País: Malta
Idioma: inglés
Fuente: Medicines Authority
SILODOSIN
Rontis Hellas Medical and Pharmaceutical Products S.A. 38, Sorou Str., Athens, Maroussi, 15125, Greece
G04CA04
SILODOSIN 4 mg
HARD CAPSULE
SILODOSIN 4 mg
POM
UROLOGICALS
Withdrawn
2019-02-19
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SILODOSIN RONTIS 4 MG HARD CAPSULES SILODOSIN RONTIS 8 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 Rontis is and what it is used for 2. What you need to know before you take Silodosin Rontis 3. How to take Silodosin Rontis 4. Possible side effects 5. How to store Silodosin Rontis 6. Contents of the pack and other information 1. WHAT SILODOSIN RONTIS IS AND WHAT IT IS USED FOR WHAT SILODOSIN RONTIS IS Silodosin Rontis belongs to a group of medicines called alpha 1A -adrenoreceptor blockers. Silodosin Rontis 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 RONTIS IS USED FOR Silodosin Rontis 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 RONTIS DO NOT TAKE SILODOSIN RONTIS 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 Rontis • If you are undergoing eye surgery because of cloudiness of the lens ( Leer el documento completo
Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Silodosin Rontis 4 mg hard capsules Silodosin Rontis 8 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Silodosin Rontis 4 mg hard capsules Each hard capsule contains 4 mg silodosin. Silodosin Rontis 8 mg hard capsules Each hard capsule contains 8 mg silodosin. Excipients with known effect: Each 4 mg hard capsule contains 0.12 mg sodium. Each 8 mg hard capsule contains 0.24 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. Silodosin Rontis 4 mg hard capsules Yellow, opaque, hard gelatin capsule, size 3, printed with black ink “4” on the cap. Silodosin Rontis 8 mg hard capsules White, opaque, hard gelatin capsule, size 0, printed with black ink “8” on the cap. 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 Rontis 8 mg daily. For special patient populations, one capsule of Silodosin Rontis 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). Page 2 of 9 _Hepatic impairment_ No dose adjustment is required for patients with mild to moderate hepatic impairment. As no data are available, therefore, the use in patients with severe hepatic impairment is not recommended (see sections 4.4 and 5.2). _Paediatric population_ There is no relevant use of Silodosin Leer el documento completo