Land: Nederländerna
Språk: nederländska
Källa: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
TADALAFIL 10 mg/stuk
Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)
G04BE08
TADALAFIL 10 mg/stuk
Filmomhulde tablet
CROSCARMELLOSE NATRIUM (E 468) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ZWART (E 172) ; LACTOSE 0-WATER ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT ; POLYSORBAAT 80 (E 433) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CROSCARMELLOSE NATRIUM (E 468) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ZWART (E 172) ; LACTOSE 0-WATER ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POLYSORBAAT 80 (E 433) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Tadalafil
Hulpstoffen: CROSCARMELLOSE NATRIUM (E 468); GLYCEROLTRIACETAAT (E 1518); HYPROLOSE (E 463); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ZWART (E 172); LACTOSE 0-WATER; LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); NATRIUMLAURILSULFAAT (E 487); POLYSORBAAT 80 (E 433); TALK (E 553 B); TITAANDIOXIDE (E 171);
1900-01-01
PACKAGE LEAFLET: INFORMATION FOR THE USER TADALAFIL STADA 10 MG, FILMOMHULDE TABLETTEN Tadalafil 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 [Product Νame] is and what it is used for 2. What you need to know before you take [Product Νame] 3. How to take [Product Νame] 4. Possible side effects 5. How to store [Product Νame] 6. Contents of the pack and other information 1. WHAT [PRODUCT ΝAME] IS AND WHAT IT IS USED FOR [Product Νame] is a treatment for adult men with erectile dysfunction. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. Tadalafil has been shown to significantly improve the ability of obtaining a hard erect penis suitable for sexual activity. [Product Νame] contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation [Product Νame] works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis. The result of this is improved erectile function. [Product Νame] will not help you if you do not have erectile dysfunction. It is important to note that [Product Νame] does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [PRODUCT ΝAME] DO NOT TAKE [PRODUCT NAME]: • if you are allergic to tadalafil or any of the other ingredients of this medicin Läs hela dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Tadalafil STADA 10 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION [Product Name] 10 mg: Each film-coated tablet contains 10 mg tadalafil. Excipient with known effect Each 10 mg tablet contains 157.65 mg of lactose (as lactose and lactose monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet [Product Name] 10 mg: yellow coloured, caplet shaped, biconvex, film coated tablet, debossed with “T 10” on one side and plain on the other, with nominal dimensions 11 mm x 5 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of erectile dysfunction in adult males. In order for tadalafil to be effective, sexual stimulation is required. [Product Name] is not indicated for use by women. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adult men _ In general, the recommended dose is 10 mg taken prior to anticipated sexual activity and with or without food. In those patients in whom tadalafil 10 mg does not produce an adequate effect, 20 mg might be tried. It may be taken at least 30 minutes prior to sexual activity. The maximum dose frequency is once per day. Doses of 10 and 20 mg are intended for use prior to anticipated sexual activity and are not recommended for continuous daily use. In patients who anticipate a frequent use of tadalafil (i.e., at least twice weekly) a once daily regimen with the lowest doses of tadalafil might be considered suitable, based on patient choice and the physician’s judgement. In these patients the recommended dose is 5 mg taken once a day at approximately the same time of day. The dose may be decreased to 2.5 mg once a day based on individual tolerability. The appropriateness of continued use of the daily regimen should be reassessed periodically. Special populations _Elderly men _ Dose adjustments are not required in elderly patients. _Men with renal impairment _ Dose adjustments are not required in patients with mild to moderate re Läs hela dokumentet