Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Avanafil
A. MENARINI SINGAPORE PTE. LTD.
Avanafil
8 Tablets; 4 Tablets; 2 Tablets; 12 Tablets
Menarini - Von Heyden GmbH
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ SPEDRA _®_ TABLET _ _ Avanafil 50 mg, 100 mg, 200 mg 1 WHAT IS IN THIS LEAFLET 1. What Spedra is used for 2. How Spedra works 3. Before you use Spedra 4. How to use Spedra 5. While you are using it 6. Side effects 7. Storage and Disposal of Spedra 8. Product Description 9. Manufacturer and Product Registration holder 10. Date of revision 11. Serial Number WHAT SPEDRA IS USED FOR Spedra contains the active substance avanafil. It belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. Spedra is a treatment for adult men suffering from erectile dysfunction (also known as impotence). This is when you cannot get, or keep a hard, erect penis suitable for sexual activity. Spedra will not help you if you do not have erectile dysfunction. Spedra is not for women. HOW SPEDRA WORKS Spedra works by helping the blood vessels in your penis to relax. This increases the blood flow into your penis, helping it stay hard and erect when you get sexually excited. Spedra does not cure your condition. It is important to note that Spedra only works if you are sexually stimulated. You and your partner will still need to use foreplay to get ready for sex – just as you would if you were not taking a medicine to help you. BEFORE YOU USE SPEDRA _- When you must not use it _ • If you are allergic to avanafil or any of the other ingredients of this medicine. • If you are taking “nitrate” medicines for chest pain (angina), such as amyl nitrite or glyceryl trinitrate. Spedra can increase the effects of these medicines and severely lower your blood pressure. • If you are taking medicines for HIV or AIDS such as ritonavir, indinavir, saquinavir, nelfinavir or atazanavir. • If you are taking medicines for fungal infections such as ketoconazole, itraconazole or voriconazole or certain antibiotics for bacterial infections, such as clarithromycin or telithromycin. • If you have a serious cardiac problem. • If you have had a stroke or heart attack in the Baca dokumen lengkap
SPEDRA® Tablets Avanafil 1. NAME OF THE MEDICINAL PRODUCT Spedra 50 mg tablets Spedra 100 mg tablets Spedra 200 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Spedra 50 mg tablets: Each tablet contains 50 mg of avanafil. Spedra 100 mg tablets: Each tablet contains 100 mg of avanafil. Spedra 200 mg tablets: Each tablet contains 200 mg of avanafil. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Spedra 50 mg tablets: Pale yellow oval tablets, debossed with “50” on one side. Spedra 100 mg tablets: Pale yellow oval tablets, debossed with “100” on one side. Spedra 200 mg tablets: Pale yellow oval tablets, debossed with “200” on one side. 4. CLINICAL PARTICULARS 4.1.THERAPEUTIC INDICATIONS Treatment of erectile dysfunction in adult men. In order for Spedra to be effective, sexual stimulation is required. 4.2. OSOLOGY AND METHOD OF ADMINISTRATION _Posology_ _Use in adult men_ The recommended dose is 100 mg taken as needed approximately 15 to 30 minutes before sexual activity (see section 5.1). Based on individual efficacy and tolerability, the dose may be increased to a maximum dose of 200 mg or decreased to 50 mg. The maximum recommended dosing frequency is once per day. Sexual stimulation is required for a response to treatment. _Special populations _ _Elderly (_ ≥ _65 years old)_ Dose adjustments are not required in elder patients. Limited data are available in elder patients aged 70 years or above. _Renal impairment_ Dose adjustments are not required in patients with mild to moderate renal impairment (creatinine clearance ≥ 30 mL/min). Spedra is contraindicated in patients with severe renal impairment (creatinine clearance < 30 mL/min) (see sections 4.3 and 5.2). Patients with mild or moderate renal impairment (creatinine clearance ≥30 mL/min but <80 mL/min) who were enrolled in phase 3 studies showed decreased efficacy compared to those with normal renal function. _Hepatic impairment_ Spedra is contraindicated in patients with severe hepatic impairment (Ch Baca dokumen lengkap