Azuzote 30 mg film-coated tablets

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

NEFOPAM HYDROCHLORIDE

थमां उपलब्ध:

Azure Pharmaceuticals Ltd

ए.टी.सी कोड:

N02BG06

INN (इंटरनेशनल नाम):

NEFOPAM HYDROCHLORIDE

डोज़:

30 milligram(s)

फार्मास्यूटिकल फॉर्म:

Film-coated tablet

चिकित्सीय क्षेत्र:

nefopam

प्राधिकरण का दर्जा:

Marketed

प्राधिकरण की तारीख:

2020-01-24

सूचना पत्रक

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AZUZOTE 30 MG FILM-COATED TABLETS
(nefopam hydrochloride)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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.
WHAT IS IN THIS LEAFLET
1.
What Azuzote Film-coated Tablets are and what they are used for
_2._
_ _
What you need to know before you take Azuzote Film-coated Tablets
_ _
_3._
_ _
How to take Azuzote Film-coated Tablets
_ _
4.
Possible side effects
_5._
_ _
How to store Azuzote Film-coated Tablets
_ _
6.
Contents of the pack and other information
1. WHAT AZUZOTE FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR
Azuzote Film-coated Tablets belong 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 Azuzote does not stop the pain from happening, but you
will not be able to feel the
pain as much.
Azuzote Film-coated Tablets are 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). Azuzote Film-
coated Tablets should not be used to treat the pain from a heart
attack.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AZUZOTE FILM-COATED TABLETS
DO NOT TAKE AZUZOTE FILM-COATED TABLETS IF:
•
You are a child under 12 years old
•
You have ever had an allergic reaction to nefopam hydrochloride or any
of the ingredients
resulting in a skin rash, swelling of the face or

उत्पाद विशेषताएं

Health Products Regulatory Authority
14 June 2022
CRN00CY62
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Azuzote 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 coloured, round, bevel edged, debossed with 'N 30'
on one side and plain on other side. Diameter: 7.10
mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Azuzote Film-coated Tablets 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 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 Azuzote
Film-coated Tablets and some cases of hallucinations and
confusion have been reported in this age group.
PAEDIATRIC POPULATION:
The safety and efficacy of Azuzote Film-coated Tablets in children
under 12 years has not yet been established. No dosage
recommendation can be given for patients under 12 years.
Patients with end stage renal disease might experience increased serum
peak concentrations during treatment with Azuzote
Film-coated Tablets. In order to avoid that, it is recommended the
daily dose should be reduced not only for the elderly, but
also for patients with terminal renal insufficiency.
Method of administration
Oral use.
4.3 CONTRAINDICATIONS
Azuzote Film-coated Tablets is contraindicated in patients with a
history of convulsive disorders and should not be given to
patients taking monoamine oxidase (MAO) inhibitors.
Azuzote F