Nazione: Paesi Bassi
Lingua: olandese
Fonte: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
PAROXETINE HYDROCHLORIDE 0,5-WATER SAMENSTELLING overeenkomend met; PAROXETINE;
GlaxoSmithKline B.V.
N06AB05
PAROXETINE HYDROCHLORIDE 0,5-WATER COMPOSITION corresponding to; PAROXETINE;
Filmomhulde tablet
Oraal gebruik
Paroxetine
Hulpstoffen: CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341); HYPROMELLOSE (E 464); MAGNESIUMSTEARAAT (E 470b); NATRIUMZETMEELGLYCOLAAT (E468); POLYETHYLEENGLYCOL (E 1521); POLYSORBAAT 80 (E 433); TITAANDIOXIDE (E 171);
1/13 PACKAGE LEAFLET 2/13 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PAROXETINE GSK 10 MG TABLET PAROXETINE GSK 20 MG PAROXETINE GSK 30 MG Paroxetine (as the hydrochloride hemihydrate) 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 GSK is and what it is used for 2. What you need to know before you take Paroxetine GSK 3. How to take Paroxetine GSK 4. Possible side effects 5. How to store Paroxetine GSK 6. Contents of the pack and other information 1. WHAT PAROXETINE GSK IS AND WHAT IT IS USED FOR PAROXETINE GSK IS A TREATMENT FOR ADULTS WITH DEPRESSION AND/OR ANXIETY DISORDERS. The anxiety disorders that Paroxetine GSK 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 GSK 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 GSK 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 Leggi il documento completo
1/18 1. NAME OF MEDICINAL PRODUCT Paroxetine GSK 10 mg tablet, film coated tablets Paroxetine GSK 20 mg, film coated tablets Paroxetine GSK 30 mg, film coated tablets Paroxetine GSK suspensie 2 mg/ml, oral suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg/20 mg/30 mg paroxetine (as paroxetine hydrochloride hemihydrate). _ _ Each 10 ml of oral suspension contains 20 mg paroxetine (as paroxetine hydrochloride hemihydrate). Excipients with known effect – each 10 ml of oral suspension contains: - 20 mg methyl parahydroxybenzoate - 6 mg propyl parahydroxybenzoate - 0.9 mg sunset yellow FCF (E110) - 4 g sorbitol (E420). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Oral suspension. <10 mg tablet>_ _Leggi il documento completo <20 mg tablet> <30 mg tablet> 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of - Major Depressive Episode - Obsessive Compulsive Disorder - Panic Disorder with and without agoraphobia 2/18 - 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