Telefil 5 mg Filmdragerad tablett

Страна: Швеция

Язык: шведский

Источник: Läkemedelsverket (Medical Products Agency)

Активный ингредиент:

tadalafil

Доступна с:

Sigillata Ltd

код АТС:

G04BE08

ИНН (Международная Имя):

tadalafil

дозировка:

5 mg

Фармацевтическая форма:

Filmdragerad tablett

состав:

laktosmonohydrat Hjälpämne; natriumlaurilsulfat Hjälpämne; tadalafil 5 mg Aktiv substans

Тип рецепта:

Receptbelagt

Статус Авторизация:

Avregistrerad

Дата Авторизация:

2017-03-30

тонкая брошюра

PACKAGE LEAFLET: INFORMATION FOR THE USER
TELEFIL 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 Telefil is and what it is used for
2.
What you need to know before you take Telefil
3.
How to take Telefil
4.
Possible side effects
5.
How to store Telefil
6.
Contents of the pack and other information
1.
WHAT TELEFIL IS AND WHAT IT IS USED FOR
Telefil contains the active substance tadalafil which belongs to a
group of medicines called
phosphodiesterase type 5 inhibitors.
Telefil 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 with age. Symptoms include
difficulty in starting to
pass water, a fe

Характеристики продукта

1.
NAME OF THE MEDICINAL PRODUCT
Telefil 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.
Telefil 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 Telefil (i.e., at least
twice weekly) a once daily regimen
with the lowest doses of Telefil 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.
The appropriateness of continued use of the daily regimen should be
reassessed periodically.
_Benign prostatic hyperplasia in adult men_
The recommended dose is 5 mg, taken at approximately the same tim