País: Malta
Língua: inglês
Origem: Medicines Authority
TADALAFIL
Aristo Pharma GmbH Wallenroder Straße 8–10, 13435, Berlin, Germany
G04BE08
TADALAFIL 20 mg
FILM-COATED TABLET
TADALAFIL 20 mg
POM
UROLOGICALS
Withdrawn
2017-07-04
PACKAGE LEAFLET: INFORMATION FOR THE USER TADALAFIL ARISTO PHARMA 10 MG FILM-COATED TABLETS TADALAFIL ARISTO PHARMA 20 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 Aristo Pharma is and what it is used for 2. What you need to know before you take Tadalafil Aristo Pharma 3. How to take Tadalafil Aristo Pharma 4. Possible side effects 5 How to store Tadalafil Aristo Pharma 6. Contents of the pack and other information 1. WHAT TADALAFIL ARISTO PHARMA IS AND WHAT IT IS USED FOR Tadalafil Aristo Pharma 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 Aristo Pharma has been shown to significantly improve the ability of obtaining a hard erect penis suitable for sexual activity. Tadalafil Aristo Pharma contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation Tadalafil Aristo Pharma 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 Aristo Pharma will not help you if you do not have erectile dysfunction. It is important to note that Tadalafil Aristo Pharma 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 Leia o documento completo
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Tadalafil Aristo Pharma 10 mg film-coated tablets Tadalafil Aristo Pharma 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Tadalafil Aristo Pharma 10 mg film-coated tablets Each film-coated tablet contains 10 mg of tadalafil. Excipient with known effect: Each film-coated tablet contains 133 mg of lactose (as monohydrate). Tadalafil Aristo Pharma 20 mg film-coated tablets Each film-coated tablet contains 20 mg of tadalafil. Excipient with known effect: 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 Tadalafil Aristo Pharma 10 mg film-coated tablets 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. Tadalafil Aristo Pharma 20 mg film-coated tablets 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 Aristo Pharma is not indicated for use by women. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adult men_ 2 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 Aristo Pharma (i.e., at least twice weekly) a once daily regimen with the lowest doses of Tadalafil Aristo Pharma might be co Leia o documento completo