Krajina: Malta
Jazyk: angličtina
Zdroj: Medicines Authority
PAROXETINE
Teva Pharma B.V. (utrecht) Swensweg 5, 2031 GA Haarlem, Netherlands
N06AB05
PAROXETINE 20 mg
FILM-COATED TABLET
PAROXETINE 20 mg
POM
PSYCHOANALEPTICS
Withdrawn
2011-03-18
1 PACKAGE LEAFLET: INFORMATION FOR THE USER [PAROXETINE 20MG FILM-COATED TABLETS] Paroxetine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. WHAT PAROXETINE IS AND WHAT IT IS USED FOR 2. BEFORE YOU TAKE PAROXETINE 3. HOW TO TAKE PAROXETINE 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE PAROXETINE 6. FURTHER INFORMATION 1. WHAT PAROXETINE IS AND WHAT IT IS USED FOR Paroxetine is a treatment for adults with depression and/or anxiety disorders. The anxiety disorders that Paroxetine 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), • generalised anxiety disorder (generally feeling very anxious or nervous). Paroxetine is one of a group of medicines called SSRIs (selective serotonin re-uptake inhibitors). Everyone has a substance called serotonin in their brain. It is not fully understood how Paroxetine and other SSRIs work but they may help by increasing the level of serotonin in the brain. Treating depression o Prečítajte si celý dokument
Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT [Paroxetine 20mg Film-coated Tablets] 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 20 mg: Each tablet contains 20 mg paroxetine (as paroxetine hydrochloride hemihydrate). 3. PHARMACEUTICAL FORM Film-coated tablet 20mg: White to off-white, round bioconvex film coated tablet, scored on one side and debossed with “2” on one side of the score and “0” on the other side of the score. The other side of the tablet is scored and debossed with “P” on one side of the score and “X” on the other side of the score. The tablet can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Treatment of - major depressive episode. - obsessive compulsive disorder (OCD). - panic disorder with and without agoraphobia. - social anxiety disorder/social phobia. - generalised anxiety disorder. - post-traumatic stress disorder. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION It is recommended that paroxetine is administered once daily in the morning with food. The tablet should be swallowed rather than chewed. _ _ _MAJOR DEPRESSIVE EPISODE _ 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 Prečítajte si celý dokument