Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
sildenafil citrate, Quantity: 140.48 mg (Equivalent: sildenafil, Qty 100 mg)
Dr Reddys Laboratories Australia Pty Ltd
Sildenafil citrate
Tablet, film coated
Excipient Ingredients: magnesium stearate; microcrystalline cellulose; croscarmellose sodium; hyprolose; calcium hydrogen phosphate dihydrate; titanium dioxide; lactose monohydrate; hypromellose; triacetin; indigo carmine aluminium lake
Oral
12 Tablets, 4 Tablet, 8 Tablet, 1 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 100 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‐DRLA CMI v2 Page 1 of 5 CONSUMER MEDICINE INFORMATION SILDENAFIL‐DRLA _(sildenafil citrate) _ WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions about sildenafil. It does not contain all the available information. It does not take the place of talking to your doctor and pharmacist. 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 SILDENAFIL‐DRLA IS USED FOR The name of your medicine is Sildenafil generichealth. 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 SILDENAFIL ‐ DRLA 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 SILDENAFIL 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 Prečítajte si celý dokument
_ _ _ _ SILDENAFIL-DRLA _25, 50 & 100MG FILM COATED TABLETS_PI_V5_ PAGE 1 OF 15 PRODUCT INFORMATION SILDENAFIL-DRLA FILM COATED TABLET (sildenafil citrate) NAME OF THE MEDICINE 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 5-[2-Ethoxy-5-[(4-methylpiperazin-1-yl)sulfonyl]phenyl]-1-methyl-3-propyl-1,6- dihydro-7 _H_ -pyrazolo[4,3- _d_ ]pyrimidin-7-one dihydrogen 2-hydroxypropane-1,2,3-tricarboxylate. CAS number: 171599-83-0 The empirical formula for sildenafil citrate is C 28 H 38 N 6 O 11 S . Molecular weight is 666.7. Sildenafil citrate has the following structural formula:- DESCRIPTION Sildenafil citrate is white to off-white crystalline powder. Its aqueous solubility is equivalent to 2.6 mg sildenafil per mL at 25°C. In addition to sildenafil citrate, each Sildenafil-DRLA 25mg, 50mg and 100mg tablet contains the following inactive ingredients: cellulose-microcrystalline, calcium hydrogen phosphate, croscarmellose sodium, hydroxypropylcellulose and magnesium stearate. The components of coating system are hypromellose, lactose, glycerol triacetate, titanium dioxide and indigo carmine CI 73015. 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. _ _ _ _ SILDENAFIL-DRLA _25, 50 & 100MG FILM COATED TABLETS_PI_V5_ PAGE 2 OF 15 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 muscle relaxation in the corpus cavernosum and allowing inflow of blood. Sildenafil is a potent and selective inhibitor of cGMP specific phosphodiesterase type Prečítajte si celý dokument