Pays: Royaume-Uni
Langue: anglais
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Trazodone hydrochloride
Flamingo Pharma (UK) Ltd
N06AX05
Trazodone hydrochloride
150mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030100; GTIN: 5060464501128
FONTS SIZE : Generic Name font size : 12 pt. Composition fonts size : 8.5 pt. FONTS : Zurich CnBT 210 mm 340 mm 210 mm WHAT IS IN THIS LEAFLET 1. What Trazodone Hydrochloride Tablets are and what they are used for 2. What you need to know before you take Trazodone Hydrochloride Tablets 3. How to take Trazodone Hydrochloride Tablets 4. Possible side effects 5. How to store Trazodone Hydrochloride Tablets 6. Contents of the pack and other information 1. WHAT TRAZODONE HYDROCHLORIDE TABLETS ARE AND WHAT THEY ARE USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRAZODONE HYDROCHLORIDE TABLETS 3. HOW TO TAKE TRAZODONE HYDROCHLORIDE TABLETS 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE TRAZODONE HYDROCHLORIDE TABLETS 6. CONTENTS OF THE PACK AND OTHER INFORMATION POM MARKETING AUTHORIZATION HOLDER FLAMINGO PHARMA (UK) LTD. 1st Floor, Kirkland House, 11-15 Peterborough Road, Harrow, Middlesex, HA1 2AX, United Kingdom. MANUFACTURER FLAMINGO PHARMA (UK) LIMITED, The Bloc, 38 Springfield Way, Anlaby, Hull, HU10 6RJ, United Kingdom PACKAGE LEAFLET: INFORMATION FOR THE USER TRAZODONE HYDROCHLORIDE 150MG FILM-COATED TABLETS 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 symptoms 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. The name of your medicine is Trazodone Hydrochloride 150mg Film-coated Tablets (called Trazodone Hydrochloride Tablets in this leaflet). Trazodone Hydrochloride Tablets contain a medicine called trazodone hydrochloride. This belongs to a group of medicines called antidepressants. Trazodone Hydrochloride Tablets can be used to treat anxiety and depression. • You are allergic ( Lire le document complet
OBJECT 1 TRAZODONE 150 MG TABLETS Summary of Product Characteristics Updated 15-Jun-2020 | Flamingo Pharma (UK) Ltd • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product Trazodone Hydrochloride 150 mg Film-coated Tablets 2. Qualitative and quantitative composition Each film-coated tablet contains 150mg of Trazodone Hydrochloride. Excipient(s) with known effect: Each film-coated tablet contains 82.00 mg lactose monohydrate. For full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated Tablet Pink, approx 10 mm round, biconvex film coated tablet debossed with “T” on upper side of breakline and plain on other side. The tablet can be divided into equal doses. 4. Clinical particulars 4.1 Therapeutic indications Relief of symptoms in all types of depression including depression accompanied by anxiety. 4.2 Posology and method of administration Route of administration: Oral. DEPRESSION: a) Adults: Initially 150mg/day in divided doses after food or as a single do Lire le document complet