Tadalafil Zentiva 5 mg Filmdragerad tablett

País: Suècia

Idioma: suec

Font: Läkemedelsverket (Medical Products Agency)

ingredients actius:

tadalafil

Disponible des:

Zentiva k.s.

Codi ATC:

G04BE08

Designació comuna internacional (DCI):

tadalafil

Dosis:

5 mg

formulario farmacéutico:

Filmdragerad tablett

Composición:

laktosmonohydrat Hjälpämne; natriumlaurilsulfat Hjälpämne; tadalafil 5 mg Aktiv substans

tipo de receta:

Receptbelagt

Resumen del producto:

Förpacknings: Blister, 14 tabletter; Blister, 28 tabletter

Estat d'Autorització:

Godkänd

Data d'autorització:

2017-07-13

Informació per a l'usuari

PACKAGE LEAFLET: INFORMATION FOR THE USER
[INVENTED NAME] 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 [Invented name] is and what it is used for
2.
What you need to know before you take [Invented name]
3.
How to take [Invented name]
4.
Possible side effects
5.
How to store [Invented name]
6.
Contents of the pack and other information
1.
WHAT [INVENTED NAME] IS AND WHAT IT IS USED FOR
[Invented name] contains the active substance tadalafil which belongs
to a group of medicines called
phosphodiesterase type 5 inhibitors.
[Invented name] 5 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
tadalafil 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 tadalafil 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.
-
urinary symptoms associated with a common condition called
BENIGN PROSTATIC HYPERPLASIA
.
This is when the prostate gland gets bigger w

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
[Invented name] 5 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg tadalafil.
Excipient with known effect:
Each coated tablet contains 123 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
5 mg film-coated tablets are: Pale yellow, oval shape, film-coated
tablets, debossed with “5” on one side
and plain on the other side. The tablet is 10 mm x 6.0 mm in diameter
and 3.3 – 3.9 mm in thickness.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of erectile dysfunction in adult males.
In order for tadalafil to be effective, for the treatment of erectile
dysfunction sexual stimulation is
required.
Treatment of the signs and symptoms of benign prostatic hyperplasia in
adult males.
[Invented name] is not indicated for use by women.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Erectile dysfunction in 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 [Invented name] (i.e., at
least twice weekly) a once daily
regimen with the lowest doses of [Invented name] 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. As <[Invented
name]> is not available as 2.5 mg film-coated tablets, other suitable
formulations should be checked
for their availability