Nefopam 30mg tablets

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Nefopam hydrochloride

Disponível em:

Meda Pharmaceuticals Ltd

Código ATC:

N02BG06

DCI (Denominação Comum Internacional):

Nefopam hydrochloride

Dosagem:

30mg

Forma farmacêutica:

Oral tablet

Via de administração:

Oral

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 04070100; GTIN: 5060035248476

Folheto informativo - Bula

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER
ACUPAN® 30MG TABLETS
(nefopam hydrochloride)
This product is available as the above name but will be referred to as
Acupan throughout the following leaflet.
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 then, 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.
IN THIS LEAFLET:
1. What Acupan is and what it is used for
2. What you need to know before you take Acupan
3. How to take Acupan
4. Possible side effects
5. How to store Acupan
6. Contents of the pack and other information
1. WHAT ACUPAN IS AND WHAT IT IS USED FOR
Acupan 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 Acupan does not stop the pain from
happening, but you will not be able to feel the pain as much.
Acupan 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). Acupan should not be used to treat
the pain from a heart attack.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ACUPAN
DO NOT TAKE ACUPAN 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 difficulty in breathing (see section 6. Contents of the pack and
other information)
•
you are taking monoamine oxidase inhibitors (MAOIs) to tre

Características técnicas

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