国: 欧州連合
言語: 英語
ソース: EMA (European Medicines Agency)
silodosin
Recordati Ireland Ltd
G04CA04
silodosin
Urologicals
Prostatic Hyperplasia
Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH)
Revision: 16
Authorised
2010-01-29
27 B. PACKAGE LEAFLET 28 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SILODYX 8 MG HARD CAPSULES SILODYX 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 Silodyx is and what it is used for 2. What you need to know before you take Silodyx 3. How to take Silodyx 4. Possible side effects 5. How to store Silodyx 6. Contents of the pack and other information 1. WHAT SILODYX IS AND WHAT IT IS USED FOR WHAT SILODYX IS Silodyx belongs to a group of medicines called alpha 1A -adrenoreceptor blockers. Silodyx 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 SILODYX IS USED FOR Silodyx 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 SILODYX DO NOT TAKE SILODYX 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 Silodyx • If you are undergoing eye surgery because of cloudiness of the lens ( CATARACT SURGERY ), it is important that you immediately inform your eye specialist that you are using or have 完全なドキュメントを読む
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Silodyx 4 mg hard capsules Silodyx 8 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Silodyx 4 mg hard capsules Each hard capsule contains 4 mg silodosin. Silodyx 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. _ _ Silodyx 4 mg hard capsules Yellow, opaque, hard gelatin capsule, size 3 (approximately 15.9 x 5.8 mm). Silodyx 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 Silodyx 8 mg daily. For special patient populations, one capsule of Silodyx 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 Silodyx in the paediatric population for the indication of benign prostatic hyperplasia (BPH). Method of administration Oral use. The capsule should be taken with food, preferably at the same time every day. The capsule should not be bro 完全なドキュメントを読む