Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
tadalafil
Eli Lilly Nederland B.V.
G04BE08
tadalafil
Urologicals
Erectile Dysfunction
Treatment of erectile dysfunction.In order for tadalafil to be effective, sexual stimulation is required.Cialis is not indicated for use by women.
Revision: 32
Authorised
2002-11-12
61 B. PACKAGE LEAFLET 62 PACKAGE LEAFLET: INFORMATION FOR THE USER CIALIS 2.5 MG FILM-COATED TABLETS 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 CIALIS is and what it is used for 2. What you need to know before you take CIALIS 3. How to take CIALIS 4. Possible side effects 5 How to store CIALIS 6. Contents of the pack and other information 1. WHAT CIALIS IS AND WHAT IT IS USED FOR CIALIS 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. CIALIS has been shown to significantly improve the ability of obtaining a hard erect penis suitable for sexual activity. CIALIS contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation CIALIS 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. CIALIS will not help you if you do not have erectile dysfunction. It is important to note that CIALIS 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 CIALIS DO NOT TAKE CIALIS IF YOU: - are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6). - are taking any form of organic nitrate or nitric oxide donors such as Læs hele dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT CIALIS 2.5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ Each tablet contains 2.5 mg tadalafil. Excipient with known effect _ _ Each coated tablet contains 87 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Light orange-yellow and almond shaped tablets, marked "C 2 ½" on one 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. CIALIS 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. 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 CIALIS (i.e., at least twice weekly) a once daily regimen with the lowest doses of CIALIS 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. 3 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 impairment. For patients with severe renal impairment 10 mg is the maximum recommended dose. Once-a-day dosing of tadalafil is not recommended in pati Læs hele dokumentet