Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Dosulepin hydrochloride
Teofarma S.R.L.
N06AA; N06AA16
Dosulepin hydrochloride
75 milligram(s)
Coated tablet
Product subject to prescription which may not be renewed (A)
Non-selective monoamine reuptake inhibitors; dosulepin
Marketed
1977-01-12
PACKAGE LEAFLET: INFORMATION FOR THE USER PROTHIADEN 75 MG COATED T A BLET S DOSULEPIN HYDROCHLORIDE 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 questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. 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 Prothiaden Coated Tablets are and what they are used for 2. What you need to know before you take Prothiaden 3. How to take Prothiaden 4. Possible side effects 5. How to store Prothiaden 6. Contents of the pack and other information 1. WHAT PROTHIADEN IS AND WHAT IT IS USED FOR The name of your medicine is Prothiaden 75mg Coated Tablets (called Prothiaden in this leaflet). The active ingredient in Prothiaden is dosulepin hydrochloride. Prothiaden belongs to a group of medicines called tricyclic antidepressants. PROTHIADEN is used to treat depression and can also help reduce feelings of anxiety. Please ask your doctor or pharmacist if you need more information. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PROTHIADEN DO NOT TAKE PROTHIADEN COATED TABLETS IF - You are allergic to dosulepin, ponceau 4R (E124), sunset yellow (E110) or any of the other ingredients in this medicine (see Section 6). - You have the eye condition known as glaucoma - You are pregnant or planning to become pregnant, or are breast feeding. - You have an irregular heartbeat, recent heart attack or any other heart problem. - You have severe liver problems. - You suffer from periods of exaggerated behaviour (mania). - You are a child or adolescent under the age of 18 years. - You are taking any of the following medicines: - A mono-amine oxidase inhibitor (MAOI), used to treat depression. - You sh Прочитать полный документ
Health Products Regulatory Authority 27 March 2024 CRN00F5DX Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Prothiaden 75mg Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each coated tablet contains 75 mg dosulepin hydrochloride. Excipients with known effect: glucose 3.6 mg per coated tablet, sunset yellow (E110), ponceau 4R (E124), sucrose, sodium benzoate (E211) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Coated tablet. A red, biconvex, sugar-coated tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prothiaden is indicated for the management of depression and associated anxiety. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration Adults: The usual total daily dose is 75 mg to 150 mg in divided doses or as a single night-time dose. Treatment should be initiated at the lower dose. In certain circumstances, _e.g._ in hospital use, dosages up to 225 mg daily have been used. Suggested regimens: 25 or 50 mg three times daily or, alternatively, 75 or 150 mg as a single dose at night. Should the regimen of 150 mg as a single night-time dose be adopted, it is better to give a smaller dose for the first few days. Elderly: 50 to 75 mg daily initially. As with any antidepressant, the initial dose should be increased with caution under close supervision. Half the normal adult dose may be sufficient to produce a satisfactory clinical response. Paediatric population: not recommended. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Prothiaden is contra-indicated following recent myocardial infarction, and in patients with any degree of heart block or other cardiac arrhythmias. It is also contra-indicated in mania, severe liver disease, narrow angle glaucoma or other causes of increased intraocular pressure. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE It may be two to four weeks from the start of treatment before there is an improvement in the patient's depression; the sub Прочитать полный документ