Country: Netherlands
Language: Dutch
Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
PAROXETINEHYDROCHLORIDE 0-WATER SAMENSTELLING overeenkomend met ; ; PAROXETINE 40 mg/stuk
Ratiopharm GmbH Graf-Arco-Strasse 3 89079 ULM (DUITSLAND)
N06AB05
PAROXETINEHYDROCHLORIDE 0-WATER SAMENSTELLING overeenkomend met ; ; PAROXETINE 40 mg/stuk
Tablet
CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551), CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551)
Oraal gebruik
Paroxetine
2005-12-20
Paroxetine, NL/H/0453/001, 08.11.23 1 rvg 33151 EU PIL IB/023 met NL info-tracked PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PAROXETINE 40 MG, TABLETTEN 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 40 mg_ is and what it is used for 2. What you need to know before you take _Paroxetine 40 mg_ 3. How to take _Paroxetine 40 mg_ 4. Possible side effects 5. How to store _Paroxetine 40 mg_ 6. Contents of the pack and other information 1. WHAT _PAROXETINE 40 MG_ IS AND WHAT IT IS USED FOR _PAROXETINE 40 MG_ IS A TREATMENT FOR ADULTS WITH DEPRESSION AND/OR ANXIETY DISORDERS. The anxiety disorders that _Paroxetine 40 mg_ 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 40 mg_ is one of a group of medicines called SSRIs (selective serotonin re-uptake inhibitors). It is not fully understood how _Paroxetine 40 mg_ and other SSRIs 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 get better. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE _PAROXETINE 40 MG _ DO NOT TAKE PAROXETINE 40 MG - IF YOU A Read the complete document
Paroxetine, NL/H/0453/001, 08.11.23 1 rvg 33151 EU SPC IB/023 met NL info-tracked SUMMARY OF PRODUCT CHARACTERISTICS 1. NAAM VAN HET GENEESMIDDEL Paroxetine 40 mg, tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 40 mg paroxetine (as hydrochloride). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet Capsule shaped off white tablet with a score line. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of − Major depressive episode − Obsessive compulsive disorder − 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 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 for a sufficient period of at least 6 months to ensure that they are free from symptoms. Obsessive compulsive disorder (OCD) The recommended dose is 40 mg daily. Patients should start on 20 mg/day and the dose may be increased gradually in 10 mg increments to the recommended dose. If after some weeks on the recommended dose insufficient response is seen some patients may benefit from having their dose increased gradually up to a maximum of 60 mg/day. Patients with OCD should be treated for a Paroxetine, NL/H/0453/001, 08.11.23 2 rvg 33151 EU SPC IB/023 met NL info-tracked sufficient period to ensure that they are free from symptoms. This period may be severa Read the complete document