Land: Malaysia
Språk: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Tadalafil
ACCORD HEALTHCARE SDN.BHD.
Tadalafil
4 Tablets
INTAS PHARMACEUTICALS LIMITED
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ TADACCORD 20 (TADALAFIL TABLETS USP 20 MG) 1 WHAT IS IN THIS LEAFLET 1.What TADACCORD 20 is used for 2.How TADACCORD 20 works 3.Before you use TADACCORD 20 4.How to use TADACCORD 20 5.While you are using it 6.Side effects 7.Storage and Disposal of TADACCORD 20 8.Product Description 9.Manufacturer and Product Registration Holder 10.Date of revision 11. Serial Number WHAT TADACCORD 20 IS USED FOR TADACCORD 20 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. TADACCORD 20 has been shown to significantly improve the ability of obtaining a hard- erect penis suitable for sexual activity. HOW TADACCORD 20 WORKS TADACCORD 20 contains the active ingredient tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE 5 inhibitors). Following sexual stimulation TADACCORD 20 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. TADACCORD 20 will not help you if you do not have erectile dysfunction. It is important to note that TADACCORD 20 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 TADACCORD 20 - _When you must not use it_ Do not take TADACCORD 20 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”). TADACCORD 20 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 withi Les hele dokumentet
FRONT SIDE FILE NAME : 10 5241 1 6018654-TADACCORD 20(MALAYSIA)PIL SIZE : 160 X 500 (MM) COLOUR : PANTONE BLACK DATE : 28/07/22 PRESCRIBING INFORMATION: For the use of a Registered Medical Practitioner or a Hospital or a Laboratory only. TADACCORD 20 (Tadalafil Tablets USP 20 mg) 1. BRAND OR PRODUCT NAME: TADACCORD 20 Tadalafil Tablets USP 20 mg 2. NAME AND STRENGTH OF ACTIVE SUBSTANCE(S): Tadalafil; 20 mg 3. PRODUCT DESCRIPTION: Yellow, capsule shaped, biconvex, beveled edged, film coated tablets, debossed with “T 20” on one side and plain on the other side. 4. PHARMACOLOGICAL PROPERTIES: _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). PDE5 is an enzyme found in corpus cavernosum smooth muscle, vascular and visceral smooth muscle, skeletal muscle, platelets, kidney, lung, and cerebellum. _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. _PHARMACOKINETICS PROPERTIES:_ _Absorption_ Tadalafil is readily absorbed after oral administration and the mean maximum observed plasma concentration (C max ) 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 TADACCORD 20 may be taken with or without food. The time of dosing (morning versus evening after a single 10 mg administration) had no clinically relevant effects on the rate and extent of absorption. _Distribution_ The mean volume of distribution is approxima Les hele dokumentet