البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
BUPROPION HYDROCHLORIDE
GLAXO SMITH KLINE (ISRAEL) LTD
N07BA02
TABLETS
BUPROPION HYDROCHLORIDE 300 MG
PER OS
Required
BAUSCH HEALTH COMPANIES INC., CANADA
BUPROPION
BUPROPION
Wellbutrin XR is indicated for the treatment of major depressive episodes.Following satisfactory response, continuation with Wellbutrin XR therapy is effective in preventingrelapse.
2024-01-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) 1986 The medicine is dispensed according to a physician’s prescription only WELLBUTRIN XR 150 mg modified release tablets Each tablet contains: bupropion hydrochloride 150 mg WELLBUTRIN XR 300 mg modified release tablets Each tablet contains: bupropion hydrochloride 300 mg For the list of the inactive and allergenic ingredients in the medicine, see section 6 Additional information . Read the leaflet carefully in its entirety before using the medicine. This leaflet contains concise information about the medicine. If you have further questions, refer to the physician or the 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. Wellbutrin XR is not intended for treatment of children under 18 years of age. 1. WHAT IS THE MEDICINE INTENDED FOR? Wellbutrin XR is a medicine intended for the treatment of depression. It is thought to interact with chemicals in the brain called noradrenaline and dopamine . Therapeutic group: Other antidepressants. 2. BEFORE USING THE MEDICINE Do not use the medicine if: • You are sensitive (allergic) to bupropion or to any of the additional ingredients contained in this medicine (listed in section 6). • You are taking any other medicines that contain bupropion • You have been diagnosed with epilepsy or have a history of seizures • You have or used to have an eating disorder (for example, bulimia or anorexia nervosa) • You have a brain tumor • You are usually a heavy drinker and have just stopped, or are about to stop, drinking • You have severe liver problems • You recently stopped taking sedatives, or you are going to stop them, while taking Wellbutrin XR • You are taking or have taken other medicines for depression or for Parkinson’s disease called monoamine oxidase inhibitors (MAOIs) in the last 14 days. If one of these apply to you, talk to your physician straight awa اقرأ الوثيقة كاملة
Page 1 of 16 WELLBUTRIN XR 1. NAME OF THE MEDICINAL PRODUCT WELLBUTRIN XR 150 mg. WELLBUTRIN XR 300 mg. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains bupropion hydrochloride 150 mg or 300 mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Modified release tablet._ _ 150 mg tablet: Creamy white to pale yellow round tablet imprinted with “GS 5FV 150 ” in black ink on one side and the other side plain. 300 mg tablet: Creamy white to pale yellow round tablet imprinted with “GS 5YZ 300 ” in black ink on one side and the other side plain. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS WELLBUTRIN XR is indicated for the treatment of major depressive episodes. Following satisfactory response, continuation with WELLBUTRIN XR therapy is effective in preventing relapse. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION WARNING: SUICIDAL THOUGHTS AND BEHAVIORS SUICIDALITY AND ANTIDEPRESSANT DRUGS ANTIDEPRESSANTS INCREASED THE RISK OF SUICIDAL THOUGHTS AND BEHAVIOR IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS IN SHORT-TERM TRIALS. THESE TRIALS DID NOT SHOW AN INCREASE IN THE RISK OF SUICIDAL THOUGHTS AND BEHAVIOR WITH ANTIDEPRESSANT USE IN SUBJECTS AGED 65 AND OLDER _[SEE WARNINGS AND PRECAUTIONS (4.4)]. _ IN PATIENTS OF ALL AGES WHO ARE STARTED ON ANTIDEPRESSANT THERAPY, MONITOR CLOSELY FOR WORSENING, AND FOR 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)]._ Page 2 of 16 Posology ADULTS The recommended starting dose is 150 mg, given once daily. An optimal dose was not established in clinical studies. If no improvement is seen after 4 weeks treatment at 150 mg_,_ the dose may be increased to 300 mg, given once daily. There should be an interval of at least 24 hours between successive doses. The onset of action for bupropion has been noted 14 days after starting therapy. As with all antidepressants the full antidepressant effect of WELLBUTRIN اقرأ الوثيقة كاملة