البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
PAROXETINE AS HYDROCHLORIDE
GLAXO SMITH KLINE (ISRAEL) LTD
N06AB05
COATED TABLETS
PAROXETINE AS HYDROCHLORIDE 20 MG
PER OS
Required
GLAXO SMITH KLINE PHARMACEUTICALS S.A., POLAND
PAROXETINE
Treatment of (in adults): Major Depressive Disorder Obsessive Compulsive Disorder (OCD) Panic Disorder with and without agoraphobia Social Anxiety Disorders/Social phobia Generalised Anxiety Disorder Post-Traumatic Stress Disorder
2016-03-02
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a physician’s prescription only Seroxat Film-Coated Tablets Each film-coated tablet contains: paroxetine (as hydrochloride) 20 mg For the list of the inactive and allergenic ingredients in the medicine, see section 2 - “Important information about some of the ingredients in the medicine” and 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 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. Antidepressants and anti-anxiety medicines increase the risk of suicidal behavior and thoughts in patients up to the age of 25. On starting treatment with the medicine, patients and their relatives should monitor any behavioral changes such as worsening of depression, suicidal thoughts, aggression, etc. If such changes should occur, refer immediately to the physician. 1. WHAT IS THE MEDICINE INTENDED FOR? Seroxat is intended for treatment of adults with major/clinical depression and/or anxiety disorders. The anxiety disorders that Seroxat is used to treat are: obsessive compulsive disorder, panic disorder, social anxiety, post-traumatic stress disorder and generalised anxiety disorder. Therapeutic group: Selective serotonin reuptake inhibitors (SSRIs). It is not fully understood how Seroxat and other selective serotonin reuptake inhibitors work, but they may help by increasing the level of serotonin in the brain. Treating depression or anxiety disorders properly is important to help you feel better. 2. BEFORE USING THE MEDICINE Do not use the medicine if: • You are sensitive (allergic) to paroxetine or to any of the additional ingredients contained in this medicine (listed in section 6). • You are taki اقرأ الوثيقة كاملة
1. NAME OF MEDICINAL PRODUCT Seroxat 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg paroxetine (as paroxetine hydrochloride hemihydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. White, film-coated tablet, oval shaped biconvex tablets debossed with “20” on one side and a break bar on the other. The 20 mg tablet can be divided into equal doses if required. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in patient under age 25 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. In patients 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. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of (in adults): - Major Depressive Disorder - Obsessive Compulsive Disorder (OCD) - Panic Disorder with and without agoraphobia - Social Anxiety Disorders/Social phobia - Generalised Anxiety Disorder - Post-Traumatic Stress Disorder _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 2/15 _IT IS RECOMMENDED THAT SEROXAT IS ADMINISTERED ONCE DAILY IN THE MORNING WITH FOOD. THE TABLET _ _SHOULD BE SWALLOWED WHOLE. _ _ _ _Major depressive disorder _ The recommended dose is 20 mg daily. Some patients not responding to a 20 mg dose may benefit from dose increases in 10 mg/day increments, up to a maximum of 50 mg/day according to the patient's response _ _ As with all antidepressant medicinal products, dosage should be reviewed and adjusted if necessary within 2 to 3 of weeks of initiation of therapy and thereafter as judged clinically appropriate. _ _ _ _ Patients with depression should be treated for اقرأ الوثيقة كاملة