Country: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
sildenafil citrate, Quantity: 70.2 mg (Equivalent: sildenafil, Qty 50 mg)
Sandoz Pty Ltd
Tablet, uncoated
Excipient Ingredients: indigo carmine aluminium lake; croscarmellose sodium; microcrystalline cellulose; calcium hydrogen phosphate; magnesium stearate; copovidone; saccharin sodium
Oral
4 tablets
(S4) Prescription Only Medicine
SILDENAFIL SANDOZ PHARMA is indicated for the treatment of erectile dysfunction in adult males. SILDENAFIL SANDOZ PHARMA is not indicated for use by women.
Visual Identification: light blue round slightly dotted tablets, with cross breaking notch and debossment 50; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2018-11-23
SILDENAFIL SANDOZ PHARMA 1 SILDENAFIL SANDOZ PHARMA _sildenafil citrate tablets _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Sildenafil Sandoz. 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 this medicine against the benefits they expect it will have for you. It should only be used 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 SANDOZ PHARMA IS USED FOR This medicine 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. It contains the active ingredient sildenafil. Sildenafil 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. Sildenafil Sandoz Pharma will work only if you are sexually excited. It will not increase your sex drive. Sildenafil Sandoz Pharma is not for use in women. This medicine is available only with a doctor's prescription. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. BEFORE YOU TAKE SILDENAFIL SANDOZ PHARMA YOU MUST NOT TAKE SILDENAFIL SANDOZ PHARMA IF YOU ARE TAKING ANY NITRATES OR NITRITE MEDICATIONS. IT MAY LEAD TO A SEVERE DROP IN 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 SILDENAFIL SANDOZ PHARMA. _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO Aqra d-dokument sħiħ
181116-Sildenafil-Sandoz-Pharma-pi Page 1 of 16 AUSTRALIAN PRODUCT INFORMATION SILDENAFIL SANDOZ PHARMA (SILDENAFIL (AS CITRATE)) 1. NAME OF THE MEDICINE Sildenafil (as citrate) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Sildenafil Sandoz Pharma 50 mg tablets contains 50 mg Sildenafil (as citrate). Sildenafil citrate is an off-white, crystalline powder. Its aqueous solubility is equivalent to 2.6 mg sildenafil per millilitre at 25 ° C. For the full list of excipients, see Section 6.1 List of excipients. _Not all presentations may be marketed in Australia. _ 3. PHARMACEUTICAL FORM Sildenafil Sandoz Pharma 50 mg tablets: Light blue round slightly dotted tablets with cross breaking notch and embossment “50”. 4. CLINICAL PARTICULARS 4.1. T HERAPEUTIC INDICATIONS Sildenafil Sandoz Pharma is indicated for the treatment of erectile dysfunction in adult males. Sildenafil Sandoz Pharma is not indicated for use by women. 4.2. D OSE AND METHOD OF ADMINISTRATION DOSAGE _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 Sandoz Pharma is not indicated for use in children. METHOD OF ADMINISTRATION Sildenafil Sandoz Pharma tablets are for oral administration. Sildenafil Sandoz Pharma tablets have a breaking notch and may be broken if necessary. 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). 181116-Sildenafil-Sandoz-Pharma-pi Page 2 of 16 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. hepatic impairment Since sildenafil cl Aqra d-dokument sħiħ