Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Trazodone hydrochloride
Sanofi-Aventis Ireland Limited T/A SANOFI
N06AX; N06AX05
Trazodone hydrochloride
50 milligram(s)
Capsule, hard
Product subject to prescription which may be renewed (B)
Other antidepressants; trazodone
Marketed
1977-02-02
PACKAGE LEAFLET: INFORMATION FOR THE USER MOLIPAXIN 50MG AND 100MG CAPSULES Trazodone hydrochloride IS THIS LEAFLET HARD TO SEE OR READ? PHONE 01 4035600 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 Capsules are and what they are used for 2. What you need to know before you take Molipaxin Capsules 3. How to take Molipaxin Capsules 4. Possible side effects 5. How to store Molipaxin Capsules 6. Contents of the pack and other information 1. WHAT MOLIPAXIN CAPSULES ARE AND WHAT THEY ARE USED FOR The name of your medicine is Molipaxin 50mg or 100mg Capsules (called Molipaxin Capsules in this leaflet). Molipaxin Capsules contain a medicine called trazodone hydrochloride. This belongs to a group of medicines called antidepressants. Molipaxin Capsules can be used to treat anxiety and depression. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MOLIPAXIN CAPSULES 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 Capsules (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 Capsules. WARNINGS AND PRECAUTIONS TAKE SPECIAL CARE WITH MOLI Read the complete document
Health Products Regulatory Authority 31 March 2022 CRN00CTT6 Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Molipaxin 50mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 50mg trazodone hydrochloride. Excipients with known effect: Each capsule contains 79.5 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard. Size No. 3 opaque violet/green hard gelatin capsules having the code ‘R365B’ imprinted on one piece, the Roussel logo on the other piece and containing a white powder. 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 According to severity, treatment should be initiated at 75 to 150 mg per day as a single evening dose and then increased to 200 or 300 mg per day, respectively, at the end of the first week. In hospitalised patients with exceptionally severe depression, dosage may further be increased to a maximum of 600 mg per day in divided doses. 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 s Read the complete document