Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Citalopram
McDermott Laboratories Ltd., T/A Gerard Laboratories
N06AB; N06AB04
Citalopram
40 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Selective serotonin reuptake inhibitors; citalopram
Marketed
2004-07-30
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CIPRAGER 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 Ciprager is and what it is used for 2. What you need to know before you take Ciprager 3. How to take Ciprager 4. Possible side effects 5. How to store Ciprager 6. Contents of the pack and other information 1. WHAT CIPRAGER IS AND WHAT IT IS USED FOR Ciprager belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs), also known as antidepressants. These medicines act on the serotonin-system in the brain by increasing the levels of a substance called serotonin. Disturbances in the serotonin-system are considered an important factor in the development of depression and related diseases. Ciprager is used to treat: • depression (major depressive episodes) • panic disorder (panic attacks), including those caused by agoraphobia, which is a fear of leaving the house, entering shops or of public places _ _ 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CIPRAGER DO NOT TAKE CIPRAGER ▪ if you are allergic to citalopram or any of the other ingredients of this medicine (listed in section 6) ▪ if you are taking MAO (monoamine oxidase) inhibitors e.g.: - moclobemide (an antidepressant), - linezolid (an antibiotic medicine), unless you are under close observation with monitoring of blood pressure. - irreversible MAO-inhibitors (other antidepressants) within the last two weeks or if you have taken a reversible MAO-inhibitor (RIMA) within the t Prečítajte si celý dokument
Health Products Regulatory Authority 04 March 2024 CRN00F26X Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ciprager 40 mg Film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains citalopram hydrobromide equivalent to 40mg of citalopram. Excipient with known effect: 106.56 mg Lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet A white, oval, normal convex, film-coated tablets debossed “CM” scoreline “40” on one side and “G” on the other. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of major depressive episodes. Treatment of panic disorder with or without agoraphobia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Major depressive episodes_ 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. In general, improvement in patients starts after 2-4 weeks. As with all antidepressant medicinal products, dosage should be reviewed and adjusted, if necessary, within 3 to 4 weeks of initiation of therapy and thereafter as judged clinically appropriate. Although there may be an increased potential for undesirable effects at higher doses, if after some weeks on the recommended dose insufficient response is seen, some patients may benefit from having their dose increased up to a maximum of 40 mg a day (see section 5.1). Dosage adjustments should be made carefully on an individual patient basis, to maintain the patient at the lowest effective dose. 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 to give adequate protection against the possibility of a relapse. _Panic disorder_ Adults: A single oral dose of 10 mg is recommended for the first week before increasing the dose to Prečítajte si celý dokument