Country: Malta
Language: English
Source: Medicines Authority
TADALAFIL
Uropharm AG Erfurtstrasse 64, 53125, Bonn,, Germany
G04BE08
TADALAFIL 10 mg
FILM-COATED TABLET
TADALAFIL 10 mg
POM
UROLOGICALS
Withdrawn
2017-07-31
1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER TADALAFIL UROPHARM 10 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 TADALAFIL UROPHARM is and what it is used for 2. What you need to know before you take TADALAFIL UROPHARM 3. How to take TADALAFIL UROPHARM 4. Possible side effects 5 How to store TADALAFIL UROPHARM 6. Contents of the pack and other information 1. WHAT TADALAFIL UROPHARM IS AND WHAT IT IS USED FOR TADALAFIL UROPHARM 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 UROPHARM has been shown to significantly improve the ability of obtaining a hard erect penis suitable for sexual activity. TADALAFIL UROPHARM contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation TADALAFIL UROPHARM 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 UROPHARM will not help you if you do not have erectile dysfunction. It is important to note that TADALAFIL UROPHARM 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 TADALAFIL UROPHARM DO NOT TAKE TADALAFIL UROPHARM IF YOU: - are allergic to tadal Read the complete document
Page 1 of 12 1. NAME OF THE MEDICINAL PRODUCT TADALAFIL UROPHARM 10 MG FILM-COATED TABLETS TADALAFIL UROPHARM 20 MG FILM-COATED TABLETS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg of tadalafil. Each film-coated tablet contains 20 mg of tadalafil. Excipient with known effect: Each film-coated tablet contains 133 mg of lactose (as monohydrate). Each film-coated tablet contains 265 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Yellow coloured, oval shaped, one side scored and other side debossed with “T 10” biconvex film-coated tablet of 11.50 x 5.90 mm. The tablet can be divided into equal doses. Yellow coloured, oval shaped, one side scored and other side debossed with “T 20” biconvex film-coated tablet of 13.90 x 7.20 mm. 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. TADALAFIL UROPHARM 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 TADALAFIL UROPHARM (i.e., at least twice weekly) a once daily regimen with the lowest doses of TADALAFIL UROPHARM might be considered suitable, based on Page 2 of 12 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 d Read the complete document