Tadalafil Zentiva 20 mg Filmdragerad tablett

Nchi: Uswidi

Lugha: Kiswidi

Chanzo: Läkemedelsverket (Medical Products Agency)

Viambatanisho vya kazi:

tadalafil

Inapatikana kutoka:

Zentiva k.s.

ATC kanuni:

G04BE08

INN (Jina la Kimataifa):

tadalafil

Kipimo:

20 mg

Dawa fomu:

Filmdragerad tablett

Tungo:

natriumlaurilsulfat Hjälpämne; tadalafil 20 mg Aktiv substans; laktosmonohydrat Hjälpämne

Dawa ya aina:

Receptbelagt

Bidhaa muhtasari:

Förpacknings: Blister, 12 tabletter; Blister, 2 tabletter; Blister, 4 tabletter; Blister, 8 tabletter

Idhini hali ya:

Godkänd

Idhini ya tarehe:

2017-07-13

Taarifa za kipeperushi

PACKAGE LEAFLET: INFORMATION FOR THE USER
[INVENTED NAME] 20 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] 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. [Invented
name] has been shown to
significantly improve the ability of obtaining a hard erect penis
suitable for sexual activity.
[Invented name] contains the active substance tadalafil which belongs
to a group of medicines called
phosphodiesterase type 5 inhibitors. Following sexual stimulation
[Invented name] 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. [Invented name] will not help you if you
do not have erectile dysfunction.
It is important to note that [Invented name] 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 [INVENTED NAME]
DO NOT TAKE [INVENTED NAME]
-
if you are allergic to tadalafil or any of the other ingredients of
this m

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
[Invented name] 20 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg tadalafil.
Excipient with known effect:
Each coated tablet contains 250 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
20 mg film-coated tablets are: Pale yellow, oval shape, film-coated
tablets, debossed with “20” on one
side and plain on the other side. The tablet is 12 mm x 7.4 mm in
diameter and 4.6 – 5.2 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.
[Invented name] 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 [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.
The appropriateness of continued use of the daily regimen should be
reassessed periodically.
Special populations
_Elderly men_
Dose adjustments