国家: 荷兰
语言: 荷兰文
来源: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
TADALAFIL
Apotex Europe BV Archimedesweg 2 2333 CN LEIDEN
G04BE08
TADALAFIL
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POLOXAMEER 407 ; TITAANDIOXIDE (E 171),
Oraal gebruik
Tadalafil
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); HYPROLOSE (E 463); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); LACTOSE 1-WATER; MACROGOL 8000; MAGNESIUMSTEARAAT (E 470b); NATRIUMLAURILSULFAAT (E 487); POLOXAMEER 407; TITAANDIOXIDE (E 171);
2018-01-03
TADALAFIL APOTEX 5 MG, FILMOMHULDE TABLETTEN – RVG 117848 MODULE 1.3 Product Information VERSION 2020-09-28 MODULE 1.3.3 Patient Information Leaflet REPLACES: 2018-10-18 1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Tadalafil Apotex 5 mg, filmomhulde tabletten (tadalafil) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Tadalafil Apotex is and what it is used for 2. What you need to know before you take Tadalafil Apotex 3. How to use Tadalafil Apotex 4. Possible side effects 5. How to store Tadalafil Apotex 6. Contents of the pack and other information 1. WHAT TADALAFIL APOTEX IS AND WHAT IT IS USED FOR Tadalafil Apotex contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Tadalafil Apotex 5 mg is used to treat 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. Following sexual stimulation Tadalafil Apotex 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. Tadalafil Apotex will not help you if you do not have erectile dysfunction. It is important to note that Tadalafil Apotex for the treatment of erectile dysfunction does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay 阅读完整的文件
TADALAFIL APOTEX 5 MG, FILMOMHULDE TABLETTEN – RVG 117848 MODULE 1.3 Product Information Version: 2020-09-28 MODULE 1.3.1 Summary of Product Characteristics Replaces: 2018-07-10 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Tadalafil Apotex 5 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg tadalafil. Excipient(s) with known effect: Each film-coated tablet contains 73.01 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Yellow, almond shaped, biconvex film coated tablets (9.59 mm x 5.85 mm). Engraved “APO” on one side, “T5” on the other side 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. Treatment of the signs and symptoms of benign prostatic hyperplasia in adult males. Tadalafil Apotex is not indicated for use by women. TADALAFIL APOTEX 5 MG, FILMOMHULDE TABLETTEN – RVG 117848 MODULE 1.3 Product Information Version: 2020-09-28 MODULE 1.3.1 Summary of Product Characteristics Replaces: 2018-07-10 2 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ _ _ _Erectile dysfunction in 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. Tadalafil 10 and 20 mg is intended for use prior to anticipated sexual activity and it is 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 approxim 阅读完整的文件