Χώρα: Ηνωμένο Βασίλειο
Γλώσσα: Αγγλικά
Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)
Duloxetine hydrochloride
Zentiva
N06AX21
Duloxetine hydrochloride
20mg
Gastro-resistant capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 07040200; GTIN: 5000283658115
PACKAGE LEAFLET: INFORMATION FOR THE USER DULOXETINE 20 MG GASTRO-RESISTANT HARD CAPSULES DULOXETINE 40 MG GASTRO-RESISTANT HARD CAPSULES Duloxetine (as hydrochloride) 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 pack and other information 1. WHAT DULOXETINE IS AND WHAT IT IS USED FOR Duloxetine 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 kno Διαβάστε το πλήρες έγγραφο
OBJECT 1 DULOXETINE ZENTIVA 20 MG GASTRO-RESISTANT HARD CAPSULES Summary of Product Characteristics Updated 11-May-2016 | Zentiva 1. Name of the medicinal product Duloxetine Zentiva 20 mg gastro-resistant hard capsules 2. Qualitative and quantitative composition Each capsule contains 20 mg of duloxetine (as hydrochloride). Excipient(s) with known effect: each capsule contains 28.17 31.05 mg sucrose. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Gastro-resistant hard capsule Hard opaque gelatin capsules of length approx. 14.3 mm with light-blue opaque body and light-blue opaque cap which contain off-white to light-brown-yellow spherical pellets. 4. Clinical particulars 4.1 Therapeutic indications Duloxetine Zentiva is indicated for women for the treatment of moderate to severe Stress Urinary Incontinence (SUI). Duloxetine Zentiva is indicated in adults. For further information see section 5.1. 4.2 Posology and method of administration Posology The recommended dose of Duloxetine Zentiva 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 Zentiva 20 mg twice daily. The efficacy of Duloxetine Zentiva 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 Zentiva 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. _Hepatic impairment_ Duloxetine Zentiva must not be used in women with liver d Διαβάστε το πλήρες έγγραφο