Страна: Австралия
Язык: английский
Источник: Department of Health (Therapeutic Goods Administration)
sildenafil citrate, Quantity: 70.24 mg (Equivalent: sildenafil, Qty 50 mg)
iX Biopharma Pty Ltd
Capsule
Excipient Ingredients: magnesium stearate; croscarmellose sodium; sunset yellow FCF; lactose monohydrate; tartrazine; titanium dioxide; Gelatin; silicon dioxide; sodium lauryl sulfate
Oral
12, 8, 4
(S4) Prescription Only Medicine
Sildenafil is indicated for the treatment of erectile dysfunction in adult males. ,Sildenafil is not indicated for use by women.
Visual Identification: SILCAP 50 mg capsules are yellow opaque/yellow opaque size 2 hard gelatin capsules with no markings.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2018-07-31
Silcap Consumer Medicine Information v1.0 010818 Page 1 of 4 SILCAP _sildenafil (as citrate) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Silcap. 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 you taking Silcap 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 SILCAP IS USED FOR Silcap 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. Silcap 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. Silcap will work only if you are sexually excited. Silcap will not increase your sex drive. Silcap is not for use in women. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE SILCAP WHEN YOU MUST NOT TAKE IT YOU MUST NOT TAKE SILCAP 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 SILCAP. DO NOT TAKE SILCAP IF YOU ARE BEING TREATED FOR ANGINA (CHEST PAIN) OR OTHER HEART CONDITIONS WITH MEDICINES CALLED NITRATES. Nitrate medicines include glyceryl trinitrate (also called nitroglycerin). Common trade names for glyceryl trinitrate tablets include Anginine and Lycinate. Common trade names for glyceryl trinitrate patches include Nitro- Dur, Transiderm-Nitro, N Прочитать полный документ
_Sildenafil (as citrate) 25 mg and 50 mg capsules _ _Product Information _ _iX Biopharma Pty Ltd _ Sildenafil capsule PI v2.0 260221 Page 1 of 15 AUSTRALIAN PRODUCT INFORMATION SILCAP (SILDENAFIL) CAPSULES 1 NAME OF THE MEDICINE Sildenafil (as citrate) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Excipients with known effect: lactose monohydrate. For the full list of excipients, see Section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM Silcap 25 mg capsules are clear/clear size 2 hard gelatin capsules with no markings. Silcap 50 mg capsules are yellow opaque/yellow opaque size 2 hard gelatin capsules with no markings. 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 capsules 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 (Cl cr = 30-80 mL/min). Since sildenafil clearance is reduced in patients with severe renal impairment (Cl cr <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 impairment (e.g., cirrhosis) 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 THE ELDERLY _Sildenafil (as citrate) 25 mg and 50 mg capsules _ _Product Information _ _iX Biopharma Pty Ltd _ Прочитать полный документ