Land: Nederland
Taal: Nederlands
Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
TADALAFIL 20 mg/stuk
Hexal AG Industriestrasse 25 D-83607 HOLZKIRCHEN (DUITSLAND)
G04BE08
TADALAFIL 20 mg/stuk
Filmomhulde tablet
CROSPOVIDON (E 1202) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MACROGOL 3350 ; NATRIUMLAURILSULFAAT (E 487) ; NATRIUMSTEARYLFUMARAAT ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; POVIDON K 12 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Tadalafil
Hulpstoffen: CROSPOVIDON (E 1202); IJZEROXIDE GEEL (E 172); LACTOSE 1-WATER; MACROGOL 3350; NATRIUMLAURILSULFAAT (E 487); NATRIUMSTEARYLFUMARAAT; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); POVIDON K 12 (E 1201); TALK (E 553 B); TITAANDIOXIDE (E 171);
2017-02-23
Hexal AG Page 1/7 Tadalafil Hexal 20 mg, filmomhulde tabletten RVG 118160 v9 1.3.1.3 Leaflet Januari 2024 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TADALAFIL HEXAL 20 MG, FILMOMHULDE TABLETTEN_ _ 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 [Nationally completed name] is and what it is used for 2. What you need to know before you take [Nationally completed name] 3. How to take [Nationally completed name] 4. Possible side effects 5. How to store [Nationally completed name] 6. Contents of the pack and other information 1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR [Nationally completed name] contains the active substance tadalafil. [Nationally completed name] 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. _Other suitable formulations, such as an oral suspension, should be checked for their availability for _ _administration to paediatric patients who require 20 mg and are not able to swallow tablets. _ 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME] DO NOT TAKE [NATIONALLY COMPLETED NAME] IF YOU: - are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6). Hexal AG Page 2/7 Tadalafil Hexal 20 mg, Lees het volledige document
Hexal AG Page 1/20 Tadalafil Hexal 20 mg, filmomhulde tabletten RVG 118160 v9 1.3.1.1 Summary of product characteristics Januari 2024 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Tadalafil Hexal 20 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg of tadalafil. _ _ Excipient with known effect Each film-coated tablet contains 335.4 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Ochre to yellow, oval shaped film-coated tablet of approximately 15 x 9 mm. On one side debossed with “20”. The other side of the tablet is bi-scored. The tablet can be divided into equal halves and/or quarters. 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 II. 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 (2 x 20 mg film-coated tablets) taken once daily. Hexal AG Page 2/20 Tadalafil Hexal 20 mg, filmomhulde tabletten RVG 118160 v9 1.3.1.1 Summary of product characteristics Januari 2024 _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. PAEDIATRIC PATIENT’S AGE AND/OR WEIGHT RECOMMENDED DAILY DOSE AND DOSING REGIMEN Age ≥ 2 years old Body weight ≥ 40 kg Body weight < 40 k 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 * Other suitable Lees het volledige document