Krajina: Holandsko
Jazyk: holandčina
Zdroj: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
SILDENAFILCITRAAT 70,2 mg/stuk SAMENSTELLING overeenkomend met ; SILDENAFIL 50 mg/stuk
Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)
G04BE03
SILDENAFILCITRAAT 70,2 mg/stuk SAMENSTELLING overeenkomend met ; SILDENAFIL 50 mg/stuk
Filmomhulde tablet
CARMELLOSE NATRIUM (E 466) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; GLUCOSE 1-WATER ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; KALIUMALUMINIUMSILICAAT (E 555) ; LACTOSE 1-WATER ; LECITHINE, SOYA (E 322) ; MALTODEXTRINE ; NATRIUMSTEARYLFUMARAAT ; POLYDEXTROSE (E 1200) ; PONCEAU 4R ALUMINIUMLAK (E 124) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; TRIGLYCERIDEN MIDDELLANGE KETEN, CARMELLOSE NATRIUM (E 466) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GLUCOSE 1-WATER ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; KALIUMALUMINIUMSILICAAT (E 555) ; LACTOSE 1-WATER ; LECITHINE, SOYA (E 322) ; MALTODEXTRINE ; NATRIUMSTEARYLFUMARAAT ; POLYDEXTROSE (E 1200) ; PONCEAU 4R ALUMINIUMLAK (E 124) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; TRIGLYCERIDEN MIDDELLANGE KETEN,
Oraal gebruik
Sildenafil
Hulpstoffen: CARMELLOSE NATRIUM (E 466); CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); GLUCOSE 1-WATER; HYPROLOSE (E 463); HYPROMELLOSE (E 464); INDIGOKARMIJN ALUMINIUMLAK (E 132); KALIUMALUMINIUMSILICAAT (E 555); LACTOSE 1-WATER; LECITHINE, SOYA (E 322); MALTODEXTRINE; NATRIUMSTEARYLFUMARAAT; POLYDEXTROSE (E 1200); PONCEAU 4R ALUMINIUMLAK (E 124); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171); TRIGLYCERIDEN MIDDELLANGE KETEN;
1900-01-01
PACKAGE LEAFLET: INFORMATION FOR THE USER SILDENAFIL STADA 25 MG FILMOMHULDE TABLETTEN SILDENAFIL STADA 50 MG FILMOMHULDE TABLETTEN SILDENAFIL STADA 100 MG FILMOMHULDE 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 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. Whatis and what it is used for 2. What you need to know before you take Prečítajte si celý dokument3. How to take 4. Possible side effects 5. How to store 6. Contents of the pack and other information 1. WHAT IS AND WHAT IT IS USED FOR 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. will only help you to get an erection if you are sexually stimulated. 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 DO NOT TAKE • If you are allergic to sildenafil, peanut or soya, 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 dangerous fall in your blood pressure. Tell your doctor if you are taking any of these medicines which are often given for relief of angina pectoris (o
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Sildenafil STADA 25 mg, filmomhulde tabletten Sildenafil STADA 50 mg, filmomhulde tabletten Sildenafil STADA 100 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 25 mg film-coated tablet contains 25 mg of sildenafil (as citrate). Each 50 mg film-coated tablet contains 50 mg of sildenafil (as citrate). Each 100 mg film-coated tablet contains 100 mg of sildenafil (as citrate). Excipients with known effect Each 25 mg film-coated tablet contains 72.888 mg lactose monohydrate, 0.207 mg glucose, 0.0039 mg Ponceau 4R aluminium lake and 0.1125 mg soya lecithin. Each 50 mg film-coated tablet contains 145.775 mg lactose monohydrate, 0.415 mg glucose, 0.0078 mg Ponceau 4R aluminium lake and 0.2250 mg soya lecithin. Each 100 mg film-coated tablet contains 291.550 mg lactose monohydrate, 0.829 mg glucose, 0.0156 mg Ponceau 4R aluminium lake and 0.450 mg soya lecithin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet.25 mg film-coated tablets are light blue pearlescent film-coated tablets, round and biconvex in shape with approx. diameter of 8 mm. Prečítajte si celý dokument50 mg film-coated tablets are light blue pearlescent film-coated tablets, round and biconvex in shape with approx. diameter of 10 mm. 100 mg film-coated tablets are light blue pearlescent film-coated tablets, round and biconvex in shape with approx. diameter of 12 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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 to be effective, sexual stimulation is required. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ _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 decr