Quốc gia: Israel
Ngôn ngữ: Tiếng Anh
Nguồn: Ministry of Health
MILNACIPRAN HYDROCHLORIDE
PERRIGO ISRAEL AGENCIES LTD
N06AX17
CAPSULES
MILNACIPRAN HYDROCHLORIDE 50.0 MG
PER OS
Required
PIERRE FABRE MEDICAMENT PRODUCTION, FRANCE
MILNACIPRAN
MILNACIPRAN
Treatment of major (i.e. all characteristics) depressive episodes in adults over 18 years old.
2013-10-31
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 Đọc toàn bộ tài liệu
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 Đọc toàn bộ tài liệu