Quốc gia: Malaysia
Ngôn ngữ: Tiếng Anh
Nguồn: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TADALAFIL
HOVID BERHAD
TADALAFIL
4 x 1 Film Sachets
ZIM Laboratories Limited
HOVID ERETAF ORODISPERSIBLE FILMS (ODF) Tadalafil (10mg, 20mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Hovid Eretaf Orodispersible Films (ODF) is used for 2. How Hovid Ereaf ODF works 3. Before you use Hovid Eretaf ODF 4. How to use Hovid Eretaf ODF 5. While you are using it 6. Side effects 7. Storage and Disposal of Hovid Eretaf ODF 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT HOVID ERETAF ORODISPERSIBLE FILMS (ODF) IS USED FOR Hovid Eretaf ODF 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 has been shown to significantly improve the ability of obtaining a hard erect penis suitable for sexual activity. HOW HOVID ERETAF ODF WORKS Hovid Eretaf ODF contains the active ingredient tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE 5 inhibitors). Following sexual stimulation tadalafil 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 will not help you if you do not have erectile dysfunction. It is important to note that treatment 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 HOVID ERETAF ODF - _When you must not use it _ Do not take Hovid Eretaf ODF 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”). Hovid Eretaf ODF has been shown to increase the effects of these medicines. If you are taking any Đọc toàn bộ tài liệu
VIERE06-0 (MY) DESCRIPTION HOVID ERETAF ORODISPERSIBLE FILMS 10MG Yellow colored, rectangular, opaque, non-sticky, orally disintegrating strip. HOVID ERETAF ORODISPERSIBLE FILMS 20MG Yellow colored, rectangular, opaque, non-sticky, orally disintegrating strip. COMPOSITION HOVID ERETAF ORODISPERSIBLE FILMS 10MG Each orodispersible film contains Tadalafil Ph. Eur. 10mg. HOVID ERETAF ORODISPERSIBLE FILMS 20MG Each orodispersible film contains Tadalafil Ph. Eur. 20mg. 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). 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. 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, and PDE4, enzymes which are found in the heart, brain, blood vessels, liver, and other organs. Tadalafil is > 10,000-fold more potent for PDE5 than for PDE3, an enzyme found in the heart and blood vessels. This selectivity for PDE5 over PDE3 is important because PDE3 is an enzyme involved in cardiac contractility. Additionally, tadalafil is approximately 700-fold more potent for PDE5 than for PDE6, an enzyme which is found in the retina and is responsible for phototransduction. Tadalafil is also > 10,000-fold more potent for PDE5 than for PDE7 through PDE10. CLINICAL EF Đọc toàn bộ tài liệu