Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Tadalafil
CIPLA MALAYSIA SDN BHD
Tadalafil
4 Tablets; 2 x 4 Tablets
CIPLA LTD
TADACIP 20 (TADALAFIL TABLETS 20MG) Tadalafil 20 mg CONSUMER MEDICATION INFORMATION (RIMUP) ____________________________________________________________________________________ 1 WHAT IS IN THIS LEAFLET 1. What TADACIP is used for 2. How TADACIP works 3. Before you use TADACIP 4. How to use TADACIP 5. While you are using TADACIP 6. Side effects 7. Storage and Disposal of TADACIP 8. Product Description 9. Manufacturer 10. Product Registration Holder 11. Date of Revision WHAT TADACIP IS USED FOR TADACIP 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. TADACIP has been shown to significantly improve the ability of obtaining a hard erect penis suitable for sexual activity. HOW TADACIP WORKS TADACIP contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation TADACIP 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. TADACIP will not help you if you do not have erectile dysfunction. It is important to note that TADACIP 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 TADACIP - _When you must not take it _ Do not take TADACIP if you: • are allergic to tadalafil or any of the other ingredients of this medicine • 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”). TADACIP has been shown to increase the effects of these medicines. If you are taking any form of nitrate or are unsure tell your doctor. • have serious heart disease or recently had a heart attack within the last 90 days. • recently had a stroke within the last 6 months. • have low blood Baca dokumen lengkap
1 _For the use of a Registered Medical Practitioner or a Hospital or a Laboratory only OR for _ _Specialist Use only _ _ _ TADACIP 20 Tadalafil Tablets 20 mg COMPOSITION Each film-coated tablet contains: Tadalafil Ph.Eur. …….20 mg Colour: Titanium dioxide & Yellow oxide of iron DOSAGE FORM Film coated tablets PRODUCT DESCRIPTION Yellow coloured, capsule shaped, biconvex film coated tablet with “T 20” debossing on one side and plain on other side. PHARMACOLOGY _PHARMACODYNAMICS_ Pharmacotherapeutic group: Urologicals, Drugs used in erectile dysfunction ATC Code: G04BE08. Mechanism of action Tadalafil is a selective, reversible inhibitor of cyclic guanosine monophosphate (cGMP)- specific phosphodiesterase type 5 (PDE5). _ _ _Erectile dysfunction_ 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 treatment of erectile dysfunction in the absence of sexual stimulation. 2 _Pulmonary arterial hypertension_ Pulmonary arterial hypertension is associated with impaired release of nitric oxide by the vascular endothelium and consequent reduction of cGMP concentrations within the pulmonary vascular smooth muscle. PDE5 is the predominant phosphodiesterase in the pulmonary vasculature. Inhibition of PDE5 by tadalafil increases the concentrations of cGMP resulting in relaxation of the pulmonary vascular smooth muscle cell and vasodilation of the pulmonary vascular bed. Pharmacodynamic effects Studies in vitro have shown that tadalafil is a selective inhibitor of PDE5. PDE5 is an enzyme found in corpus cavernosum smooth muscle, vascular and visceral smooth muscle, skeletal muscle, platelets, kidney, lung, and cerebellum. The effect of tadalafil is more potent on PDE5 than on other phosphodiesterases. Tadalafil is > 10,000-fold more potent for PDE5 than for PDE1, PDE2, an Baca dokumen lengkap