국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
TRAZADONE HYDROCHLORIDE
Azure Pharmaceuticals Ltd
N06AX05
TRAZADONE HYDROCHLORIDE
Capsule, hard
trazodone
Not marketed
2022-09-30
PACKAGE LEAFLET: INFORMATION FOR THE USER TRAZODONE HYDROCHLORIDE AZURE 50 MG HARD CAPSULES TRAZODONE HYDROCHLORIDE AZURE 100 MG HARD CAPSULES Trazodone 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 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 Trazodone Capsules are and what they are used for _2._ _ _ What you need to know before you take Trazodone Capsules _ _ _3._ _ _ How to take Trazodone Capsules _ _ 4. Possible side effects _5._ _ _ How to store Trazodone Capsules _ _ 6. Contents of the pack and other information 1. WHAT TRAZODONE CAPSULES ARE AND WHAT THEY ARE USED FOR The name of your medicine is Trazodone Hydrochloride Azure 50 mg or 100 mg Hard Capsules (referred to as Trazodone Capsules throughout this leaflet). It contains a medicine called Trazodone hydrochloride. Trazodone belongs to a group of medicines called antidepressants. Trazodone Capsules are indicated for anxiety, depression, mixed anxiety and depression. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRAZODONE CAPSULES DO NOT TAKE TRAZODONE CAPSULES IF: You are allergic (hypersensitive) to trazodone hydrochloride or any of the other ingredients of Trazodone Capsules (listed in Section 6). Signs of an allergic reaction can include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. You have recently had a heart attack. You are a heavy drinker or are taking sleeping tablets. You are under 18 years of age. Do not take this medicine if any of the above applies to you. If you are not sure, talk to you 전체 문서 읽기
Health Products Regulatory Authority 30 September 2022 CRN009KGJ Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Trazodone Hydrochloride Azure 50 mg Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 50 mg trazodone hydrochloride. Excipient(s) with known effect: Each capsule contains 73.75 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard capsule. Hard gelatin capsule of size '3' with blue/opaque cap marked 'THC' with black colour and green opaque body marked '50' with black colour containing white to off white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Anxiety, depression, mixed anxiety and depression. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Depression: _Adults:_ Initially 150 mg/day in divided doses after food or as a single dose on retiring. This may be increased up to 300 mg/day in a single or divided doses. The major portion of a divided dose to be taken on retiring. The dose may be further increased to 600 mg/day in divided doses in hospitalised patients. _Elderly:_ For very elderly or frail patients the recommended initial starting dose is reduced to 100 mg/day given in divided doses or as a single night-time dose (see section 4.4). This may be incrementally increased, under supervision, according to efficacy and tolerance. In general, single doses above 100 mg should be avoided in these patients. It is unlikely that 300 mg/day will be exceeded. _Children:_ There are insufficient data on safety to recommend the use of Trazodone in children below the age of 18 years. Depression accompanied by anxiety: As for depression. _ _ Anxiety: 75 mg/day increasing to 300 mg/day as necessary. A decrease in side-effects (increase of the resorption and decrease of the peak plasma concentration) can be reached by taking Trazodone hydrochloride after a meal. _Hepatic Impairment:_ Health Products Regulatory Authority 30 September 2022 CRN009KGJ Page 2 of 8 Trazodone hydrochloride underg 전체 문서 읽기