Land: Malaysia
Sprog: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TADALAFIL
ZUELLIG PHARMA SDN BHD
TADALAFIL
4Tablet Tablets; 8 Tablet Tablets; 4 Tablet Tablets
Lilly del Caribe Inc.,
CIALIS 20 MG FILM-COATED TABLETS Tadalafil 20 mg 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Cialis is used for 2. How Cialis works 3. Before you use Cialis 4. How to use Cialis 5. While you are using it 6. Side effects 7. Storage and Disposal of Cialis 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT CIALIS IS USED FOR Cialis 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. Cialis has been shown to significantly improve the ability of obtaining a hard erect penis suitable for sexual activity. HOW CIALIS WORKS Cialis contains the active ingredient tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE 5 inhibitors). Following sexual stimulation Cialis 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. Cialis will not help you if you do not have erectile dysfunction. It is important to note that Cialis 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 CIALIS _- When you must not use it _ Do not take Cialis 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”). Cialis 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 the last 6 months. • have low blood pr Læs hele dokumentet
1. NAME OF THE MEDICINAL PRODUCT CIALIS 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg tadalafil. Excipient with known effect: Each coated tablet contains 233 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. Yellow and almond shaped tablets, marked "C 20" on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of erectile dysfunction in adult males. In order for tadalafil to be effective, sexual stimulation is required. CIALIS 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 CIALIS (i.e., at least twice weekly) a once daily regimen with the lowest doses of CIALIS 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_ 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 severe renal impairment (see sections 4.4 and 5.2). _Men with hepatic impairment_ T Læs hele dokumentet