Country: Israel
Language: English
Source: Ministry of Health
MILNACIPRAN AS HYDROCHLORIDE
BIOAVENIR LTD, ISRAEL
N06AX17
CAPSULES
MILNACIPRAN AS HYDROCHLORIDE 50 MG
PER OS
Required
RIVOPHARM SA, SWITZERLAND
MILNACIPRAN
Treatment of major (i.e. all characteristics) depressive episodes in adults over 18 years old
2022-05-24
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). Read the complete document
. 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 Read the complete document