Země: Velká Británie
Jazyk: angličtina
Zdroj: myHealthbox
Duloxetine (as duloxetine hydrochloride)
Consilient Health Ltd
N06AX21
Duloxetine (as duloxetine hydrochloride)
20 mg
Gastro-resistant capsule, hard
Oral use
7, 10, 14, 28, 30, 56, 60, 90 and 100 hard gastro-resistant capsules, in a box.
POM - Prescription Only Medicine
KRKA, d.d., TAD Pharma GmbH
Psychoanaleptics, other antidepressants
It is indicated for women for the treatment of moderate to severe Stress Urinary Incontinence (SUI).
Authorised
2015-05-20
1. WHAT DULOXETINE IS AND WHAT IT IS USED FOR This medicine contains the active substance duloxetine. Duloxetine increases the levels of serotonin and noradrenaline in the nervous system. Duloxetine 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 exercise. Duloxetine is believed to work by increasing the strength of the muscle that holds back urine when you laugh, sneeze, or perform physical activities. The efficacy of Duloxetine is reinforced when combined with a training program called Pelvic Floor Muscle Training (PFMT). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DULOXETINE Do not take Duloxetine if you: • are allergic to Duloxetine or any of the other ingredients of this medicine (listed in section 6). • have liver disease • have severe kidney disease • are taking or have taken within the last 14 days, another medicine known as a monoamine oxidase inhibitor (MAOI) (see “Other medicines and Duloxetine”) 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 Duloxetine is and what it is used for 2. What you need to know before you take Duloxetine 3. How to take Duloxetine 4. Possible side effects 5. How to store Duloxetine 6. Contents of the Přečtěte si celý dokument
Duloxetine 20 mg gastroresistant capsules Summary of Product Characteristics Updated 15Jun2015 | Consilient Health Ltd 1. Name of the medicinal product Duloxetine 20 mg gastroresistant capsules 2. Qualitative and quantitative composition Each hard gastroresistant capsule contains 20 mg duloxetine (as duloxetine hydrochloride). Excipient with known effect: sucrose. Each 20 mg capsule contains 26.73 mg – 28.93 mg sucrose. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Gastroresistant capsule, hard White to almost white pellets in a hard gelatine capsule size 4. The capsule body and cap are light blue. The capsule body is imprinted with 20 in black. 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 24 weeks of treatment, patients should be reassessed 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 20 mg 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 placebocontrolled studies. The benefit of treatment should be reassessed at regular intervals. Combining Duloxetine with a pelvic floor muscle training (P Přečtěte si celý dokument