Tadalafil Actavis 2,5 mg Filmdragerad tablett

Krajina: Švédsko

Jazyk: švédčina

Zdroj: Läkemedelsverket (Medical Products Agency)

Aktívna zložka:

tadalafil

Dostupné z:

Actavis Group PTC ehf.

ATC kód:

G04BE08

INN (Medzinárodný Name):

tadalafil

Dávkovanie:

2,5 mg

Forma lieku:

Filmdragerad tablett

Zloženie:

natriumlaurilsulfat Hjälpämne; laktosmonohydrat Hjälpämne; tadalafil 2,5 mg Aktiv substans

Typ predpisu:

Receptbelagt

Prehľad produktov:

Förpacknings: Blister, 4 tabletter; Blister, 28 tabletter

Stav Autorizácia:

Godkänd

Dátum Autorizácia:

2016-07-20

Príbalový leták

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
TADALAFIL ACTAVIS 2.5 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 Tadalafil Actavis is and what it is used for
2.
What you need to know before you take Tadalafil Actavis
3.
How to take Tadalafil Actavis
4.
Possible side effects
5.
How to store Tadalafil Actavis
6.
Contents of the pack and other information
1.
WHAT TADALAFIL ACTAVIS IS AND WHAT IT IS USED FOR
Tadalafil Actavis is a treatment for adult men with erectile
dysfunction. This is when a man cannot get, or
keep a hard, erect penis suitable for sexual activity. Tadalafil
Actavis has been shown to significantly
improve the ability of obtaining a hard erect penis suitable for
sexual activity.
Tadalafil Actavis contains the active substance tadalafil which
belongs to a group of medicines called
phosphodiesterase type 5 inhibitors. Following sexual stimulation
Tadalafil Actavis 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 Actavis will not help you if you
do not have erectile dysfunction.
It is important to note that Tadalafil Actavis 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TADALAFIL ACTAVIS
DO NOT TAKE TADALAFIL ACTAVIS:
-
if you are allergic to tadalafil or any of the

Súhrn charakteristických

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Tadalafil Actavis 2.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg tadalafil.
Excipient with known effect
Each film-coated tablet contains 84 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
2.5 mg film-coated tablets are: Light yellow, oval shape, film-coated
tablets, debossed with “2.5” on one side
and plain on the other side. The tablet is 9 mm x 5.2 mm in diameter
and 2.7 – 3.3 mm in thickness.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of erectile dysfunction in adult males.
In order for tadalafil to be effective, sexual stimulation is
required.
Tadalafil Actavis is not indicated for use by women.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adult men_
In general, the recommended dose is 10 mg taken prior to anticipated
sexual activity and with or without
food. In those patients in whom tadalafil 10 mg does not produce an
adequate effect, 20 mg might be tried. It
may be taken at least 30 minutes prior to sexual activity.
The maximum dose frequency is once per day.
Tadalafil 10 and 20 mg is intended for use prior to anticipated sexual
activity and it is not recommended for
continuous daily use.
In patients who anticipate a frequent use of Tadalafil Actavis (i.e.,
at least twice weekly) a once daily
regimen with the lowest doses of Tadalafil Actavis might be considered
suitable, based on patient choice and
the physician’s judgement.
In these patients the recommended dose is 5 mg taken once a day at
approximately the same time of day. The
dose may be decreased to 2.5 mg once a day based on individual
tolerability.
2
The appropriateness of continued use of the daily regimen should be
reassessed periodically.
Special populations
_Elderly men_
Dose adjustments are not required in elderly patients.
_Men with renal impairment_
Dose adjustments are not required in patients with mild