Country: Netherlands
Language: Dutch
Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
DULOXETINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; DULOXETINE
Hetero Europe S.L. Viladecans Business Park, Edificio Brasil, Catalunya 83-85 08840 VILADECANS (SPANJE)
N06AX21
DULOXETINEHYDROCHLORIDE COMPOSITION corresponding to ; DULOXETINE
Maagsapresistente capsule, hard
AMMONIA (E 527) ; CARMELLOSE (E 466) ; CROSPOVIDON (E 1202) ; GELATINE (E 441) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ZWART (E 172) ; INDIGOKARMIJN (E 132) ; KALIUMHYDROXIDE (E 525) ; MACROGOL 400 ; MAÏSZETMEEL ; NATRIUMLAURILSULFAAT (E 487) ; POLYSORBAAT 80 (E 433) ; POVIDON K 30 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SACCHAROSE ; SCHELLAK (E 904) ; SUGAR SPHERES ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT,
Oraal gebruik
Duloxetine
Hulpstoffen: AMMONIA (E 527); CARMELLOSE (E 466); CROSPOVIDON (E 1202); GELATINE (E 441); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ZWART (E 172); INDIGOKARMIJN (E 132); KALIUMHYDROXIDE (E 525); MACROGOL 400; MAÏSZETMEEL; NATRIUMLAURILSULFAAT (E 487); POLYSORBAAT 80 (E 433); POVIDON K 30 (E 1201); PROPYLEENGLYCOL (E 1520); SACCHAROSE; SCHELLAK (E 904); SUGAR SPHERES; TALK (E 553 B); TITAANDIOXIDE (E 171); ZWARTE INKT;
2015-10-29
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER DULOXETINE HETERO 20 MG HARDE MAAGSAPRESISTENTE CAPSULES DULOXETINE HETERO 40 MG HARDE MAAGSAPRESISTENTE 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 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 Duloxetine Hetero is and what it is used for 2. What you need to know before you take Duloxetine Hetero 3. How to take Duloxetine Hetero 4. Possible side effects 5. How to store Duloxetine Hetero 6. Contents of the pack and other information 1. WHAT DULOXETINE HETERO IS AND WHAT IT IS USED FOR Duloxetine Hetero contains the active substance duloxetine. Duloxetine Hetero increases the levels of serotonin and noradrenaline in the nervous system. Duloxetine Hetero 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 Hetero 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 Hetero is reinforced when combined with a training program called Pelvic Floor Muscle Training (PFMT). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DULOXETINE HETERO DO NOT TAKE DULOXETINE HETERO 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 Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Duloxetine Hetero 20 mg harde maagsapresistente capsules Duloxetine Hetero 40 mg harde maagsapresistente capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 20 mg of duloxetine (as hydrochloride). Each capsule contains 40 mg of duloxetine (as hydrochloride). Excipient with known effect: Each 20 mg capsule contains 64.16 mg sucrose. Each 40 mg capsule contains 128.33 mg sucrose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant capsule, hard. 20 mg: Opaque green cap and opaque green body size ‘4’ (14.40 ± 0.40 mm) hard gelatin capsules, imprinted with ‘H’ on cap and ‘190’ on body, filled with white to off white colored pellets. 40 mg: Opaque blue cap and opaque orange body size ‘2’ (17.80 ± 0.40 mm) hard gelatin capsule imprinted with ‘H’ on cap and ‘D3’ on body with black ink, filled with white to off white colored pellets. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Duloxetine Hetero is indicated for women for the treatment of moderate to severe Stress Urinary Incontinence (SUI). Duloxetine Hetero is indicated in adults. For further information see section 5.1. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose of Duloxetine Hetero 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 Hetero 20 mg twice daily. The efficacy of Duloxetine Hetero has not been evaluated for longer than 3 months in placebo-controlled studies. The benefit of treatment should be re-asses Read the complete document