国家: 英国
语言: 英文
来源: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sertraline hydrochloride
Wockhardt UK Ltd
N06AB06
Sertraline hydrochloride
100mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030300; GTIN: 5012727904955
Depression is a clinical illness with symptoms like feeling sad, unable to sleep properly or to enjoy life as you used to. • Social anxiety disorder (in adults). Medicines are not always suitable for everyone. Tell your doctor before you take Sertraline, if you suffer from or have suffered in the past from any of the following conditions: • If you have or have previously had thoughts of harming or killing yourself (see below-Thoughts of suicide and worsening of your depression or anxiety disorder). Medicines like Sertraline (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment. • Obsessive compulsive disorder (OCD) (in adults and children and adolescents aged 6-17 years old). • If you have suffered from bleeding disorders or have been taking medicines which thin the blood (e.g. acetylsalicyclic acid (aspirin) or warfarin) or may increase the risk of bleeding. • If you are having electro-convulsive therapy (ECT). • If you have epilepsy (fit) or a history of seizures. If you have a fit (seizure), contact your doctor immediately. Sertraline contains the active substance sertraline. • Depression and prevention of recurrence of depression (in adults). PTSD is a condition that can occur after a very emotionally traumatic experience, and has some symptoms that are similar to depression and anxiety. Social anxiety disorder (social phobia) is an illness linked to anxiety. It is characterised by feelings of intense anxiety or distress in social situations (for example: talking to strangers, speaking in front of groups of people, eating or drinking in front of others or worrying that you might behave in an embarrassing manner). SERTRALINE CAN BE USED TO TREAT: OCD and Panic disorders are illnesses linked to anxiety with symptoms like being constantly troubled by persistent ideas (obsessions) that make you carry out repetitive rituals (compulsions). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SERTRALINE • Panic diso 阅读完整的文件
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sertraline 100mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 100 mg of sertraline (as hydrochloride). Excipient(s) with known effect: Each film-coated tablet contains 87.42 mg lactose (as monohydrate) and 1.34 mg (0.058 mmol) sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White to off-white, capsule shaped tablet scored on one side. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sertraline is indicated for the treatment of: Major depressive episodes. Prevention of recurrence of major depressive episodes. Panic disorder, with or without agoraphobia. Obsessive compulsive disorder (OCD) in adults and paediatric patients aged 6-17 years. Social anxiety disorder. Post traumatic stress disorder (PTSD) 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Initial treatment _ _Depression and OCD _ Sertraline treatment should be started at a dose of 50 mg/day. _Panic Disorder, PTSD, and Social Anxiety Disorder _ Therapy should be initiated at 25 mg/day. After one week, the dose should be increased to 50 mg once daily. This dose regimen has been shown to reduce the frequency of early treatment emergent adverse reactions characteristic of panic disorder. _Titration _ _Depression, OCD, Panic Disorder, Social Anxiety Disorder and PTSD _ Patients not responding to a 50 mg dose may benefit from dose increases. Dose changes should be made in steps of 50 mg at intervals of at least one week, up to a maximum of 200 mg/day. Changes in dose should not be made more frequently than once per week given the 24-hour elimination half life of sertraline. The onset of therapeutic effect may be seen within 7 days. However, longer periods are usually necessary to demonstrate therapeutic response, especially in OCD. _Maintenance _ Dose during long-term therapy should be kept at the lowest effective level, with subsequent adjustment depending 阅读完整的文件