Acupan
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Patient Information leaflet
(PIL)
19-04-2020
Summary of Product characteristics
(SPC)
19-04-2020
Active ingredient:
Nefopam hydrochloride 30mg;
Available from:
iNova Pharmaceuticals (New Zealand) Limited
INN (International Name):
Nefopam hydrochloride 30 mg
Dosage:
30 mg
Pharmaceutical form:
Tablet
Composition:
Active: Nefopam hydrochloride 30mg Excipient: Calcium hydrogen phosphate dihydrate Colloidal silicon dioxide Hydrogenated vegetable oil Hypromellose Magnesium stearate Microcrystalline cellulose Starch Titanium dioxide
Units in package:
Blister pack, 1x10, 10 tablets
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Orgapharm SAS
Therapeutic indications:
ACUPAN is indicated for the relief of acute pain, including post-operative, dental, musculo-skeletal and acute traumatic pain.
Product summary:
Package - Contents - Shelf Life: Blister pack, 1x10 - 10 tablets - 60 months from date of manufacture stored at or below 25°C - Blister pack, 1x30 - 30 tablets - 60 months from date of manufacture stored at or below 25°C - Blister pack, 3x30 - 90 tablets - 60 months from date of manufacture stored at or below 25°C
Authorization date:
1980-05-15
Patient Information leaflet
ACUPAN
CONSUMER MEDICINE INFORMATION
ACUPAN™
NEFOPAM HYDROCHLORIDE
30 MG TABLETS
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about ACUPAN tablets.
However,
it does not contain all the available information. It does not take
the place of
talking to your doctor or pharmacist. IF YOU HAVE ANY QUESTIONS ABOUT
ACUPAN THAT ARE NOT ANSWERED BY THIS LEAFLET, ASK YOUR DOCTOR OR
PHARMACIST.
All medicines have risks and benefits. Your doctor has weighed the
risks of you
taking ACUPAN against the benefits before prescribing it to you. IF
YOU ARE
WORRIED ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR MEDICINE AS YOU MAY WANT TO READ IT AGAIN.
WHAT ACUPAN IS USED FOR
The name of your medicine is ACUPAN. ACUPAN belongs to a group of
medicines called analgesics, commonly known as pain killers or pain
relievers. It
contains nefopam hydrochloride as the active ingredient. 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 both short term pain and long lasting pain
(for
example pain after an operation, dental pain, joint or muscle pain or
after an
injury). ACUPAN should not be used to treat the pain from a heart
attack.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed ACUPAN for another purpose.
ACUPAN
BEFORE YOU TAKE ACUPAN
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ACUPAN IF YOU HAVE AN ALLERGY TO:
Any medicine containing nefopam
Any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include:
Shortness of breath
Wheezing or difficulty breathing
Swelling of the face, lips, tongue, or other parts of the body
Rash, itching, or hives on the skin.
DO NOT USE THIS MEDICINE FOR THE TREATMENT OF A H
Read the complete document
Summary of Product characteristics
NEW ZEALAND DATA SHEET
ACUPAN
TM
ACUPAN
TM
Page 1 of 5
1. PRODUCT NAME
ACUPAN 30 mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains nefopam hydrochloride 30 mg.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
White, round, biconvex, film-coated tablets (7 mm diameter) engraved
APN on one face.
4. CLINICAL PARTICULARS
4.1
Therapeutic indications
ACUPAN is indicated for the relief of acute pain, including
post-operative, dental, musculoskeletal
and acute traumatic pain.
4.2
Dose and method of administration
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.
Children
ACUPAN is not recommended for children under the age of 12 years.
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. Some
cases of hallucination and
confusion have been reported in this age group.
4.3
Contraindications
ACUPAN is contraindicated in patients with a history of convulsive
disorders and should not be given
to patients taking monoamine oxidase (MAO) inhibitors.
ACUPAN is contraindicated in patients with known hypersensitivity to
any of the ingredients.
ACUPAN should not be used in the treatment of myocardial infarction.
This advice is based on the
lack of clinical experience for this indication.
4.4
Special warnings and precautions for use
Hepatic and renal insufficiency may interfere with the metabolism and
excretion of nefopam.
ACUPAN should be used with caution in patients with angle closure
glaucoma.
Cases of nefopam dependence and abuse have been reported with nefopam
use.
ACUPAN should be used with caution in patients with, or at risk of,
urinary retention.
NEW ZEALAND DATA SHEET
ACUPAN
TM
ACUPAN
TM
Page 2 of 5
The side effects of ACUPAN may be additive to those of other agents
with a
Read the complete document
