Land: Malaysia
Sprog: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
VENLAFAXINE HYDROCHLORIDE
VIATRIS SDN. BHD.
VENLAFAXINE HYDROCHLORIDE
28Capsule Capsules; 14 Capsule Capsules
PFIZER IRELAND PHARMACEUTICALS
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ EFEXOR ® XR CAPSULE Venlafaxine hydrochloride (37.5 mg, 75 mg, 150 mg) 2 WHAT IS IN THIS LEAFLET 1. What EFEXOR XR is used for 2. How EFEXOR XR works 3. Before you use EFEXOR XR 4. How to use EFEXOR XR 5. While you are using it 6. Side effects 7. Storage and Disposal of EFEXOR XR 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT EFEXOR XR IS USED FOR EFEXOR XR is an antidepressant. EFEXOR XR capsules are given to people suffering from depression, anxiety disorders or panic disorder. HOW EFEXOR XR WORKS EFEXOR XR belongs to a group of medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs). Serotonin and noradrenaline are chemical messengers that allow certain nerves in the brain to work. It is thought that people who are depressed and/or anxious may 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. BEFORE YOU USE EFEXOR XR - _When you must not use it_ - If you are allergic to venlafaxine or to any of the other ingredients in EFEXOR XR capsules - If you are also taking, or have taken within the last 14 days, any medicines known as irreversible monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson’s disease (a progressive movement disorder). Also, you must wait at least 7 days after you stop taking EFEXOR XR before you take any MAOI _Pregnancy and lactation_ Tell your doctor if you become pregnant, or you are trying to become pregnant. You should use EFEXOR XR only after discussing the potential benefits and the potential risks to your unborn child with your doctor. If you are taking this medicine during pregnancy, the baby born might experience some symptoms like not feeding properly, in addition to having breathing difficulties. If your baby has these symptoms when it is born and you are concerned, contact y Læs hele dokumentet
1 1. NAME OF THE MEDICINAL PRODUCT Efexor ® XR capsule 2. QUALITATIVE AND QUANTITATIVE COMPOSITION EFEXOR ® XR 37.5 MG Each extended-release capsule contains venlafaxine hydrochloride equivalent to 37.5 mg venlafaxine. EFEXOR ® XR 75 MG Each extended-release capsule contains venlafaxine hydrochloride equivalent to 75 mg venlafaxine. EFEXOR ® XR 150 MG Each extended-release capsule contains venlafaxine hydrochloride equivalent to 150 mg venlafaxine. 3. PHARMACEUTICAL FORM EFEXOR ® XR 37.5 MG Hard gelatin capsule, opaque light grey cap and opaque peach body branded with a flying “W” on the cap and “37.5” on the body with red ink, containing white to off-white spheroids of about 1 mm in diameter. EFEXOR ® XR 75 MG Hard gelatin capsule, opaque light peach cap and body branded with a flying “W” on the cap and “75” on the body in red ink, containing white to off-white spheroids of about 1 mm in diameter. EFEXOR ® XR 150 MG Elongated hard gelatin capsule, opaque dark orange cap and body branded with flying “W” on cap and ‘150’ on body in white ink containing white to off-white spheroids of about 1 mm in diameter. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATION Venlafaxine is indicated for the treatment of depression, including depression with associated anxiety, in hospitalized patients. Treatment of anxiety or Generalized Anxiety Disorder (GAD), including long-term treatment. The effectiveness of venlafaxine in long term use for GAD has been evaluated for up to 6 months in controlled clinical trials. For prevention of relapse of an episode of depression or for prevention of the recurrence of new depressive episodes. 2 Venlafaxine is indicated for the treatment of Social Anxiety Disorder, also known as Social Phobia, as defined in DSM-IV. Social Anxiety Disorder (DSM-IV) is characterized by a marked and persistent fear of one or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. Exposure to the feared situation al Læs hele dokumentet