Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
tadalafil
Viatris Limited
G04BE08
tadalafil
Urologicals
Hypertension, Pulmonary
Talmanco is indicated in adults for the treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.
Revision: 8
Authorised
2017-01-09
22 B. PACKAGE LEAFLET 23 Package leaflet: Information for the patient Talmanco 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 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 Talmanco is and what it is used for 2. What you need to know before you take Talmanco 3. How to take Talmanco 4. Possible side effects 5. How to store Talmanco 6. Contents of the pack and other information 1. What Talmanco is and what it is used for Talmanco contains the active substance tadalafil. Talmanco is a treatment for pulmonary arterial hypertension in adults. 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 Talmanco Do not take Talmanco: - if you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6). - if you are taking any form of nitrates such as amyl nitrite, used in the treatment of chest pain. Tadalafil 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 pulmona Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Talmanco 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 237.9 mg lactose (234.5 mg as anhydrous and 3.4 mg as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. A white, film-coated, round, biconvex, bevelled edge tablet (approximately 10.7 mm diameter) debossed with ‘M’ on one side of the tablet and ‘TA20’ on the other side. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Talmanco is indicated in adults for the 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. 4.2 Posology and method of administration Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH. Posology The recommended dose is 40 mg (2 x 20 mg) taken once daily with or without food. Elderly Dose adjustments are not required in elderly patients. Renal impairment In patients with mild to moderate renal impairment a starting dose of 20 mg once per day is recommended. The dose may be increased to 40 mg once per day, based on individual efficacy and tolerability. In patients with severe renal impairment the use of tadalafil is not recommended (see sections 4.4 and 5.2). Hepatic impairment Due to limited clinical experience in patients with mild to moderate hepatic cirrhosis (Child-Pugh Class A and B), following single doses of 10 mg, a starting dose of 20 mg once per day may be considered. If tadalafil is prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician. Patients with severe hepatic cirrhosis (Child-Pugh Class C) have not been studied and therefore dosing of tadalafil is not recommended Прочетете целия документ