Country: Malta
Language: English
Source: Medicines Authority
SILDENAFIL
PharmSol Europe Limited The Victoria Centre Unit 2, Lower Ground Floor, Valletta Road, Mosta MST 9012 , Malta
G04BE03
SILDENAFIL 100 mg
CHEWABLE TABLET
SILDENAFIL 100 mg
POM
UROLOGICALS
Licence number in the source country: NOT APPLICAPABLE
Authorised
2021-02-02
PIL - Sibefil chewable tablets 1 PACKAGE LEAFLET: INFORMATION FOR THE USER SIBEFIL 25 MG CHEWABLE TABLETS SIBEFIL 50 MG CHEWABLE TABLETS SIBEFIL 100 MG CHEWABLE 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 Sibefil is and what it is used for 2. What you need to know before you take Sibefil 3. How to take Sibefil 4. Possible side effects 5. How to store Sibefil 6. Contents of the pack and other information 1. WHAT SIBEFIL IS AND WHAT IT IS USED FOR Sibefil 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. Sibefil will only help you to get an erection if you are sexually stimulated. Sibefil 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 SIBEFIL DO NOT TAKE SIBEFIL: 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 yo Read the complete document
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Sibefil 25 mg chewable tablets Sibefil 50 mg chewable tablets Sibefil 100 mg chewable tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Sibefil 25 mg contains 25 mg sildenafil formed in situ from 35.12 mg sildenafil citrate. Sibefil 50 mg contains 50 mg sildenafil formed in situ from 70.24 mg sildenafil citrate. Sibefil 100 mg contains 100 mg sildenafil formed in situ from 140.48 mg sildenafil citrate. Excipients with known effect Sibefil 25 mg: Each chewable tablet contains 2.15 mg of aspartame, 70.457 mg of lactose monohydrate and 0.702 mg of sodium. Sibefil 50 mg: Each chewable tablet contains 4.30 mg of aspartame, 140.915 mg of lactose monohydrate and 1.404 mg of sodium. Sibefil 100 mg: Each chewable tablet contains 8.60 mg of aspartame, 281.83 mg of lactose monohydrate and 2.808 mg of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Chewable tablet Sibefil 25 mg: White, triangular, biconvex, embossed with “25” on one side with diameter of 7.3 x 7.0 + 0.2 mm, nominal thickness 3.7±0.3 mm Sibefil 50 mg: White, triangular, biconvex, embossed with “50” on one side with diameter of 8.8 x 8.6 + 0.2 mm, nominal thickness 4.7±0.3 mm Sibefil 100 mg: White, triangular, biconvex, embossed with “100” on one side with diameter of 11.8 x 11.6 + 0.2 mm, nominal thickness 5.8±0.3 mm 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Sibefil 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 Sibefil to be effective, sexual stimulation is required. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology _Use in adults _ 2 The recommended dose is 50 mg taken as needed approximately one hour before sexual activity. The tablets should be chewed before swallowed. Based on efficacy and tolerability, the dose may be increased to 100 mg or decreased to 25 mg. The maximum recommended dose is 10 Read the complete document