Šalis: Malaizija
kalba: anglų
Šaltinis: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Tadalafil
GENPHARMA SDN. BHD
Tadalafil
8 Tablets; 8 Tablets; 4 Tablets; 4 Tablets
Alembic Pharmaceuticals Limited (Formulation Division)
TADAFLO 20MG TABLETS Tadalafil 20 mg _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ _ _ _ _ WHAT IS IN THIS LEAFLET 1. What TADAFLO 20mg Tablets is used for 2. How TADAFLO 20mg Tablets works 3. Before you use TADAFLO 20mg Tablets 4. How to use TADAFLO 20mg Tablets 5. While you are using it 6. Side effects 7. Storage and Disposal of TADAFLO 20mg Tablets 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT TADAFLO 20MG TABLETS IS USED FOR TADAFLO 20mg Tablets 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. TADAFLO 20mg Tablets has been shown to significantly improve the ability of obtaining a hard erect penis suitable for sexual activity. HOW TADAFLO 20MG TABLETS WORKS TADAFLO 20mg Tablets contains the active ingredient _tadalafil _ which belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE 5 inhibitors). Following sexual stimulation TADAFLO 20mg Tablets 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. TADAFLO 20mg Tablets will not help you if you do not have erectile dysfunction. It is important to note that TADAFLO 20mg Tablets 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 would if you were not taking a medicine for erectile dysfunction. BEFORE YOU USE TADAFLO 20MG TABLETS - _When you must not use it _ Do not take TADAFLO 20mg Tablets if you: are allergic to tadalafil or any of the other ingredients of this medicine (see section PRODUCT DESCRIPTION ). are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. This is a group of medicines (“nitrates”) used in the treatment of angina pectoris (“chest pain”). TADAFLO 20mg Tablets has been shown to increase the effects of these m Perskaitykite visą dokumentą
1. NAME OF THE MEDICINAL PRODUCT TADAFLO 20mg Tablets 2. NAME AND STRENGTH OF ACTIVE SUBSTANCES Tadalafil 20mg 3. PRODUCT DESCRIPTION TADAFLO 20mg Tablets Yellow to light yellow, oval shaped, beveled edge, coated tablets debossed with ‘L339’ on one side and plain on other side. 4. DOSAGE FORM Tablet 5. PHARMACODYNAMIC PROPERTIES Pharmacotherapeutic group: Urologicals, Drugs used in erectile dysfunction, ATC Code: G04BE08. Tadalafil is a selective, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). When sexual stimulation causes the local release of nitric oxide, inhibition of PDE5 by tadalafil produces increased levels of cGMP in the corpus cavernosum. This results in smooth muscle relaxation and inflow of blood into the penile tissues, thereby producing an erection. Tadalafil has no effect in the absence of sexual stimulation. 6. PHARMACOKINETIC PROPERTIES Absorption Tadalafil is readily absorbed after oral administration and the mean maximum observed plasma concentration (Cmax) is achieved at a median time of 2 hours after dosing. Absolute bioavailability of tadalafil following oral dosing has not been determined. The rate and extent of absorption of tadalafil are not influenced by food, thus TADALAFIL may be taken with or without food. The time of dosing (morning versus evening) had no clinically relevant effects on the rate and extent of absorption. Distribution The mean volume of distribution is approximately 63 l, indicating that tadalafil is distributed into tissues. At therapeutic concentrations, 94 % of tadalafil in plasma is bound to proteins. Protein binding is not affected by impaired renal function. Less than 0.0005 % of the administered dose appeared in the semen of healthy subjects. Biotransformation Tadalafil is predominantly metabolised by the cytochrome P450 (CYP) 3A4 isoform. The major circulating metabolite is the methylcatechol glucuronide. This metabolite is at least 13,000-fold less potent than tadalafil for PDE5. Consequently, it is Perskaitykite visą dokumentą