Country: Իսրայել
language: անգլերեն
source: Ministry of Health
VENLAFAXINE AS HYDROCHLORIDE
PFIZER PFE PHARMACEUTICALS ISRAEL LTD
N06AX16
CAPSULES EXTENDED RELEASE
VENLAFAXINE AS HYDROCHLORIDE 75 MG
PER OS
Required
PFIZER IRELAND PHARMACEUTICALS
VENLAFAXINE
VENLAFAXINE
For the treatment of depression. Maintenance of recurrent depression. Generalized anxiety disorder (GAD) - short term and long-term. Social anxiety Disorder (SAD).
2019-03-31
Efexor XR 75; Efexor XR 150 Capsules PIL CC 140822 1 2021-0067337 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only EFEXOR ® XR 75 EACH CAPSULE CONTAINS: Venlafaxine (as hydrochloride) 75 mg EFEXOR ® XR 150 EACH CAPSULE CONTAINS: Venlafaxine (as hydrochloride) 150 mg EXTENDED RELEASE CAPSULES Inactive ingredients and allergens in the preparation: See section 2 under ‘Important information about some of this medicine’s ingredients’ and section 6 ‘Further information’. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. Antidepressants and anti-anxiety medicines increase the risk of suicidal behavior and thoughts in children, adolescents and young adults up to the age of 25. Upon initiation of treatment with the medicine, patients of all ages, and their relatives, must monitor behavioral changes such as: worsening of depression, suicidal thoughts, aggression and the like. If such changes occur, refer to a doctor immediately (see section 2). 1. WHAT IS THIS MEDICINE INTENDED FOR? Efexor XR is intended for treatment of patients with depression and for maintenance therapy of recurrent depression. It is also for treatment of patients with the following anxiety disorders: generalized anxiety and social anxiety. THERAPEUTIC GROUP: Efexor XR is an antidepressant that belongs to a group of medicines called SNRIs (serotonin and norepinephrine reuptake inhibitors). This group of medicines is used to treat depression and other conditions such as various anxiety disorders. The mode of action of antidepressants is not fully understood, but the medicines can have an affect by increasing the levels of serotonin and no read_full_document
Efexor XR 75 Efexor XR150 Capsules LPD WC 140822 1 2021-0067337 EFEXOR ® XR 75 EFEXOR ® XR 150 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Efexor ® XR 75 Efexor ® XR 150 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Efexor XR 75 – Extended release capsules: Each Extended -release capsule contains 84.85 mg of venlafaxine hydrochloride, equivalent to 75 mg of venlafaxine free base. Efexor XR 150 – Extended release capsules: Each Extended -release capsule contains 169.7 mg of venlafaxine hydrochloride, equivalent to 150 mg of venlafaxine free base. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard Extended -release capsule. 75mg: Opaque peach capsules printed in red with ‘W’ and ’75’, hard gelatin capsule, size 1. 150mg: Opaque dark orange capsules printed in white with ‘W’ and ’150’, hard gelatin capsule, size 0. • WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 25; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions (4.4)]. In patients of all ages who are started on antidepressant therapy monitor closely for clinical worsening and emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions (4.4)]. Efexor XR 75 Efexor XR150 Capsules LPD WC 140822 2 2021-0067337 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of depression. Maintenance of recurrent depression. Generalized anxiety disorder (GAD) - short term and long-term. Social anxiety Disorder (SAD). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Major depressive episodes The recommended starting dose for prolonged-release venlafaxin read_full_document