Land: Holland
Tungumál: hollenska
Heimild: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
VENLAFAXINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; VENLAFAXINE
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
N06AX16
VENLAFAXINEHYDROCHLORIDE COMPOSITION corresponding to ; VENLAFAXINE
Capsule met verlengde afgifte, hard
CHINOLINEGEEL (E 104) ; DIBUTYLSEBACAAT ; ETHYLCELLULOSE (E 462) ; GELATINE (E 441) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MAÏSZETMEEL ; NATRIUMLAURILSULFAAT (E 487) ; OLIEZUUR ; PATENTBLAUW V (E131) ; SACCHAROSE ; SILICIUMDIOXIDE (E 551) ; SUGAR SPHERES ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZONNEGEEL FCF (E 110), CHINOLINEGEEL (E 104) ; DIBUTYLSEBACAAT ; ETHYLCELLULOSE (E 462) ; GELATINE (E 441) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; MAÏSZETMEEL ; NATRIUMLAURILSULFAAT (E 487) ; OLIEZUUR ; PATENTBLAUW V (E131) ; SACCHAROSE ; SILICIUMDIOXIDE (E 551) ; SUGAR SPHERES ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZONNEGEEL FCF (E 110),
Oraal gebruik
Venlafaxine
Hulpstoffen: CHINOLINEGEEL (E 104); DIBUTYLSEBACAAT; ETHYLCELLULOSE (E 462); GELATINE (E 441); HYPROLOSE (E 463); HYPROMELLOSE (E 464); MAÏSZETMEEL; NATRIUMLAURILSULFAAT (E 487); OLIEZUUR; PATENTBLAUW V (E131); SACCHAROSE; SILICIUMDIOXIDE (E 551); SUGAR SPHERES; TALK (E 553 B); TITAANDIOXIDE (E 171); ZONNEGEEL FCF (E 110);
2006-09-04
Sandoz B.V. Pagina 1 van 11 Venladoz XR 37,5/ 75/ 150 mg capsules met verlengde afgifte, hard RVG 34343-34344-34345 1313-V18 1.3.1.3 Package Leaflet April 2021 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT VENLADOZ XR 37,5 MG CAPSULES MET VERLENGDE AFGIFTE, HARD VENLADOZ XR 75 MG CAPSULES MET VERLENGDE AFGIFTE, HARD VENLADOZ XR 150 MG CAPSULES MET VERLENGDE AFGIFTE, HARD 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 [Nationally completed name] is and what it is used for 2. What you need to know before you take [Nationally completed name] 3. How to take [Nationally completed name] 4. Possible side effects 5. How to store [Nationally completed name] 6. Contents of the pack and other information 1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR [Nationally completed name] 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. [Nationally completed name] is a treatment for adults with depression. It is also a treatment for adults with the following anxiety disorders: generalised anxiety disorder, social anxiety disorder (fear or avoidance of s Lestu allt skjalið
20201217 Sandoz B.V. Pagina 1 van 22 Venladoz XR 37,5/75/150 mg capsules met verlengde afgifte, hard RVG 34343-34344-34345 1311-V14 1.3.1.1 Summary of Product Characteristics April 2021 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Venladoz XR 37,5 mg capsules met verlengde afgifte, hard Venladoz XR 75 mg capsules met verlengde afgifte, hard Venladoz XR 150 mg capsules met verlengde afgifte, hard 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 37.5 mg: One prolonged-release capsule, hard contains venlafaxine hydrochloride, equivalent to 37.5 mg of venlafaxine. Excipients with known effect One prolonged-release capsule, hard contains up to 46.6 mg of sucrose and up to 0.0279 mg of azo colouring agent ponceau 4R. _75 mg: _ One prolonged-release capsule, hard contains venlafaxine hydrochloride, equivalent to 75 mg of venlafaxine. Excipients with known effect One prolonged-release capsule, hard contains up to 93.2 mg of sucrose and 0.0006 mg of azo colouring agent sunset yellow FCF. _150 mg: _ One prolonged-release capsule, hard contains venlafaxine hydrochloride, equivalent to 150 mg of venlafaxine. Excipients with known effect One prolonged-release capsule, hard contains up to 186.4 mg of sucrose and 0.0169 mg of azo colouring agent sunset yellow FCF. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release capsule, hard. [Nationally completed name] 37.5 mg prolonged-release capsules, hard: White to off-white granules in a hard gelatin capsule ‘size 3’ with orange cap and clear transparent body. [Nationally completed name] 75 mg prolonged-release capsules, hard: White to off-white granules in a hard gelatin capsule ‘size 1’ with yellow cap and clear transparent body. [Nationally completed name] 150 mg prolonged-release capsules, hard: White to off-white granules in a hard gelatin capsule ‘size 0’ with ochre-coloured cap and clear transparent body. 20201217 Sandoz B.V. Pagina 2 van 22 Venladoz XR 37,5/75/150 mg capsules met verlengde afgifte, hard RVG 3 Lestu allt skjalið