Maa: Alankomaat
Kieli: hollanti
Lähde: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
AGOMELATINE CITROENZUUR SAMENSTELLING overeenkomend met ; AGOMELATINE
Krka d.d., Novo mesto Smarjeska cesta 6 8501 NOVO MESTO (SLOVENIË)
N06AX22
AGOMELATINE CITRIC acid COMPOSITION corresponding to ; AGOMELATINE
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; NATRIUMSTEARYLFUMARAAT ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; STEARINEZUUR (E 570) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)
Oraal gebruik
Agomelatine
2018-12-07
1.3.1 Agomelatine SPC, Labeling and Package Leaflet NL-Netherlands PI_Text000060_2 - Updated: Page 18 of 23 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AGOMELATINE KRKA 25 MG, FILMOMHULDE TABLETTEN agomelatine 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 Agomelatine Krka is and what it is used for 2. What you need to know before you take Agomelatine Krka 3. How to take Agomelatine Krka 4. Possible side effects 5. How to store Agomelatine Krka 6. Contents of the pack and other information 1. WHAT AGOMELATINE KRKA IS AND WHAT IT IS USED FOR Agomelatine Krka contains the active ingredient agomelatine. It belongs to a group of medicines called antidepressants and you have been given Agomelatine Krka to treat your depression. Agomelatine Krka is used in adults. Depression is a continuing disturbance of mood that interferes with everyday life. The symptoms of depression vary from one person to another, but often include deep sadness, feelings of worthlessness, loss of interest in favourite activities, sleep disturbances, feeling of being slowed down, feelings of anxiety, changes in weight. The expected benefits of Agomelatine Krka are to reduce and gradually remove the symptoms related to your depression. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AGOMELATINE KRKA DO NOT TAKE AGOMELATINE KRKA: - if you are allergic to agomelatine or any of the other ingredients of this medicine (listed in section 6). - IF YOUR LIVER DOES NOT WORK PROPERLY (HEPATIC IMPAIRMENT). - if you are taking fluvoxamine (anothe Lue koko asiakirja
1.3.1 Agomelatine SPC, Labeling and Package Leaflet NL-Netherlands PI_Text000060_2 - Updated: Page 1 of 23 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Agomelatine Krka 25 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains agomelatine-citric acid equivalent to 25 mg agomelatine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (Tablet) Yellow, oblong, biconvex film-coated tablets 9.0 mm long, 4.5 mm wide. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Agomelatine is indicated for the treatment of major depressive episodes in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is 25 mg once daily taken orally at bedtime. After two weeks of treatment, if there is no improvement of symptoms, the dose may be increased to 50 mg once daily, i.e. two 25 mg tablets, taken together at bedtime. Decision of dose increase has to be balanced with a higher risk of transaminases elevation. Any dose increase to 50 mg should be made on an individual patient benefit/risk basis and with strict respect of liver function test monitoring. Liver function tests should be performed in all patients before starting treatment. Treatment should not be initiated if transaminases exceed 3 X upper limit of normal (see sections 4.3 and 4.4). During treatment transaminases should be monitored periodically after around three weeks, six weeks (end of acute phase), twelve weeks and twenty-four weeks (end of maintenance phase) and thereafter when clinically indicated (see also section 4.4). Treatment should be discontinued if transaminases exceed 3 X upper limit of normal (see sections 4.3 and 4.4). When increasing the dosage, liver function tests should again be performed at the same frequency as when initiating treatment. _Treatment duration_ Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free of symptoms. _Switching therapy from SSRI/S Lue koko asiakirja