Land: Niederlande
Sprache: Niederländisch
Quelle: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
SILDENAFILCITRAAT 35,12 mg/stuk SAMENSTELLING overeenkomend met ; SILDENAFIL 25 mg/stuk
Aurobindo Pharma B.V. Baarnsche Dijk 1 3741 LN BAARN
G04BE03
SILDENAFILCITRAAT 35,12 mg/stuk SAMENSTELLING overeenkomend met ; SILDENAFIL 25 mg/stuk
Kauwtablet
ASPARTAAM (E 951) ; CROSCARMELLOSE NATRIUM (E 468) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; PEPERMUNTSMAAKSTOF ; POLACRILINE KALIUM ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551),
Oraal gebruik
Sildenafil
Hulpstoffen: ASPARTAAM (E 951); CROSCARMELLOSE NATRIUM (E 468); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); PEPERMUNTSMAAKSTOF; POLACRILINE KALIUM; POVIDON K 30 (E 1201); SILICIUMDIOXIDE (E 551);
1900-01-01
_Version 2303 _ PACKAGE LEAFLET _Version 2303 _ PACKAGE LEAFLET: INFORMATION FOR THE USER /../ 25 MG CHEWABLE TABLETS /../ 50 MG CHEWABLE TABLETS /../ 100 MG CHEWABLE TABLETS 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. What _/../_ is and what it is used for 2. What you need to know before you take _/../ _ 3. 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. Sildenafil 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 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 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 (or “chest pain”). If you are not certain, ask your doctor or pharmacist. - If you are using any of the medicin Lesen Sie das vollständige Dokument
_Version 2303 _ SUMMARY OF PRODUCT CHARACTERISTICS _Version 2303 _ 1. NAME OF THE MEDICINAL PRODUCT Rosytona 25 mg, kauwtabletten Rosytona 50 mg, kauwtabletten Rosytona 100 mg, kauwtabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains 25 mg sildenafil formed in situ from 35.12 mg sildenafil citrate. Excipients with known effect: 2.15 mg of aspartame (E951) 70.4575 mg of lactose monohydrate Each chewable tablet contains 50 mg sildenafil formed in situ from 70.24 mg sildenafil citrate. Excipients with known effect: 4.30 mg of aspartame (E951) 140.915 mg of lactose monohydrate Each chewable tablet contains 100 mg sildenafil formed in situ from 140.48 mg sildenafil citrate. Excipients with known effect: 8.60 mg of aspartame (E951) 281.83 mg of lactose monohydrate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Chewable tablet. 25 mg: White, triangular, with a side of 7.3 mm, biconvex, embossed with “25” on one side. 50 mg: White, triangular, with a side of 8.8 mm, biconvex, embossed with “50” on one side. 100 mg: White, triangular, with a side of 11.8 mm, biconvex, embossed with “100” on one side. 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 _ _ _Use in adults: _ The recommended dose is 50 mg taken as needed approximately one hour before sexual activity. The tablets should be chewed before swallowed. _Version 2303 _ 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 /../ is taken with food, the onset of activity may be delayed compared to the fasted state (see section 5.2). Special populations _Elderly patients: _ Lesen Sie das vollständige Dokument