Nefopam Hydrochloride 30mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

NEFOPAM HYDROCHLORIDE

Available from:

RIA Generics Limited (Ireland) The Black Church, St. Mary's Place Dublin 7, D07 P4AX, Ireland

ATC code:

N02BG06

INN (International Name):

NEFOPAM HYDROCHLORIDE 30 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

NEFOPAM HYDROCHLORIDE 30 mg

Prescription type:

POM

Therapeutic area:

ANALGESICS

Authorization status:

Suspended

Authorization date:

2018-08-06

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 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.
The name of your medicine is
NEFOPAM HYDROCHLORIDE 30 MG FILM-COATED TABLETS
(referred to
as Nefopam Tablets throughout this leaflet).
WHAT IS IN THIS LEAFLET:
1. What Nefopam Tablets is and what it is used for
2. What you need to know before you take Nefopam Tablets
3. How to take Nefopam Tablets
4. Possible side effects
5. How to store Nefopam Tablets
6. Contents of the pack and other information
1.
WHAT NEFOPAM TABLETS IS AND WHAT IT IS USED FOR
Nefopam Tablets 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 Tablets does not stop the pain from happening,
but you will not be
able to feel the pain as much.
Nefopam Tablets 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
Tablets should not be used to treat the pain from a heart attack.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEFOPAM TABLETS:
DO NOT TAKE NEFOPAM TABLETS:
•
if you are a child under 12 years old
• if 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 d

Summary of Product characteristics

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 Nefopam hydrochloride 30 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
White round film-coated tablets marked with “30N” on one side and
smooth on other 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 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. 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 the active substance
or to any of the excipients liste