Država: Nizozemska
Jezik: nizozemski
Izvor: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
VENLAFAXINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; VENLAFAXINE
Centrafarm B.V. Nieuwe Donk 3 4879 AC ETTEN LEUR
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 (E 464) ; MAÏSZETMEEL ; NATRIUMLAURILSULFAAT (E 487) ; OLIEZUUR ; 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; SACCHAROSE; SILICIUMDIOXIDE (E 551); SUGAR SPHERES; TALK (E 553 B); TITAANDIOXIDE (E 171); ZONNEGEEL FCF (E 110);
2008-01-09
PACKAGE LEAFLET: INFORMATION FOR THE USER VENLAFAXINE RETARD CF 37,5 MG, CAPSULES MET VERLENGDE AFGIFTE, HARD VENLAFAXINE RETARD CF 75 MG, CAPSULES MET VERLENGDE AFGIFTE, HARD VENLAFAXINE RETARD CF 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 [XXX] is and what it is used for 2. What you need to know before you take [XXX] 3. How to take [XXX] 4. Possible side effects 5. How to store [XXX] 6. Contents of the pack and other information 1. WHAT [XXX] IS AND WHAT IT IS USED FOR [XXX] contains the active substance venlafaxine. [XXX] 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. [XXX] 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 social situations) and panic disorder (panic attacks). Treating depression or anxiety disorders properly is important to help you get better. If it is not treated, your condition may not go away and may become more serious and more difficult to Pročitajte cijeli dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Venlafaxine retard CF 37,5 mg, capsules met verlengde afgifte, hard Venlafaxine retard CF 75 mg, capsules met verlengde afgifte, hard Venlafaxine retard CF 150 mg, capsules met verlengde afgifte, hard 2. QUALITATIVE AND QUANTITATIVE COMPOSITION [For 37.5 mg strength:] One capsule contains venlafaxine hydrochloride, equivalent to 37.5 mg of venlafaxine. Excipients with known effect Sucrose max. 46.35 mg Ponceau 4R red (E124) 0.0267 mg [For 75 mg strength:] One capsule contains venlafaxine hydrochloride, equivalent to 75 mg of venlafaxine. Excipients with known effect Sucrose max. 92.69 mg Sunset yellow FCF (E110) 0.0006 mg [For 150 mg strength:] One capsule contains venlafaxine hydrochloride, equivalent to 150 mg of venlafaxine. Excipients with known effect Sucrose max. 185.38 mg Sunset yellow FCF (E110) 0.0183 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release capsule, hard. [XXX] 37.5 mg prolonged-release capsules, hard: White to off-white granules in a capsule size “3” with an orange cap and transparent body. [XXX] 75 mg prolonged-release capsules, hard: White to off-white granules in a capsule size “1” with a yellow cap and transparent body. [XXX] 150 mg prolonged-release capsules, hard: White to off-white granules in a capsule size “0” with a buff cap and transparent body. 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. • Treatment of panic disorder, with or without agoraphobia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Major depressive episodes The recommended starting dose for prolonged-release venlafaxine is 75 mg given once daily. Patients not responding to the initial 75 mg/day dose may benefit from dose increases up to a maximum dose of 375 mg/day. Dosage increases can be mad Pročitajte cijeli dokument