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CONSUMER MEDICINE INFORMATION
Version: A01-1111
1
Supercedes: NIL
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
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Version: A01-041111
Page 1 of 19
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PRODUCT INFORMATION
JONCIA
®
25, 50, 100 MG CAPSULES
NAME OF THE MEDICINE
milnacipran hydrochloride
(1RS, 2SR)-2-(aminomethyl)-_N,N_-diethyl-1-phenylcyclopropane-1-carboxamide
hydrochloride (IUPAC name)
CAS number: 101152-94-7
DESCRIPTION
Milnacipran hydrochloride is
a white to almost white crystalline powder with the
molecular formula C
15
H
23
ClN
2
O and a molecular weight of 282.8. Milnacipran
hydrochloride is freely soluble in water,
methanol, ethanol, butanol, chloroform,
dichloromethane and very slightly soluble in ethyl ether.
It is non to slightly
hygroscopic
with a pKa value of 9.65. Milnacipran hydrochloride is
a racemic
mixture of the isomers
1R, 2S and 1S, 2R. The partition coefficient between octanol
and an aqueous buffer (pH = 7.2), P=0.27 shows
the highly hydrophilic character of
milnacipran hydrochloride.
The milnacipran hydrochloride drug product is
presented in an immediate-release
hard
capsule containing 25, 50 and 100 mg of milnacipran hydrochloride.
Milnacipran hydrochloride capsules also contain the excipients: calcium hydrogen
phosphate, carmellose calcium, povidone K30, silica hydrophobic colloidal,
magnesium stearate and talc-purified. The hard
capsule shells for the 25 mg and
100 mg strengths contain titanium dioxide (E171),
quinoline yellow (E104), sunset
yellow FCF (E110) and gelatin. The hard capsule shell for
the 50 mg strength
contains titanium dioxide (E171), sunset yellow FCF (E110)
and gelatin. The
capsules are marked with food grade ink.
Version: A01-041111
Page 2 of 19
Supercedes: NIL
PHARMACOLOGY
PHARMACODYNAMICS
Milnacipran is a balanced, specific, dual reuptake inhibitor
of noradrenaline (NA) and
serotonin (5-hydroxytryptamine [5 HT])
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