Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Trazodone hydrochloride
Neuraxpharm Ireland Limited
N06AX; N06AX05
Trazodone hydrochloride
Film-coated tablet
Other antidepressants; trazodone
Marketed
1985-12-02
PACKAGE LEAFLET: INFORMATION FOR THE USER MOLIPAXIN 150MG TABLETS Trazodone hydrochloride IS THIS LEAFLET HARD TO SEE OR READ? PHONE +353 1 428 7777 FOR HELP 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. IN THIS LEAFLET: 1. What Molipaxin Tablets are and what they are used for 2. What you need to know before you take Molipaxin Tablets 3. How to take Molipaxin Tablets 4. Possible side effects 5. How to store Molipaxin Tablets 6. Contents of the pack and other information 1. WHAT MOLIPAXIN TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Molipaxin 150mg Film-coated Tablets (called Molipaxin Tablets in this leaflet). Molipaxin Tablets contain a medicine called trazodone hydrochloride. This belongs to a group of medicines called antidepressants. Molipaxin Tablets can be used to treat anxiety and depression. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MOLIPAXIN TABLETS DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF: • You are allergic (hypersensitive) to trazodone hydrochloride or any of the other ingredients of Molipaxin Tablets (listed in section 6 Contents of the pack and other information). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. • You consume alcohol or are taking sleeping tablets. • You have recently had a heart attack. Do not take this medicine if this applies to you. If you are not sure, talk to your doctor or pharmacist before taking Molipaxin Tablets. WARNINGS AND PRECAUTIONS TAKE SPECIAL CARE WITH MOLIPAXIN TABLETS Read the complete document
Health Products Regulatory Authority 29 September 2023 CRN00D8TJ Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Molipaxin 150mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains trazodone hydrochloride 150.0 mg. Excipients with known effect: Each tablet contains 97.65 mg lactose monohydrate. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated Tablets. Salmon-pink bi-convex tablet, 11mm in diameter. One side has a breakline and the other is embossed ‘Molipaxin’ and ‘150’. The tablet can be divided into equal halves. 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 Posology Adults The usual initial daily dose is 75 to 150 mg as a single evening dose or in divided doses after food during the day, with subsequent slow increments to the level of optimal control which may be as high as 600 mg. Doses above 300 mg should only be administered to hospitalised patients. Elderly For very elderly, or frail patients, the recommended initial dose is reduced to 100 mg a day, administered in divided doses or as a single night time dose (see section 4.4). This may be incrementally increased, as described under Adults, under supervision, according to tolerance and efficacy. In general, single doses above 100 mg should be avoided in these patients. It is unlikely that a dose of 300 mg per day will be exceeded. Paediatric population The safety and efficacy of Molipaxin in children below the age of 18 years has not yet been established therefore Molipaxin is not recommended for use in this age group. Hepatic impairment Trazodone undergoes extensive hepatic metabolism (see section 5.2) and has also been associated with hepatotoxicity (see sections 4.4 and 4.8). Therefore caution should be exercised when prescribing for patients with hepatic impairment, particularly in cases of severe hepatic impairme Read the complete document