JONCIA
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
29-11-2017
Active ingredient:
milnacipran hydrochloride
Available from:
Pierre Fabre Australia Pty Ltd
INN (International Name):
Milnacipran hydrochloride
Authorization status:
Registered
Patient Information leaflet
JONCIA
®
_25, 50, 100 MG CAPSULES_
_Milnacipran hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Joncia
®
.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Joncia
®
against
the benefits this medicine is expected
to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT JONCIA
® IS USED
FOR
Joncia
®
is used to manage
fibromyalgia.
Fibromyalgia is a health problem
involving muscle and joint pain,
tenderness, tiredness, sleep problems
and a number of symptoms such as
morning stiffness, mood disturbances
and cognition problems.
Joncia
®
is a kind of medicine called a
serotonin-noradrenaline reuptake
inhibitor which has the ability to
increase the levels of the
biochemicals, serotonin and
noradrenaline thereby improving the
problems experienced with
fibromyalgia syndrome.
Your doctor may have prescribed
Joncia
®
for another purpose.
Ask your doctor if you have any
questions about why Joncia
®
has
been prescribed for you.
This medicine is available only on a
doctor’s prescription.
BEFORE YOU TAKE
JONCIA
®
_WHEN YOU MUST NOT TAKE IT_
YOU MUST NOT TAKE JONCIA
® IF YOU
ARE TAKING MEDICINE TO TREAT
DEPRESSION.
Joncia
®
is not used to treat
depression, but it acts like medicines
that are used to treat depression
(antidepressants) and other
psychiatric disorders. If you are
taking medicine to treat another
psychiatric disorder you should
discuss this with your doctor before
you take Joncia
®
.
If you take Joncia
®
with medicines to
treat depression, the potentially life-
threatening condition of serotonin
syndrome may occur. Serotonin
syndrome may include agitation,
hallucinations, coma, changes in
blood pressure, fast heart rate,
increased body temperature,
incoordination,
Read the complete document
Summary of Product characteristics
Version: A03-201219
Page 1 of 21
Supersedes: A02-090818 AUSTRALIAN PRODUCT INFORMATION – JONCIA
®
(MILNACIPRAN HYDROCHLORIDE) HARD CAPSULE
1
NAME OF THE MEDICINE
milnacipran hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The milnacipran hydrochloride drug product is presented in an
immediate-release
hard capsule containing 25, 50 and 100 mg of milnacipran
hydrochloride.
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
25 mg hard capsule:
yellow cap with “PFM” imprinted in black, white body with “25”
imprinted in black.
50 mg hard capsule: orange cap with “PFM” imprinted in black,
white body with
“50” imprinted in black.
100 mg hard capsule: orange cap with “PFM” imprinted in black,
yellow body with
“100” imprinted in black.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Management of fibromyalgia.
4.2
DOSE AND METHOD OF ADMINISTRATION
JONCIA
®
capsules are for oral use.
The recommended dose is 100 mg per day in two divided doses (morning
and
evening, preferably during meals).
Based on efficacy and tolerability dosing may be titrated according to
the following
schedule:
Day 1 – Day 2: 25 mg once daily (in the evening).
Version: A03-201219
Page 2 of 21
Supersedes: A02-090818
Day 3 – Day 7: 50 mg daily in two divided doses (25 mg morning and
25 mg evening).
After Day 7: 100 mg daily in two divided doses (50 mg morning and 50
mg evening).
Based on individual patient response, the dose may be increased to 200
mg/day
(100 mg twice daily). Doses above 200 mg/day have not been studied.
After an initial 12 week period patients should be assessed and those
with little or no
benefit should discontinue treatment. In patients with apparent
benefit, consideration
should be given to periodically reassessing the need for ongoing
treatment.
JONCIA
®
should be tapered and not abruptly discontinued after extended use
(see
Section 4.4 Special warnings and precautions for use: Discontinuation
of treatment).
USE IN PATIENTS WITH RENAL INSUFFICIENC
Read the complete document
