Țară: Israel
Limbă: engleză
Sursă: Ministry of Health
SILDENAFIL AS CITRATE
TARO INTERNATIONAL LTD, ISRAEL
G04BE03
SUSPENSION FOR ORAL SPRAY
SILDENAFIL AS CITRATE 25 MG / 1 ML
ORAL
Required
FARMALIDER S.A., SPAIN
SILDENAFIL
Sildazen is indicated in the treatment for adult men with erectile dysfunction.
2022-10-19
1 Patient leaflet in accordance with the Pharmacists' Regulations (Preparations) - 1986 This medicine is dispensed with a doctor's prescription only Sildazen 12.5 mg/actuation, oral suspension Active ingredient 1 ml of suspension contains 25 mg sildenafil (as citrate) Inactive ingredients and allergens: see section 2 under ‘Important information about some of this medicine’s ingredients’, and section 6 ‘Additional information'. Read the entire leaflet carefully before you start using this medicine. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. 1. What is this medicine intended for? Sildazen is intended for treatment of erectile dysfunction in adult men (impotence). This happens when a man cannot get, or keep a firm erection suitable for satisfactory sexual activity. Therapeutic group: phosphodiesterase type 5 inhibitor (PDE5). Sildazen works by dilating the blood vessels in your penis, allowing blood to flow into it when you are sexually stimulated. Sildazen will only help you to get an erection if you are sexually stimulated. 2. Before using this medicine Do not use this medicine if: - You are sensitive (allergic) to sildenafil or to any of the other ingredients in this medicine (see section 6). - 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 (chest pain). - You are using any of the medicines known as nitric oxide donors such as amyl nitrite (“poppers”), such as certain medicines for treatment of angina pectoris (chest pain), as the combination may lead to a dangerous fall in your blood pressure. - You are taking riociguat. This medicine is used to treat pulmonary arterial hyper Citiți documentul complet
1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Sildazen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each millilitre of suspension contains sildenafil citrate equivalent to 25 mg of sildenafil (35.1 mg as sildenafil citrate). Each actuation delivers 0.5 mL of suspension which contains 12.5 mg of sildenafil. Excipient with known effect: Each millilitre of suspension contains 1 mg of sodium benzoate (E211). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM White to off-white suspension, free of foreign substances with mint odour. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Sildazen is indicated in adult men with erectile dysfunction. In order for Sildazen to be effective, sexual stimulation is required. 4.2 Posology and method of administration Posology _Use in adults _ The recommended dose is 2 mL (4 actuations), equivalent to 50 mg of sildenafil taken as needed, approximately one hour before sexual activity. Based on efficacy and tolerability, the dose may be increased to 4 mL (8 actuations), equivalent to 100 mg, or decreased to 1 mL (2 actuations), equivalent to 25 mg of sildenafil. The maximum recommended dose is 4 mL (8 actuations), equivalent to 100 mg of sildenafil. The maximum recommended dosing frequency is once per day. If Sildazen is taken with food, the onset of its pharmacological activity may be delayed compared to the fasted state (see section 5.2). Number of actuations Quantity of suspension delivered Quantity of sildenafil 2 1 mL 25 mg 4 2 mL 50 mg 8 4 mL 100 mg Each actuation delivers 0.5 mL of product which contains 12.5 mg of sildenafil. Special populations _Elderly_ _ _ Dosage adjustments are not required in elderly patients (patients aged 65 years or older). Page 2 of 17 _Renal impairment _ The dosage recommendations described under “Use in adults” are applicable 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 ( Citiți documentul complet