Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
Duloxetine
Clonmel Healthcare Ltd
N06AX21
Duloxetine
40mg
Gastro-resistant capsule, hard
oral use
Packs of 28, 56 and 98 capsules.
Product subject to prescription which may not be renewed (A)
STADA Arzneimittel AG
Psychoanaleptics; Other antidepressants
Duloxetine Clonmel is indicated for women for the treatment of moderate to severe Stress Urinary Incontinence (SUI).
Authorised
2015-09-25
WHAT IS IN THIS LEAFLET 1. What Duloxetine Clonmel is and what it is used for 2. What you need to know before you take Duloxetine Clonmel 3. How to take Duloxetine Clonmel 4. Possible side effects 5. How to store Duloxetine Clonmel 6. Contents of the pack and other information 1. WHAT DULOXETINE CLONMEL IS AND WHAT IT IS USED FOR Duloxetine Clonmel contains the active substance duloxetine. Duloxetine Clonmel increases the levels of serotonin and nora- drenaline in the nervous system. Duloxetine Clonmel is a medicine to treat Stress Urinary Incon- tinence (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 Clonmel 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 Clonmel is reinforced when combined with a training program called Pelvic Floor Muscle Training (PFMT). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DULOXETINE CLONMEL DO NOT TAKE DULOXETINE CLONMEL 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 medi cines and Duloxetine Clonmel’) – are taking fluvoxamine which is usually used to treat depres- sion, ciprofloxacin or enoxacin which are used to treat some Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Duloxetine 40 mg Gastro-resistant capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 40 mg of duloxetine (as hydrochloride). Excipient with known effect: Each 40 mg capsule contains 128.33 mg sucrose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant capsule, hard. Opaque blue cap and opaque orange body size ‘2’ (17.80 ± 0.40 mm) hard gelatin capsule imprinted with ‘H’ on cap and ‘D3’ on body with black ink, filled with white to off white colored pellets. 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 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 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 Прочитайте повний документ