Țară: Malta
Limbă: engleză
Sursă: Medicines Authority
TADALAFIL
Sandoz Pharmaceuticals d.d. Verovškova Ulica 57, SI-1000 Ljubljana, Slovenia
G04BE08
TADALAFIL 2.5 mg
FILM-COATED TABLET
TADALAFIL 2.5 mg
POM
UROLOGICALS
Withdrawn
2016-11-30
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TADALAFIL SANDOZ 2.5 MG FILM-COATED TABLETS TADALAFIL SANDOZ 5 MG FILM-COATED TABLETS TADALAFIL SANDOZ 10 MG FILM-COATED TABLETS TADALAFIL SANDOZ 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 Sandoz is and what it is used for 2. What you need to know before you take Tadalafil Sandoz 3. How to take Tadalafil Sandoz 4. Possible side effects 5. How to store Tadalafil Sandoz 6. Contents of the pack and other information 1. WHAT TADALAFIL SANDOZ IS AND WHAT IT IS USED FOR Tadalafil Sandoz contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Tadalafil Sandoz 2.5 MG, 5 MG, 10 MG AND 20 MG film-coated tablets 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 Sandoz has been shown to significantly improve the ability of obtaining a hard erect penis suitable for sexual activity. Following sexual stimulation Tadalafil Sandoz 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 Sandoz will not help you if you do not have erectile dysfunction. It is important to note that Tadalafil Sandoz 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 Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Tadalafil Sandoz 2.5 mg film-coated tablets Tadalafil Sandoz 5 mg film-coated tablets Tadalafil Sandoz 10 mg film-coated tablets Tadalafil Sandoz 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 2.5 mg of tadalafil. Excipient with known effect Each tablet contains 41.9 mg of lactose (as monohydrate). Each film-coated tablet contains 5 mg of tadalafil. Excipient with known effect Each tablet contains 83.8 mg of lactose (as monohydrate). Each film-coated tablet contains 10 mg of tadalafil. Excipient with known effect Each tablet contains 167.7 mg of lactose (as monohydrate9. Each film-coated tablet contains 20 mg of tadalafil. Excipient with known effect Each tablet contains 335.4 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. _2.5 mg film-coated tablets _ Ochre to yellow, round shaped film-coated tablet of approximately 5 mm in diameter. On one side debossed with “2.5” and plain on the other side. _5 mg film-coated tablets _ Ochre to yellow, oval shaped film-coated tablet of approximately 8 x 4 mm. On one side debossed with “5” and plain on the other side. _10 mg film-coated tablets _ Ochre to yellow, oval shaped film-coated tablet of approximately 11 x 6 mm. On one side debossed with “10”. The other side of the tablet is plain. _20 mg film-coated tablets _ Ochre to yellow, oval shaped film-coated tablet of approximately 15 x 9 mm. On one side debossed with “20”. The other side of the tablet is bi-scored. The tablet can be divided into equal halves and/or quarters. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tadalafil Sandoz 2.5 mg, 5 mg, 10 mg and 20 mg film-coated tablets: Treatment of erectile dysfunction in adult males. In order for tadalafil to be effective for the treatment of erectile dysfunction, sexual stimulation is required. Tadalafil Sandoz 5 mg film-coated tablets: Treatment of the Citiți documentul complet