Tadalafil Teva B.V. 2,5 mg Filmdragerad tablett

Country: Шведска

Језик: Шведски

Извор: Läkemedelsverket (Medical Products Agency)

Активни састојак:

tadalafil

Доступно од:

Teva B.V.

АТЦ код:

G04BE08

INN (Међународно име):

tadalafil

Дозирање:

2,5 mg

Фармацеутски облик:

Filmdragerad tablett

Састав:

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

Тип рецептора:

Receptbelagt

Резиме производа:

Förpacknings: Blister, 4 tabletter; Blister, 28 tabletter

Статус ауторизације:

Godkänd

Датум одобрења:

2017-02-17

Информативни летак

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
TADALAFIL TEVA B.V. 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 Teva B.V. is and what it is used for
2.
What you need to know before you take Tadalafil Teva B.V.
3.
How to take Tadalafil Teva B.V.
4.
Possible side effects
5.
How to store Tadalafil Teva B.V.
6.
Contents of the pack and other information
1.
WHAT TADALAFIL TEVA B.V. IS AND WHAT IT IS USED FOR
Tadalafil Teva B.V. 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 Teva
B.V. has been shown to significantly
improve the ability of obtaining a hard erect penis suitable for
sexual activity.
Tadalafil Teva B.V. contains the active substance tadalafil which
belongs to a group of medicines called
phosphodiesterase type 5 inhibitors. Following sexual stimulation
Tadalafil Teva B.V. 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 Teva B.V. will not help you if
you do not have erectile dysfunction.
It is important to note that Tadalafil Teva B.V. 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 TEVA B.V.
DO NOT TAKE TADALAFIL TEVA B.V.:
-
if you are allergi

Карактеристике производа

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Tadalafil Teva B.V. 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 Teva B.V. 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 Teva B.V.
(i.e., at least twice weekly) a once daily
regimen with the lowest doses of Tadalafil Teva B.V. 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 w