Երկիր: Միացյալ Թագավորություն
Լեզու: անգլերեն
Աղբյուրը: myHealthbox
Duloxetine
Caduceus Pharma Ltd
N06AX21
Duloxetine
20mg
Gastro-resistant capsule, hard
Oral use
Pack sizes: 28 and 56 capsules
POM - Prescription Only Medicine
Balkanpharma-Dupnitsa AD
Other antidepressants
It is indicated for women for the treatment of moderate to severe Stress Urinary Incontinence (SUI).
Authorised
2015-03-13
Duloxetine 20mg & 40mg Capsules PIL - UK item no: AAAH5163 print proof no: 1 origination date: 17.12.14 originated by: S.Anson revision date: revised by: dimensions: 145 x 400 pharmacode: colours/plates: approved for print/date Non Printing Colours 1. Black 2. 3. 4. 5. 6. 1. 2. 3. date sent: 17.12.14 supplier: Actavis Bulgaria Dupnitsa technically app. date: 17.12.14 min pt size: 8 TECHNICAL APPROVAL 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. • The full name of this medicine is Duloxetine 20mg and 40mg Gastro-resistant Capsules, hard but within the leaflet it will be referred to as Duloxetine capsules. WHAT IS IN THIS LEAFLET 1. What Duloxetine capsules are and what they are used for 2. What you need to know before you take Duloxetine capsules 3. How to take Duloxetine capsules 4. Possible side effects 5. How to store Duloxetine capsules 6. Contents of the pack and other information 1. WHAT DULOXETINE CAPSULES ARE AND WHAT THEY ARE USED FOR Duloxetine capsules contain the active substance duloxetine. Duloxetine capsules increases the levels of serotonin and noradrenaline in the nervous system. Duloxetine capsules is a medicine to be taken by mouth to treat Stress Urinary Incontinence (SUI) in women. Stress urinary incontinence is a medical condition in which patients have accidental loss or leakage of urine during physical exertion or activities such as laughing, coughing, sneezing, lifting or exerci Կարդացեք ամբողջական փաստաթուղթը
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Duloxetine 20mg Gastro-resistant Capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 20 mg of duloxetine (as hydrochloride). Excipient with known effect: Each capsule contains 67.1 mg sucrose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant capsule, hard. Opaque blue body imprinted with ‘DLX 20’ and an opaque blue cap, imprinted with ‘DLX 20’. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Duloxetine is indicated for women for the treatment of moderate to severe Stress Urinary Incontinence (SUI). Duloxetine is indicated in adults. For further information see section 5.1. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose of Duloxetine is 40 mg twice daily without regard to meals. After 2-4 weeks of treatment, patients should be re-assessed in order to evaluate the benefit and tolerability of the therapy. Some patients may benefit from starting treatment at a dose of 20 mg twice daily for two weeks before increasing to the recommended dose of 40 mg twice daily. Dose escalation may decrease, though not eliminate, the risk of nausea and dizziness. A 20mg capsule is also available. However, limited data are available to support the efficacy of Duloxetine 20 mg twice daily. The efficacy of Duloxetine has not been evaluated for longer than 3 months in placebo-controlled studies. The benefit of treatment should be re-assessed at regular intervals. Combining Duloxetine with a pelvic floor muscle training (PFMT) programme may be more effective than either treatment alone. It is recommended that consideration be given to concomitant PFMT. Special populations _Paediatric population _ The safet Կարդացեք ամբողջական փաստաթուղթը