Nefopam 30mg tablets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Nefopam hydrochloride

Dostopno od:

Advanz Pharma

Koda artikla:

N02BG06

INN (mednarodno ime):

Nefopam hydrochloride

Odmerek:

30mg

Farmacevtska oblika:

Oral tablet

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 04070100; GTIN: 5060410770752

Navodilo za uporabo

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 is and what it is used for
2. What you need to know before you take Nefopam
3. How to take Nefopam
4. Possible side effects
5. How to store Nefopam
6. Contents of the pack and other information
1. WHAT NEFOPAM IS AND WHAT IT IS USED FOR
The name of your medicine is Nefopam hydrochloride
30mg Film-coated Tablets (referred to as Nefopam
throughout this leaflet). Nefopam 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 does NOT stop the pain from happening, but
you will not be able to feel the pain as much.
NEFOPAM IS 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 should NOT be used to treat the pain from a
heart attack.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
NEFOPAM
DO NOT TAKE NEFOPAM:
-
if you are allergic or have ever had an allergic reaction
to nefopam hydrochloride or any of the ingredients of
this medicine (listed in section 6), particularly if resulting
in a skin rash, swelling of the face or difficulty in
breathing (see section 4, “Possible side effects”)
-
if you are taking monoamine oxidase inhibitors (MAOIs)
to treat your depression (see “Other medici

Lastnosti izdelka

OBJECT 1
NEFOPAM HYDROCHLORIDE 30 MG FILM COATED
TABLETS
Summary of Product Characteristics Updated 19-Jul-2017 | Concordia
International- formerly Focus
Pharmaceuticals Ltd
1. Name of the medicinal product
Nefopam Hydrochloride 30mg Film-coated Tablets
2. Qualitative and quantitative composition
Each coated tablet contains Nefopam Hydrochloride 30 mg.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
White to off white, round, biconvex film coated tablets with 'NFP'
debossed on one side and plain on
other side.
4. Clinical particulars
4.1 Therapeutic indications
Nefopam 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: Elderly 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 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 has not
been evaluated in children under 12
years, 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 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
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Nefopam is contra-indicated in patients with a history of convulsive
disorders and should not be given to
patie