מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
PAROXETINE
Aurobindo Pharma Limited
N06AB05
PAROXETINE
30 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
Selective serotonin reuptake inhibitors
Authorised
2008-05-30
_ _ PACKAGE LEAFLET: INFORMATION FOR THE USER PAROXETINE AUROBINDO 20 MG FILM-COATED TABLETS PAROXETINE AUROBINDO 30 MG FILM-COATED TABLETS Paroxetine 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 Paroxetine Aurobindo is and what it is used for 2. What you need to know before you take Paroxetine Aurobindo 3. How to take Paroxetine Aurobindo 4. Possible side effects 5. How to store Paroxetine Aurobindo 6. Contents of the pack and other information 7. 1. WHAT PAROXETINE AUROBINDO IS AND WHAT IT IS USED FOR Paroxetine Aurobindo belongs to a group of medicines called Selective Serotonin Reuptake Inhibitors (SSRIs), which are antidepressants. Paroxetine Aurobindo is used in the treatment of: - Depression (major depressive episodes). - Obsessive Compulsive Disorder (compulsive thoughts and compulsive actions) (OCD). - Panic disorder with and without agoraphobia (e.g. fear of leaving the house, entering shops, or fear of public places). - Social phobia (overwhelming fear or avoidance of everyday social situations). - Generalized anxiety disorder (more permanent present fear, in which cronic nervous worring is prominent). - Post-traumatic stress disorder (anxiety caused by a traumatic event). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PAROXETINE AUROBINDO DO NOT TAKE PAROXETINE AUROBINDO - Ff you are allergic to paroxetine or any of the other ingredients of this medicine (listed in section 6). - If you are taking medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylth קרא את המסמך השלם
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paroxetine Aurobindo 30 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 30mg paroxetine (as paroxetine hydrochloride hemihydrate). Excipient with known effect: anhydrous lactose 14.25mg /film-coated tablet. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Blue coloured film-coated capsule shaped, biconvex tablets debossed with ‘F’ on one side and ‘12’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of - Major depressive episode. - 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 Method of administration It is recommended that paroxetine is administered once daily in the morning with food. The film-coated tablet should be swallowed rather than chewed. Posology _MAJOR DEPRESSIVE EPISODES_ The recommended dose is 20 mg daily. In general, improvement in patients starts after one week but may only become evident from the second week of therapy. As with all antidepressant medicinal products, dosage should be reviewed and adjusted if necessary within 3 to 4 weeks of initiation of therapy and thereafter as judged clinically appropriate. In some patients, with insufficient response to 20 mg, the dose may be increased gradually up to a maximum of 50 mg a day in 10 mg steps according to the patient’s response. Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free from symptoms. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ קרא את המסמך השלם