Riik: Armeenia
keel: inglise
Allikas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
venlafaxine (venlafaxine hydrochloride)
KRKA d.d.
N06AX16
venlafaxine (venlafaxine hydrochloride)
37,5mg
capsules prolonged-release
(28/2x14/) in blister, (56/4x14/) in blister
Prescription
Registered
2020-12-30
Package leaflet CONFIDENTIAL Alventa prolonged-release capsules 37.5 mg, 75 mg, 150 mg MODULE 1 VOL: 1; P: 54 / 274 1.3.1 Venlafaxine hydrochloride SPC, Labeling and Package Leaflet AM SmPCPIL132844_1 23.07.2019 – Updated: 23.07.2019 Page 1 of 9 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ALVENTA 37.5 MG PROLONGED-RELEASE CAPSULES ALVENTA 75 MG PROLONGED-RELEASE CAPSULES ALVENTA 150 MG PROLONGED-RELEASE CAPSULES Venlafaxine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Alventa is and what it is used for 2. What you need to know before you take Alventa 3. How to take Alventa 4. Possible side effects 5. How to store Alventa 6. Contents of the pack and other information 1. WHAT ALVENTA IS AND WHAT IT IS USED FOR Alventa contains the active substance venlafaxine. Alventa is an antidepressant that belongs to a group of medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs). This group of medicines is used to treat depression and other conditions such as anxiety disorders. It is thought that people who are depressed and/or anxious have lower levels of serotonin and noradrenaline in the brain. It is not fully understood how antidepressants work, but they may help by increasing the levels of serotonin and noradrenaline in the brain. Alventa is a treatment for adults with depression. Alventa is also a treatment for adults with the following anxiety disorders: generalised anxiety disorder, social anxiety disorder (fear or avoidance of social situations) and panic disorder (panic at Lugege kogu dokumenti
1.3.1 Venlafaxine hydrochloride SPC, Labeling and Package Leaflet AM SmPCPIL132842_1 23.07.2019 – Updated: 23.07.2019 Page 1 of 19 1. NAME OF THE MEDICINAL PRODUCT Alventa 37.5 mg Prolonged-release capsules Alventa 75 mg Prolonged-release capsules Alventa 150 mg Prolonged-release capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Alventa 37.5 mg Prolonged-release capsules Each Prolonged-release capsule, contains 37.5 mg venlafaxine (as 42.43 mg venlafaxine hydrochloride). Alventa 75 mg Prolonged-release capsules Each Prolonged-release capsule, contains 75 mg venlafaxine (as 84.85 mg venlafaxine hydrochloride). Alventa 150 mg Prolonged-release capsules Each Prolonged-release capsule, contains 150 mg venlafaxine (as 169.70 mg venlafaxine hydrochloride). Excipient with known effect: 37.5 mg capsule 75 mg capsule 150 mg capsule sucrose 32.5 mg 65 mg 130 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release capsule. Alventa 37.5 mg Prolonged-release capsules Hard gelatine capsules, the body of the capsule is white and the cap of the capsule is brownish-pink coloured. The capsules are filled with white to almost white pellets. Alventa 75 mg Prolonged-release capsules Hard gelatine capsules, the body and the cap of the capsule are light pink coloured. The capsules are filled with white to almost white pellets. Alventa 150 mg Prolonged-release capsules Hard gelatine capsules, the body and the cap of the capsule are orange-brownish coloured. The capsules are filled with white to almost white pellets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of major depressive episodes. For prevention of recurrence of major depressive episodes. Treatment of generalised anxiety disorder. Treatment of social anxiety disorder (SAD). Treatment of panic disorder, with or without agoraphobia. CONFIDENTIAL Alventa prolonged-release capsules 37.5 mg, 75 mg, 150 mg MODULE 1 VOL: 1; P: 35 / 274 1.3.1 Venlafaxine hydrochloride SPC, Labeling and Package Leaflet AM SmPCPIL132842_1 23.07. Lugege kogu dokumenti