IXEL 25 MG

Nchi: Israeli

Lugha: Kiingereza

Chanzo: Ministry of Health

Viambatanisho vya kazi:

MILNACIPRAN HYDROCHLORIDE

Inapatikana kutoka:

PERRIGO ISRAEL AGENCIES LTD

ATC kanuni:

N06AX17

Dawa fomu:

CAPSULES

Tungo:

MILNACIPRAN HYDROCHLORIDE 25 MG

Njia ya uendeshaji:

PER OS

Dawa ya aina:

Required

Viwandani na:

PIERRE FABRE MEDICAMENT PRODUCTION, FRANCE

Kundi la matibabu:

MILNACIPRAN

Eneo la matibabu:

MILNACIPRAN

Matibabu dalili:

Treatment of major (i.e. all characteristics) depressive episodes in adults over 18 years old.

Idhini ya tarehe:

2013-10-31

Taarifa za kipeperushi

PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’
REGULATIONS )PREPARATIONS( - 1986
This medicine is dispensed with a doctor’s
prescription only
IXEL
® 25 MG
IXEL
® 50 MG
Capsules
COMPOSITION OF THE ACTIVE INGREDIENT AND ITS
QUANTITY:
IXEL 25 MG Each capsule contains: Milnacipran
Hydrochloride 25 mg
IXEL 50 MG Each capsule contains: Milnacipran
Hydrochloride 50 mg
Inactive ingredients and allergens in the medicine:
see section 6.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE YOU
START USING THIS MEDICINE. This leaflet contains
concise information about the medicine. If you
have any further questions, refer to the doctor or
pharmacist.
This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if you
think that their medical condition is similar.
The medicine is intended for adults over the age
of 18 years.
Antidepressants
and
anti-anxiety
medicines
increase
the
risk
of
suicidal
behavior
and
thoughts in children, adolescents and young
adults up to 25 years of age.
At
the
beginning
of
the
treatment
with
the
medicine, patients of all ages and their relatives
should
follow
behavioral
changes
such
as:
worsening
of
depression,
suicidal
thoughts,
aggressiveness, etc. In case changes like these
occur, refer to the doctor immediately.
1. WHAT IS THE MEDICINE INTENDED FOR?
Treatment of depression in adults over the age of
18 years.
THERAPEUTIC GROUP: Antidepressants of the SNRI
group )Serotonin Noradrenaline Reuptake Inhibitors(.
2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE:
• if you are hypersensitive )allergic( to the active
ingredient milnacipran or to any of the other
ingredients the medicine contains - see section
6 "ADDITIONAL INFORMATION".
• in
combination
with
irreversible
monoamine
oxidase inhibitors )MAOIs( )iproniazid( - see
section 2 "DRUG INTERACTIONS".
• if you are breastfeeding.
• if
you
suffer
from
uncontrolled
high
blood
pressure or a severe or unstable coronary heart
disease.
SPECIAL WARNINGS REGARDING THE USE OF THIS
MEDICINE
• Suicidal
tho

Tabia za bidhaa

1
טמרופ
ע עבקנ הז ןולע
"
ינויב רשואו קדבנ ונכותו תואירבה דרשמ י
2013
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
IXEL 50 MG
IXEL 25MG
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
IXEL 50mg:
Milnacipran
hydrochloride…………………………………………………….50.00
mg
Quantity equivalent to Milnacipran free
base…………………………………43.55 mg
IXEL 25mg:
Milnacipran
hydrochloride…………………………………………………….25.00
mg
Quantity equivalent to Milnacipran free
base…………………………………21.77 mg
For one hard capsule
For excipients, see 6.1
3. PHARMACEUTICAL FORM
Hard capsule.
Pink cap and body, imprinted with “Ixel 25”.
Pink cap and rust-coloured body, imprinted with « Ixel 50 ».
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Treatment of major depressive episodes in adults over 18 years old.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_U_
Dosage and Method of Administration
Recommended dosage is 100 mg a day in two divided 50 mg doses, 1
capsule morning and evening
preferably during meals.
In this case, use the 50 mg capsules.
In the elderly, dosage adjustment is not necessary as long as renal
function is normal.
(see Pharmacokinetic properties).
In patients with renal failure, dosage adjustment is necessary.
The recommended dosage is reduced to 50 or 25 mg depending on the
degree of alteration of renal
function (see Pharmacokinetic properties).
In this case, use 25 mg capsules.
The following dosage adjustment is recommended:
CREATININE CLEARANCE (CLCR)
(ML/MIN)
DOSAGE /24 H
Clcr
≥
60
50 mg x 2
60 > Clcr
≥
30
25 mg x 2
30 > Clcr
≥
10
25 mg
_U_
Duration of treatment:
Treatment with antidepressants is symptomatic.
As with all antidepressants, the efficacy of Milnacipran only becomes
apparent after a certain delay
which can vary from 1 to 3 weeks.
For one episode treatment should last for several months (usually
about 6 months) in order to prevent
relap