Land: Nederland
Taal: Nederlands
Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
CITALOPRAMHYDROBROMIDE SAMENSTELLING overeenkomend met ; ; CITALOPRAM 20 mg/stuk
Teva Pharma B.V. Swensweg 5 2031 GA HAARLEM
N06AB04
CITALOPRAMHYDROBROMIDE SAMENSTELLING overeenkomend met ; ; CITALOPRAM 20 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE (E 464) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; POLYETHYLEENGLYCOL (E 1521) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Citalopram
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); HYPROMELLOSE (E 464); MAGNESIUMSTEARAAT (E 470b); MANNITOL (D-) (E 421); POLYETHYLEENGLYCOL (E 1521); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);
2002-04-02
Citalopram, NL/H/0460/002-003, 07.12.20 1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CITALOPRAM 20 CT, FILMOMHULDE TABLETTEN CITALOPRAM 40 CT, FILMOMHULDE TABLETTEN citalopram 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 _Citalopram_ is and what it is used for 2. What you need to know before you take _Citalopram_ 3. How to take _Citalopram_ 4. Possible side effects 5. How to store _Citalopram_ 6. Contents of the pack and other information 1. WHAT _CITALOPRAM_ IS AND WHAT IT IS USED FOR Citalopram belongs to a group of antidepressants called selective serotonin re-uptake inhibitors (SSRIs). Everyone has a substance called serotonin in the brain. Low levels of serotonin are thought to be a cause of depression. It is not fully understood how citalopram works, but it may help by increasing the amount of serotonin in the brain. _CITALOPRAM_ IS USED TO TREAT ● depression (major depressive episodes) 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE _CITALOPRAM_ DO NOT TAKE _CITALOPRAM_ ● if you are ALLERGIC to citalopram or any of the other ingredients of this medicine (listed in section 6). ● if you are taking or have recently taken medicines called MONOAMINE OXIDASE INHIBITORS (MAOIs; amongst others used to treat depression, e.g. moclobemide). You may have to wait for up to 14 days after quitting the use of a MAOI. The MAOI selegiline (used to treat Parkinson’s disease) may be used, but not in doses exceeding 10 mg per day. When changing from _Citalopram_ to MAOIs, you have to wait for at least s Lees het volledige document
Citalopram, NL/H/0460/002-003, 07.12.20 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Citalopram 20 ct, filmomhulde tabletten Citalopram 40 ct, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 20 MG Each film-coated tablet contains 20 mg citalopram (as hydrobromide). 40 MG Each film-coated tablet contains 40 mg citalopram (as hydrobromide). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet 20 MG Round, white tablets with a break-line and diameter of 8 mm. 40 MG Round, white tablets with a break-line and diameter of 10 mm. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of major depressive episodes. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Citalopram should be administered as a single oral dose, either in the morning or in the evening. The tablets can be taken with or without food, but with fluid. Following treatment initiation, an antidepressant effect should not be expected for at least two weeks. Treatment should continue until the patient has been free of symptoms for 4-6 months. Use in children and adolescents under 18 years of age Citalopram should not be used in the treatment of children and adolescents under the age of 18 years (see section 4.4). Adults Citalopram should be administered as a single oral dose of 20 mg daily. Dependent on individual patient response, the dose may be increased to a maximum of 40 mg daily. Citalopram, NL/H/0460/002-003, 07.12.20 2 Elderly patients (> 65 years of age) For elderly patients the dose should be decreased to half of the recommended dose, e.g. 10-20 mg daily. The recommended maximum dose for the elderly is 20 mg daily. Reduced renal function Dosage adjustment is not required if the patient has mild to moderate renal impairment. Caution is advised in patients with severe renal impairment (creatinine clearance less than 30 mL/min, see section 5.2). Reduced hepatic function An initial dose of 10 mg daily for the first two weeks of Lees het volledige document