hydrochloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White to off-white, circular shaped, biconvex, film coated tablets,
debossed with ‘NT’ on one face and plain on other face,
approximately 7.00 mm in diameter.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Nefopam Hydrochloride 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
1-2 tablets three times daily.
Elderly: 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 Nefopam
Hydrochloride and some cases of hallucinations and confusion
have been reported in this age group.
Paediatric population: The safety and efficacy of Nefopam
Hydrochloride in children under 12 years has not yet been
established. No dosage recommendation can be given for patients under
12 years.
Renal impairment: 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.
Method of administration
Oral use.
4.3 CONTRAINDICATIONS
Nefopam Hydrochloride is contra-indicated in patients with a history
of convulsive disorders and should not be given to
patients taking mono-amine-oxidase (MAO) inhibitors. Nefopam
Hydrochloride is contraindicated in patients with know