Χώρα: Μαλαισία
Γλώσσα: Αγγλικά
Πηγή: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Tadalafil
NOVUGEN PHARMA SDN. BHD.
Tadalafil
2 Tablets; 10 Tablets; 30 Tablets; 30 Tablets; 10 Tablets
NOVUGEN PHARMA SDN. BHD.
_Consumer Medication Information Leaflet (RiMUP) _ TADIGRA 5MG FILM COATED TABLETS Tadalafil 5mg 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 5 mg is used to treat 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. • urinary symptoms associated with a common condition called BENIGN PROSTATIC HYPERPLASIA . This is when the prostate gland gets bigger with age. Symptoms include difficulty in starting to pass water, a feeling of not completely emptying the bladder and a more frequent need to pass water even at night. 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. Tadigra improves blood flow to, and relaxes, the muscles of, the prostate and bladder which may reduce symptoms of benign prostatic hyperplasia. Tadigra has been shown to improve these urinary symptoms as early as 1-2 weeks after starting treatment. BEFORE YOU USE TADIGRA − _When you must not use it _ Do not take Tadigra if you: • Διαβάστε το πλήρες έγγραφο
1. NAME OF THE MEDICINAL PRODUCT Tadigra 5mg Film Coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5mg of Tadalafil. Excipient with known effect: Each coated tablet contains 305.800 mg lactose (as monohydrate). For the full list of excipients, see section List of excipients. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Light yellow, almond-shaped biconvex film coated tablet debossed with “N” on one side and “45” 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. Treatment of the signs and symptoms of benign prostatic hyperplasia in adult males. Tadigra is not indicated for use by women. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Erectile dysfunction in 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 10 and 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 5MG FILM COATED TABLETS _Benign prostatic hyperplasia in adult men _ The recommended dose is 5 mg, taken at approximately the same time every day with or without food. For adult men being treated for both benign prostatic hyperplasia and erectile dysfunction the Διαβάστε το πλήρες έγγραφο