Nefopam 30mg tablets

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

有効成分:

Nefopam hydrochloride

から入手可能:

DE Pharmaceuticals

ATCコード:

N02BG06

INN（国際名）:

Nefopam hydrochloride

投薬量:

30mg

医薬品形態:

Oral tablet

投与経路:

Oral

クラス:

No Controlled Drug Status

処方タイプ:

Valid as a prescribable product

製品概要:

BNF: 04070100

情報リーフレット

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.
What is in this leaflet
1. What Nefopam Hydrochloride is and what it is used for
2. What you need to know before you use Nefopam Hydrochloride
3. How to use 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
The name of your medicine is Nefopam Hydrochloride 30mg Tablets
(referred to as Nefopam Hydrochloride throughout this leaflet).
Nefopam Hydrochloride includes the active substance nefopam
hydrochloride.
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 of 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 use Nefopam Hydrochloride
Do not take Nefopam Hydrochloride:
◆ if you are a child under 12 years old
◆ if you are allergic to nefopam hydrochloride or any of the other
ingredients of this medicine (listed in section 6)
◆ if yo

製品の特徴

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nefopam Hydrochloride 30 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nefopam Hydrochloride 30 mg.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film coated, white, round tablet and marked APN on one side
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 2 tablets three times
daily.
OLDER PEOPLE: 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.
Patients with end stage renal disease might experience increased serum
peak
concentrations during treatment with Nefopam Hydrochloride. 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
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 known hypersensitivity to any of the ingredients.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The side effects of Nefopam Hydrochloride may be additive to those