Land: Storbritannien
Sprog: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sertraline hydrochloride
Relonchem Ltd
N06AB06
Sertraline hydrochloride
50mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030300; GTIN: 05055144200798
ARTWORK LEGEND PRODUCT NAME PRODUCT LICENCE NO. COMPONENT DIMENSION STRENGTH PACK SIZE FONT & SIZE REMARKS REASON FOR CHANGE COUNTRY MANUFACTURER SOFTWARE ARTIST SERTRALINE FILM-COATED TABLETS PL 20395/0276 - 0277 Pil 335 x 480 mm 50 mg & 100 mg - Humanst521 BT (12 pt, 9 pt) - Comments received from Tracey Chadwick on 02.08.2021 UK (English) MARKSANS Adobe illustrator CC Gurukiran NO. OF COLORS 01 ██ Black ██ Dieline 3.3 VERSION XXXXX DATE 03.08.2021 297 mm 480 mm 38 mm 38 mm 297 mm 480 mm Pharma Code Pharma Code If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away. You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse or if they are worried about changes in your behaviour. CHILDREN AND ADOLESCENTS Sertraline should not usually be used in children and adolescents less than 18 years old, except for patients with Obsessive Compulsive Disorder (OCD). Patients under 18 years have an increased risk of undesirable effects, such as suicide attempt, thoughts of harming or killing themselves (suicidal thoughts) and hostility (mainly aggressiveness, oppositional behaviour and anger) when they are treated with this class of medicines. Nevertheless, it is possible that your doctor decides to prescribe Sertraline Tablets to a patient under 18 years if it is in the patient's interest. If your doctor has prescribed Sertraline Tablets to you and you are less than 18 years old and you want to discuss this, please contact him/her. Furthermore, if any of the symptoms listed above appear or worsen while you are taking Sertraline Tablets, you should inform your doctor. Also, the long-term safety of Sertraline Tablets in regard to growth, maturation and learning (cognitive) and behavioural development in this age group has not yet been demonstrated. OTHER MEDICINES AND SERTRALINE TABLE Læs hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sertraline 50 mg film-coated tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg of sertraline (as hydrochloride). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White, capsule shaped, biconvex, film-coated tablet debossed with SRN and 50 on either side of break line and plain on other 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 dosage regimen has been shown to reduce the frequency of early treatment emergent side effects 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 _ Dosage during long-term therapy should be kept at the lowest effective level, with subsequent adjustment depending on therapeutic response. _Depression _ Longer-term treatment may also be appropriate for preven Læs hele dokumentet