Država: Nizozemska
Jezik: nizozemščina
Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
SILDENAFILCITRAAT 140,5 mg/stuk SAMENSTELLING overeenkomend met ; SILDENAFIL 100 mg/stuk
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
G04BE03
SILDENAFILCITRAAT 140,5 mg/stuk SAMENSTELLING overeenkomend met ; SILDENAFIL 100 mg/stuk
Tablet
CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; COPOVIDON (E 1208) ; CROSCARMELLOSE NATRIUM (E 468) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; MAGNESIUMSTEARAAT (E 470b) ; SACCHAROIDE NATRIUM X-WATER (E 954), CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOVIDON ; CROSCARMELLOSE NATRIUM (E 468) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; MAGNESIUMSTEARAAT (E 470b) ; SACCHAROIDE NATRIUM X-WATER (E 954), CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOVIDON ; CROSCARMELLOSE NATRIUM (E 468) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; MAGNESIUMSTEARAAT (E 470b) ; SACCHAROIDE NATRIUM X-WATER (E 954)
Oraal gebruik
Sildenafil
1900-01-01
Sandoz B.V. Sildenafil Sandoz 100 mg, tabletten Page 1/8 RVG 121771 1311-V6 1.3.1.1 Samenvatting van de Productkenmerken Mei 2023 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SILDENAFIL SANDOZ 100 MG, TABLETTEN sildenafil 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What [nationally completed name] is and what it is used for 2. What you need to know before you take [nationally completed name] 3. How to take [nationally completed name] 4. Possible side effects 5. How to store [nationally completed name] 6. Contents of the pack and other information 1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR [Nationally completed name] contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by helping to relax the blood vessels in your penis, allowing blood to flow into your penis when you get sexually excited. [Nationally completed name] will only help you to get an erection if you are sexually stimulated. [Nationally completed name] is a treatment for adult men with erectile dysfunction, sometimes known as impotence. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME] DO NOT TAKE [NATIONALLY COMPLETED NAME] _ _ - if you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6). - if you are taking medicines called nitrates, as the combination may lead to a Preberite celoten dokument
Sandoz B.V. Sildenafil Sandoz 100 mg, tabletten Page 1/14 RVG 121771 1311-V6 1.3.1.1 Samenvatting van de Productkenmerken Mei 2023 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Sildenafil Sandoz 100 mg, tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100 mg of sildenafil (as citrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Light blue round slightly dotted tablets, with cross breaking notch on both sides and “100” debossed on one side. Diameter: 12.5 mm The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sildenafil is indicated in adult men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for sildenafil to be effective, sexual stimulation is required. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Use in adults _ The recommended dose is 50 mg taken as needed approximately one hour before sexual activity. Based on efficacy and tolerability, the dose may be increased to 100 mg, or decreased to 25 mg. The maximum recommended dose is 100 mg. The maximum recommended dosing frequency is once per day. If sildenafil is taken with food, the onset of activity may be delayed compared to the fasted state (see section 5.2). Special populations _Elderly _ Dose adjustments are not required in elderly patients (≥ 65 years old). _Renal impairment _ The dosing recommendations described in “Use in adults” apply to patients with mild to moderate Sandoz B.V. Sildenafil Sandoz 100 mg, tabletten Page 2/14 RVG 121771 1311-V6 1.3.1.1 Samenvatting van de Productkenmerken Mei 2023 renal impairment (creatinine clearance = 30-80 mL/min). Since sildenafil clearance is reduced in patients with severe renal impairment (creatinine clearance < 30 mL/min) a 25 mg dose should be considered. Based on efficacy and tolerability, the dose may be inc Preberite celoten dokument