Land: Nederland
Taal: Nederlands
Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
CITALOPRAMHYDROBROMIDE SAMENSTELLING overeenkomend met ; ; CITALOPRAM 20 mg/stuk
Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)
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);
2002-03-12
PACKAGE LEAFLET: INFORMATION FOR THE USER CITALOPRAM STADA 10 MG 20 MG 40 MG, FILMOMHULDE TABLETTEN 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 STADA is and what it is used for 2. What you need to know before you take Citalopram STADA 3. How to take Citalopram STADA 4. Possible side effects 5. How to store Citalopram STADA 6. Contents of the pack and other information 1. WHAT CITALOPRAM STADA IS AND WHAT IT IS USED FOR Citalopram STADA is an antidepressant. It belongs to a group of medicines called selective serotonin re-uptake inhibitors (SSRIs). Citalopram STADA is used to: • treat episodes of major depression 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CITALOPRAM STADA DO NOT TAKE CITALOPRAM STADA • if you are allergic to citalopram or any of the other ingredients of this medicine (listed in section 6) • if you are taking a type of medicine known as a monoamine oxidase (MAO) inhibitor. These medicines are normally used for treatment of depression or Parkinson’s disease. The MAO- inhibitor selegiline may be taken at the same time as citalopram, provided the dose of selegiline is not more than 10 mg per day • if you have recently taken MAO-inhibitors. Depending on the type of MAO-inhibitor, you may have to wait for up to 14 days after stopping the MAO-inhibitor before starting to take Citalopram (see also “Other medicines and Citalopram STADA”). If you stop taking Citalopram and you want to start taking an MAO-inhibitor, you will have to wait for at least 7 day Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Citalopram STADA 10 mg filmomhulde tabletten Citalopram STADA 20 mg filmomhulde tabletten Citalopram STADA 40 mg filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Citalopram STADA 10 mg film-coated tablet Each film-coated tablet contains 12.495 mg citalopram hydrobromide, equivalent to 10 mg citalopram. Citalopram STADA 20 mg film-coated tablet Each film-coated tablet contains 24.99 mg citalopram hydrobromide, equivalent to 20 mg citalopram. Citalopram STADA 40 mg film-coated tablet Each film-coated tablet contains 49.98 mg citalopram hydrobromide, equivalent to 40 mg citalopram. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Film-coated tablet Citalopram STADA 10 mg film-coated tablet Round, white tablets with a diameter of 6 mm. Citalopram STADA 20 mg film-coated tablet Round, white tablets with a break-line and diameter of 8 mm. The tablets can be divided into equal doses. Citalopram STADA 40 mg film-coated tablet Round, white tablets with a break-line and diameter of 10 mm. The tablets 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 Posology _ _ _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. _SPECIAL POPULATIONS _ 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 per day. The recommended maximum dose for older people is 20 mg daily. Renal impairment 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). Hepatic impairment An initial dose of 10 mg daily for the first two weeks of treatment is recommended in patients with Lees het volledige document