Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Sildenafil
Rowex Ltd
G04BE; G04BE03
Sildenafil
25 milligram(s)
Tablet
Product subject to prescription which may not be renewed (A)
Drugs used in erectile dysfunction; sildenafil
Marketed
2009-10-09
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SIDENA 25 MG TABLETS SIDENA 50 MG TABLETS SIDENA 100 MG 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Sidena is and what it is used for 2. What you need to know before you take Sidena 3. How to take Sidena 4. Possible side effects 5. How to store Sidena 6. Contents of the pack and other information 1. WHAT SIDENA IS AND WHAT IT IS USED FOR Sidena 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. Sidena will only help you to get an erection if you are sexually stimulated. Sidena 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 SIDENA DO NOT TAKE SIDENA - 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 Soma hati kamili
Health Products Regulatory Authority 02 August 2022 CRN00CZ92 Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sidena 25 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 25 mg of sildenafil (as citrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Sidena 25 mg tablet is a light blue, round, slightly dotted tablet with breaking notch on one side and debossment “25” on the other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sildenafil is indicated in adult men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for sildenafil to be effective, sexual stimulation is required. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Use in adults_ The recommended dose is 50 mg taken as needed approximately one hour before sexual activity. Based on efficacy and tolerability, 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 sildenafil is taken with food, the onset of activity may be delayed compared to the fasted state (see section 5.2). Special populations _Elderly_ Dosage adjustments are not required in elderly patients (≥ 65 years old). _Renal impairment_ 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 tolerability, the dose may be increased step-wise to 50 mg up to 100 mg as necessary. Health Products Regulatory Authority 02 August 2022 CRN00CZ92 Page 2 of 12 _Hepatic impairment_ Since sildenafil clearance is reduced in patients with hep Soma hati kamili