Pajjiż: Olanda
Lingwa: Olandiż
Sors: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
TADALAFIL 20 mg/stuk
GAP S.A. Agissilaou 46 17341 AGIOS DIMITRIOS (GRIEKENLAND)
G04BE08
TADALAFIL 20 mg/stuk
Capsule, zacht
BUTYLHYDROXYANISOL (E 320) ; GELATINE (E 441) ; GLYCEROL (E 422) ; GLYCEROL MONOCAPRYLOCAPRAAT, TYPE I ; LAUROYLMACROGOLGLYCERIDEN ; MACROGOLGLYCEROLRICINOLEAAT ; POLOXAMEER 407 ; SOJAOLIE, GEZUIVERD ; TITAANDIOXIDE (E 171) ; WATER, GEZUIVERD
Oraal gebruik
Tadalafil
1900-01-01
1 PACKAGE LEAFLET: INFORMATION FOR THE USER LIGION 5 MG, ZACHTE CAPSULES LIGION 10 MG, ZACHTE CAPSULES LIGION 20 MG, ZACHTE CAPSULES 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. 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 Ligion is and what it is used for 2. What you need to know before you take Ligion 3. How to take Ligion 4. Possible side effects 5. How to store Ligion 6. Contents of the pack and other information 1. WHAT LIGION IS AND WHAT IT IS USED FOR Ligion contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Ligion 5 mg, 10 mg and 20 mg is used to treat adult men with erectile dysfunction • This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. Tadalafil has been shown to significantly improve the ability of obtaining a hard erect penis suitable for sexual activity. Following sexual stimulation Ligion works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis. The result of this is improved erectile function. Tadalafil will not help you if you do not have erectile dysfunction. It is important to note that Ligion for the treatment of erectile dysfunction does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction. Ligion 5 mg is used to treat adult men with urinary symptoms associated with a common condition called benign prostatic hyperplasia • This Aqra d-dokument sħiħ
1 SAMENVATTING VAN DE PRODUCTKENMERKEN 1. NAME OF THE MEDICINAL PRODUCT Ligion 5 mg, zachte capsules Ligion 10 mg, zachte capsules Ligion 20 mg, zachte capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 mg soft capsule contains 5 mg of Tadalafil. Excipients with known effect: each soft capsule contains 24.20 mg of soya-bean oil refined and 48.38 mg of macrogolglycerol ricinoleate. Each 10 mg soft capsule contains 10 mg of Tadalafil. Excipients with known effect: each soft capsule contains 48.39 mg of soya-bean oil refined and 96.77 mg of macrogolglycerol ricinoleate. Each 20 mg soft capsule contains 20 mg of Tadalafil. Excipients with known effect: each soft capsule contains 96.78 mg of soya-bean oil refined and 193.53 mg of macrogolglycerol ricinoleate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule, soft. The 5 mg soft capsules white/yellow, size 2, oval soft capsules. Capsule length is approximately 9.6 mm and width is approximately 6.4 mm. The 10 mg soft capsules white/yellow, size 5, oval soft capsules . Capsule length is approximately 12.7 mm and width is approximately 7.5 mm. The 20 mg soft capsules white/yellow, size 10, oval soft capsules. Capsule length is approximately 14.7 mm and width is approximately 9.3 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS LIGION 5 MG, 10 MG AND 20 MG IS INDICATED FOR: • Treatment of erectile dysfunction in adult males. In order for tadalafil to be effective for the treatment of erectile dysfunction, sexual stimulation is required. LIGION 5 MG IS INDICATED FOR: • Treatment of the signs and symptoms of benign prostatic hyperplasia in adult males. LIGION 20 MG IS INDICATED FOR: • 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. 2 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ERECTILE DYSFUNCTION IN ADULT MEN_ In general Aqra d-dokument sħiħ