Country: Malta
Language: English
Source: Medicines Authority
TADALAFIL
Hennig Arzneimittel GmbH & Co KG Liebigstrasse 1-2, D-65439 Flörsheim am Main, Germany
G04BE08
TADALAFIL 5 mg
FILM-COATED TABLET
TADALAFIL 5 mg
POM
UROLOGICALS
Withdrawn
2017-06-15
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER TADALAFIL HENNIG 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 Tadalafil Hennig 5 mg film-coated tablets are and what they are used for 2. What you need to know before you take Tadalafil Hennig 5 mg film-coated tablets 3. How to take Tadalafil Hennig 5 mg film-coated tablets 4. Possible side effects 5 How to store Tadalafil Hennig 5 mg film-coated tablets 6. Contents of the pack and other information 1. WHAT TADALAFIL HENNIG 5 MG FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR Tadalafil Hennig 5 mg contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Tadalafil Hennig 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 Hennig 5 mg has been shown to significantly improve the ability of obtaining a hard erect penis suitable for sexual activity. Following sexual stimulation Tadalafil Hennig 5 mg 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 Hennig 5 mg will not help you if you do not have erectile dysfunction. It is important to note that Tadalafil Hennig 5 mg 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, just as you wo Read the complete document
1 1. NAME OF THE MEDICINAL PRODUCT Tadalafil Hennig 5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg of tadalafil. Excipient with known effect: Each film-coated tablet contains 66 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 5” biconvex film-coated tablet of 8.70 x 4.50 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 for the treatment of erectile dysfunction, sexual stimulation is required. Treatment of the signs and symptoms of benign prostatic hyperplasia in adult males. Tadalafil Hennig is not indicated for use by women. 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 Hennig (i.e., at least twice weekly) a once daily regimen with the lowest doses of Tadalafil Hennig 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. 2 The appropriateness of continued use of the daily regimen should be reassessed periodically. _Benign prostatic hyperplasia in adult men _ The recommended dose is 5 mg, taken at approximately t Read the complete document