Maa: Alankomaat
Kieli: hollanti
Lähde: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
SILDENAFILCITRAAT 140,5 mg/stuk SAMENSTELLING overeenkomend met ; SILDENAFIL 100 mg/stuk
LABORMED-PHARMA S.A. 44B Theodor Pallady Blvd, 3rd District 032266 BUCHAREST (ROEMENIË)
G04BE03
SILDENAFILCITRAAT 140,5 mg/stuk SAMENSTELLING overeenkomend met ; SILDENAFIL 100 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
EN-NL PI_SILDENAFIL CITRATE_chewable tablet_NL/H/2413/001-002_2022.04 CMDh recommendation 21 C2-Internal PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Entranin 50 mg, kauwtabletten Entranin 100 mg, kauwtabletten 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 [Product name] is and what it is used for 2. What you need to know before you take [Product name] 3. How to take [Product name] 4. Possible side effects 5. How to store [Product name] 6. Contents of the pack and other information 1. WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR [Product 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. [Product name] will only help you to get an erection if you are sexually stimulated. [Product 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 [PRODUCT NAME] DO NOT TAKE [PRODUCT 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 dangerous fall in your blood pressure. Tell your doctor if you are taking any of these medicines which are often given for relief of Lue koko asiakirja
EN-NL PI_SILDENAFIL CITRATE_chewable tablet_NL/H/2413/001-002_2022.04 CMDh recommendation 2 C2-Internal 1. NAME OF THE MEDICINAL PRODUCT Entranin 50 mg kauwtabletten Entranin 100 mg kauwtabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains sildenafil citrate equivalent to 50 mg sildenafil. Excipients with known effect: Each tablet contains 4.30 mg of aspartame (E951) and 140.915 mg of lactose monohydrate. Each chewable tablet contains sildenafil citrate equivalent to 100 mg sildenafil. Excipients with known effect: Each tablet contains 8.60 mg of aspartame (E951) and 281.83 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Chewable tablet. White, triangular, biconvex tablets, embossed with “50” on one side, with a diameter of 8.8 x 8.6±0.2 mm. White, triangular, biconvex tablets, embossed with “100” on one side, with a diameter of 11.8 x 11.6±0.2 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS [Product name] 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 [Product name] 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 [Product name] is taken with food, the onset of activity may be delayed compared to the fasted state (see section 5.2). *The dose of 25 mg is not available with this product. For doses not achievable with [Product name] chewable tablets, other brands of sildenafil are available and can be used. EN-NL PI_SILDENAFIL CITRATE_chewable tablet_NL/H/2413/001-002_2022.04 CMDh recommendation 3 C2-Internal Special populations _Elderly Lue koko asiakirja