Ülke: Avrupa Birliği
Dil: İngilizce
Kaynak: EMA (European Medicines Agency)
silodosin
Recordati Ireland Ltd
G04CA04
silodosin
Urologicals, Alpha-adrenoreceptor antagonists
Prostatic Hyperplasia
Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in adult men.
Revision: 2
Authorised
2019-01-07
24 B. PACKAGE LEAFLET 25 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SILODOSIN RECORDATI 8 MG HARD CAPSULES SILODOSIN RECORDATI 4 MG HARD CAPSULES silodosin 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 Silodosin Recordati is and what it is used for 2. What you need to know before you take Silodosin Recordati 3. How to take Silodosin Recordati 4. Possible side effects 5. How to store Silodosin Recordati 6. Contents of the pack and other information 1. WHAT SILODOSIN RECORDATI IS AND WHAT IT IS USED FOR WHAT SILODOSIN RECORDATI IS Silodosin Recordati belongs to a group of medicines called alpha 1A -adrenoreceptor blockers. Silodosin Recordati is selective for the receptors located in the prostate, bladder and urethra. By blocking these receptors, it causes smooth muscle in these tissues to relax. This makes it easier for you to pass water and relieves your symptoms. WHAT SILODOSIN RECORDATI IS USED FOR Silodosin Recordati is used in adult men to treat the urinary symptoms associated with benign enlargement of the prostate (prostatic hyperplasia), such as: • difficulty in starting to pass water, • a feeling of not completely emptying the bladder, • a more frequent need to pass water, even at night. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SILODOSIN RECORDATI DO NOT TAKE SILODOSIN RECORDATI if you are allergic to silodosin or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Silodosin Recordati • I Belgenin tamamını okuyun
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Silodosin Recordati 4 mg hard capsules Silodosin Recordati 8 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Silodosin Recordati 4 mg hard capsules Each hard capsule contains 4 mg silodosin. Silodosin Recordati 8 mg hard capsules Each hard capsule contains 8 mg silodosin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. _ _ Silodosin Recordati 4 mg hard capsules Yellow, opaque, hard gelatin capsule, size 3 (approximately 15.9 x 5.8 mm). Silodosin Recordati 8 mg hard capsules White, opaque, hard gelatin capsule, size 0 (approximately 21.7 x 7.6 mm). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in adult men. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is one capsule of Silodosin Recordati 8 mg daily. For special patient populations, one capsule of Silodosin Recordati 4 mg daily is recommended (see below). _Elderly _ No dose adjustment is required in the elderly (see section 5.2). _Renal impairment _ No dose adjustment is required for patients with mild renal impairment (CL CR ≥ 50 to ≤ 80 mL/min). A starting dose of 4 mg once daily is recommended in patients with moderate renal impairment (CL CR 30 to < 50 mL/min), which may be increased to 8 mg once daily after one week of treatment, depending on the individual patient’s response. The use in patients with severe renal impairment (CL CR < 30 mL/min) is not recommended (see sections 4.4 and 5.2). _ _ _Hepatic impairment _ No dose adjustment is required for patients with mild to moderate hepatic impairment. As no data are available, the use in patients with severe hepatic impairment is not recommended (see sections 4.4 and 5.2). 3 _Paediatric population _ There is no relevant use of Silodosin Recordati in the paediatric population for the indication of benign prostatic hyperplasia (BPH). Method of administration Oral use. The Belgenin tamamını okuyun