Land: Nederland
Taal: Nederlands
Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
VENLAFAXINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; VENLAFAXINE
Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)
N06AX16
VENLAFAXINEHYDROCHLORIDE COMPOSITION corresponding to ; VENLAFAXINE
Capsule met verlengde afgifte, hard
AMMONIA (E 527) ; AZORUBINE (E 122) ; BLAUWE INKT ; CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOVIDON ; ETHYLCELLULOSE (E 462) ; GELATINE (E 441) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 90 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), AMMONIA (E 527) ; AZORUBINE (E 122) ; BLAUWE INKT ; CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOVIDON ; ETHYLCELLULOSE (E 462) ; GELATINE (E 441) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 90 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Venlafaxine
Hulpstoffen: AMMONIA (E 527); AZORUBINE (E 122); BLAUWE INKT; CELLULOSE, MICROKRISTALLIJN (E 460); COPOVIDON; ETHYLCELLULOSE (E 462); GELATINE (E 441); INDIGOKARMIJN ALUMINIUMLAK (E 132); MAGNESIUMSTEARAAT (E 470b); POVIDON K 90 (E 1201); PROPYLEENGLYCOL (E 1520); SCHELLAK (E 904); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);
2017-10-26
PL Venlafaxine NL3669 - PRAC recommendations on signals Adopted at the 28 September-1 October 2020 PRAC meeting (published 26-Oct-2020); EMA publication letter EMA/PRAC/513083/2020: EPITT No 19552-Signal on postpartum hemorrhage 2020-11-06/PH PACKAGE LEAFLET: INFORMATION FOR THE USER VENLAFAXINE STADA 37,5 MG, HARDE CAPSULES MET VERLENGDE AFGIFTE VENLAFAXINE STADA 75 MG, HARDE CAPSULES MET VERLENGDE AFGIFTE VENLAFAXINE STADA 150 MG, HARDE CAPSULES MET VERLENGDE AFGIFTE VENLAFAXINE STADA 225 MG, HARDE CAPSULES MET VERLENGDE AFGIFTE 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 [product name] is and what is used for 2. What you need to know before you take [product name] 3. How to take [product name] 4. Possible side effects 5. How to store [product name] 6. Contents of the pack and other information 1. WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR [product name] contains the active substance venlafaxine. [product 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. [product name] is a treatment for adults with depression. It is also a treatmen Lees het volledige document
SmPC Venlafaxine NL3669 - PRAC recommendations on signals Adopted at the 28 September-1 October 2020 PRAC meeting (published 26-Oct-2020); EMA publication letter EMA/PRAC/513083/2020: EPITT No 19552-Signal on postpartum hemorrhage 2020-11-06/PH SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Venlafaxine STADA 37,5 mg, harde capsules met verlengde afgifte Venlafaxine STADA 75 mg, harde capsules met verlengde afgifte Venlafaxine STADA 150 mg, harde capsules met verlengde afgifte Venlafaxine STADA 225 mg, harde capsules met verlengde afgifte 2. QUALITATIVE AND QUANTITATIVE COMPOSITION [Product name] 37.5 mg prolonged-release capsules, hard: Each capsule contains 42.45 mg venlafaxine hydrochloride equivalent to 37.5 mg venlafaxine. [Product name] 75 mg prolonged-release capsules, hard: Each capsule contains 84.9 mg venlafaxine hydrochloride equivalent to 75 mg venlafaxine. [Product name] 150 mg prolonged-release capsules, hard: Each capsule contains 169.8 mg venlafaxine hydrochloride equivalent to 150 mg venlafaxine. Excipients with known effect Contains 0.2 mg allura red AC (E129) and 0.4 mg sunset yellow FCF (E110). [Product name] 225 mg prolonged-release capsules, hard: Each capsule contains 254.7 mg venlafaxine hydrochloride equivalent to 225 mg venlafaxine. Excipients with known effect Contains 0.02 mg carmoisine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release capsule, hard [Product name] 37.5 mg prolonged-release capsules, hard: Light grey opaque / peach opaque, size ‘3’ hard gelatin capsules of approximately 15.40 mm to 16.20 mm having thick and thin radial circular band on the body in red ink and thick and thin radial circular band on the cap in red ink. The capsule is filled with 3 white to off-white, round, biconvex, film coated mini tablets of 12.5 mg each. [Product name] 75 mg prolonged-release capsules, hard: Peach opaque / peach opaque, size ‘1’ hard gelatin capsules of approximately 18.90 mm to 19.70 mm having thick and thin radial Lees het volledige document