Ülke: Hollanda
Dil: Hollandaca
Kaynak: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
TADALAFIL 10 mg/stuk
TADALAFIL 10 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT ; POLYSORBAAT 80 (E 433) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POLYSORBAAT 80 (E 433) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)
Oraal gebruik
2022-12-28
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. Always take this medicine exactly as described in this leaflet or as your pharmacist or doctor has told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects talk to your pharmacist or doctor. This includes any possible side effects not listed in this leaflet. See section 4. - If you have takenas directed (see section 3) and were not able to get or keep an erection hard enough for satisfactory sex, you should talk to your pharmacist or doctor. WHAT IS IN THIS LEAFLET 1. What Belgenin tamamını okuyunis 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 is a treatment for adult men who have erection problems (erectile dysfunction). This is when a man cannot get or keep an erection hard enough for satisfactory sexual activity. contain the active substance tadalafil. It belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by relaxing the blood vessels in your penis, allowing blood flow into your penis. It is important to know that you will not get an erection just by taking . This medicine works with your body’s natural function to get an erection only when you are sexually stimulated. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DO NOT TAKE IF YOU: • do not have an erection problem, as this medicine will not provide any benefit to you • are allergic to tadalafil or any of the other ingredients in this medicine (listed in section 6) • take any MEDICINES CALLED NITRATES OR NITRIC
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Tadalafil STADA 10 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION10 mg: Each film-coated tablet contains 10 mg tadalafil. Excipient with known effect Each 10 mg tablet contains 116.3 mg of lactose (as lactose monohydrate) and 1.1 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Yellow, round, biconvex, film-coated tablet with score line on one side, white at the cross section with 8.1 ± 0.2 mm diameter. The tablet can be divided into equal doses. 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. Belgenin tamamını okuyunis 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 renal i