Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Duloxetine
KRKA, d.d., Novo mesto
N06AX; N06AX21
Duloxetine
20 milligram(s)
Gastro-resistant capsule, hard
Oral use
Packs containing 7, 10, 14, 28, 30, 56, 60, 90 and 100 capsules in blisters.
Product subject to prescription which may not be renewed (A)
KRKA, d.d, TAD Pharma GmbH
Antidepressants
Other antidepressants; duloxetine
It treats Stress Urinary Incontinence (SUI) in women
Marketed
2015-05-15
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LOXENTIA 20 MG HARD GASTRO-RESISTANT CAPSULES LOXENTIA 40 MG HARD GASTRO-RESISTANT CAPSULES 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 Loxentia is and what it is used for 2. What you need to know before you take Loxentia 3. How to take Loxentia 4. Possible side effects 5. How to store Loxentia 6. Contents of the pack and other information 1. WHAT LOXENTIA IS AND WHAT IT IS USED FOR Loxentia contains the active substance duloxetine. Loxentia increases the levels of serotonin and noradrenaline in the nervous system. Loxentia 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. Loxentia 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 Loxentia is reinforced when combined with a training program called Pelvic Floor Muscle Training (PFMT). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOXENTIA DO NOT TAKE LOXENTIA 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 medicine Läs hela dokumentet
Health Products Regulatory Authority 08 June 2022 CRN00CS12 Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Loxentia 20mg hard gastro-resistant capsule 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard gastro-resistant capsule contains 20 mg duloxetine (as duloxetine hydrochloride). Excipient with known effect: sucrose. Each 20 mg hard gastro-resistant capsule contains up to 29 mg sucrose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard gastro-resistant capsule White to almost white pellets in a hard gelatine capsule size 4 (average length: 14.4 mm). The capsule body and cap are light blue. The capsule body is imprinted with 20 in black 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Loxentia is indicated for women for the treatment of moderate to severe Stress Urinary Incontinence (SUI). Loxentia is indicated in adults. For further information see section 5.1. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose of Loxentia 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 Loxentia 20 mg twice daily. The efficacy of Loxentia 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 Loxentia 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 _ Loxentia must not be used in women with liver disease resulting in hepatic impairment (see s Läs hela dokumentet