MILN-AVENIR 25 MG

Pays: Israël

Langue: anglais

Source: Ministry of Health

Ingrédients actifs:

MILNACIPRAN AS HYDROCHLORIDE

Disponible depuis:

BIOAVENIR LTD, ISRAEL

Code ATC:

N06AX17

forme pharmaceutique:

CAPSULES

Composition:

MILNACIPRAN AS HYDROCHLORIDE 25 MG

Mode d'administration:

PER OS

Type d'ordonnance:

Required

Fabriqué par:

RIVOPHARM SA, SWITZERLAND

Domaine thérapeutique:

MILNACIPRAN

indications thérapeutiques:

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

Date de l'autorisation:

2022-05-24

Notice patient

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
MILN-AVENIR 25 MG
MILN-AVENIR 50 MG
CAPSULES
ACTIVE INGREDIENT
Each capsule contains milnacipran 25/50 mg
Inactive ingredients and allergens: See section 6 "Additional
information".
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains concise information about this medicine. If you have any
further questions, consult
your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if it seems to you that their medical condition is similar to
yours.
Antidepressants and anti-anxiety medicines increase the risk of
suicidal behavior and
thoughts in children, adolescents and young adults up to the age of
25.
Upon starting treatment with the medicine, patients of all ages and
their relatives must
follow behavioral changes, such as depression worsening, suicidal
thoughts, aggression,
etc.
If such changes occur, contact your doctor immediately.
1. WHAT IS THIS MEDICINE INTENDED FOR?
For treatment of depression in adults above the age of 18 years.
THERAPEUTIC GROUP: SNRI (Serotonin Noradrenaline Reuptake Inhibitor)
antidepressants
The effect of Miln-Avenir is visible after a certain period of time
varying from 1 to 3 weeks.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
●
You are allergic to the active ingredient or to any of the other
ingredients in this
medicine (see section 6).
●
You are already taking other medicines for treatment of depression:
irreversible
monoamine oxidase inhibitors (iproniazid, nialamide).
●
You are already taking certain medicines for treatment of
Parkinson’s disease:
selective monoamine oxidase-B-inhibitors (selegiline).
●
You are already taking certain medicines affecting the heart
(digitalis (digoxin)).
●
You are already taking certain medicines for treatment of migraines
(sumatriptan
and other medicines of the same group).
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Résumé des caractéristiques du produit

.
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Miln-Avnir 25 mg
Miln-Avnir 50 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 25 mg of milnacipran hydrochloride (equivalent
to 21.77 mg milnacipran) or
50 mg of milnacipran hydrochloride (equivalent to 43.55 mg
milnacipran).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard.
Miln-Avnir 25 mg capsules: Caramel opaque capsules, size 4 containing
white or almost white
powder.
Miln-Avnir 50 mg capsules: Red caramel opaque capsules, size 3
containing white or almost white
powder.
4.
CLINICAL PARTICULARS
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Antidepressants increased the risk of suicidal thoughts and behavior
in children, adolescents, and
young adults in short-term studies. These studies did not show an
increase in the risk of suicidal
thoughts and behavior with antidepressant use in patients over age 25;
there was a reduction in risk
with antidepressant use in patients aged 65 and older [see Special
warnings and precautions for use
(4.5)].
In patients of all ages who are started on antidepressant therapy
monitor closely for clinical worsening
and emergence of suicidal thoughts and behaviors. Advise families and
caregivers of the need for close
observation and communication with the prescriber [see Special
warnings and precautions for use
(4.5)].
4.1
THERAPEUTIC INDICATIONS
Treatment of major (i.e. all characteristics)
depressive episodes in adults over 18 years old.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
.
2
Oral use.
_ADULTS _
Recommended daily dose is 100 mg divided into two 50 mg doses, 1
capsule in the morning and 1
capsule in the evening, preferably during meals.
In this case, use 50 mg capsules.
_SPECIAL POPULATIONS _
Elderly: dosage adjustment is not necessary as long as renal function
is normal (see section 5.2).
Patients with renal insufficiency: dosage adjustment is necessary. It
is recommended to reduce the
dose to 50 or 25 mg depending on the degree of alteration in rena