Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
tadalafil
Eli Lilly Nederland B.V.
G04BE08
tadalafil
Urologicals
Hypertension, Pulmonary
AdultsTreatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity (see section 5.1).Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.Paediatric populationTreatment of paediatric patients aged 2 years and above with pulmonary arterial hypertension (PAH) classified as WHO functional class II and III.
Revision: 17
Authorised
2008-10-01
47 B. PACKAGE LEAFLET 48 PACKAGE LEAFLET: INFORMATION FOR THE USER ADCIRCA 20 MG FILM-COATED TABLETS tadalafil 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 of the 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. What ADCIRCA is and what it is used for 2. What you need to know before you take ADCIRCA 3. How to take ADCIRCA 4. Possible side effects 5 How to store ADCIRCA 6. Contents of the pack and other information 1. WHAT ADCIRCA IS AND WHAT IT IS USED FOR ADCIRCA contains the active substance tadalafil. ADCIRCA is a treatment for pulmonary arterial hypertension in adults and in children aged 2 years and above. It belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors which work by helping the blood vessels around your lungs relax, improving the flow of blood into your lungs. The result of this is an improved ability to do physical activity. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ADCIRCA DO NOT TAKE ADCIRCA - if you are allergic to tadalafil or any of the other ingredients (see section 6). - if you are taking any form of nitrates such as amyl nitrite, used in the treatment of chest pain. ADCIRCA has been shown to increase the effects of these medicines. If you are taking any form of nitrate or are unsure tell your doctor. - if you have ever had loss of vision – a condition described as “stroke of the eye” (non-arteritic anterior ischemic optic neuropathy - NAION). - if you have had a heart attack in the last 3 months. - if you have low blood pressure. - if you are taking riociguat. This medicine is used to treat Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT ADCIRCA 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ Each film-coated tablet contains 20 mg tadalafil. Excipient with known effect Each film-coated tablet contains 233 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Orange and almond shaped film-coated tablets of 12.09 mm x 7.37 mm, marked "4467" on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adults Treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity (see section 5.1). Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease. Paediatric population Treatment of paediatric patients aged 2 years and above with pulmonary arterial hypertension (PAH) classified as WHO functional class II and III. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH. Posology _Adults _ The recommended dose is 40 mg (two x 20 mg film-coated tablets) taken once daily. _Paediatric population (age 2 years to 17 years) _ The recommended once daily doses based on age and weight categories in paediatric patients are shown below. 3 PAEDIATRIC PATIENT’S AGE AND/OR WEIGHT RECOMMENDED DAILY DOSE AND DOSING REGIMEN Age ≥ 2 years old Body weight ≥ 40 kg Body weight < 40 kg 40 mg (two 20 mg tablets) once daily 20 mg (one 20 mg tablet or 10 mL of oral suspension (OS), 2 mg/mL tadalafil*) once daily * Oral suspension is available for administration to paediatric patients who require 20 mg and are not able to swallow tablets. For patients < 2 years old no PK or efficacy data are available from clinical trials. The most appropriate dose of ADCIRCA in children aged between 6 months to < 2 years has not been established. Therefore, ADCIRCA is not recommended in this age subset. _Delayed dose, m Прочетете целия документ