Country: Malta
Language: English
Source: Medicines Authority
DULOXETINE HYDROCHLORIDE
1 A Pharma GmbH Keltenring 1+3, 82041 Oberhaching, Germany
N06AX21
DULOXETINE HYDROCHLORIDE 20 mg
GASTRO-RESISTANT HARD CAPSULE
DULOXETINE HYDROCHLORIDE 20 mg
POM
PSYCHOANALEPTICS
Withdrawn
2018-02-06
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER [Duloxetin - 1 A Pharma 20 mg hard gastro-resistant capsules] [Duloxetin - 1 A Pharma 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. WHAT IS IN THIS LEAFLET : 1. What [Duloxetin - 1 A Pharma] is and what it is used for 2. What you need to know before you take [Duloxetin - 1 A Pharma] 3. How to take [Duloxetin - 1 A Pharma] 4. Possible side effects 5. How to store [Duloxetin - 1 A Pharma] 6. Contents of the pack and other information 1. WHAT [DULOXETIN - 1 A PHARMA] IS AND WHAT IT IS USED FOR [Duloxetin - 1 A Pharma] contains the active substance duloxetine. [Duloxetin - 1 A Pharma] increases the levels of serotonin and noradrenaline in the nervous system. [Duloxetin - 1 A Pharma] 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. [Duloxetin - 1 A Pharma] 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 [Duloxetin - 1 A Pharma] is reinforced when combined with a training program called Pelvic Floor Muscle Training (PFMT). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [DULOXETIN - 1 A PHARMA] Page 2 of 8 DO NOT TAKE [DULOXETIN - 1 A PHARMA] IF YOU: - are allergic to duloxe Read the complete document
Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT [Duloxetin - 1 A Pharma 20 mg hard gastro-resistant capsules] [Duloxetin - 1 A Pharma 40 mg hard gastro-resistant capsules] 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 20 mg of duloxetine (as hydrochloride). Excipient(s) with known effect: Each capsule contains 34.37 mg sucrose. For the full list of excipients, see section 6.1. Each capsule contains 40 mg of duloxetine (as hydrochloride). Excipient(s) with known effect: Each capsule contains 68.74mg sucrose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard gastro-resistant capsule. Opaque blue body, imprinted with ‘163’ and an opaque blue cap, imprinted with ‘A’. Size “4” hard gastro-resistant capsules filled with white to off white colored pellets Hard gastro-resistant capsule. Opaque orange body, imprinted with ‘162’ and an opaque blue cap, imprinted with ‘A’. Size “2” hard gastro-resistant capsules filled with white to off white colored pellets 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS [Duloxetin - 1 A Pharma ] is indicated for women for the treatment of moderate to severe Stress Urinary Incontinence (SUI). [Duloxetin - 1 A Pharma ] is indicated in adults. For further information see section 5.1. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose of [Duloxetin - 1 A Pharma ] 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 Page 2 of 17 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. [Duloxetin - 1 A Pharma 40 mg gastro-resistant capsule, hard] A 20 mg capsule is also available. However, limited data are available to support the efficacy of Duloxetin - 1 A Pharma Read the complete document