JONCIA

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

milnacipran hydrochloride

Commercializzato da:

Pierre Fabre Australia Pty Ltd

INN (Nome Internazionale):

Milnacipran hydrochloride

Stato dell'autorizzazione:

Registered

Foglio illustrativo

CONSUMER MEDICINE INFORMATION
Version: A02-090818
1
Supercedes: A01-1111
JONCIA
® 25, 50, 100 MG CAPSULES
_Milnacipran hydrochloride _
_ _
_ _
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 he

Scheda tecnica

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