国家: 荷兰
语言: 荷兰文
来源: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
SILDENAFILCITRAAT SAMENSTELLING overeenkomend met ; SILDENAFIL
Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)
G04BE03
SILDENAFILCITRAAT COMPOSITION corresponding to ; SILDENAFIL
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MALTODEXTRINE ; NATRIUMSTEARYLFUMARAAT ; POLYDEXTROSE (E 1200) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; TRIGLYCERIDEN MIDDELLANGE KETEN,
Oraal gebruik
Sildenafil
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); HYPROLOSE (E 463); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); LACTOSE 1-WATER; MALTODEXTRINE; NATRIUMSTEARYLFUMARAAT; POLYDEXTROSE (E 1200); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171); TRIGLYCERIDEN MIDDELLANGE KETEN;
2016-11-15
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SILDENAFIL STADA 20 MG, FILMOMHULDE TABLETTEN 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. Whatis and what it is used for 2. What you need to know before you take 阅读完整的文件3. How to take 4. Possible side effects 5. How to store 6. Contents of the pack and other information 1. WHAT IS AND WHAT IT IS USED FOR contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. brings down blood pressure in the lungs by widening the blood vessels in the lungs. Sildenafil is used to treat adults and children and adolescents from 1 to 17 years old with high blood pressure in the blood vessels of the lungs (pulmonary arterial hypertension). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DO NOT TAKE IF YOU: • are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6) • are taking medicines containing nitrates, or nitric oxide donors such as amyl nitrate ("poppers"). These medicines are often given for relief of chest pain (or "angina pectoris"). can cause a serious increase in the effects of these medicines. Tell your doctor if you are taking any of these medicines. If you are not certain, ask your doctor or pharmacist • are taking riociguat. This drug is used to treat pulmonary arterial hypertensi
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Sildenafil STADA 20 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg of sildenafil (as citrate). Excipient with known effect Each tablet also contains 58.31 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Round, biconvex, white film-coated tablets with approx. diameter of 7.1 mm and approx. thickness of 3.4 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adults Treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease. Paediatric population Treatment of paediatric patients aged 1 year to 17 years old with pulmonary arterial hypertension. Efficacy in terms of improvement of exercise capacity or pulmonary haemodynamics has been shown in primary pulmonary hypertension and pulmonary hypertension associated with congenital heart disease (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should only be initiated and monitored by a physician experienced in the treatment of pulmonary arterial hypertension. In case of clinical deterioration in spite oftreatment, alternative therapies should be considered. Posology _ _ _Adults_ The recommended dose is 20 mg three times a day (TID). Physicians should advise patients who forget to take 阅读完整的文件to take a dose as soon as possible and then continue with the normal dose. Patients should not take a double dose to compensate for the missed dose. _ _ _Paediatric population (1 year to 17 years)_ For paediatric patients aged 1 year to 17 years old, the recommended dose in patients ≤ 20 kg is 10 mg three times a day and for patients > 20 kg is 20 mg three times a day. Higher than recommended doses should not be used in paediatri