Pays: Malte
Langue: anglais
Source: Medicines Authority
PAROXETINE HYDROCHLORIDE, HEMIHYDRATE
Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta
N06AB05
PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg
FILM-COATED TABLET
PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg
POM
PSYCHOANALEPTICS
Authorised
2016-10-18
Page 21 of 11 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 or nurse. 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 1. WHAT PAROXETINE AUROBINDO IS AND WHAT IT IS USED FOR PAROXETINE AUROBINDO IS A TREATMENT FOR ADULTS WITH DEPRESSION AND/OR ANXIETY DISORDERS. : The anxiety disorders that Paroxetine Aurobindo is used to treat are: obsessive compulsive disorder (repetitive, obsessive thoughts with uncontrollable behaviour); panic disorder (panic attacks, including those caused by agoraphobia, which is a fear of open spaces); social anxiety disorder (fear or avoidance of social situations); post-traumatic stress disorder (anxiety caused by a traumatic event); and generalised anxiety disorder (generally feeling very anxious or nervous). Paroxetine Aurobindo is one of a group of medicines called SSRIs (selective serotonin reuptake inhibitors). Everyone has a substance called serotonin in their brain. People who are depressed or anxious have lower levels of serotonin than others. It is not fully understood how Paroxetine Aurobindo and other SSRIs work but they may help by increasing the level of serotonin in the brain. Treating depression or anxiety d Lire le document complet
Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Paroxetine Aurobindo 20 mg film-coated tablets Paroxetine Aurobindo 30 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg paroxetine (as paroxetine hydrochloride hemihydrate). Excipient with known effect: Lactose monohydrate 10 mg /film-coated tablet. Each film-coated tablet contains 30 mg paroxetine (as paroxetine hydrochloride hemihydrate). Excipient with known effect: Lactose monohydrate 15 mg /film-coated tablet. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. _ _ _20 mg:_ White to off-white colored film-coated modified capsule shaped, biconvex tablets debossed with ‘56’ on one side and ‘C’ with a deep break line on the other side. The tablet can be divided into equal doses. _30 mg:_ Blue coloured film-coated modified 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. - Generalized anxiety disorder. - Post-traumatic stress disorder 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ 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 Page 2 of 16 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 Lire le document complet