Maa: Yhdistynyt kuningaskunta
Kieli: englanti
Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Trazodone hydrochloride
Focus Pharmaceuticals Ltd
N06AX05
Trazodone hydrochloride
10mg/1ml
Oral solution
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030100; GTIN: 5060064791417
PACKAGE LEAFLET: INFORMATION FOR THE USER TRAZODONE HYDROCHLORIDE 50MG/5ML ORAL SOLUTION Trazodone Hydrochloride SEVEN IMPORTANT THINGS YOU NEED TO KNOW ABOUT TRAZODONE ORAL SOLUTION. You should read all of this leaflet carefully before taking your medicine. It includes a lot of additional important information. • TRAZODONE ORAL SOLUTION TREATS DEPRESSION AND DEPRESSION ACCOMPANIED BY ANXIETY. Like all medicines it can cause side effects. Before you start taking your medicine it is important that you and your doctor discuss the benefits of treatment against the possible side effects (see section 4, Possible side effects). • TRAZODONE ORAL SOLUTION SHOULD NOT BE USED BY CHILDREN AND ADOLESCENTS UNDER 18 YEARS OLD (see section 3, How to take Trazodone Oral Solution). • SOME PEOPLE WHO ARE DEPRESSED OR ANXIOUS THINK OF HARMING OR KILLING THEMSELVES. If you start to feel worse, or think of harming or killing yourself, SEE YOUR DOCTOR OR GO TO A HOSPITAL STRAIGHT AWAY (see section 4, Possible side effects). • TRAZODONE ORAL SOLUTION MAY NOT WORK STRAIGHT AWAY. Some people taking antidepressants feel worse before feeling better. Your doctor should ask to see you again in a couple of weeks after you first start treatment. Tell your doctor if you haven’t started feeling better (see section 3, How to take Trazodone Oral Solution). • DON’T STOP TAKING TRAZODONE ORAL SOLUTION WITHOUT TALKING TO YOUR DOCTOR (see section 3, How to take Trazodone Oral Solution). • TAKING SOME OTHER MEDICINES WITH TRAZODONE ORAL SOLUTION CAN CAUSE PROBLEMS. You may need to talk to your doctor (see section 2, Before you take Trazodone Oral Solution). • If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. READ ALL OF THIS LEAFLET. It includes a lot of important information about this medicine. This medicine has been prescribed for you. Do not pass it onto others. It may harm them, even if their symptoms are the same as yours. Keep this leafle Lue koko asiakirja
OBJECT 1 TRAZODONE HYDROCHLORIDE 50MG/5ML ORAL SOLUTION Summary of Product Characteristics Updated 05-Sep-2017 | Concordia International- formerly Focus Pharmaceuticals Ltd 1. Name of the medicinal product Trazodone Hydrochloride 50mg/5ml Oral Solution 2. Qualitative and quantitative composition Each 5ml contains 50mg of Trazodone hydrochloride. Excipients: sorbitol 350mg/5ml and sodium 3mg/5ml. For a full list of excipients, see section 6.1. 3. Pharmaceutical form Oral Solution. Colourless to yellowish clear solution with an orange odour. 4. Clinical particulars 4.1 Therapeutic indications Relief of symptoms in all types of depression including depression accompanied by anxiety. Symptoms of depression likely to respond in the first week of treatment include depressed mood, insomnia, anxiety, somatic symptoms and hypochondriasis. 4.2 Posology and method of administration Route of administration: Oral. _ADULTS:_ Starting dose is 150mg/day in divided doses after food or as a single dose before retiring. This may be increased to 300mg/day, the major portion of which is preferably taken on retiring. In hospitalised patients dosage may be further increased to 600mg/day. _CHILDREN:_ There are insufficient data on safety to recommend the use of trazodone in children below the age of 18 years. _ELDERLY OR FRAIL:_ For very elderly or frail patients, the recommended initial starting dose is reduced to 100mg/day given in divided doses or as a single night-time dose. This may be incrementally increased, under supervision, according to efficacy and tolerance. In general, single doses above 100mg should be avoided in these patients. Doses above 300mg/day are unlikely to be required. 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. In conformity with current psychiatric opinion, it is suggested that trazodone be continued for several months after remission. Cessation of trazodone treatment should be gradual. _HEPA Lue koko asiakirja