국가: 오스트레일리아
언어: 영어
출처: Department of Health (Therapeutic Goods Administration)
sildenafil citrate, Quantity: 35.121 mg (Equivalent: sildenafil, Qty 25 mg)
Alphapharm Pty Ltd
Sildenafil citrate
Tablet, film coated
Excipient Ingredients: purified water; croscarmellose sodium; calcium hydrogen phosphate; magnesium stearate; microcrystalline cellulose; titanium dioxide; hypromellose; triacetin; indigo carmine aluminium lake
Oral
4, 8, 1
(S4) Prescription Only Medicine
VEDAFIL is indicated for the treatment of erectile dysfunction in adult males. . VEDAFIL is not indicated for use by women.
Visual Identification: Blue, film-coated, round biconvex tablets debossed with 'M' on one side and 'SL over 25' on the other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2013-05-20
VEDAFIL ® _sildenafil (as citrate)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about VEDAFIL. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking VEDAFIL against the benefits expected for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT VEDAFIL IS USED FOR The name of your medicine is VEDAFIL. It contains the active ingredient called sildenafil citrate. VEDAFIL is used to treat erectile dysfunction, more commonly known as impotence, in men. This is when a man cannot get, or keep, a hard erect penis suitable for sexual activity. VEDAFIL belongs to a group of medicines called phosphodiesterase type 5 inhibitors. It works by relaxing the blood vessels in your penis when you are sexually excited. This allows blood to flow into your penis, allowing you to get an erection in the natural way. VEDAFIL will work only if you are sexually excited. VEDAFIL will not increase your sex drive. VEDAFIL is not for use in women. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY VEDAFIL HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE VEDAFIL BECAUSE SEXUAL ACTIVITY MAY PLACE A STRAIN ON YOUR HEART, YOUR DOCTOR WILL NEED TO CHECK WHETHER YOU ARE FIT ENOUGH TO TAKE VEDAFIL. _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE VEDAFIL IF YOU ARE TAKING ANY NITRATE OR NITRITE MEDICATIONS, USED TO TREAT ANGINA (CHEST PAIN) OR OTHER HEART CONDITIONS. IT MAY LEAD TO A SEVER DROP IN YOUR BLOOD PRESSURE, WHICH MAY BE DIFFICULT TO TREAT. Nitrate medicines include: • glyceryl trinitrate (also called nitroglycerin). • tablets; such as Anginine, Lycinate, Nitrostat, Imdur Durules, Monodur durules, Sorbidin, Isordil, Corangin, ISMO 20, Imtrate, Duride, Isomonit, Ikorel and S 전체 문서 읽기
AUSTRALIAN PRODUCT INFORMATION VEDAFIL ® _Sildenafil (as citrate) film coated tablets _ 1 NAME OF THE MEDICINE Sildenafil (as citrate). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Sildenafil citrate is an orally active selective inhibitor of cGMP - specific PDE5 (phosphodiesterase type 5) which is the predominant PDE isoenzyme in human corpora cavernosa. VEDAFIL film coated tablets contain 25, 50 or 100 mg sildenafil (as citrate) as the active ingredient. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. _ _ 3 PHARMACEUTICAL FORM VEDAFIL (Sildenafil (as citrate)) 25 mg tablets : Blue film-coated, round biconvex tablets debossed with ‘M’ on one side and ‘SL over 25’ on other side. VEDAFIL (Sildenafil (as citrate)) 50 mg tablets : Blue film-coated, round biconvex tablets debossed with ‘M’ on one side and ‘SL over 50’ on other side. VEDAFIL (Sildenafil (as citrate)) 100 mg tablets : Blue film-coated, round biconvex tablets debossed with ‘M’ on one side and ‘SL over 100’ on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS VEDAFIL is indicated for the treatment of erectile dysfunction in adult males. VEDAFIL is not indicated for use by women. 4.2 DOSE AND METHOD OF ADMINISTRATION Sildenafil citrate tablets are for oral administration. USE IN ADULTS The recommended dose is 50 mg taken as needed approximately one hour before sexual activity. Based on the efficacy and toleration, the dose may be increased to 100 mg or decreased to 25 mg. The maximum recommended dose is 100 mg. The maximum recommended dosing frequency is once per day. DOSAGE ADJUSTMENT IN RENAL IMPAIRMENT The dosing recommendations for Use in Adults should be followed for patients with mild to moderate renal impairment (Cl cr = 30-80 mL/min). Since sildenafil clearance is reduced in patients with severe renal impairment (Clcr <30 mL/min) a 25 mg starting dose should be considered. Based on efficacy and toleration, the dose may be increased to 50 mg and 100 mg. DOSAGE ADJUSTMENT IN HEPATIC IMPAIRMENT 전체 문서 읽기