Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
sildenafil citrate, Quantity: 140.5 mg (Equivalent: sildenafil, Qty 100 mg)
Accord Healthcare Pty Ltd
Sildenafil citrate
Tablet, film coated
Excipient Ingredients: calcium hydrogen phosphate; microcrystalline cellulose; croscarmellose sodium; hypromellose; magnesium stearate; titanium dioxide; lactose monohydrate; triacetin; indigo carmine aluminium lake
Oral
12 Tablets in blister pack, 8 Tablets in blister pack, 4 Tablets in blister pack
(S4) Prescription Only Medicine
Indicated for the treatment of erectile dysfunction in adult males. Sildenafil Citrate 100 mg tablets is not indicated for use by women.
Visual Identification: Blue, almond shaped, biconvex, film-coated tablets, debossed with '100' on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2012-09-10
SILDANIL 25, 50, 100 CONSUMER MEDICINE INFORMATION Version: 1.0 -2012- Page 1 of 4 SILDANIL 25, 50, 100 (SILDENAFIL (AS CITRATE) 25 MG, 50 MG, 100 MG FILM-COATED TABLETS) CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Sildanil. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of your taking Sildanil tablets 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 SILDANIL IS USED FOR Sildanil tablet 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. Sildanil tablet 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. Sildanil tablet will work only if you are sexually excited. Sildanil tablet will not increase your sex drive. Sildanil tablet is not for use in women. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE SILDANIL YOU MUST NOT TAKE SILDANIL TABLET IF YOU ARE TAKING ANY NITRATE MEDICATION. 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 SILDANIL TABLET. WHEN YOU MUST NOT TAKE IT DO NOT TAKE SILDANIL TABLET IF: 1. 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). Com Prečítajte si celý dokument
Sildanil 25/50/100 (Sildenafil (as citrate) 25 mg, 50 mg, 100 mg film-coated Tablets) Version 1.0 -2012- Page 1 of 16 PRODUCT INFORMATION SILDANIL 25, 50, 100 (SILDENAFIL (AS CITRATE) 25 MG, 50 MG, 100 MG FILM-COATED TABLETS) NAME OF THE MEDICINE Sildenafil (as citrate) DESCRIPTION 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. Sildenafil citrate is 1-[4-ethoxy-3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H- pyrazolo[4,3-d]pyrimidin-5-yl)phenylsulphonyl]-4-methylpiperazine citrate. CAS number 171,599-83-0. The empirical formula for sildenafil citrate is C 22 H 30 N 6 O 4 S.C 6 H 8 0 7 Sildenafil citrate has the following structural formula:- Sildenafil citrate is an off-white, crystalline powder with a molecular weight of 666.7. Its aqueous solubility is equivalent to 2.6 mg sildenafil per mL at 25°C. In addition to sildenafil citrate, each sildenafil tablet contains the following inactive ingredients: microcrystalline cellulose, calcium hydrogen phosphate anhydrous, croscarmellose sodium, hypromellose, magnesium stearate. The film-coating contains opadry II complete film coating system 31K80865 Blue (ARTG No.107653), which consists of hypromellose, titanium dioxide, lactose, glycerol triacetate and indigo carmine aluminium lake (E132). Sildanil 25/50/100 (Sildenafil (as citrate) 25 mg, 50 mg, 100 mg film-coated Tablets) Version 1.0 -2012- Page 2 of 16 PHARMACOLOGY PHARMACODYNAMIC PROPERTIES Sildenafil is an oral therapy for erectile dysfunction which restores impaired erectile function by increasing blood flow to the penis, resulting in a natural response to sexual stimulation. The physiological mechanism responsible for erection of the penis involves the release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation. Nitric oxide then activates the enzyme, guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate (cGMP), producing smooth musc Prečítajte si celý dokument