Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
Citalopram
Teva Pharma B.V.
N06AB; N06AB04
Citalopram
20 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Selective serotonin reuptake inhibitors; citalopram
Marketed
2007-01-19
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CITALOPRAM TEVA 10 MG FILM-COATED TABLETS CITALOPRAM TEVA 20 MG FILM-COATED TABLETS CITALOPRAM TEVA 40 MG FILM-COATED TABLETS 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 TEVA FILM-COATED TABLETS IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CITALOPRAM TEVA FILM-COATED TABLETS 3. HOW TO TAKE CITALOPRAM TEVA FILM-COATED TABLETS 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE CITALOPRAM TEVA FILM-COATED TABLETS 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT CITALOPRAM TEVA FILM-COATED TABLETS IS AND WHAT IT IS USED FOR Citalopram Teva film-coated tablets belongs to a group of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). Citalopram Teva film-coated tablets is used for the treatment of depression (major depressive episodes). 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE CITALOPRAM TEVA FILM-COATED TABLETS DO NOT TAKE CITALOPRAM TEVA FILM-COATED TABLETS 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 taken in the last 2 weeks an antidepressant medicine of the type called monoamine oxidase inhibitors (MAOIs) e.g. selegiline or moclobemide. If you are treated with linezolid (an antibiotic medicine) unless you are under close observation and monitoring of blood pressure. If you are born with or have had an episode of abnormal heart rhythm (seen at ECG; an examination to evalua Διαβάστε το πλήρες έγγραφο
Health Products Regulatory Authority 06 August 2021 CRN00C7VY Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Citalopram Teva 20 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coatedtablet contains 20 mg citalopram (as hydrobromide). Excipients with known effect Each tablet contains 26,667 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Oval, white tablets with a break-line on one side and diameter of 8 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 Posology 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. Citalopram should be withdrawn slowly, it is advised that the dose is gradually reduced over 1-2 week periods. _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. _Paediatric population_ Citalopram should not be used in the treatment of children and adolescents under the age of 18 years (see section 4.4). _Elderly (>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. _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 30ml/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 mild or moderate hepatic impairment. Depending on individual patient response, the dose may be increased to a maximum of 20 mg daily. Caution and extra careful Διαβάστε το πλήρες έγγραφο