Quốc gia: Malta
Ngôn ngữ: Tiếng Anh
Nguồn: Medicines Authority
DULOXETINE HYDROCHLORIDE
Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus
N06AX21
DULOXETINE HYDROCHLORIDE 40 mg
GASTRO-RESISTANT HARD CAPSULE
DULOXETINE HYDROCHLORIDE 40 mg
POM
PSYCHOANALEPTICS
Authorised
2016-03-15
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ONELAR 40 MG HARD GASTRO-RESISTANT 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 of the 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 Onelar is and what it is used for 2. What you need to know before you take Onelar 3. How to take Onelar 4. Possible side effects 5. How to store Onelar 6. Contents of the pack and other information 1. WHAT ONELAR IS AND WHAT IT IS USED FOR Onelar contains the active substance duloxetine. Onelar increases the levels of serotonin and noradrenaline in the nervous system. Onelar 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. Onelar 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 Onelar is reinforced when combined with a training program called Pelvic Floor Muscle Training (PFMT). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ONELAR DO NOT TAKE ONELAR 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 Onelar’) - are taking fluvoxamine whi Đọc toàn bộ tài liệu
spcdulocaps40mg1.6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Onelar 40 mg hard gastro-resistant capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 40 mg of duloxetine (as hydrochloride). Excipients with known effect: each capsule contains 102 mg of sucrose and 0.0277 mg carmoisine For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard gastro-resistant capsule. Hard gelatine capsules, size “2”, about 18.0mm in length, with blue body and dark blue cap containing off white pellets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Onelar is indicated for women for the treatment of moderate to severe Stress Urinary Incontinence (SUI). Onelar is indicated in adults. For further information see section 5.1. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose of Onelar 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 Onelar 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. spcdulocaps40mg1.6 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. _ _ _Special populations_ _Hepatic impairment_ Onelar must not be used in women with liver disease resulting in hepatic impairment (see sections 4.3 and 5.2). _ _ _Renal impairment_ No dosage adjustment is necessary for patients with mild or modera Đọc toàn bộ tài liệu