Country: Велика Британија
Језик: Енглески
Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sildenafil citrate
Consilient Health Ltd
G04BE03
Sildenafil citrate
100mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 07040500; GTIN: 5391512452230
PACKAGE LEAFLET: INFORMATION FOR THE USER VIZARSIN 100 MG FILM-COATED TABLETS Sildenafil READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Vizarsin is and what it is used for 2. What you need to know before you take Vizarsin 3. How to take Vizarsin 4. Possible side effects 5. How to store Vizarsin 6. Contents of the pack and other information 1. WHAT VIZARSIN IS AND WHAT IT IS USED FOR Vizarsin contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by helping to relax the blood vessels in your penis, allowing blood to flow into your penis when you get sexually excited. Vizarsin will only help you to get an erection if you are sexually stimulated. Vizarsin is a treatment for adult men with erectile dysfunction, sometimes known as impotence. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VIZARSIN DO NOT TAKE VIZARSIN: - If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6). - If you are taking medicines called nitrates, as the combination may lead to a dangerous fall in your blood pressure. Tell your doctor if you are taking any of these medicines which are often given for relief of angina pectoris (or “chest pain”). If you are not certain, ask your doctor or pharmacist. - If you are using any of the medicines known as nitric oxide donors such as amyl nitrite (“poppers”), as th Прочитајте комплетан документ
OBJECT 1 VIZARSIN 100 MG FILM-COATED TABLETS Summary of Product Characteristics Updated 05-Dec-2013 | Consilient Health Ltd 1. Name of the medicinal product Vizarsin 100 mg film-coated tablets 2. Qualitative and quantitative composition Each film-coated tablet contains 100 mg sildenafil (as citrate). Excipient with known effect: Each film-coated tablet contains 8 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet. White, oblong tablets, marked 100 on one side. 4. Clinical particulars 4.1 Therapeutic indications Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for Vizarsin to be effective, sexual stimulation is required. 4.2 Posology and method of administration For oral use. _Use in adults:_ The recommended dose is 50 mg taken as needed approximately one hour before sexual activity. Based on 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. If Vizarsin is taken with food, the onset of activity may be delayed compared to the fasted state (see section 5.2). _Use in the elderly:_ Dosage adjustments are not required in elderly patients. _Use in patients with impaired renal function:_ The dosing recommendations described in 'Use in adults' apply to patients with mild to moderate renal impairment (creatinine clearance = 30-80 ml/min). Since sildenafil clearance is reduced in patients with severe renal impairment (creatinine clearance <30 ml/min) a 25 mg dose should be considered. Based on efficacy and toleration, the dose may be increased to 50 mg and 100 mg. _Use in patients with impaired hepatic function:_ Since sildenafil clearance is reduced in patients with hepatic impairment (e.g. cirrhosis) a 25 mg dose should be considered. Based on efficacy and toleration, the dose may be increased to 50 mg and 100 Прочитајте комплетан документ