מדינה: מלזיה
שפה: אנגלית
מקור: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Tadalafil
NOVUGEN PHARMA SDN. BHD.
Tadalafil
2 Tablets; 4 Tablets; 8 Tablets
NOVUGEN PHARMA SDN. BHD.
_Consumer Medication Information Leaflet (RiMUP) _ TADIGRA 20MG FILM COATED TABLETS Tadalafil 20mg 1 WHAT IS IN THIS LEAFLET 1. What Tadigra is used for 2. How Tadigra works 3. Before you use Tadigra 4. How to use Tadigra 5. While you are using Tadigra 6. Side effects 7. Storage and Disposal of Tadigra 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT TADIGRA IS USED FOR Tadigra 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. Tadigra has been shown to significantly improve the ability of obtaining a hard erect penis suitable for sexual activity. HOW TADIGRA WORKS Tadigra contains the active ingredient tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE 5 inhibitors). Following sexual stimulation Tadigra 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. Tadigra will not help you if you do not have erectile dysfunction. It is important to note that Tadigra 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 TADIGRA − _When you must not use it _ Do not take Tadigra 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”). Tadigra 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 קרא את המסמך השלם
1. NAME OF THE MEDICINAL PRODUCT Tadigra 20mg Film Coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg of Tadalafil. Excipient with known effect: Each coated tablet contains 290.800 mg lactose (as monohydrate). For the full list of excipients, see section List of excipients. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Yellow, almond-shaped biconvex film coated tablet debossed with “N” on one side and “44” on other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of erectile dysfunction in adult males. In order for tadalafil to be effective for the treatment of erectile dysfunction, sexual stimulation is required. Tadigra is not indicated for use by women. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adult men _ In general, the recommended dose is 10 mg taken prior to anticipated sexual activity and with or without food. In those patients in whom tadalafil 10 mg does not produce an adequate effect, 20 mg might be tried. It may be taken at least 30 minutes prior to sexual activity. The maximum dose frequency is once per day. Tadalafil 20 mg is intended for use prior to anticipated sexual activity and it is not recommended for continuous daily use. In patients who anticipate a frequent use of Tadigra (i.e., at least twice weekly) a once daily regimen with the lowest doses of Tadigra might be considered suitable, based on patient choice and the physician’s judgement. In these patients the recommended dose is 5 mg taken once a day at approximately the same time of day. The appropriateness of continued use of the daily regimen should be reassessed periodically. TADIGRA 20MG FILM COATED TABLETS Special populations _Elderly men _ Dose adjustments are not required in elderly patients. _Men with renal impairment _ Dose adjustments are not required in patients with mild to moderate renal impairment. For patients with severe renal impairment 10 mg is the maximum recommended dose. Once-a-day dosing of tadalafil is not recommended in patients with se קרא את המסמך השלם