Land: Malaysia
Språk: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Tadalafil
STADPHARM SDN. BHD.
Tadalafil
2 Tablets
STELLAPHARM J.V. Co., LTD. - BRANCH 1
TADALAFIL STELLA _Consumer Medication Information Leaflet (RiMUP)_ Active Ingredient/generic name (Strength): Tadalafil (10 mg, 20 mg) Page 1 of 3 WHAT IS IN THIS LEAFLET 1. What Tadalafil STELLA is used for 2. How Tadalafil STELLA works 3. Before you use Tadalafil STELLA 4. How to use Tadalafil STELLA 5. While you are using it 6. Side effects 7. Storage and Disposal of Tadalafil STELLA 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT TADALAFIL STELLA IS USED FOR Tadalafil STELLA contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Tadalafil STELLA is a treatment of erectile dysfunction in adult males. In order for tadalafil to be effective, sexual stimulation is required. Tadalafil is not indicated for use by women. HOW TADALAFIL STELLA WORKS Following sexual stimulation Tadalafil STELLA 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 STELLA will not help you if you do not have erectile dysfunction. It is important to note that Tadalafil STELLA 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 TADALAFIL STELLA _WHEN YOU MUST NOT USE IT _ Do not take the medicine 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”). Tadalafil 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 pressure o Les hele dokumentet
TADALAFIL STELLA COMPOSITION _Each TADALAFIL STELLA 10 MG film-coated tablet contains _10 mg of tadalafil. _Each TADALAFIL STELLA 20 MG film-coated tablet contains _20 mg of tadalafil. DESCRIPTION _TADALAFIL STELLA_ _10 MG:_ Yellow, almond-shaped, film - coated tablet, biconvex, engraved with “T10” on one side and plain on the other side. Dimension: About 6.1 mm x 9.6 mm. Thickness: About 3.75 mm. _TADALAFIL STELLA 20 MG:_ Yellow, almond-shaped, film - coated tablet, biconvex, engraved with “T20” on one side and plain on the other side. Dimension: About 7.8 mm x 12.6 mm. Thickness: About 4.80 mm. 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 treatment of erectile dysfunction 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 th Les hele dokumentet