Страна: Великобритания
Език: английски
Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Paroxetine hydrochloride
Genus Pharmaceuticals Ltd
N06AB05
Paroxetine hydrochloride
20mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030300
approved for print/date PROOF ROUND Technical Approval DATE SENT: DATE RECEIVED: Item number: ORIGINATOR: ORIGINATION DATE: REVISION DATE: REVISED BY: DIMENSIONS: MIN BODY TEXT SIZE: SUPPLIER: NON PRINTING COLOURS COLOURS 1. 2. 3. 4. 5. 6. 1. 2. 3. EU-Artwork-Support@accord-healthcare.com G. Worth 12/12/2019 18/02/2019 G. Worth 190 x 380 8 pt Teva Zdravlje Serbia 13/12/2019 13/12/2019 PAROXETINE ALL STRENGTHS FILM-COATED TABLET PIL - UK Black Profile BBBA7129 4 * Please note that ONLY Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. GTIN 13 (Belgium, Slovenia & Slovakia): n/a Version 5 06.12.2019 German GTIN 14 (incorporating PZN): n/a PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PAROXETINE 20MG AND 30MG TABLETS 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. IMPORTANT THINGS YOU NEED TO KNOW ABOUT PAROXETINE IF YOU HAVE ANY CONCERNS ABOUT HOW YOU FEEL, OR ABOUT THIS MEDICATION, IT IS IMPORTANT THAT YOU TALK TO YOUR DOCTOR - EVEN IF YOU FEEL ANXIOUS OR WORRIED ABOUT DOING SO. YOU MAY FIND IT HELPFUL TO TELL A FRIEND OR RELATIVE THAT YOU ARE DEPRESSED OR SUFFERING FROM AN ANXIETY DISORDER, AND THAT YOU HAVE BEEN PRESCRIBED THIS MEDICATION; IT MIGHT BE USEFUL TO SHOW THEM THIS LEAFLET. • PAROXETINE MAY NOT START TO WORK IMMEDIATELY. SOME PEOPLE TAKING ANTIDEPRESSANTS MAY FEEL WORSE BEFORE FEELING BETTER. YOUR DOCTOR MAY ASK TO SEE YOU AGAIN A COUPLE OF WEEKS AFTER YOU START TREATMENT AND THEN REGULARLY U Прочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paroxetine 20 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg paroxetine (as paroxetine hydrochloride anhydrous). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Flat faced bevel edged off white round tablet, diameter 9.1mm, inscribed 20 on one side with a score line. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of: • Major Depressive Episode • Obsessive Compulsive Disorder • Panic Disorder with and without agoraphobia • Social Anxiety Disorders / Social phobia • Generalised Anxiety Disorder • Post – traumatic Stress Disorder 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology MAJOR DEPRESSIVE EPISODE The recommended dose is 20 mg daily. In general, improvement in patients starts after one week but may only become evident from the second week of therapy. As with all antidepressant medicinal products, dosage should be reviewed and adjusted if necessary within 3 to 4 weeks of initiation of therapy and thereafter as judged clinically appropriate. In some patients, with insufficient response to 20 mg, the dose may be increased gradually up to a maximum of 50 mg a day in 10 mg steps according to the patient’s response. Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free from symptoms. OBSESSIVE COMPULSIVE DISORDER The recommended dose is 40 mg daily. Patients should start on 20 mg/day and the dose may be increased gradually in 10 mg increments to the recommended dose. If after some weeks on the recommended dose insufficient response is seen some patients may benefit from having their dose increased gradually up to a maximum of 60 mg / day. Patients with OCD should be treated for a sufficient period to ensure that they are free from symptoms. This period may be several months or even longer (see section 5.1 Pharmacodynamic properties). PANIC DISORDER T Прочетете целия документ