Telefil 10 mg Filmdragerad tablett

Šalis: Švedija

kalba: švedų

Šaltinis: Läkemedelsverket (Medical Products Agency)

Veiklioji medžiaga:

tadalafil

Prieinama:

Sigillata Ltd

ATC kodas:

G04BE08

INN (Tarptautinis Pavadinimas):

tadalafil

Dozė:

10 mg

Vaisto forma:

Filmdragerad tablett

Sudėtis:

natriumlaurilsulfat Hjälpämne; tadalafil 10 mg Aktiv substans; laktosmonohydrat Hjälpämne

Recepto tipas:

Receptbelagt

Autorizacija statusas:

Avregistrerad

Leidimo data:

2017-03-30

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE USER
TELEFIL 10 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 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. Telefil has been shown
to significantly improve the
ability of obtaining a hard erect penis suitable for sexual activity.
Telefil contains the active substance tadalafil which belongs to a
group of medicines called
phosphodiesterase type 5 inhibitors. Following sexual stimulation
Telefil 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. Telefil will not help you if you do not
have erectile dysfunction.
It is important to note that Telefil 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 TELEFIL
DO NOT TAKE TELEFIL:
-
if you are allergic to tadalafil or any of the other ingredients of
this medicine (listed in section
6).
-
if you are taking any form of organic nitrate or nitric oxide donors
such as amyl

Prekės savybės

1.
NAME OF THE MEDICINAL PRODUCT
Telefil 10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg tadalafil.
Excipient with known effect:
Each coated tablet contains 177 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
10 mg film-coated tablets are: Pale yellow, oval shape, film-coated
tablets, debossed with ‘10’ on one
side and plain on the other side. The tablet is 11 mm x 6.6 mm in
diameter and 3.9 – 4.5 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.
Telefil 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 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.
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 to moderate
renal impairment. For patients
with severe renal impairment 10 mg is the max