Krajina: Spojené kráľovstvo
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Duloxetine hydrochloride
Milpharm Ltd
N06AX21
Duloxetine hydrochloride
40mg
Gastro-resistant capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 07040200
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 known as a monoamine oxidase inhibitor (MAOI) (see ‘Other medicines and Duloxetine’) - are taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacin which a Prečítajte si celý dokument
OBJECT 1 DULOXETINE MILPHARM 40MG GASTRO-RESISTANT CAPSULES Summary of Product Characteristics Updated 19-Sep-2016 | Aurobindo Pharma - Milpharm Ltd. 1. Name of the medicinal product Duloxetine Milpharm 40 mg gastro-resistant capsules, hard 2. Qualitative and quantitative composition Each hard capsule contains 40 mg of duloxetine (as hydrochloride). Excipient(s) with known effect: Each capsule contains 95.68 mg sucrose. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Gastro-resistant capsule, hard Blue opaque /orange opaque, size "2" hard gelatin capsules filled with white to off white pellets and imprinted with "DLX" on blue opaque cap and "40" on orange opaque body with black ink 4. Clinical particulars 4.1 Therapeutic indications Duloxetine Milpharm is indicated for women for the treatment of moderate to severe stress urinary incontinence (SUI). Duloxetine Milpharm is indicated in adults. For further information see section 5.1. 4.2 Posology and method of administration POSOLOGY The recommended dose of Duloxetine Milpharm is 40mg 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 20mg twice daily for two weeks before increasing to the recommended dose of 40mg 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 Milpharm 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. _Hepatic impairment_ Duloxetine Milpharm must not be used in w Prečítajte si celý dokument