Страна: Австралія
мова: англійська
Джерело: Department of Health (Therapeutic Goods Administration)
sildenafil citrate, Quantity: 35.12 mg (Equivalent: sildenafil, Qty 25 mg)
Dr Reddys Laboratories Australia Pty Ltd
Sildenafil citrate
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; hyprolose; croscarmellose sodium; calcium hydrogen phosphate dihydrate; magnesium stearate; titanium dioxide; lactose monohydrate; hypromellose; triacetin; indigo carmine aluminium lake
Oral
8 Tablet, 12 Tablets, 1 Tablet, 4 Tablet
(S4) Prescription Only Medicine
Treatment of erectile dysfunction in adult males. It is not indicated for use by women.
Visual Identification: Blue coloured, round film-coated tablet debossed with SC on one side and 25 on other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2012-09-24
SILDENAFIL APOTEX _(sildenafil citrate) _ CONSUMER MEDICINE INFORMATION FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 WHAT IS IN THIS LEAFLET This leaflet answers some common questions about this medicine. It does not contain all the available information. It does not take the place of talking to your doctor. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you. It should be used only under strict medical supervision. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is Sildenafil APOTEX. It contains the active ingredient sildenafil citrate. Sildenafil belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Sildenafil 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. Sildenafil 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. Sildenafil will only work if you are sexually excited. It will not increase your sex drive. Sildenafil is not for use in women. This medicine is available only with a doctor’s prescription. BEFORE YOU TAKE THIS MEDICINE YOU MUST NOT TAKE SILDENAFIL IF YOU ARE TAKING NITRATES OR NITRITE MEDICATIONS. IT MAY LEAD TO A SEVERE DROP IN YOUR BLOOD PRESSURE, WHICH MAY BE DIFFICULT TO TREAT. BECAUSE SEXUAL ACTIVITY MAY PLACE A STRAIN ON YOUR HEART, YOUR DOCTOR WILL NEED TO CHECK WHETHER YOU ARE FIT ENOUGH TO TAKE THIS MEDICINE. _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE THIS MEDICINE IF: • YOU ARE BEING TREATED FOR ANGINA (CHEST PAIN) OR OTHER HEART CONDITIONS WITH CERTAIN MEDICINES CALLED NITRATES. Nitrate medicines include glyceryl trinitrate (also called nitroglycerin). Прочитайте повний документ
AUSTRALIAN PRODUCT INFORMATION – SILDENAFIL APOTEX (SILDENAFIL CITRATE) 1 NAME OF THE MEDICINE Sildenafil citrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 25 mg, 50 mg or 100 mg sildenafil (as citrate) per tablet. Sildenafil citrate is a white to off-white crystalline powder. Its aqueous solubility is equivalent to 2.6 mg sildenafil per mL at 25°C. Ingredients with known effects: lactose. For the full list of excipients, see 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM The 25 mg tablets are blue coloured, round film-coated tablet debossed with ‘SC’ on one side and ‘25’ on other side. AUST R 186300. The 50 mg tablets are blue coloured, round film-coated tablet debossed with ‘SC’ on one side and ‘50’ on other side. AUST R 186292. The 100 mg tablets are blue coloured, round film-coated tablet debossed with ‘SC’ on one side and ‘100’ on other side. AUST R 186284. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Sildenafil is indicated for the treatment of erectile dysfunction in adult males. Sildenafil is not indicated for use by women. 4.2 D OSE AND METHOD OF ADMINISTRATION Sildenafil 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. USE IN CHILDREN Sildenafil is not indicated for use in children. DOSAGE ADJUSTMENT IN RENAL IMPAIRMENT The dosing recommendations for USE IN ADULTS should be followed for patients with mild to moderate renal impairment (Clcr = 30 to 80 mL/min). 1 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 Since sildenafil clearance is reduced in patients with hepatic impai Прочитайте повний документ