País: Malàisia
Idioma: anglès
Font: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TADALAFIL
ABBOTT LABORATORIES (M) SDN. BHD.
TADALAFIL
2 Sachets; 15 Sachets
CTCBIO Inc
Consumer Medication Information Leaflet (RiMUP) CALIBERI ® ORODISPERSIBLE FILM Tadalafil (5mg and 20mg) 1 WHAT IS IN THIS LEAFLET 1. What Caliberi ® is used for 2. How Caliberi ® works 3. Before you use Caliberi ® 4. How to use Caliberi ® 5. While you are using it 6. Side effects 7. Storage and Disposal of Caliberi ® 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT CALIBERI ® IS USED FOR _CALIBERI_ _®_ _ 5MG AND 20MG_ are 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. Caliberi ® has been shown to significantly improve the ability of obtaining a hard erect penis suitable for sexual activity. _CALIBERI_ _®_ _ 5MG_ is used to treat adult men with: • 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 CALIBERI ® WORKS Caliberi ® contains the active ingredient tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE 5 inhibitors). Following sexual stimulation Caliberi ® 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. Caliberi ® will not help you if you do not have erectile dysfunction. It is important to note that Caliberi ® 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. Caliberi ® improves blood flow to, and relaxes, the muscles of, the prostate and bladder which may reduce symptoms of benign prostatic hyperplasia. Caliberi ® has been shown to improve these urinary symptoms as early as 1-2 w Llegiu el document complet
CALIBERI ® ORODISPERSIBLE FILM 5MG CALIBERI ® ORODISPERSIBLE FILM 20MG 1. NAME OF THE MEDICINAL PRODUCT Caliberi® Orodispersible Film 5mg Caliberi ® Orodispersible Film 20mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Caliberi ® Orodispersible Film 5mg contains 5mg tadalafil Each Caliberi ® Orodispersible Film 20mg contains 20mg tadalafil For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Orodispersible Film (ODF) Caliberi ® Orodispersible Film (ODF) 5mg and 20mg is light yellow, rectangular orodispersible films. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _CALIBERI_ _® _ _ORODISPERSIBLE FILM (ODF) 5MG AND 20MG_ Treatment of erectile dysfunction (ED) in adult males. In order for tadalafil to be effective for the treatment of erectile dysfunction, sexual stimulation is required. _CALIBERI_ _® _ _ORODISPERSIBLE FILM (ODF) 5MG _ Treatment of the signs and symptoms of benign prostatic hyperplasia in adult males. Caliberi ® is not indicated for use by women. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _CALIBERI_ _® _ _ORODISPERSIBLE FILM (ODF) 5MG AND 20MG _ _Erectile dysfunction (ED)_ _Adult men _ In general, the recommended dose is 10 mg (2 ODF × 5mg) taken prior to anticipated sexual activity without food. In those patients in whom tadalafil 10 mg (2 ODF × 5mg) 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 10mg (2 ODF X 5mg) 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 Caliberi ® (i.e., at least twice weekly) a once daily regimen with the lowest doses of Caliberi ® 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 Llegiu el document complet