Tarektin 20mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TADALAFIL

Available from:

mibe GmbH Arzneimittel Münchner Straße 15, 06796, Brehna, Germany

ATC code:

G04BE08

INN (International Name):

TADALAFIL 20 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

TADALAFIL 20 mg

Prescription type:

POM

Therapeutic area:

UROLOGICALS

Authorization status:

Withdrawn

Authorization date:

2017-06-16

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
TAREKTIN 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 Tarektin is and what it is used for
2.
What you need to know before you take Tarektin
3.
How to take Tarektin
4.
Possible side effects
5.
How to store Tarektin
6.
Contents of the pack and other information
1.
WHAT TAREKTIN IS AND WHAT IT IS USED FOR
Tarektin 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. Tarektin has
been shown to significantly
improve the ability of obtaining a hard erect penis suitable for
sexual activity.
Tarektin contains the active substance tadalafil which belongs to a
group of medicines called
phosphodiesterase type 5 inhibitors.
Following sexual stimulation Tarektin 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. Tarektin
will not help you if you do not have erectile dysfunction.
It is important to note that Tarektin does not work if there is no
sexual stimulation. You and your
partner will need to engage in foreplay, as you would if you were not
taking a medicine for
erectile dysfunction.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TAREKTIN
DO NOT TAKE TAREKTIN IF YOU:
-
are allergic to tadalafil or any of the other ingredients of this
medicine (listed in section 6).
-
are taking any form of organic nitrate or nitric oxide donors such as
am

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
TAREKTIN 10 MG FILM-COATED TABLETS
TAREKTIN 20 MG FILM-COATED TABLETS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg of tadalafil.
Each film-coated tablet contains 20 mg of tadalafil.
Excipient with known effect:
Each film-coated tablet contains 133 mg of lactose (as monohydrate).
Each film-coated tablet contains 265 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 10” biconvex
film-coated tablet of 11.50 x 5.90 mm. The tablet can be divided into
equal doses.
Yellow coloured, oval shaped, one side scored and other side debossed
with “T 20” biconvex
film-coated tablet of 13.90 x 7.20 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, sexual stimulation is
required.
Tarektin 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.
Tarektin 10 mg 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 Tarektin (i.e., at least
twice weekly) a once daily regimen
2
with the lowest doses of Tarektin 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 Tadalafil mg once a day based on
individual to