Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Citalopram hydrobromide
Bluefish Pharmaceuticals AB
N06AB; N06AB04
Citalopram hydrobromide
10 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Selective serotonin reuptake inhibitors; citalopram
Marketed
2010-04-09
PACKAGE LEAFLET: INFORMATION FOR THE USER CITALOPRAM BLUEFISH 10 MG FILM-COATED TABLETS CITALOPRAM BLUEFISH 20 MG FILM-COATED TABLETS CITALOPRAM BLUEFISH 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 Bluefish is and what it is used for 2. What you need to know before you take Citalopram Bluefish 3. How to take Citalopram Bluefish 4. Possible side effects. 5. How to store Citalopram Bluefish 6. Contents of the pack and other information 1. WHAT CITALOPRAM BLUEFISH 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 their brain. It is not fully understood how citalopram works, but it may help by acting on the serotonin system in the brain. Citalopram Bluefish is used in the treatment of depression.(major depressive episodes). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CITALOPRAM BLUEFISH DO NOT TAKE CITALOPRAM BLUEFISH: - 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). Before starting with Citalopram Bluefish, you must talk to your doctor, because 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 Olvassa el a teljes dokumentumot
Health Products Regulatory Authority 08 March 2024 CRN00F2F6 Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Citalopram Bluefish 10 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 12.49 mg citalopram hydrobromide, equivalent to 10 mg citalopram. Excipients with known effect: Lactose monohydrate Each tablet Citalopram Bluefish 10 mg contains 12.665 mg lactose (anhydrous). For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet Citalopram Bluefish 10 mg film-coated tablets are round, white tablets with a diameter of 6 mm 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. _Paediatric population_ Citalopram should not be used in the treatment of children and adolescents under the age of 18 years (see section 4.4). _Depression_ 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. _Elderly patients (>65 years):_ 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 since there are no clinical data in this population (creatinine clearance less than 30mL/min, see section 5.2). _Reduced hepatic function:_ 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 20 mg daily. Caution and extra careful Olvassa el a teljes dokumentumot