Krajina: Malajzia
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Tadalafil
SYNERRV SDN BHD
Tadalafil
1 x 4 Tablets; 2 x 4 Tablets
Aurobindo Pharma Limited, Unit-VII (SEZ)
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ CIATUFF 10 (TADALAFIL TABLETS 10MG) CIATUFF 20 (TADALAFIL TABLETS 20MG) Tadalafil Tablets (10mg, 20 mg) 1 WHAT IS IN THIS LEAFLET 1. What CIATUFF is used for 2. How CIATUFF works 3. Before you use CIATUFF 4. How to use CIATUFF 5. While you are using it 6. Side effects 7. Storage and Disposal of CIATUFF 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT CIATUFF IS USED FOR CIATUFF 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. CIATUFF has been shown to significantly improve the ability of obtaining a hard erect penis suitable for sexual activity. HOW CIATUFF WORKS CIATUFF contains the active ingredient tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE 5 inhibitors). Following sexual stimulation CIATUFF 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. CIATUFF will not help you if you do not have erectile dysfunction. It is important to note that CIATUFF 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 CIATUFF _- When you must not use it _ Do not take CIATUFF 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”). CIATUFF 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 Prečítajte si celý dokument
NAME OF DRUG PRODUCT : Tadalafil Tablets 10 mg Tadalafil Tablets 20 mg (TRADE) NAME OF PRODUCT : CIATUFF 10 CIATUFF 20 STRENGTH : 10 mg and 20 mg PHARMACEUTICAL DOSAGE FORM : Tablet QUALITATIVE AND QUANTITATIVE COMPOSITIONS: _Tadalafil Tablets 10 mg: _Each film-coated tablet contains 10 mg of Tadalafil Ph. Eur. _Tadalafil Tablets 20 mg: _Each film-coated tablet contains 20 mg of Tadalafil Ph. Eur. PHARMACEUTICAL FORM _Tadalafil Tablets 10 mg_: Light yellow colored, oval shaped, film-coated tablets debossed with ‘10’ on one side and ‘TL’ on other side. _Tadalafil Tablets 20 mg_: Yellow colored, oval shaped, film-coated tablets debossed with ‘20’ on one side and ‘TL’ on other side. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS 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. 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 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 Tadalafil (i.e., at least twice weekly) a once daily regimen with the lowest doses of Tadalafil 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 dose may be decreased to 2.5 mg once a day based on individual tolerability. The appropriateness of continued use of the daily regimen should be reassessed periodically. Special populations _Elderly men_ Dose adjustments are not required in elderly patients. _Men with renal impairment_ Prečítajte si celý dokument