Tadalafil Maxmind 5mg film-coated tablets

Maa: Malta

Kieli: englanti

Lähde: Medicines Authority

Aktiivinen ainesosa:

TADALAFIL

Saatavilla:

Maxmind Pharmaceutical S.L. Calle Copenhague, N 12, Oficina 205, Edificio Tifán 28232 Las Rozas (Madrid) , Spain

ATC-koodi:

G04BE08

INN (Kansainvälinen yleisnimi):

TADALAFIL 5 mg

Lääkemuoto:

FILM-COATED TABLET

Koostumus:

TADALAFIL 5 mg

Prescription tyyppi:

POM

Terapeuttinen alue:

UROLOGICALS

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2017-06-14

Pakkausseloste

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

Valmisteyhteenveto

1
1.
NAME OF THE MEDICINAL PRODUCT
Tadalafil Maxmind 5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg of tadalafil.
Excipient with known effect:
Each film-coated tablet contains 66 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Yellow coloured, oval shaped, one side scored and other side debossed
with “T 5” biconvex film-
coated tablet of 8.70 x 4.50 mm. The tablet can be divided into equal
doses.
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.
Tadalafil Maxmind 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 Tadalafil Maxmind (i.e.,
at least twice weekly) a once
daily regimen with the lowest doses of Tadalafil Maxmind 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.
_Benign prostatic hyperplasia in adult men _
The recommended dose is 5 mg, taken at approximat