Nefopam 30mg tablets

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

유효 성분:

Nefopam hydrochloride

제공처:

Galen Ltd

ATC 코드:

N02BG06

INN (국제 이름):

Nefopam hydrochloride

복용량:

30mg

약제 형태:

Oral tablet

관리 경로:

Oral

수업:

No Controlled Drug Status

처방전 유형:

Valid as a prescribable product

제품 요약:

BNF: 04070100; GTIN: 5016298364880

환자 정보 전단

PACKAGE LEAFLET: INFORMATION FOR THE USER
NEFOPAM HYDROCHLORIDE 30MG FILM-COATED TABLETS
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, pharmacist or
nurse.
•
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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Nefopam Hydrochloride 30mg Film-Coated Tablets are and what they
are used
for
2.
What you need to know before you take Nefopam Hydrochloride 30mg
Film-Coated
Tablets
3.
How to take Nefopam Hydrochloride 30mg Film-Coated Tablets
4.
Possible side effects
5.
How to store Nefopam Hydrochloride 30mg Film-Coated Tablets
6.
Contents of the pack and other information
1.
WHAT NEFOPAM HYDROCHLORIDE 30MG FILM-COATED TABLETS ARE AND WHAT THEY
ARE
USED FOR
Nefopam Hydrochloride 30mg 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 Nefopam
Hydrochloride 30mg Film-
Coated Tablets do not stop the pain from happening, but you will not
be able to feel the pain
as much.
Nefopam Hydrochloride 30mg 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). Nefopam Hydrochloride 30mg Film-Coated Tablets
should not be
used to treat the pain from a heart attack.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEFOPAM HYDROCHLORIDE 30MG FILM-
COATED TABLETS
DO NOT TAKE NEFOPAM HYDROCHLORIDE 30MG FILM-COA

제품 특성 요약

OBJECT 1
NEFOPAM HYDROCHLORIDE 30MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 26-Sep-2017 | Galen Limited
1. Name of the medicinal product
Nefopam hydrochloride 30mg film-coated tablets.
2. Qualitative and quantitative composition
Nefopam hydrochloride 30mg per tablet.
Excipients with known effect: lactose monohydrate.
For the full list of excipients, see Section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Round, normal convex shaped, white tablets debossed with 'N30' on one
side and plain on the other.
4. Clinical particulars
4.1 Therapeutic indications
For the relief of acute and chronic pain, including post-operative
pain, dental pain, musculo-skeletal pain,
acute traumatic pain and cancer pain.
Nefopam hydrochloride 30mg film-coated tablets are indicated in
adults, including the elderly, and
children aged 12 years and older.
4.2 Posology and method of administration
Posology
ADULTS AND CHILDREN AGED 12 YEARS AND OLDER:
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 POPULATION:
Elderly patients may require reduced dosage due to slower metabolism.
It is strongly recommended that the starting dose does not exceed 1
tablet three times daily as the elderly
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.
PAEDIATRIC POPULATION:
The safety and efficacy of nefopam 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 that
the daily dose should be reduced,
not only for the elderly, but also for patients with terminal renal
insufficiency.
Method of administration
For oral use.
4.3 Contraindications
Hypersensitivity to the active substanc