Country: United Kingdom
Bahasa: Inggeris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sertraline hydrochloride
Milpharm Ltd
N06AB06
Sertraline hydrochloride
50mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030300; GTIN: 8901175007455
PACKAGE LEAFLET: INFORMATION FOR THE USER SERTRALINE 50 MG FILM-COATED TABLETS SERTRALINE 100 MG FILM-COATED TABLETS (sertraline) 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. See section 4. WHAT IS IN THIS LEAFLET 1. What Sertraline is and what it is used for 2. What you need to know before you take Sertraline 3. How to take Sertraline 4. Possible side effects 5. How to store Sertraline 6. Contents of the pack and other information 1. WHAT SERTRALINE IS AND WHAT IT IS USED FOR Sertraline contains the active substance sertraline. Sertraline is one of a group of medicines called Selective Serotonin Re-uptake Inhibitors (SSRIs); these medicines are used to treat depression and or anxiety disorders. SERTRALINE CAN BE USED TO TREAT: • Depression and prevention of recurrence of depression (in adults). • Social anxiety disorder (in adults). • Post traumatic stress disorder (PTSD) (in adults). • Panic disorder (in adults). • Obsessive compulsive disorder (OCD) (in adults and children and adolescents aged 6-17 years old). Depression is a clinical illness with symptoms like feeling sad, unable to sleep properly or to enjoy life as you used to. 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). 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 t Baca dokumen lengkap
OBJECT 1 SERTRALINE 50MG TABLETS Summary of Product Characteristics Updated 12-Jul-2022 | Aurobindo Pharma - Milpharm Ltd. • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product Sertraline 50 mg film-coated tablets 2. Qualitative and quantitative composition Each film-coated tablet contains 50 mg sertraline (as sertraline hydrochloride). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet. White capsule shaped, film coated tablets debossed with 'A' on one side and score line in between '8' and '1' on the other 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 Posolog Baca dokumen lengkap