Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Dosulepin hydrochloride
Azure Pharmaceuticals Ltd
N06AA16
Dosulepin hydrochloride
Capsule, hard
dosulepin
Not marketed
2022-08-05
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DOSULEPIN HYDROCHLORIDE 25 MG HARD CAPSULES 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 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 sign 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 Dosulepin is and what it is used for 2. What you need to know before you take Dosulepin 3. How to take Dosulepin 4. Possible side effects 5. How to store Dosulepin 6. Contents of the pack and other information 1. WHAT DOSULEPIN IS AND WHAT IT IS USED FOR The name of your medicine is Dosulepin Hydrochloride 25 mg Hard Capsules (called Dosulepin in this leaflet). The active ingredient in Dosulepin is dosulepin hydrochloride. Dosulepin belongs to a group of medicines called antidepressants. Dosulepin 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 DOSULEPIN DO NOT TAKE DOSULEPIN: If you are allergic to dosulepin hydrochloride or any of the other ingredients of this medicine (listed in section 6). If you have the eye condition known as glaucoma. If you are pregnant or planning to become pregnant, or are breast feeding. If you have an irregular heartbeat, recent heart attack or any other heart problem. If you have severe liver problems. If you suffer from periods of exaggerated behaviour (mania). If you are a child or adolescent under the age of 18 years. If you are taking any of the following medicines: A mono-amine oxidase inhibitor (MAOI), used to treat depression. You shou Read the complete document
Health Products Regulatory Authority 05 August 2022 CRN00C0KV Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dosulepin Hydrochloride 25 mg Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 25 mg of dosulepin hydrochloride. Excipient(s) with known effect Lactose monohydrate 109.40 mg per capsule. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard. Hard gelatin capsule size "4" with brown opaque body and reddish-brown opaque cap containing white to off white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dosulepin is indicated for the management of depression and associated anxiety. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _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. _Children:_Not recommended. Method of administration For oral administration. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Dosulepin is contraindicated following recent myocardial infarction, and in patients with any degree of heart block or other cardiac arrhythmias. It is also contraindicated 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 ther Read the complete document