Ligion 10 mg, zachte capsules

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

TADALAFIL 10 mg/stuk

Beschikbaar vanaf:

GAP S.A. Agissilaou 46 17341 AGIOS DIMITRIOS (GRIEKENLAND)

ATC-code:

G04BE08

INN (Algemene Internationale Benaming):

TADALAFIL 10 mg/stuk

farmaceutische vorm:

Capsule, zacht

Samenstelling:

BUTYLHYDROXYANISOL (E 320) ; GELATINE (E 441) ; GLYCEROL (E 422) ; GLYCEROL MONOCAPRYLOCAPRAAT, TYPE I ; LAUROYLMACROGOLGLYCERIDEN ; MACROGOLGLYCEROLRICINOLEAAT ; POLOXAMEER 407 ; SOJAOLIE, GEZUIVERD ; TITAANDIOXIDE (E 171) ; WATER, GEZUIVERD

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Tadalafil

Autorisatie datum:

1900-01-01

Bijsluiter

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

Productkenmerken

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